News - Pharmaceutical Thinking, Health and Nutrition
We have become so used to thinking vaguely that science decides the truth of all, that we don’t recognise the assumptions and basic structures of thought that underlie approaches to health. We need to question what are the foundations of our philosophies, theories, science and practice of health and medicine. The result of ignoring such questions is evident in the confusion that is leading a regulatory onslaught on natural medicine and nutrition, and a highly derogatory attitude from supporters of ‘pharmaceutical medicine’. This article turns the spotlight on drug-based medicine to examine whether it is truly scientific and whether its hold on the medical and regulatory world is justifiable, or in the best interests of patients.
Pharmaceutical medicine is based on the development of new drugs to address widespread diseases, an explanation at a biochemical level for the action of drugs and the acceptance of the double-blind placebo-controlled trial as the basis for licensing new drugs. Regulation is based on the belief that this is the scientific and ethical standard for all approaches to medicine and health.
Science, Statistics and Individual Differences
When comparing symptoms, diseases and normal health across a group of individuals, differences are inevitable, due to the complexity of normal biochemistry and the whole being and environment of the individual. When testing a drug, an end-point of measurable symptoms is defined, and statistical probability averages and simplifies the conclusion of the effect of a drug on these symptoms. The statistical method pushes the profile of licensed drugs toward those that have very obvious, strong effects.
Remedies with more subtle effects on health will not be suitable for this probability model; nor would any process of healing that follows a sequence of bodily states. For example, the healing process described in naturopathy follows the inflammation cycle (established biochemistry and physiology). By allowing body temperature to rise within limits, the activity of many infective microbes is reduced and elimination of toxins increased. This protocol is too complex and individual to result in licensed medicines and is rejected, as unscientific. The pharmaceutical solution to inflammation is simple, measurable and a very blunt instrument – use of steroid drugs can have very dangerous consequences.
Side-Effects, Multiple Prescriptions, Adverse Reactions and Death
Strong side-effects are an inevitable feature of the drug development process. The drug has to be a unique, non-natural chemical and it must produce a clear, strong action in as many people as possible.
Everyone can read the side effects listed on prescription medicines, but there is very great tolerance by regulators and the pharmaceutical industry before considerations of safety come into play. SSRI drugs for depression have ‘suicidal thoughts’ as one of many potentially dangerous, even lethal, side effects in clear contradiction with the licensed use of the drugs. ‘Preventitive medicine’, using drugs like statins, relentlessly promoted to be prescribed to the majority of the population in a certain age range, can open the patient to other serious problems, like muscle pain, rhabdomyolysis, muscle weakness, neuropathy, memory loss and so on. Generally, doctors prescribe more drugs to counter side effects and a list of prescription drugs is standard for most patients, rather than a single drug for a single disease.
Doctors using licensed drugs are not achieving good results – figures for prescription drug diseases and death are alarmingly high. A 1998 US study1 found that more than two million American hospitalised patients suffered a serious adverse drug reaction (ADR) within the 12 month period of the study and, of these, excluding prescription errors, 106,000 died as a result. The researchers found that over 75% of these ADRs were dose-dependent, which suggests they were due to the inherent toxicity of the drugs. The data did not include fatal reactions caused by accidental overdoses or errors in administration of the drugs. If these had been included, it is estimated that another 100,000 deaths would be added to the total every year. The researchers concluded that ADRs are now the fourth leading cause of death in the United States, after heart disease, cancer and stroke.
The pharmaceutical industry, from the foundation of its scientific view, is set on a course of producing drugs with high levels of side effects and, thereby, manifesting serious health problems in a significant proportion of patients. It addresses those problems by recommending yet more drugs.
Side effects are very rare in nutritional and natural medicine because the remedies used are part of natural biochemistry. Death from overdose is almost unknown.
Placebos, Science and Mind
A placebo is a neutral substance that can be given in place of the drug being tested to give a baseline measure of no effect - theoretically. Again, the theory does not hold. In experiment after experiment, the effect of placebos is seen to be strong. In Natural Medicine Company clinical trials, one placebo effect was so strong (reduction of symptoms by over 40%) that it obscured the effect of the treatment. The fact that many people recover from illness when treated with a ‘medicine’ with no known physiological action shows that our view of health and illness needs to include this as a fact within our theory of health, and develop it as a benefit, without side-effects, risks or other costs.
