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Self-Administered Medicines

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Self-administration of medicine started out with simple people turning to the green pharmacy growing in the fields where they lived and ended up being a global market trading in herbal remedies. Huge fortunes are made by the herbal industry which services today’s lifestyle. Throughout the western world health care consumers are hooked on self-medication. Popping pills to prevent illness or relieve symptoms has, for many of us, simply become a habitual part of our lives. Collectively these self-medications are known as patent medicines, over-the-counter (OTC) preparations, herbal or traditional medicines, dietary supplements or non-prescription pharmaceuticals. Most of these are not licensed as medicines; they are called dietary supplements because they are considered sufficiently harmless to take without any medical supervision. While these products are mild in their action, it will be demonstrated that, under certain circumstances, they are certainly not harmless. This highlights the need for consumer access to accurate information and strategies to improve health literacy about OTC medicine.

Servicing this propensity to self-diagnosis and self-medication really has become a big business. In the developed countries of the world the use of dietary and herbal supplements has grown dramatically in recent years and OTC pills and potions are a multi-billion-dollar industry. Americans are big spenders, according to the National Institutes of Health Office of Dietary Supplements. In 2012 they outlaid a total US$32.5 billion on dietary supplements and one fifth of this large sum was spent on multivitamin/mineral supplements (MVMs).[i] A Wall Street Journal article stated that expenditure was only $23 billion and the journalist found the lesser sum encouraging because it left plenty of room for market expansion.

Australians are great pill poppers and the advertisers and the media all know this and trade on it. We are consistently bombarded with advertisements for pills and potions and articles promoting health fads, while the media regularly portray scientific breakthroughs as if there is endless medical progress towards solving all our health problems. The result is that, even in our prime, we worry that we might fall ill, or we worry that we are not as well as we think we ought to be. Which raises the questions: who are the pill poppers, and will the industry encourage them to take more or will the industry try to attract a new section of the community?

Studies show that MVM use is more frequent among women, and their children, who live relatively healthy lifestyles and have good diets. Whether any health benefits for this segment of the market are due to MVMs intake or to their healthier lifestyle choices is difficult to untangle. Australian television networks are currently featuring male sportsmen to advertise an Australian brand of dietary supplements. These advertisements suggest men who play sport need more vitamins to be a success, like the man in the ad. As men currently take MVMs less frequently than women then pushing vitamins to this group would lead to a growth in sales.

MVMs only represent one section of dietary supplements. In 2007 the US expenditure on non-vitamin, non-mineral and so-called ‘natural’ products, such as fish oil, glucosamine, and echinacea was $14.8 billion. That is one-third of the sum Americans spend on prescription drugs. Over-the-counter medicines are a fast growth industry[ii] and research shows that current industry profit is expected to grow from $3.5 billion to $4.6 billion in 2017-2018. Other countries are experiencing a similar growth in self-medication. For example, in Australia, Canada, and the United Kingdom annual expenditure on herbal medicine is estimated to be US$80 million, US$1 billion, and US$2.3 billion respectively.[iii]

One Australian study found that more than eighty per cent of its participants took one or more OTC medicines daily, and of those two-fifths had taken five or more in the previous twenty-four hours. Prescription drugs are also part of many people’s daily routine, a survey in the UK found 43% of men and 50% of women had taken such a drug in the previous week and some had taken three.[iv] Interestingly, most participants used both dietary supplements and conventional remedies. The most commonly used medicines were antihypertensive agents, natural marine and animal products including fish oil and glucosamine, and lipid-lowering agents (for cholesterol control). The items on this list represent a growing tendency for packaged drugs (as well as those ordered by prescription) to aim at curtailing health risk factors; that is, disease prevention.

In Germany the story is slightly different since about 20% of herbal medicine is sold only on a prescription-basis and about 80% is sold over the counter. Regardless of how they are obtained the rate of herbal medicine use is on the increase. Between 1970 and 2010 the overall number of Germans using herbal medicine increased to well over two-thirds of the population. All expenditure on herbal remedies amounts to approximately one billion euros. Given there are other retail outlets such as drugstores and the internet, the usage is probably considerably higher. The propensity to pop pills seems endless in many countries, so why has this trend occurred?

