Australian Government Inquiry into Complementary and Alternative Medicine 

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Response to the Report of the Expert Committee on Complementary Medicine in the Health System

1. regulatory controls covering standards of quality, safety, and efficacy for complementary medicines 
2. consumer information 
3. education and training of healthcare practitioners 
4. interactions between complementary and prescribed medicines 
5.  restrictions on advertising activities to promote an innovative, responsible and viable complementary medicine industry."

This response to the Report of the Committee will also be guided by the fact that the fundamental purpose of this inquiry, according to government, is to "restore confidence in the complementary medicines industry" (6,7). 

In order to restore any lost confidence it is necessary firstly to determine the cause of this loss of confidence and secondly, to decide if sweeping regulatory reforms, as proposed by the Committee, would be the most effective solution. Since any loss of confidence which has occurred is due to the unscientific, uninformed and biased comments which have been made by various medical authorities during the Pan crisis (1,2), the most appropriate solution is clearly to ensure that the medical profession adopts a more responsible attitude and are better educated about alternative medicines. 

Interestingly, concerns about lack of confidence frequently seem to originate from sources outside the alternative medicine industry, especially amongst those who have long been opposed to the industry and those who could be seen to have a vested interest in establishing tighter regulatory control of the industry. The perception that those who have been traditionally opposed to alternative medicines are deliberately seeking to undermine confidence in the industry in an effort to justify the need for regulatory reforms contributes nothing to reversing the longstanding antagonistic reputation of orthodox medicine when it comes to the alternative industry.

Even in spite of the fact that some authorities have used the Pan crisis to try and discredit the alternative medicine industry (1,2), the facts reveal that any local loss of confidence in the industry is dwarfed by the unprecedented rate at which the industry is expanding throughout the world (8,9,10). The Committee has acknowledged that this global boom in alternative medicines is also occurring in Australia (6). The Travacalm drug scare could not be expected to have any significant impact upon this international trend. 

This response to the Report will also reflect the three principles stipulated by Bollen, the Chairman of the Committee, as being fundamental to consideration of the Committee's terms of reference (6; p7):

1. "The need to protect public health and safety." 
2. "The primacy of the right of consumers to be able to make informed choices on matters of health care." 
3. "The ethical responsibilities of all healthcare providers - from manufacturers to healthcare practitioners."

The TGA also emphasises that submissions should include (5) "information and data concerning the impact of proposed changes on affected parties and, in particular, the estimated costs and benefits of any proposed changes." In line with the TGA's suggestion that submissions may also (5) "identify and discuss any perceived omissions or alternative approaches, findings and recommendations in addition to those already included in the Report", this submission will consider some fundamental matters which have not been dealt with by the Committee.

By the use of extensive scientific evidence this article will establish:

1. The most appropriate way of restoring lost confidence.
2. That safety reforms are urgently required to ensure the safety of pharmaceutical drugs but safety reforms for the alternative medicine industry are totally unjustified and may have negative effects.
3. The most appropriate way of educating consumers.
4. The reasons why efficacy standards applied to symptom suppressing drugs are not applicable to Listed alternative medicines.
5. Why alternative practitioners should be subsidised and play a much greater role in primary health care.
6. The fundamental importance of urgent safeguards to ensure the future independence of the alternative medicine industry.

Terminology and Definitions

In considering the Committee's terms of reference it is absolutely vital that significant terms are clearly defined. I refer here to two terms in particular, "safety" and "efficacy", both of which are absolutely vital to the entire inquiry. The fact that the Committee has sought to avoid a precise definition of these terms is a major shortcoming of the Report. This oversight in fact, makes much of the Report meaningless. I will briefly consider these terms.

a) Safety

Since it is generally considered impossible to justify a regulatory takeover of the alternative medicine industry without first creating a considerable degree of public paranoia about the safety of such products (2,4) it is imperative that any allegations of safety problems are clearly examined.

While the Committee does acknowledge the vast amount of evidence which demonstrates the safety of alternative medicines, they also make the unsubstantiated claim that adverse reactions to such products are under reported (6, p104):

The Committee continues (p145):

"compared with other medicines, complementary medicines may offer lower risk and more cost-effective options for the prevention and treatment of some diseases, conditions and disorders."

Yet, in spite of all this the Committee expresses concern about safety and recommends that herbal medicines should meet an (p97) "appropriate standard of safety." Remarkably, the Committee avoids describing what they consider would constitute an "appropriate standard of safety."

In order to establish a suitable safety standard it is clearly necessary to first determine an acceptable yardstick by which safety can be measured. The only guidelines used by the Committee in this regard seem to be that medicines should conform to "international" safety standards (p15) and standards which exist in "comparable countries" (p41). The Committee also recommends that the standards of the National Medicines Policy (11) should be implemented in regard to alternative medicines (6, p11). The yardstick used by the National Medicines Policy (11) is also that the "safety and efficacy of medicines available in Australia should be equal to that of comparable countries."

It is noteworthy that health authorities display an absolute determination to avoid the use of any yardstick which would result in the safety of alternative medicines being directly compared with the safety of pharmaceutical drugs. More importantly however, in evaluating the safety of a medicine the Committee clearly regards the number of deaths or serious adverse reactions to a product as being completely unimportant and irrelevant as long as it compares favourably with international standards. The Committee endorses a safety standard which is totally unrelated to the number of deaths or the amount of suffering which a product causes. The important point, according to the Committee, is that a specific medicine only kills or harms approximately the same proportion of people in Australia as occurs in other countries. This after all is the National Medicines Policy which is endorsed by the Committee.

This is completely unsatisfactory. The TGA and the Department of Health should endorse a safety policy which is directly linked to a drug's toxicity and the number and severity of adverse reactions which it causes.