The effect of perception and belief is deliberately ignored by pharmaceutical medicine, in order to achieve what is thought of as objective, scientific certainty. This very illusion of certainty has a placebo effect in itself. It is highly plausible that trial subjects feel the side effects of drugs as an indication that
they are ‘real medicines’ and not placebos. This factor is not considered in any drug trials. The thought that a drug may be ‘no more than a placebo’ is rejected by pharmaceutical medicine and projected onto natural medicine.
Proof in Pharmaceutical Medicine
A biochemical / pharmacological explanation for the action of a drug is required for licensing. However, since drugs are not natural biochemicals, but engineered molecules, this explanation may be speculative or based on assumptions of equivalent action that cannot be proven. Biochemistry is a real science, based on observation, lawful processes and real proof, that is seldom available for drugs.
Trial results are considered proven if there is a low probability of being a chance occurrence – less than 5% is considered low. ‘Chance’ and ‘probability’ are, of course, not real causes – one process can only be caused by a preceding one that has an intimate and lawful connection. In clinical trials, statistics are an aid to make inferences, guesses, about what is happening and are used because of the confusion of different factors that could all affect the process being studied. Statistics are used appropriately in social sciences and policy making, not objective science, which works according to laws.
The assumption that reduction of defined symptoms is a cure of a disease is not logically correct, because the concepts of the disease and cure themselves are not proven in the trial. The concepts are used to set up a hypothesis that the drug will reduce certain symptoms. In pharmaceutical medicine, the result is ‘proven’ only relative to the concepts used to define and measure the disease, symptoms and cure in that experiment.
The Effect of Experimental and Medical Staff
Making a trial ‘double-blind’ means that the clinical and experimental staff do not know which is the drug and which the placebo until after the trial, when the code is broken and, thus, differences are averaged out. This would seem to improve the reliability of observation of the drug’s effect. We all know that a good doctor, with a sympathetic approach and keen intelligence, will make us feel much more confident and that this, and other human qualities, can have real effects on health and wellbeing, particularly where there are psychological components to the illness. But, when it comes to the practice of medicine, the whole issue of patient care and the effect of the doctor on patients’ recovery is commonly dismissed as unscientific.
There is plainly a case for considering the effects on disease and recovery of the emotional, mental and spiritual state of the patient and the ability of the doctor or healer to improve that state. From personal experience, I know that the role of the patient’s family and friends in a hospital setting is seldom recognised and that the role of the patient’s interpersonal life in their health and recovery is severely underestimated in medical training.
Diseases require diagnosis by a real human interpretation of symptoms. The ‘Star Trek’ fantasy of a machine that can give an objective readout of a complex biochemical and physiological state is simply that - a fantasy. Diagnosis brings into play the whole theoretical basis of medicine. There is a conceptual loop, where pharmaceutical medicine defines diseases in a particular way, because it has developed drugs to cure or improve those symptoms.
Pharmaceutical medicine reduces the role of the doctor as healer and diagnostician to a minimum, and dismisses the possibilities of healing by other methods as unscientific.
Dangerous, Distorted Molecules and Licensed Medicines
The process of clinical trials leading to licensing as a prescription medicine is at the core of establishing rules for medicine and health in Europe and most other countries, and it is based firmly on pharmaceutical thinking.
Pharmaceutical R&D companies investigate new chemical entities, in their search for effective and profitable drugs. They do not look at natural substances because these cannot be patented and, therefore, anyone can produce an identical medicine and undermine the company’s sales. This understandable need to pay for expensive research - by securing the sole rights to profit from a new drug - has a major downside: the drugs that are licensed are deliberately distorted versions of natural biochemical molecules and that distortion inevitably leads to different properties, including dangerous side effects. Pharmaceutical medicine is keen to demolish natural medicine and to ban natural substances that can be effective medicines in the place of its own, expensively gained, exclusive and enormously profitable drugs.