There are several reasons for self-medicating. Since we are no longer the passive consumers of health we once were, many of us want to take charge of our own health and what happens to our body. Self-diagnosing and medicating engenders a feeling of control. But how many of us take the time to thoroughly investigate whether the OTC remedies actually relieve symptoms and/or promote health? The answer is probably very few. Yet it is an indisputable fact that consumers in the USA, UK, Europe and Australia do not take herbal remedies and vitamins simply as dietary supplements, although this is how they are officially classified. Nearly a quarter of Australian adults use complementary and alternative medicine in the treatment of chronic illness according to a National Health Survey database. In this group the complementary medicines were used for arthritis and osteoporosis but fewer than 10 per cent used non-prescription medicines for asthma, diabetes or heart and circulatory conditions. As might be expected these users tended to be older females with lower education levels and income,[v] and that is unlike Australian OTC users in general, who tend to have higher education and incomes levels as noted below.

Quite obviously many people expect OTC medicines to have a therapeutic effect. When taking echinacea for colds or flu it is expected to have some effect on the body, just as a prescription for an antibiotic for pneumonia is expected to work. When an analgesic such as Panadol is taken for arthritis pain, relief is the expected outcome and the same applies for non-steroidal anti-inflammatory drugs (NSAIDs). In terms of effectiveness the reason for taking these OTC remedies is much the same as the reason for taking prescription drugs and they are used in similar ways.

Another reason why self-medication is so widely used is that remedies for mild complaints are extensively advertised and are readily available. Since a visit to a practitioner is not required, popping a pill saves time and money. No doubt changing attitudes to conventional health care, and increased knowledge of health matters, also play a part. Trust in orthodox medicine has declined over the last thirty years. Press reports of medical negligence and malpractice, as well as the overuse of antibiotics, and their effects on the environment, suggest that orthodox medicine is less trustworthy than previously believed. Yet quite a few people happily trust long-used, traditional ‘natural’ remedies but as we will later discover such trust is not always justified.

Surveys have found that our reasons for buying pre-packaged medicines fall into two broad categories. The first is health maintenance or improvement: for extra energy or stamina, improved memory or mental agility, prevention or treatment of common illnesses like colds and flu or more serious illnesses, to slow down the aging process or to improve sexual function. It is difficult to be certain if any of those conditions are improved by OTC remedies, therefore it is not surprising that health maintenance and improvement is a mainstays of the diet supplement industry which thrives more on hope than effective performance. Since laws are in place to prevent claims of efficacy appearing on OTC labels, the characteristics of the people who are its greatest supporters do seem surprising. Australian and American surveys suggest that those who use OTC remedies are mostly females between the ages of 15 and 50. By comparison to non-users, they are more likely to be well-educated, have a higher economic status and a higher household income. So, it is mainly middle-class women who are filling the coffers of mineral and vitamin supplement manufacturers. Since these people are likely to be savvy consumers, they know that the biggest killers are cancer, heart conditions and strokes. Hence, they are concerned to maintain their health status by exercising, dieting and supplementing their diets with minerals and vitamins. Everyone wants to remain healthy, so instead of swallowing tonics as they did in previous centuries, they pop a pill and go to the gym.

Laudable as the pursuit of health maintenance is, high consumption of these items may not be necessary. The irony is that people living in western countries with a high living standard have ready access to balanced diets which provide the essential nutrients. The recommended dietary allowance (RDA) for minerals and vitamins has been set in the United States at a level which should meet the needs of ninety-seven to ninety-eight per cent of averagely healthy individuals. This level is aimed at decreasing the risk of chronic disease as well as normal health maintenance. Of course, there are groups of people who do need to supplement their diet with added vitamins and minerals. Patients recovering from major surgery or debilitating illnesses may benefit from added vitamins and minerals. Anyone who, for some reason, is unable to eat a balanced diet for a prolonged period is advised to use supplements. Artificially-fed infants and pregnant women usually require vitamin supplements. Those who are on a vegan diet may need supplements but vegetarians who eat a varied diet probably do not. Clearly different individuals have different requirements depending on their health status or age, but the perception that all and sundry require supplements is an artefact of advertising.

Another reason for self-medication is the treatment or reduction of symptoms such as anxiety, stress or depression, or to help women’s menopausal symptoms, or to treat or relieve symptoms such as the pain associated with some illnesses.[vi] Medicines to relieve allergies such as hay fever are also widely used. Some non-prescription drugs containing antihistamines can provide temporary relief but may cause drowsiness in susceptible people, so sometimes pseudoephedrine, which helps nose blockage and chest wheezing, is sometimes also added to counteract any sedative effect.