The Committee's refusal to endorse a safety policy which is based upon the number and severity of adverse reactions which a product causes also demonstrates a fundamental disagreement with the emphasis placed upon safety by the Chairman of the Committee who emphasises that healthcare providers should "do no harm" (6, p8) (as noted above, the Committee contradicts this stance, believing instead that practitioners and drug manufacturers should do as much harm as occurs in other countries). According to the Chairman (6, p8):

The Chairman's concerns are indeed admirable as the goal should always be to "do no harm" rather than to do the same amount of harm as occurs in other countries. So important is this matter it is instructive to examine some examples of the various categories of harm mentioned by the Chairman.

Direct Harm

Since the Committee confirms the fact that 98% of adverse drug reactions in Australia are due to over the counter and prescription drugs examples of direct harm are almost exclusively due to doctors and drug companies. Since the incidence of adverse reactions to pharmaceutical drugs is almost identical in other countries however (12,13), according to the Committee's safety requirement this standard is quite acceptable. The bottom line here of course is that there is absolutely no evidence that the safety of alternative medicines in Australia is not also inline with international trends and therefore totally consistent with the requirements of the national Medicines Policy!!

Indirect Harm

There are various aspects to the category of indirect harm. Let us consider first the Chairman's concern that " unreasonable expectations might otherwise discourage patients and their families from accepting and dealing effectively with their health problem". There are many well established examples of this. Since antidepressant drugs for instance, tend to create feelings of indifference about threats to personal health and safety the use of these drugs has been reported to cause alcoholics not to wish to rehabilitate and may even cause women to become satisfied with abusive relationships (23). Such people, when treated with antidepressants, lose the motivation to extricate themselves from harmful situations (23).

There are also numerous examples of patients who have been encouraged to reject diet and nutritional therapies in favour of toxic drug treatments which do nothing to address the underlying cause. With heart disease for instance, patients who have sought to use nutritional supplements and diet either for treatment or prevention have been discouraged by their doctors who instead have encouraged them to become dependent on toxic symptomatic drug therapies. This bias against dietary or nutritional treatment resulted in an iatrogenic increase in the incidence of heart disease (25). Now of course it is common knowledge that taking nutritional supplements saves billions of dollars in health care costs (14,15,16,17,18,19,20,21,22). Conversely of course, doctors who have traditionally opposed the use of nutritional supplements have cost society billions of dollars in additional health care costs (not to mention suffering). For instance, it is estimated that the negative attitude of doctors to the use of nutritional supplements during pregnancy has cost the USA 7.5 billion dollars in health care costs for deformed babies in a single decade (24). There are almost unlimited examples of the foolishness of encouraging dependence upon toxic symptomatic drug treatments (13).

There are other examples of indirect harm also. The use of antidepressants which cause mania and breakdown in personal relationships for instance (26,27,28,29,30). Cholesterol lowering drugs which encourage dietary indiscretions and dependence upon drugs (31). Antidiarrheal drugs which encourage increased complications and delayed recovery from infections (32,33) and cough medicines which encourage lung disease (32,34). The list is almost endless.

Economic Harm

The foolishness of "encouraging expenditure on ineffective, unnecessary or unsafe medicines and therapies without providing an awareness of the unproven nature of the treatment or modality being offered" is already clear from my comments above about heart disease. In spite of the extraordinary costs of modern high tech medical treatments for heart disease these treatments have been totally unable to prevent the rising epidemic of heart disease which occurred throughout the 20th century (31). Since doctors have now been forced to endorse nutritional treatments for heart disease, we can see a graphic example here of the economic harm of ineffective therapies. Science has now confirmed that if doctors had encouraged the use of nutritional treatments for heart disease around 70 years ago when the evidence first became available (24) then an enormous amount of money (and suffering) could have been saved.

The bottom line when it comes to safety is that the alternative medicine industry, as it is presently structured, has achieved a safety standard which absolutely dwarfs anything which has been achieved by the orthodox medico-pharmaceutical industry, even in spite of its various regulations. The Committee should learn from this and seek to apply these same standards to the pharmaceutical industry.

The Committee has failed to provide any evidence whatsoever that regulatory reforms are required as far as the safety of alternative medicine is concerned. In fact, there is a definite risk that any reforms may result in detrimental trends as far as public health is concerned, as has already occurred in the pharmaceutical industry. The current safety of the alternative industry must be protected and preserved and serve as an example for the pharmaceutical industry. Since the Committee accepts a risk based approach to safety requirements they should focus their attention primarily upon those products which are known to be the most dangerous, namely, pharmaceutical drugs. To do otherwise is to openly display a contemptuous disregard for public health.

Also most disturbing, in view of the Committee's admission of the safety of alternative medicines, is the recommendation that the Therapeutic Goods Act should be "immediately" amended to make it easier to cancel or suspend the manufacturing licence of companies producing alternative products (6, p28,No.14; p97, No.14):

Where is the justification for this draconian recommendation? The TGA was able to cancel the licence of Pan quite promptly but yet they need more power and strangely, this power should only apply to the manufacturers of "complementary medicines", not drugs. The Committee has noted the extreme rarity of serious adverse reactions to alternative medicines so now they seek to move the goal posts so they can cancel a company's licence even if there is only vague evidence of a minor adverse effect associated with an alternative medicine. Amazingly, the Committee is recommending a penalty for a safety infringement without identifying a safety problem and without even specifying what constitutes an acceptable level of safety. This is completely inconsistent with their own endorsement of the standards of the National Medicines Policy. THIS SHOULD NOT BE TOLERATED. 