Unethical, Unscientific and Unstoppable
Pharmaceutically-funded scientists have admitted to extraordinarily high levels of falsification, fabrication and other misconduct, and doctors and publishers are not immune from bad science and illogical prejudice. This is so prevalent that the whole basis of medical and pharmacological research should be questioned:
In a 2009 survey by Dr Fanelli of Edinburgh University, ‘a pooled weighted average of 1.97% of scientists admitted to have fabricated, falsified or modified data or results at least once –a serious form of misconduct by any standard – and up to 33.7% admitted other questionable research practices. In surveys asking about the behaviour of colleagues, admission rates were 14.12% for falsification, and up to 72% for other questionable research practices. Misconduct was reported more frequently by medical / pharmacological researchers than others. Considering that these surveys ask sensitive questions and have other limitations, it appears likely that this is a conservative estimate of the true prevalence of scientific misconduct2.
This misconduct is a shocking condemnation for any group calling themselves scientists. When a whole body of professionals ignores the basic questions of scientific methods, laws and principles and accepts a form of medicine and drug licensing on flawed assumptions and flawed practice, it is a matter of grave concern. If they go on to take a partisan position, promoting forms of treatment distorted by economic considerations and prejudices, we should recognise that we are very far from a real medicine, based on truth, science, ethics and awareness, and are, in fact, allowing a flawed and unethical form of medicine to dominate our society.
The rise of the natural sciences made it possible to understand the human body in entirely new ways, with the background of biochemistry and physiology becoming the new context of medicine and scientific method raising the standard of knowledge. During the tremendous growth in wealth, urban living and industrialisation of the nineteenth and early twentieth centuries, great improvements were made in dealing with infectious diseases by improving sanitation and hygiene, and the meagre diets of the working and lower classes were gradually improved. These factors, more than anything else, reduced infant and adult mortality rates and gave modern societies the expectation of a longer and healthier life.
Pharmaceutical medicine did not become conventional medicine until the advent of antibiotics, which changed the prospects of recovery from war wounds and infectious diseases very radically. From the beginning, pharmaceutical companies and the medical establishment began working together to dominate medical science and the practice of medicine and, ultimately, the government bodies controlling health and medicine. There are hundreds of recorded examples of attack and outlawing of traditional and natural approaches, the epithet of ‘quack’ and worse being used to devastate true healers and more dubious practitioners alike, which show that the current situation is the culmination of well over a century of deliberate conquest and domination.
Although there are many well-intentioned and ethical people involved, there is currently no way to penetrate the mindset of authorities and regulators to question the very real issues at the heart of drug development, clinical trials, licensing, regulation, laws governing all forms of medicine, and the supremacy of this distorted thought in institutions, politics and media.
Health, Nutrition and Natural Medicine
Whereas the basic concepts in pharmaceutical medicine are disease and cure, the theory of natural medicine is founded on the principle of Health as the biochemical and physiological state that the body is designed to maintain and restore, given the right conditions, including adequate nutrition. The body may be challenged by stresses, infections, accidents, genetics and so on, but the central, inbuilt principle of health involves a continuous self-regulating activity that encourages a return to that state. Emotional, mental and spiritual life have extremely important parts to play in maintaining health and any theory of natural medicine must bring understanding of these realms to bear.
The theory of nutrition focuses on the maintenance of health and uses biochemical and physiological knowledge to suggest nutritional strategies that might help restore health. Body processes in all their intricacy are initiated and controlled by DNA / RNA blueprints and the enzymes, co-enzymes, hormones and neurotransmitters that catalyse reactions and coordinate biochemical processes into a physiological system. Nutrients, including vitamins, minerals, amino acids and other nutrients are basic in constructing enzymes and other catalysers and are, therefore, potent in normalising the whole body toward health.
Nutritional Medicine began with the knowledge and use of food as medicine, which has been accumulating throughout biological time. Modern nutritional science began with the study of deficiency diseases, where there is a clear connection between the lack of a single nutrient and a departure from health, with symptoms that can be traced directly to the interruption of a normal biochemical process or cycle.
Knowledge of the beneficial effects of nutrients has been extended enormously in the last half century, through increasing understanding of biochemistry and physiology, sciences that are based firmly on scientific observation and laws. Theory and clinical and personal experience produces hypotheses that are tested and confirmed by experiment. There have been countless scientific experiments, some using randomised, placebo-controlled clinical trials, some using scientific methods to discover the chemical basis and physiological effects of nutrition and others using survey methods and other accepted scientific experimental methods. This provides adequate levels of proof of the support of health for a great majority of nutrients available. Far less research has been attempted to prove that a single nutrient can ‘cure a disease’, other than a deficiency disease, but this drug approach is not appropriate to nutrition and there are many nutritional factors involved in every imbalance.