Other non-prescription medicines in wide use are pain-relievers such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin (a derivative of the bark of the willow tree) has been known as a painkiller and antipyretic with an anti-inflammatory effect since 1763, along with other trees and plants contain salicylates, such as wintergreen, black cohosh root, poplar tree bark and sweet birch bark.[vii] Then in 1950 an English family doctor observed its anti-clotting properties and published several papers on the subject. Twenty years passed before his observation was taken up by a biochemist, John Vane, who won a Nobel Prize in 1982 for showing how aspirin discouraged small platelets in the blood from sticking to blood vessel walls, and each other, to form clots. Aspirin is now widely given in very small doses as a prophylactic against heart attacks and strokes. It is considered a safe drug with only two adverse effects. Aspirin should never be given to children under 16 as an antipyretic if they have a viral infection, because of the risk of Reye’s syndrome, a potentially fatal disease. Its usefulness for adults must also be measured against the risk. When high doses are used it can cause bleeding in the stomach that may be severe.

While attention has focussed on OTC pills, the internet now provides opportunities for self-medication that are virtually unlimited. Many prescription drugs considered harmful if used inappropriately are now available online through internet marketers. One online pharmacy lists over a hundred drugs including such items as isosorbide mononitrate (vasodilator), Prozac (treatment of depression and obsessive-compulsive disorder), beta-blockers (to reduce workload on the heart) and penicillin. A detailed description of each drug was given together with warnings about side effects. Purchasers fill in a health history questionnaire and are asked not to take any of the drugs purchased in this way without consulting a pharmacist.[viii] When I accessed this site I did not test whether a purchaser would be refused a supply of a drug if their health history suggested it was unsuitable or dangerous. Where a physician’s prescription is not required, online pharmacies are in direct competition with the conventional medical profession and with complementary and alternative therapists.

Many of the herbal remedies that homeopaths, naturopaths and herbalists include in their repertoire are available pre-packaged in retail outlets or via the internet. As a service to consumers, product labels list all the ailments each one is suitable for and give instructions for its use. So, purchasing remedies over-the-counter or online obviates the need for a consultation. However, consumers should be aware that some so-called homeopathic remedies are being formulated with little or no regard to traditional homeopathy principles or practice.

Reliance on pre-packaged self-medication is not a modern phenomenon. In earlier centuries those who could not afford physicians’ fees bought their ready-made remedies from peddlers in the market place. The difference is that, instead of being mixed by peddlers and apothecaries, today’s products are processed in factories and distributed by wholesalers in the same way as prescription drugs. Vitamins, minerals, diet supplements, plus herbal and homeopathic remedies, are all pre-processed to some extent and pre-packaged for our convenience. Processing raising the question of what the term ‘natural’ means. It is widely used on OTC labels suggesting that swallowing a ‘natural’ product is much better than one that is factory or laboratory produced.

Herbal remedies are valued as ‘natural’ medications because they are derived from plants, but ironically it is this very characteristic that makes them variable in quality and composition. Not only that – herbs ‘naturally’ have built in microbial flora to protect them from predators which may cause unwanted effects in humans. The constituents of raw herbs ‘naturally’ vary. Active ingredients are influenced by the soil content in which they are grown, the time they are harvested, the use of pesticides or the part of plant that is used. Root herbs and those harvested at ground level are prone to contamination from the soil in which they grow. For example, herbal teas made of nettles and those made from valerian root have been found to contain faecal matter and grit.[ix] Herbs, like other plants are subject to deterioration and decomposition. So, to ensure purity and maintain their quality, most herbals are processed to some extent. Finding out how OTC remedies are processed and packaged helps us to understand a few of the possible pitfalls in self-medication.

All medicine, whether it is prescribed by a doctor or sold over-the-counter, includes one or more active ingredients. The active chemical substance is usually referred to as a ‘drug’, since it affects the processes of the mind or body, and is used in the treatment or prevention of disease or other conditions that are considered abnormal or unhealthy. Sometimes another substance is added to make the ingredients more stable and convenient for use.[x] But the main processing methods used today are those pioneered by the eighth century Arab pharmacists. Infusion, evaporation and distillation are used to produce extracts, so that the remedies can be sold in the form of pills, syrups, tinctures and pastes. Vitamins are also processed, although some are synthesized. Minerals usually undergo transformation into compounds to make them more palatable or more readily absorbed. The main processing difference is that modern technology is employed.