Especially since the Committee notes that the most severe form of corrective action in response to adverse drug reaction reports is usually (p100) "to restrict the availability of the medicine" or "remove the medicine from the market", why is it they now seek to cancel the licence of manufacturers of complementary medicines in response to minor adverse reactions? Why is it that the manufacturers of pharmaceutical drugs are permitted to produce products which kill hundreds or even thousands of people and yet they incur none of these penalties? When it comes to the safety of alternative medicines the Committee has been unable to provide any evidence whatsoever that the current system is not working. The Committee certainly should not be seen to be endorsing the comments of some experts that the toxicity of drugs such as Travacalm somehow proves that alternative medicines are unsafe.

There is also no justification for the Committee's bias against alternative medicines as far as adverse reaction reports are concerned (p29, no.20). There should be increased vigilance of ALL adverse reactions, but especially those which are associated with the more dangerous products, namely, pharmaceutical drugs. Since alternative medicines are only responsible for around 2% of the total number of adverse reactions to medicines, the Committee seems to display a most disturbing preoccupation with this exceedingly small subset of adverse reactions. Furthermore, the Committee also stresses the importance of interactions between complementary medicines and pharmaceuticals (p103): 

According to the Committee therefore, interactions between alternative and prescription medicines may be responsible for less than 1% of the total number of adverse reaction reports. Why this inordinate concern about such a small number of reactions? Isn't anyone concerned about the other 99%? The Committee should not be seen to be endorsing a bias in favour of the most dangerous products.

b) Efficacy

It has long been accepted throughout the world that Listed alternative medicines, as long as they conform to standards of safety and quality, do not have to satisfy standards of efficacy. Unlike Registered medicines of course, this also means manufacturers are restricted in the types of health claims they can make for such products. Judging from the popularity of alternative medicines this situation has worked exceedingly well and, as I have already mentioned, has produced an alternative medicine industry with safety standards that the pharmaceutical industry can only dream about. Now however, in line with the desire of the medico-pharmaceutical industry to control alternative medicine (2,3), the Committee has recommended that Listed alternative medicines satisfy specific criteria of efficacy (6, p17): "the marketing of products that do not have evidence of efficacy was considered by the Committee to be unethical." 

The odd thing about this is that the drug Travacalm, the product which precipitated the current crisis, was a REGISTERED product which therefore possessed all the safeguards which the Committee would like to see bestowed upon alternative medicines - such as those that made no one ill during the Pan crisis. While the Committee considers "the marketing of products that do not have evidence of efficacy" to be unethical, it is most noteworthy that the Committee makes no ethical judgement about the marketing of Registered drugs such as Travacalm which poison people. What was learned from the Pan crisis is that Registered pharmaceutical drugs must be much more tightly controlled in the interests of public health and safety and consumers should be encouraged to seek safer alternatives.

If implemented these recommendations will destroy the alternative medicine industry as we know it today. As accepted criteria for demonstrating efficacy are modified over time (this is merely the beginning of these changes, certainly not the end), numerous health promoting products which have been available for generations will become unavailable as manufacturers are forced to meet narrow, artificial and unattainable standards of efficacy. Products that do meet these standards will be increasingly taken over by the medico-pharmaceutical industry, perhaps becoming prescription items. As is noted by the Committee (6, p44), "as CAM practices are proven safe and effective, they may become adopted into mainstream healthcare practice."

This has also been confirmed by Jonas (35):

It seems that the medical profession is intent upon keeping the cream of the crop for themselves, banning various products which they consider to be ineffective, and leaving the remainder for the alternative medicine industry and consumers.

At first glance some may suggest the current efficacy recommendations of the Committee, which are stipulated in the TGA's "Guidelines for Levels and Kinds of Evidence to Support Indications and Claims", do not appear excessive since they permit manufacturers to make "general level indications and claims" based solely on evidence from "three independent written histories of use in the classical or traditional medical literature." However, there may be numerous products, particularly nutritional supplements, which would fail to satisfy this requirement. Such a system is deliberately biased against those products which promote optimum health or are primarily preventative in nature. Health authorities are still unable to define optimum health let alone establish criteria of efficacy for products which bring about this condition. With preventative medicines also, proof of efficacy may be difficult to obtain. 

This raises a vitally important matter relating to the fundamentally different cause based and health based nature of alternative medicine as compared to the symptom based and disease based nature of orthodox medicine. Orthodox medical therapies are aimed at suppressing symptoms of disease, not the maintenance of optimum health, a concept which medicine can neither define nor understand. This is highlighted by medicine's current confusion regarding heart disease.

While medicine readily acknowledges  the overwhelming evidence that heart disease is dramatically affected by diet and nutrition, scientists all over the world have been unable to pin point the "magic" nutrients which are responsible. According to alternative or holistic medicine however, nutrients and dietary constituents are effective because they maximise the body's vital energy and permit the body to repair itself and function at optimum efficiency - NOT because they function as medicines. In other words, any nutrient that is lacking may impair the body's metabolic processes and predispose to disease. While some nutrients, such as vitamin E, vitamin B6, folate, magnesium, and essential fatty acids, may be particularly important for the health of the cardiovascular system, in the end these nutrients are effective only because they function as members of a team the combined effects of which is to bring about a condition of optimum health. There is no magic nutrient that will always be effective by itself. Medicine's belief in the existence of a magic nutrient that can function independently of other nutrients and will always be effective in short term clinical trials demonstrates a fundamental misunderstanding of nutrition.

Since medicine's reductionist symptomatic interventionist perspective is not consistent with an understanding of the above facts, and in view of the greater importance of alternative medicine in preventing disease and reducing health costs, alternative practitioners should play a much greater and subsidised role in primary health care. Failure to subsidise alternative practitioners is a deterrent to many who seek preventative treatments.