The safety of nutrients is sufficiently understood (but not accepted by the authorities), with a wide margin between normal body levels and toxic levels, and adverse reactions and deaths from nutrient overdose are absolutely negligible - nutrients do not force biochemical change, like drugs, but help restore normal processes. Now, tremendously exciting scientific work is threatened by arbitrary decisions on maximum levels of nutrients.
Inappropriate Regulation and Health
The authorities are demanding inappropriate types of proof for health claims, as if health is some special set of symptoms that can be tested, like drugs and medical claims. The register of nutrients and ingredients that can be sold requires an inappropriate level of proof, equating the complexes of foods with the chemical purity of drugs. Maximum levels of nutrients are set at the RDA in some countries, meaning that nutrients can only be used to prevent frank deficiency and the principle of maximum safe levels has not yet been accepted. There is a problem of logic here – the committees working on regulations, examining claims and registrations are dominated by pharmaceutical thinking. They reject applications that are backed by biochemical and physiological knowledge, but do not relate a specific molecule to a specific aspect of health, as if this were a drug, tested on disease symptoms.
The EU is overwhelmed - the committees are completely confused between nutrition for health and drugs for disease but at least they know that they should be in charge! There is no understanding of health as a natural state of the body. The tragedy is that this approach is potentially devastating to natural and nutritional approaches to health. If nutrients are not to be regulated out of the market, the cost of trialling and licensing nutrients becomes comparable to trialling and licensing drugs: all this without the same patent protection, the same access to major healthcare systems, or the industrial and economic systems that support the gigantic pharmaceutical industry. The battle for free access has been lost for herbal supplements in Europe. This is a real tragedy for humanity and one that has been allowed to happen because of the overwhelming dominance of pharmaceutical thought.
Ordinary people recognise the importance of nutrition and natural medicine to maintain their health, and the great dangers of relying on toxic drugs. Everyone can understand what is meant by health because we can feel it directly in the body. It is a natural state and not something we have to discover, and have confirmed, by science. However, this is not enough. We who are involved in the practice of nutrition and natural medicine must take hold of the foundations of thought in medicine and science. We must expose the rational, moral, logical and critical bankruptcy of pharmaceutical medicine and the economic and political imperatives that have propelled it into domination. We must be able to present real and effective alternative natural medicine and nutrition: based on firm theoretical foundations with Health at the core. This entails appropriate use of science, clinical and historical knowledge, and the practical demonstration that it works to maintain health in harmony with the body. This will be the mission of critical importance in the coming decades.
Please lend your support whenever possible to the protest about the EU supplement regulations that threaten our rights to receive and supply health information, nutritional supplements and natural medicine. Make your views clear by writing to your MP and MEP, or join the Consumers for Health Choice campaign sign-up!
Brian and Celia Wright founded Higher Nature in 1994 after 15 years of pioneering work and education in nutrition, based on a clear, ethical proposition. The company maintains the highest possible quality standards of product formulation, sourcing and manufacture, and aims to provide information and services to match or join the Comsumer for Health Choice campain, sign up!
In 1997, they set up The Natural Medicine Company with a highly qualified medical and pharmaceutical team, to take a natural progesterone cream on the journey toward a full pharmaceutical licence, and conducted clinical trials up to phase 3 level. In 2004, the completion of the project was suspended after the exit of potential pharmaceutical partners from the HRT market (following the news of high risks for conventional HRT users), resulting in no possibility of the funding or market development required.
Following the death of Celia during surgery in February 2009, both companies continue with the same inspiration, principles and dedication to Health.
1. Jason, et al. (Lazarou et al), Incidence of Adverse Drug Reactions in Hospitalized Patients, Journal of the American Medical Association (JAMA), Vol. 279. April 15, 1998, pp. 1200-05. Also Bates, David W., Drugs and Adverse Drug Reactions: How Worried Should We Be? JAMA, Vol. 279. April 15, 1998, pp. 1216-17.
2. Fanelli D (2009) How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data. PLoS ONE 4(5): e5738. doi:10.1371/journal.pone. 0005738