Consumers have no way of knowing whether OTC medications are properly labelled or carefully manufactured—we take them on trust. Unfortunately, the herbal industry is so competitive and profitable; this leads to some disreputable practices. Substitution of cheaper ingredients is not uncommon. There are instances of inadequate labelling, inadequate measurement of active ingredients, and unjustifiable claims of efficacy. Careless production in the effort to make a quick profit is a recipe for low quality products. Fortunately, in all developed countries there are statutory authorities whose job it is to protect us from inadequate processing procedures and fraud.

Vigilance by statutory authorities, such as the US Food and Drug Administration (FDA), is vital. The FDA polices the various consumer protection laws on labelling and processing. The FDA provides a database, Natural Products Alert (NAPRALERT) which regularly publishes warnings about products. One American state has challenged this activity on the grounds that the FDA is restricting the public’s right of access to remedies and is therefore restricting trade. An ‘Access to Medical Treatment Act’ was introduced in Minnesota to prevent the FDA from interfering with the sale and distribution of unproven drugs and devices. While this challenge may have some validity, the product warnings provide such a useful service to consumers that other countries have similar authorities.

In all western countries, information on drug alerts or product withdrawals is promulgated through newspaper advertisements and the internet. In the UK the Food Standards Agency, established by an Act of Parliament in 2000, has a similar role to the FDA. The National Poisons Unit provides a database of adverse effects. In Australia the Therapeutic Goods Administration (TGA) oversees dietary supplements and complementary medicines. The Australia Register of Therapeutic Goods (ARTG) lists medicines considered to be low risk and registers those that fall outside this category. For example, three hundred and nineteen gingko preparations, seven hundred and eighty-four fish oil dietary supplements and twenty-four varieties of saw palmetto products are low-risk listed, whereas pills containing codeine are registered.

The TGA publishes ‘Urgent medicine and medical device recall notices’ that have three categories of urgency. The vital contribution of these services is illustrated by three stories of product investigations—two occurred in Australia and the other in the United States of America:

In January 2003, the TGA became aware of adverse reactions to a travel sickness remedy. Of the eighty-seven consumers who had taken a particular batch of the preparation, nineteen were hospitalized with a variety of symptoms including hallucination, disorientation, hysteria and vomiting. The tablets were immediately recalled from the market. Known as Travacalm, this travel sickness remedy was produced by Pan Pharmaceuticals, the largest manufacturer of OTC herbal products in Australia. The TGA commenced an exhaustive investigation of all Pan Pharmaceuticals products seizing computer records and auditing manufacturing procedures. It found serious irregularities such as a lack of adequate testing and the manipulation of test results for a number of ingredients. There was also substitution of ingredients from unauthorized sources, a lack of proper cleaning practices when switching from production of one product to another, and a lack of control of the amount of active ingredients. Some Travacalm tablets were reported to have seven times the prescribed amount of hyascine while others had none.[xi]

By April 2003, more than seven hundred products had been withdrawn from retailers’ shelves and a twenty-four-hour consumer ‘helpline’ was opened. The TGA list of the recalled products covered several broadsheet pages in The Age. The recall was complicated. Many products were sold under the labels of at least ten different companies in Australia and overseas, all of which had to be identified and notified. The manufacturing company had their licence suspended for six months pending further investigations and later went into liquidation. Although other Australian manufacturers have a blemish-free reputation and continue manufacturing, the effect of the recall devastated retailers. Trust in herbal remedies declined to such an extent that sales dropped by thirty per cent.

Stories about the lack of proper product control are certainly not uncommon. In the US, it was found that out of twenty-five echinacea (purple coneflower or Sampson root) products purchased between October and November 2000, six did not have adequate ingredient labelling as required by law. Five of the remaining nineteen samples failed tests because they either did not have the expected levels of a constituent they were supposed to contain, or had no detectable levels of one or more of the constituents.[xii] Plant substitution has also been a problem. It has been estimated that fifty to ninety per cent of echinacea sold in the USA, up until 1991, was actually Missouri snakeroot (an American Indian herb).