The Committee's recommendations are deliberately biased in favour of all those products which can be demonstrated to have rapid symptom suppressing effects during short term clinical trials. Products which have more long term curative or preventative effects will be considerably less likely to satisfy the Committee's requirements and will be more likely to be banned or withdrawn from sale. If the Committee's recommendations are adopted we will continue to have a health care system which is structured for short term relief of symptoms at the expense of long term curative and preventative ideals. It will continue to be a system based upon disease rather than optimum health. The Committee's recommendations should reflect recent trends in medical science towards a health based and preventative system rather than a symptomatic system which continues to promote dependence upon drugs.

It is important to realise that this is very much the thin end of the wedge. The Guidelines which are endorsed by the Committee may be varied at any time in the future at the slightest whim of the TGA. Once compliance with these guidelines receives legislative backing then hundreds or thousands of products could be banned if the TGA decides that current efficacy standards are not satisfied. The Committee is seeking to give the TGA this type of power. Furthermore, since the Committee has been unable to justify this power grab on the basis of public health and safety the clear perception is created that these proposed legislative reforms are commercially motivated.

Those who seek to impose efficacy standards on alternative medicines often seek to justify their stance by claiming that such products should have to satisfy the same efficacy requirements as pharmaceutical drugs. However, various experts have repeatedly confirmed the fact that medical treatments are frequently not based upon convincing evidence of efficacy at all (36,37,38,39,40,41). According to Kemper and colleagues for instance (36), "many mainstream practitioners continue to recommend therapies that have been disproved in randomized trials." This is hardly surprising since new "wonder drugs" are constantly being produced to replace those that are withdrawn because of their ineffectiveness and/or toxicity. Health statistics for diseases such as heart disease, cancer, asthma, osteoporosis, diabetes and arthritis (31) unquestionably confirm the ineffectiveness of medical drugs the use of which has correlated with an unprecedented increase in all these diseases (31). So ineffective are mainstream therapies for heart disease for instance, that orthodox medicine is increasingly resorting to alternative nutritional and diet therapies, the same therapies they have long regarded as quackery and which they now claim are so dangerous and ineffective that regulatory reforms are urgently needed.

What is particularly interesting is that although medical authorities such as Professor MacLennan claim that the same standards should apply to both pharmaceutical products and complementary medicines (81), these same experts would probably be the first to complain if alternative medicines killed even one quarter as many people as are killed by pharmaceutical drugs. 

The Committee has created the clear impression that their real concerns are unrelated to either the safety or efficacy of alternative medicines. Why else would they be seeking to impose standards for alternative medicines which are so inconsistent with the available scientific evidence and which are so far above the standards which are expected of pharmaceutical drugs?

Information and Education

This section will consider the Committee's terms of reference which require it to advise government regarding the need for "consumer information", the "education and training of healthcare practitioners," and "activities to promote an innovative, responsible and viable complementary medicines industry." It is divided into two sections. While the first section will develop a general overview of matters pertaining to this topic the second section will deal specifically with common misinformation about the need for nutritional supplements, a matter which is of absolutely vital importance given the extensive scientific evidence linking diseases such as heart disease to inadequate nutrition.

a) General Considerations

Generally speaking, with access to the internet, consumers today are better informed about alternative medicine than ever before. However, the pronounced traditional bias against alternative medicine which still exists in the medical profession (42,43,44) undoubtedly does cause some confusion amongst consumers. In fact, much of the unscientific misinformation to which consumers are exposed regarding alternative medicine originates from the orthodox medico-pharmaceutical community. We have seen an excellent example of this during the recent Pan crisis. As Bollen, the Chairman of the Committee points out (6, p7), the Pan crisis was characterised by "ill informed publicity" and "conflicting statements in the media" which "inevitably confused the many users of complementary medicine." Bollen's concern about the standard of information available to the public during the Pan crisis is commendable. Let us briefly examine the cause of the public confusion to which Bollen referred.

Undoubtedly one of the most confusing aspects of the Pan crisis for consumers was the fact that when the Registered drug Travacalm was found to be toxic and the cause of serious adverse reactions, various medical experts claimed that this example of drug toxicity was somehow caused by alternative medicines and therefore such products should be more tightly controlled. Professor Dwyer for instance, claimed that the (45) "toxicity associated with the consumption of one of its products (ie. Pan Pharmaceuticals) brings into focus the need to pay more attention to the risk-versus-benefit ratio associated with consuming 'complementary' medicines." Geraldine Moses of the Pharmaceutical Society of Australia (46) also noted that the toxicity of the drug Travacalm revealed the need for more stringent regulation of, not drugs like Travacalm, but rather complementary medicines. Amazingly, a similar attitude was expressed by the TGA when they advised the public to stop taking all "herbal and vitamin preparations and complementary medicines" (47,48). 

While it may be understandable for representatives of the pharmaceutical industry to adopt the attitude that vitamins are dangerous and drugs are safe and what we therefore need is more drugs and less vitamins, this type of biased attitude should certainly not be displayed by medical experts and the TGA. If we are to blame complementary medicines for adverse drug reactions, what next?

Even Health Minister Kay Patterson was involved in spreading this misinformation when she claimed that the recall of Pan products only affected "complementary medicines" (49). Whether she was deliberately misadvised by her advisers in their eagerness to control alternative medicine is not yet clear. Especially in view of the Committee's concern about accurate information it is vitally important we determine why the Minister made such blatantly false statements. This is a suitable topic for a further inquiry.

But the standard of public debate about the Pan crisis amongst the medical profession descended to an even lower level.

Consumers who were hungry for accurate information about the Pan crisis must have been extremely disappointed if they expected medical experts to reveal the scientific facts about the alleged dangers of alternative medicines because the level of debate frequently revolved around snake oil and the value of urine. According to Professor MacLennan for instance (50),who is a member of the Committee, "it has given an opportunity for people to say - we're not really having to debate how much snake is in the snake oil, or whether there is goanna contaminating the snake oil. We are really having to debate - should you be on snake oil at all, and is this snake oil doing you any good, or, more of a worry, is this snake oil doing you harm?" In spite of this Professor MacLennan advised consumers to keep an open mind about alternative therapies (51): "Keep an open mind about alternative therapies, but not so open that your brain falls out."

