As with many countries we have a lot of complementary and alternative medicines on the store shelves, which often includes those of pharmacies. As with many countries, people go to ask their GP about such drugs ranging from herbal medicines to vitamins etc. Ginseng is one of these drugs which is even promoted through medical representatives, as an additive in vitamin preparations. Ginseng is one of those which has been studied somewhat. But the problem with many other products is that the GP may simply not know what effects such preparations have. A medical doctor is trained mostly in the prescribing and knowledge of drugs which have been approved by drug administrations following intensive studying and drug trials and follow-up on side effects. Such would not be available for many powders and pills which the client takes to the doctor. This has led to a situation in which doctors do not highly recommend things which are even bought in a pharmacy. Two common classes are slimming products and vitamin supplementation.

Whilst it is true that a pharmacist who is selling an item should be in a position to explain the drug, it is often the case that much of the content has not been studied adequately. I am sure that pharmacists go through pains to explain to patients the limits of such formulations, but on the other hand they also have the competing interest of selling and it would simply not be wise to put something on the shelf when one intends to put patients off. Conversely once something has not been shown to be harmful, one cannot prohibit its sale especially if local authorities approve it as a non-medicinal.

So where does the difference between these drugs and those which we prescribe lie? Prescription drugs go through a thorough process of study. When a drug company researches and wants to develop a new drug, a whole process of research–ethics approval has to be met and the drug has to go through various phases of research. This history of drug development follows the thalidomide tragedy which many people still remember. For thousands of years, herbals were the mainstay of treatments. At the end of the nineteenth century one had the development of biological drugs such as codeine, morphine and quinine. The first semisynthetic drugs, such as vitamins, vaccines and oral contraceptives came out in the 1930s and 1940s, following by drugs developed for molecular targets in the 50s. Drug approval was based upon proof of safety; a situation which clearly needed to be changed following the severe congenital defects (including babies born without limbs) of Thalidomide. By 1962 strong safety demonstration was necessary. Within this context however the attitude towards the herbals and other former preparations did not change.

What we had was a change in attitude towards synthetic drugs, which therefore created a rift (I would say imaginary) between ‘natural’ and ‘medical’ drugs. At the end of the day even a natural drug is a drug and many poisons exist in nature in the form of herbs and plant secretions.

In order to be able to understand and advise patients better on all alternative and complementary preparations, one would need to assess them with the same rigour that ‘medical’ and synthetic drugs are assessed. But this costs money and the problem would be finding bodies which are willing to pay for such research. Nowadays 98-99% of drug research is sponsored by pharmaceutical companies, leaving only a mere 1-2% being funded by universities. The reason is that without the help of business and industry, medicines would not be produced. We cannot induce altruism, and often only those drugs which produce a profit are researched. Society should change this, as this column has often said before. We should levy the pharmaceutical industry, which after all is profiting from the ailments of sick people, to study and produce even that drug for the rare disease, and perhaps study these herbal and alternative medicines.

In order to get an idea of how complicated the process is to get a drug approved, even after all the investment of researching the drug and producing it in a swallowable form, one need only look at the four phases of what has become the golden standard of drug research. In Phase 1, the new drug is administered on healthy individuals. These are usually healthy volunteers and they are small in number. They need to be healthy so that no disease or body disorder interacts or affects what the drug does to the body or vice–versa under normal physiological conditions. There are inherent risks here, even though the drug would usually have been studied on animals beforehand. Only recently, two students died in the UK in this phase, and it is a stage which is highly scrutinised.

The second stage, Phase 2, is a first evaluation of the efficacy and safety of the drug on patients. It is also at this stage that one identifies the correct doses. The number of people participating in this phase ranges into the hundreds. But the gold standard is Phase 3 where we have what has come to be called the Double-Blind controlled study. Here patients are given either the drug being studied or the drug against which this new drug is being compared. The patient cannot know, as otherwise one cannot eliminate psychological conditioning – if I know I may be receiving a good drug I may be affected either way as to whether the drug works on me or not. But it was found that if the doctor knows what the patient was receiving, there may be conditioning in the selection of patients who get one drug or the other – even though the doctor is supposed to be in what is called ‘clinical equipoise’, that is, he is supposed to be neutral. In effect this neutrality can only be a moral position but no-one has control over subconscious decisions. Therefore both patient and researcher have to be ‘blind’ as to who is receiving the drug under study or not – hence ‘double-blind controlled trial’. It is the researcher who would then have the code and is able to notice whether the drug under study did significantly better than the other. This stage involves thousands of patients and one can imagine the cost involved.