The lack of an active ingredient in thirty-eight bottles of Vital brand Vitamin B Complex capsules was potentially far more serious. Many women of childbearing age take foliate supplements to help prevent birth defects of the brain and spinal cord, such as the neural tube defects associated with spina bifida. The label on this product mentioned that supplementation is recommended when the body might be low in nutrients and cited pregnancy as one example. The label also suggested that one capsule containing four hundred micrograms of folic acid was the recommended dose per day. Alas, the capsules labelled as containing four hundred micrograms of folic acid contained only forty micrograms.

Control of the labelling and processing of herbal remedies is difficult because many plants are known by more than one name, often depending on the country or region of origin. Naming problems not only confuse consumers, they can lead to inappropriate substitution by producers, either ignorantly or deliberately, as a cheaper alternative. Unscrupulous producers can also include additives that do not appear on the label. For example, non-herbal substances, such as prescription drugs or toxic metals (mercury) have been found in imports labelled ‘Chinese herbal medicine’, although they were manufactured in other Asian countries. In some cases of imported herbs, unwitting substitution of a similar plant occurs. For example, a tonic labelled ‘ginseng’ may contain Siberian ginseng, which is a related plant (eleuthero) that has quite different active ingredients. A remedy may also be taken because it is known to contain a particular active ingredient, but if the whole herb is used other active ingredients in the plant may have unwanted effects. On the other hand, it may be the combination of ingredients in the whole herb that makes it therapeutic and using one extracted ingredient may not have the same synergetic effect. Some of the complexities surrounding constituents can be illustrated, again using the herb echinacea as an example.

Although now used for reducing the symptoms of colds and flu, echinacea was once used to treat a variety of complaints including wound healing, toothache and painful joints or even given as an antidote to rattlesnake bite. There are nine species of echinacea, but today only three are commonly used (E. pupurea, E. angustifolia and E. pallida). These three species between them contain at least seventy different biochemical compounds.[xiii] Most of the seventy compounds are common to all three but the rest are only present in two of them. Processing and storage temperatures are known to affect some of the chemical components in one of the species (E. pupurea).[xiv] [xv] Thus using the correct processing method and the correct species are particularly important. Nonetheless, research has shown that correctly produced echinacea derivatives are effective in alleviating flu-like symptoms and they continue to be popular as a self-medication although problems of quality can arise. The Consumers Association in Australia reported in their journal, Choice, that, when ten of the most popular echinacea products found in retail outlets in Sydney were tested, the quantity of their known active ingredients varied. The Association questioned whether the level in most of them would have any greater effect than a placebo. Two of the manufacturers concerned pointed out that not all the active ingredients in echinacea were known. So, in their view, whether the amount of echinacea found in their products was effective was an open question.[xvi] In other words, it did not matter!

Existing laws in most developed countries preclude producers of OTC remedies from claiming any therapeutic value. As previously noted the product label cannot suggest that it is useful in treating, diagnosing, curing or preventing any specific disease. The exceptions are the few OTC preparations that have been approved as ‘drugs’, since these have been subject to the same rigorous testing required of prescription drugs. Among these are the stronger pain relievers (such as paracetamol and codeine phosphate) and the cough mixtures that are sold in pharmacies.

The efficacy of all drugs depends on getting the dose right. In excessive doses all remedies are potentially capable of being lethal. Even a substance as apparently innocuous as water can prove fatal if consumed in sufficiently large quantities to dilute the blood. The science of medicines is intimately linked to the science of poisons. If a remedy interferes powerfully with any body system, an excess is likely to cause unwanted side effects as the story of the Travacalm disaster illustrated. Such disasters are not confined to pre-packaged medicines. Throughout the history of medicine, overdosing with prescribed remedies has led to disaster, as we shall see in later chapters.

Despite the popularity of herbal remedies in the US, little research on their efficacy and safety has been undertaken there. Demonstrating efficacy and safety to FDA’s satisfaction can take ten to fifteen years and, according to pharmaceutical companies, it can cost as much as US$500 million. Herbs cannot be patented because they are found in nature and are not considered an invention. American manufacturers are not interested in pursuing this avenue of research without the protection a patent gives. A patent prevents other companies from reaping the benefits of another company’s research. It is obviously uneconomic to spend money on research and development if others can reap the rewards—another reason why herbal products are likely to remain in the dietary supplement category.