Other experts however, adopted a more economic approach and expressed more anxiety about the possibility that the use of alternative medicines may result in expensive urine (52). Still other claims, such as that made by Professor MacLennan (53), described alternative medicine as a "religion". One claim was even made in the media that alternative medicines are "potentially much more potent and harmful" than "conventional medicines" (54). This amazing campaign of misinformation, which has been (82) "misleading" and (82) "hysterical" and resulted in (82) "devastating economic damage", was undoubtedly the driving force that led many consumers to seek the truth on the internet as web sites devoted to the Pan debacle became increasingly popular. This example of the standard of information available from the medical profession and the media illustrates most graphically why the TGA should be encouraging the public to use the extensive resources of the internet.

In view of the above facts it is abundantly clear that the Chairman of the Committee was totally correct in his assertions about the "ill informed" publicity surrounding the Pan crisis. However, since the evidence we have cited above clearly reveals that this misinformation emanated predominantly from the medico-pharmaceutical industry, it is the doctors and pharmacists who are in most urgent need of education and accurate information about alternative medicine. The fact that consumers and medical practitioners need to be accurately informed about alternative medicine (this applies equally to the hazards of pharmaceutical drugs) is stressed by the Committee (6, p115): 

According to the Committee therefore, the type of "bad" information which emanated from some medical experts during the Pan crisis would be expected to have a negative impact upon health outcomes. The solution to this problem however, goes far beyond the supply of more accurate information to medical practitioners for it also involves counteracting the pro drug bias of those involved in the manufacture, sale and prescription of pharmaceutical drugs.

The standard of public debate which is occurring amongst medical experts in Australia conflicts sharply with that which is occurring overseas where, as I have previously mentioned, medical experts are becoming increasingly concerned about the billions of dollars in health care costs which could be saved if everyone took vitamins (14,15,16,17,18,20,21,22). Although various medical experts have warned that people who do not take supplemental vitamins are risking serious diseases such as heart disease and cancer (55,56,57), Australian medical experts on the other hand generally seem more concerned about snake oil and the value of urine. Why is it that Americans are told that anyone who does not take vitamins is risking very serious diseases while Australians are told that anyone who does take vitamins is merely creating expensive urine? The fact that Australian medical experts, with few exceptions (58,59), seem determined to avoid warning the public about the established scientific risks of NOT taking vitamins is most noteworthy and underlines the importance of the Committee's concerns about accurate information.

Given the fact that the Committee also admits that (6, p144) "complementary medicines may improve health, reduce disease, and lower health costs" and (p145) "compared with other medicines, complementary medicines may offer a lower risk and more cost effective option for the prevention and treatment of some diseases", why don't the public statements of prominent medical experts such as Professor Dwyer and Professor MacLennan, a member of the Committee, reflect these scientific facts? While talk of snake oil and expensive urine contribute nothing to restoring the lost confidence which is of such fundamental importance to government, there is absolutely no doubt on the other hand, that a publicity campaign aimed at informing the public of the scientific facts regarding the risks of NOT taking vitamins would go a long way to achieving this goal. The Department of Health should be more proactive in warning the public of the dangers of NOT taking vitamins.

It is this bias against, and persecution of, the alternative health industry which has caused, and is continuing to cause, many consumers to have a justifiably negative attitude towards medical practitioners when it comes to alternative medicine. As has been pointed out by Gregor (60), most consumers consider magazines and health food stores to be more reliable sources of information than doctors who are seen as having a rather negative and antagonistic attitude not only to alternative medicines, but also to consumers of alternative medicines. Doctors, pharmacists and drug companies are frequently seen to prefer their patients become dependent upon drugs rather than more preventative alternative treatments, a perception which is encouraged by the refusal of most doctors to openly and honestly publicise the iatrogenic hazards of drugs. The Committee's recommendation that medical practitioners should relate to patients in a (6, p29) "non-judgemental" way when it comes to alternative medicine will be fruitless as long as the leaders of the medical community continue with their openly antagonistic and biased attitude.

The Committee draws attention to the fact that medical practitioners in Australia are not competent in nutrition and alternative medicine since they have received little or no formal training in such areas of health care. This is in spite of the fact that nearly thirty years ago the Committee of Inquiry into Chiropractic, Osteopathy, Homeopathy and Naturopathy (61) recommended that "nutrition education should become a more significant part of medical education at all levels." Interestingly, the Committee also claimed, as far as herbal medicines were concerned, that at that time, in 1977, no further therapeutic development of herbs was possible since all potent and therapeutic herbs had already been discovered and exploited by the pharmaceutical industry. According to the Committee (61): "herbal lists nowadays appear only to include substances available without restriction by any type of Poisons Act legislation, and consequently do not contain potent substances." The Committee continues: "the thoroughness with which the pharmaceutical industry has surveyed the global flora for pharmacologically active substances renders the probability of any significant range of effective herbal medicine remaining most unlikely." Little did the 1977 Committee realise that their counterparts in 2003 would find herbs to be so potent that urgent safety regulations would be recommended!

In spite of the claims by the 1977 Committee however, which incidentally was comprised of pharmacologists and doctors, almost thirty years later, in 2001, Gregor (60) has commented that "scientists have only begun to identify the active components in these herbal medicines." Thirty years after distinguished Australian scientists announced that all potent herbs had been discovered and exploited by the pharmaceutical industry now it seems science is just beginning to identify the active ingredients in herbs!! There is a vitally important lesson here regarding the current Committee inquiring into alternative medicine. The appointment of committee members to inquire into alternative medicine who have no expertise or experience in the area, or who have a vested interest in denouncing such therapies, will result in the outcome of such an inquiry being totally unscientific, unreliable and predictable. The establishment of this one sided Committee represents a shameful demonstration of the Australian governments commitment to health care. 