There is yet another phase after the drug has been approved for marketing. This Phase 4, is a long term evaluation of benefits and risks, cost vs effectiveness, efficacy and long term safety etc. At this stage doctors will have a better idea of how cost-effective a drug is and its risk/benefit ratio – that is whether its risk of side effects balance well against the good that the drug produces. Indeed this information is what is necessary to tell patients. Patients want to know the possible side-effects and any harms that a drug does. But how can a doctor know this without this kind of solid evidence. It would be mere speculation and based on individual experience – something which does not hold strong ground.

What concerns doctors mostly however is that after giving someone a drug for a condition, a patient, desperate to find a cure, is given the advice to stop the drug because, what used to be called quacks, but today hide under generally acceptable names like nutritionists or beauty therapists, stop the drug. It is not the first time someone has his acne treatment stopped in order to be encouraged to use a particular cream or soap. These therapies should only be complementary and if they cannot be used as such but need to be alternative there are clear implications. Unfortunately many such people with qualifications amounting to a six weeks correspondence course, or an apprenticeship in a saloon, are out there playing professor. Unfortunately friendship and trust builds and some people foolishly believe them. The doctor is portrayed as the enemy because he or she advises against such things and because he can only give you what is impudently called ‘chemicals’.

What we need to understand is not only the safety of such alternative medicines, but also in what doses they actually work well. There is a window, called the therapeutic window, below which a drug simply does not work, and above which it causes harm. This information is often unknown for the many alternative medicine which have not been studied. Moreover you often find products which as much as 40 items listed on the side of the container. Not only do we not have the information on each individual item, but let alone the information how they work when you put them all together in a cocktail.

The point here is not to act as the scaremonger, but to put people on their guard and heed the advice of both pharmacist and physician. One should balance the cost against any effect to be given. Just because something is herbal does not mean it is without side effects. We often think that the magic word ‘herbal’ means ‘natural’ which in turn means without any possible harm. And in turn we often have to enquire whether people presenting with, say, palpitations, are taking any powders, drinks or herbal pills to lose weight, which tend to work on the bodies’ metabolism.

Without knowledge of the therapeutic window, we simply cannot judge a drug. At low doses it may be safe but not effective and vice-versa. We now know, for example, and because it is being studied, that Omega 3 is effective only in large doses which are not found in the normal preparations. You need, example, almost three times the amount found in current over-the-counter preparations in order to have adequate protection for the heart. Whether these high doses, in the long term, would be harmful in any way, we still do not know as not enough time has passed since it was introduced. Now Omega 3 is something which the medical world looks at with hope and it is studied by both pharmaceutical industry and researchers in universities. There are many alternative drugs which we know nothing about until they cause harm. It was found that a Chinese preparation for joint pain, labelled as having only natural products, contained steroid – a strong anti-inflammatory. Yet many people in my practice had these in there homes and thought the world of them because they thought they were backed by the tradition of Chinese medicine. Not all that contains the word ‘Chinese’ carries the same reputation as Chinese Medicine itself.

If we can teach the public to raise its awareness and its antennas when they hear words like ‘natural’, ‘herbal’, or some oriental name, we would have gone a long way to protecting people from harm. It is true that much of the medicines we take are synthetic; but they have been studied, tried and tested and are safe within a therapeutic window which the doctor knows about. When a doctor tries to explain that something has not been tested, one is taking a risk which ironically they often are not willing to take with a simple panadol. What is worse, it is these people who more often than not fall for these adjectives because of their fear of drugs.

Pierre Mallia is Associate Professor in Family Medicine, Patients’ Rights and Bioethics at the University of Malta; he is also Ethics Advisor to the Medical Council of Malta. He is also former president of the Malta College of Family Doctors.