The National Center for Complementary and Alternative Medicine (NCCAM) has supported randomized-controlled trials for dietary supplements. The trials cited here were conducted with the same scientific rigor required for new drugs; that is double-blind, placebo-controlled and randomized. In the gingko biloba study participants were 3,069 normal elderly people (aged 75 years or older) with mild cognitive impairment. It was found that one hundred and twenty milligrams twice a day was not effective in lowering the overall incidence rate of dementia or Alzheimer's disease, but this OTC preparation did reduce blood pressure. Another widely used botanical product consists of the fruit extract of saw palmetto (serenoa repens) which is widely advertised on Australian TV by a well-known manufacturer. The ad features a well-known sportsman without claiming he takes the substance. This extract is reputed to reduce urinary symptoms associated with prostate enlargement in older men. In the trial three hundred and sixty-nine men were randomly assigned to take either the saw palmetto extract or a placebo, and the strength of the dose was increased three times during the study. The effects of the herb were the same as those for the placebo. Other trials of slightly different varieties of saw palmetto also found no effect. In another study on the effect of the fish oil, which many people take because it contains omega-3 polyunsaturated acids and is thought to suppress inflammation and modify the immune system, the outcome was more encouraging. Unfortunately, in this trial the participants were laboratory mice – these little creatures are frequently used for preliminary tests. Half the mice were thin and the others obese. The results showed that omega-3 polyunsaturated acids targeted immune cells in both groups of mice and did appear to enhance immunity.

As an article by NCCAM points out, the eighteen percent of American adults use natural products such as herbs and botanicals do so without much evidence to support their use. The complex chemical mixtures that natural products contain can present a real challenge, particularly when some of the chemical components are so similar that even sensitive tests fail to tell them apart. Encouragingly the results of a recent study suggest a new technique which will allow the study of highly complex products more powerfully and efficiently than previously possible. The new technique enabled researchers to distinguish between nearly identical compounds in the milk thistle plant. If this technique can be used on other plants, it may help resolve one of the frequently stated reasons for the lack of herbal research – it is too difficult.

Most research aims at establishing a baseline against which products can be measured. As mentioned previously, commercially available products are not well standardized. Nor has there been a systematic determination of the optimal dose, schedule or the method of administration. In addition, the frequency and extent of drug reactions are usually unknown.[xvii] All these factors must be established before large-scale trials can begin, although some herbalists have claimed that scientists are so completely committed to western medicine they are not really interested in botanical remedies. That, of course, was one of the reasons that NCCAM was set up in the National Institutes of Health.

In Europe, the amount of research on herbal remedies depends on the country and Germany leads the way. If research on plant-based remedies takes place in the US and UK, each active ingredient must be separately investigated, which is another reason why trials are so expensive and time-consuming. But in Germany a plant-based remedy does not have to be evaluated for each known active ingredient that it contains; it can be evaluated as a whole plant. Hence most research on herbal remedies is carried out there. Another reason for a high level of research activity is that part of the cost of herbal remedies (called phytomedicines) is covered by government health insurance, and eighty per cent of doctors regularly prescribe these for their patients. Therefore, German suppliers are required to provide evidence of quality, safety and efficacy. Evidence may include empirical medical findings or personal experience, as well as findings from controlled clinical studies. A monograph is published for each plant. This lays down the safety and efficacy criteria that become the basis of licensing decisions.

Evidence of traditional use is sufficient to allow the sale of an herbal remedy in France, whereas other pharmaceuticals are subject to strict controls. The same applies to over-the-counter herbals in the UK, although the European Union is trying to introduce laws that will be common to all members. Where ancient herbal medicine continues, in such countries as the People’s Republic of China and India, herbal preparations are considered traditional medicine and exempt from the tests required for other drugs.

It is often claimed that ‘traditional use over many centuries’ means the medicine is safe. This is not necessarily true. One compelling reason is that many forms of possible toxicity, such as carcinogenicity or interactions with modern drugs, were unknown to previous generations.[xviii]

Consumers who want to avoid manufactured products in favour of more ‘natural’ products should be aware that the terms ‘non-pharmaceutical’ or ‘natural’ do not necessarily mean a product is harmless. As a rough rule of thumb, any drug that is powerful enough to have an effect is probably capable of doing harm. The very reason prescription drugs are so tightly controlled, and well researched, is that they are powerful enough to produce serious side effects. For example, in 1997 the US FDA banned or restricted eleven popular drugs because doctors ignored safety warnings or prescribed them inappropriately. If you are self-medicating be warned—follow the instructions for use and do not overdose—more is not necessarily better.