The alternative medicine industry has survived and flourished because of the persistence of its practitioners and the safety and effectiveness of its therapies and in spite of the bias and negative attitude of those in the medico-pharmaceutical industry.

b) Nutritional Supplements

There is no doubt that one of the most effective means of restoring consumer confidence about alternative medicines is simply to have a positive publicity campaign aimed at informing the public about the exceedingly promising developments which are occurring in the fields of nutritional individuality and genetics. The groundbreaking work of Roger Williams (62-69), Abram Hoffer (70-73) and Linus Pauling (74-77) 50 years ago is being increasingly confirmed by modern scientists who now predict that many genetic diseases may soon be treatable by megadoses of vitamins specifically individualised for each person (78,79,80). Scientists are now confirming that many people have a genetically increased need for specific nutrients which can only be satisfied by taking large doses of the affected nutrients. According to Eckhardt for instance (78), "the advancing wave of knowledge about the human genome has confirmed the idea that each of us must be genetically unique in our nutritional needs."

According to Ames and coworkers (80) the treatment of many genetic diseases will soon be based upon megavitamin therapy using vitamin doses perhaps "hundreds of times" higher than the RDA: "provided safe doses are used there is potentially much benefit and possibly little harm in trying high dose nutrient therapy because of the nominal cost, ease of application, and low level of risk."

The vindication of the work of Williams and Pauling is highly significant. The rejection by mainstream medicine of the scientific facts underlining the importance of nutritional individuality and the use of megavitamins over the past 50 years has resulted in this concept becoming the exclusive domain of alternative medicine. This of course was largely inevitable due to the constructive holistic approach to health care which is central to alternative medicine. Because nutrition was considered incompatible with medicine's reductionist symptomatic drug oriented perspective, Linus Pauling was regarded as a quack by the mainstream medical community (42,83,84). By the late 1990's however Pauling was acknowledged as a genius (42,84) and the concept of megavitamin therapy became a (42) "respectable hypothesis".

Since that time progress has continued with the development of the "new" science of nutritional genomics or nutrigenomics (85,86,87) which is based upon the principles of the genetotrophic concept described by Williams fifty years earlier (63-66,68,69,88). Like the genetotrophic concept, nutrigenomics accepts that our nutritional needs are highly individual and largely genetically determined, hence the frequent need for megadoses of nutrients to maintain health.

While these are the scientific facts, in Australia mainstream doctors and nutritionists still cling to the outdated belief that everyone in the world requires virtually the same daily amount of each vitamin. Supporters of this belief system, who contradict brilliant scientists such as Williams and Pauling, commonly claim that nutritional supplements are unnecessary as everyone obtains all the nutrients they need from their diet. As I have mentioned previously, they also frequently claim that people who take supplements are merely creating expensive urine.

The significance of all of this lies in the fact that the alternative medicine industry, because of its understanding of, and experience in, the maintenance of optimum health and the use of megavitamins, is uniquely placed to use this new information to benefit public health. Mainstream medicine however, with their traditional emphasis on reductionism, drugs, and the adequacy of the RDA system, are completely inexperienced in this area. While alternative medicine has been using megavitamin therapy successfully for decades, mainstream medicine on the other hand has regarded this as quackery. Given the fact that science has now confirmed that many people require megadoses of vitamins these products should be made more readily available and their advantages publicised.

In keeping with their desire to ensure accuracy and honesty in the supply of information the Committee, the TGA, and the Minister, should immediately inform the public that these types of campaigns of misinformation about snake oil and expensive urine are completely unsupported by scientific evidence. Health authorities should also, in keeping with their desire for honesty and accuracy, inform the public about the 50 years of scientific evidence in support of nutritional individuality and the need for nutritional supplements and megavitamin therapy. To do so would go a very long way towards satisfying the Committee's aims of "restoring confidence", supplying "reliable consumer information", and ensuring a "viable complementary medicine industry".

Those who indulge in deliberate campaigns of misinformation in an attempt to promote the medico-pharmaceutical industry and/or undermine the credibility of alternative medicine are reminded of the warning issued by Bollen, the Chairman of the Committee (p8): 

A final point of concern here relates to the meaning of the term "accurate" when it comes to consumer information. Who decides what is "accurate"? Well, according to the Committee the only information provided to consumers should be that which is judged to be (p116) "consistent with the current TGA Guidelines for Levels and Kinds of Evidence to Support Indications and Claims." They also seek to "tailor" the information to the audience and "frame" the information "against an understanding of what information consumers need." And who decides what information consumers need?

This is totally unacceptable. The TGA should not have a monopoly on the truth. The facts should not be vetted and censored to satisfy the desires of statutory authorities. The public should not be spoon fed the TGA's version of the truth. THERE SHOULD BE UNRESTRICTED ACCESS TO INFORMATION SUCH AS OCCURS ON THE INTERNET. And there should be an immediate termination of scientifically baseless media campaigns of misinformation. As has been noted by the National Medicines Policy (11), which is endorsed by the Committee, "issues relating to use of medicines should be reported accurately and responsibly by the media", something which certainly has not occurred during and since the Pan crisis.

Also of concern here are attempts to prevent the flow of factual information to consumers (via the internet) by classifying such information as "advertisements". According to the Committee initial proposals for the definition of "advertisement" include (p115):

This is totally unacceptable. Statutory authorities should not be seeking to impede the flow of factual information to consumers. There should be no restrictions upon telling the truth.

Future Directions in Health Care

This section is intended to address certain matters which are of fundamental importance as far as the future viability of the alternative medicine industry is concerned but which were not considered in the Report. It will focus primarily upon directional trends in health care and the long term agenda of health authorities and the probable impact of these matters upon the long term viability of the alternative medicine industry.