Much of this discussion on self-medicating has dwelt on the negative aspects because these are usually only talked about when some disaster occurs. Most of the time, we just take our OTC medicines trusting that all is well. Yet OTC preparations are not always benign, or free from side effects. Their safety and efficacy are not guaranteed just because they are considered ‘natural’ or because they have had centuries of traditional use. As we have already seen, the belief that dietary supplements are always harmless is erroneous—incorrect processing or substitution can cause safety hazards and an incorrect dosage can lead to unwanted effects that are quite serious.

On a more positive note, OTC medicines are generally both gentle and safe. After all, they are intended for the self-treatment of minor ailments or health maintenance. Provided they are properly processed or manufactured, there are relatively few reports of serious adverse reactions compared to those for prescription medicines. In Australia, for example, only three per cent of reported adverse reactions concern over-the-counter remedies, but another ninety-four per cent are for medicines prescribed by physicians. This may be because OTC remedies are self-administered, and so unwanted effects are seldom reported and, in any case, most consumers lack information on how to go about reporting, whereas professionals have clearly identified mechanisms for advising on adverse events for prescription drugs.

Although consumers in developed countries are supposed to be protected from fraud, quackery and unsafe products by their statutory authorities, unfortunately protection sometimes arrives after a catastrophe has happened, so being an informed and critical consumer is essential. In the next chapter we will examine the ways in which advertisers can influence how we self-diagnose and self-medicate. Astute advertising can make suckers out of any one of us. ‘Buyer beware’ is still a good maxim.

[i] National Institutes of Health Office of Dietary Supplements (2013). Multivitamin/mineral Supplements Fact Sheet for Health Professionals, P.1.

[ii] Freeman, L.W. (2001). Herbs as a medical intervention. In Freeman, L.W. and Lawlis, G.F., Mosby’s complementary & alternative medicine: a research-based approach. St Louis: Mosby. p.388.

[iii] Wachtel-Galor & Benzie, F.F. 2011 Herbal Medicine. http://www.ncbi.rim.nih.gov/books (accessed October 2015).

[iv] Lambert, C. (2015). Should you swallow it? New Scientist, 16 May, p.30.

[v] http://www.healthissuescentre.org.au/documents/items/2011 (accessed October 2015)

[vi] 6Eisenberg, D.M, Davis, R.B, Ettner, S.L., Appel, S., Wilkey, S., Van Romay, M. & Kessler, R.C. (1998) Trends in Alternative Medicine in the United States, 1990–1997: Results of a Follow-up National Survey. JAMA, 280: 1569–1575.

[vii] Jeffreys, D. (2004). Aspirin: The Story of a Wonder Drug. London: Bloomsbury Publishing, p. 13.

[viii] http://www.online-pharmacy.com [Accessed 22 March 2004]

[ix] Tang, S. (1996). Microbiological Quality of Herbal Teas. Therapeutic Goods Administration Laboratory Information Bulletin. Australia.

[x] Weatherall, M. (1990). In search of a cure. Oxford, New York: Oxford University Press. pp.v-vi.

[xi] The Age, (2003). Melbourne, Wednesday, 30 April, p. 1.

[xii] Consumerlab.com.Product Review: Echinacea. Wednesday, 2 July 2003. http://www.consumerlab.com

[xiii] Mazza, G. & Cottrell, T. (1999). Volatile Components of Roots, Stems, Leaves, and Flowers of Echinacea Species. Journal of Agricultural and Food Chemistry, 47(8): 3081–5.

[xiv] Perry, N.B., van Klink, J.W., Burgess, E.J. & Parmenter, G.A. (2000). Alkamide Levels in Echinacea Purpurea: Effects of Processing, Drying and Storage. Planta Medica, 66(1): 54–6.

[xv] Livesy, J., Awang, D.V., Arnason, J.T., Letchamo, W., Barrett, M. & Pennyroyal, G. (1999). Effects of Temperature on Stability of Marker Constants in Echinacea Purpura Root Formulations. Phytomedicine, 6(5): 347-9.

[xvi] Choice (2003). Echinacea—Power Pill or Placebo? November: 8–13.

[xvii] Nahin, R.L. and Strauss, S.E. (2001). Research into Complementary and Alternative Medicine: Problems and Potential. British Journal of Medicine, 322:161–4.

[xviii] Medicine Control Agency (2002). Report on the Safety of Herbal Medicines, p. 8.

Take Your Medicine with a Pinch of Salt

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