Since the reforms recommended by the Committee are just one small part of an ongoing agenda of change in the nature of health care it is vitally important that the totality of this agenda, which is frequently not mentioned by health authorities, is closely examined, especially for its probable impact upon the alternative medicine industry. It is the long term goals of this agenda which are of particular importance. Yet, in spite of this, the Committee has avoided any detailed description of these long term goals. An examination of international trends in health care is one means of putting the Committee's recommendations into perspective, especially in regard to their long term objectives.

The current Australian government inquiry into alternative medicine is taking place in an international health care environment in which:

1. the increasing incidence of iatrogenic diseases and various chronic diseases is forcing health authorities to reconsider dependence upon pharmaceutical drugs.
2. increasing evidence that many diseases are linked to diet and nutrition is forcing health authorities to endorse the use of traditional alternative therapies and recognise that such therapies may be much more cost effective than drugs.
3. at a time when the hazardous nature of medical treatments has created a crisis in medical insurance the alternative medicine industry is enjoying an unprecedented global boom and an enhanced reputation for the safety and effectiveness of its treatments. 
4. medicine is becoming increasingly corporatised and the future of medicine increasingly determined by potential profits. 
5. pharmaceutical companies and health authorities in America and Europe are moving towards a complete takeover of the alternative medicine industry by discrediting the industry and restricting the availability of its products.

With the cancellation of Pan's licence, the government, the TGA and the Minister have already made their intentions abundantly clear regarding the alternative medicine industry. And now they seek more power so they can cancel the licences of alternative manufacturers more easily. Predictably, when it comes to extremely dangerous drugs this action is never taken, in extreme circumstances the drug concerned simply being withdrawn from sale. These trends which are occurring in Australia are totally consistent with international trends to move towards a medico-pharmaceutical takeover of the alternative medicine industry.

If the alternative medicine industry is to be successfully included under the umbrella of the medico-pharmaceutical industry then certain conditions must be met. Firstly, the security of the major players in the pharmaceutical industry must be guaranteed by eliminating competition from the current alternative medicine industry. Secondly, consumers and practitioners of alternative medicine must be prevented from accessing many alternative medicines, particularly the most lucrative ones, so that these products will only be available from medical practitioners. As I have mentioned previously, the Committee has acknowledged that alternative medicines may (p44) "become adopted into mainstream healthcare practice." But where does this leave consumers and practitioners of alternative medicine? What safeguards will be put in place to protect the "primacy of consumers" and ensure long term job security for practitioners of alternative medicine?

Given the increasing global demand for alternative medicines there will probably be "room" for some of the larger manufacturers of alternative medicines, provided of course that quality standards are maintained. However, consumers and practitioners of alternative medicine are in a much less secure position. When alternative medicines are "adopted into mainstream healthcare practice" will alternative practitioners be competing directly with medical practitioners? This of course is most unlikely. Instead, alternative practitioners will probably be forced to choose from a small number of treatments which have been largely discredited and relegated to a category of products which have failed to meet the efficacy standards required by medical practitioners.

What makes these problems even more serious is medicine's longstanding antagonism and bias against the alternative medicine industry. In the past we have seen the eagerness of the medico-pharmaceutical system to exploit, frequently with disastrous consequences, any herbs which they considered to have therapeutic potential while others they considered unimportant were left to the alternative medicine industry. This clearly must be prevented from happening again and the government must therefore describe in detail the safeguards it intends to put in place to protect the future viability of the alternative medicine industry. The government should also, in order to reassure the industry, describe in detail their long term goals for the industry and make absolutely clear their position in regard to international trends towards a medico-pharmaceutical takeover of the industry.

The Committee has been conspicuously silent on these vitally important issues.

Conclusions and Recommendations

I could not conclude this article without expressing my concerns, as a consumer of alternative medicines, about some recent trends in health care in Australia. While it is indeed exciting to see so many of the practices of alternative  increasingly being vindicated, it is extremely disappointing, on the other hand, to witness the kind of intolerance which was displayed during the Pan crisis by so many in the medico-pharmaceutical industry. It is a tragedy that the medical profession has traditionally been so opposed to nutrition and alternative therapies and has adopted such a negative attitude towards consumers who assume more responsibility for their health by using various dietary supplements and health foods. Sadly, the Pan crisis brought to the attention of the public the fact that these attitudes are still flourishing within the medico-pharmaceutical industry. The healthcare professions should be about healing patients and adopting a positive supportive attitude to those consumers who seek to assume more responsibility for their health, certainly not a negative antagonistic attitude.

The following conclusions and recommendations are based upon the evidence cited throughout this article.

1. Restoring confidence and promoting an innovative alternative medicine industry.

The evidence clearly indicates that loss of confidence in the alternative medicine industry as a result of the Pan crisis was caused predominantly by inaccurate and biased media comments, particularly emanating from prominent members of the medico-pharmaceutical industry. Typically, such experts consistently confused the drug Travacalm with vitamins, herbs, and other alternative medicines, they consistently avoided publicising scientific evidence of the advantages of alternative medicines with regard to heart disease and other diseases, and they consistently avoided warning the public about the voluminous amount of scientific evidence proving the dangers of pharmaceutical drugs. The solution to this problem is clearly to correct this media bias and misinformation.
Recommendations
There should be a prolonged publicity campaign to emphasise the scientific facts about the advantages of alternative medicines and the dangers of pharmaceutical drugs. In keeping with the recommendations of the Chairman of the Committee, healthcare professionals who make inaccurate, biased or irresponsible public statements about health matters, such as occurred during the Pan crisis, should be disciplined.

2. Safety Reforms

The Committee noted the extreme rarity of significant adverse reactions to alternative medicines and was unable to produce precise statistics about the incidence of serious or fatal reactions to such products or supply evidence that there has been a significant increase in such reactions. On the other hand the Committee pointed out that pharmaceutical drugs are far more dangerous than alternative medicines, being responsible for 98% of all adverse reaction reports. The Committee also endorsed a risk based approach to safety reforms which would focus upon products known to be of greatest risk such as pharmaceutical drugs. The Committee also endorsed a safety standard for all medicines that is based upon international trends rather than the toxicity or adverse reactions caused by the various products. No evidence was cited by the Committee that would justify any safety reforms for alternative medicines whatsoever. 
Recommendations 
The alternative medicine industry has set an exceedingly high safety standard under present regulations and no safety reforms are warranted. Quality control procedures however, should be strengthened and applied more vigorously for all medicines. In keeping with the Committee's risk based approach there should be mandatory reporting of any suspected adverse reaction to pharmaceutical drugs. Adverse reactions to pharmaceutical drugs should be included in death certificates and official statistics. There is absolutely no justification for granting the TGA extra powers to cancel licences of manufacturers of alternative medicines on safety grounds.

3. Consumer education

Although the Committee recommended that the TGA should determine what information consumers needed to know about alternative medicines no justification was provided for such a move. To the contrary, the Committee noted that the present structure of the alternative medicine industry has resulted in a global boom in the use of alternative medicines and an exceptional level of safety. Additionally, although not noted by the Committee, this widespread use of alternative medicines has resulted in enormous cost savings as far as public health is concerned and has brought the advantages of alternative medicines to the attention of doctors and scientists. 
Recommendations 
Consumers should have unrestricted access to information about alternative medicines and should be encouraged to seek independent sources of information such as occurs on the internet. The importance of this was highlighted by the Chairman of the Committee who pointed out the unsatisfactory and unreliable nature of information in the media about the Pan crisis. These comments apply to information about the hazards of pharmaceutical drugs also. There is absolutely no justification for the TGA determining what information consumers need.

4. Efficacy standards

The Committee has sought to establish a definition for the term "efficacy" which strongly favours quick acting symptom suppressing drugs and then recommended that this standard should be applied to Listed alternative medicines. Since the effectiveness of alternative medicines, particularly nutritional supplements, is judged by their ability to prevent disease and restore optimum functioning and health however, and not their ability to conceal symptoms, such a system is entirely inappropriate. The suggestion that both pharmaceutical drugs and alternative medicines can be assessed by the same efficacy standards represents a gross misunderstanding of the ways in which alternative medicines work. If drugs were assessed by their ability to prevent disease and restore optimum health we would have no drugs. Consumers who wish to maintain optimum health and prevent disease by taking nutritional supplements should be encouraged to do so by separate efficacy standards which distinguish between the symptomatic effects of drugs and the restorative preventative effects of nutrients. Consumers should not be discouraged from taking perfectly safe products simply because of the application of totally inappropriate efficacy standards. The bottom line as far as efficacy is concerned is that the Committee was unable to supply any data whatsoever confirming an upsurge in complaints from consumers about the efficacy of alternative medicines.
Recommendations 
There is absolutely no justification for the recommendation that current efficacy standards should be applied to Listed alternative medicines. The current system of Listed and Registered medicines should be maintained with the following modification. Regulations should formally acknowledge the different efficacy standards for alternative medicines and pharmaceutical drugs by requiring that the former, particularly nutritional supplements, are labelled "For Disease Prevention and Optimum Health" or similar, while drugs should be labelled "For Suppression of Symptoms" or similar. Exemptions could of course be granted in specific cases where this is warranted. Such a system would be totally consistent with all the available scientific evidence. This distinction must be formally acknowledged in the interests of public health.

5. Subsidising of alternative practitioners

As the Committee acknowledges, alternative medicines are increasingly being shown to play a vital role in optimum health and disease prevention which clearly distinguishes them from pharmaceutical drugs. The important point however is WHY they are more effective than drugs. The reasons for this effectiveness relates to the holistic vitalistic principles of alternative medicine as compared to the reductionist symptomatic perspective of orthodox medicine. Unlike doctors, alternative practitioners, through training and experience, possess a unique understanding of these principles which underlie the success of alternative therapies. For instance, almost thirty years ago, during the last inquiry into alternative medicine, experts in medicine and pharmacology predicted that no further developments in herbal medicine were possible since all potent herbs had already been discovered and exploited by the pharmaceutical industry. Where they went wrong was they asked experts in drugs, not herbs. THIS MISTAKE SHOULD NOT BE REPEATED. Over the past 50 years it has become increasingly clear that society has paid an enormous price for the relegation of alternative practitioners to a secondary level of health care which is not subsidised by Medicare or most private health funds. Medical experts now acknowledge the terrible consequences of ignoring nutrition and encouraging dependence upon drugs.
Recommendations 
In view of the greater emphasis upon optimum health and prevention of disease in modern society alternative practitioners should be subsidised and play a greater role in primary health care. Steps should also be taken to ensure the preservation of alternative medicine's underlying holistic vitalistic principles.

6. The long term independence of alternative medicine

In keeping with international trends to move towards a medico-pharmaceutical takeover of the alternative medicine industry the Committee has noted that alternative therapies may become "integrated" into standard medical practice.
Recommendations
The government should clearly set out their long term agenda for the alternative medicine industry and state their position regarding international trends to move towards a medico-pharmaceutical takeover of the industry. As a matter of absolute urgency, the TGA and the Minister, should put comprehensive safeguards in place to ensure the independence and long term viability of the industry. As long as orthodox medicine retains its reductionist, symptomatic, drug oriented, and interventionist approach, alternative medicine should remain very much an ALTERNATIVE  industry, not just another division of orthodox medicine.

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