Can the scientist and the shaman be friends?
by Kathleen Lucia, EAU Vice-President

Growth in the take-up of various forms of traditional or alternative medicines is booming. The world’s policymakers have decided that they are too big to ignore and too useful to discourage. They want traditional and science-based medicine to work together. Is that possible?

Increasingly, over the past 40 years, providers of complementary and alternative medicine (CAM) have been doing a brisk trade in a vast array of healthcare products and services. Now this business is very big indeed. According to Themedica.com, a medical business-to-business web directory, the global market for herbal products is now worth US$120bn, for homeopathic medicine, $2bn and for aromatherapy products, US$400m. In the UK one in five adults are regular CAM customers making an annual spend that even in times of economic austerity, may well exceed US$5bn, 50% up on a decade ago. And globally, the “nutraceuticals” market in vitamins, minerals and similar supplements is estimated to be worth around US$200bn, led by EU and US consumers.

National and supranational decision-makers now worry, of course, about the lack of regulation in the sector. They cite counterfeit, poor quality, or adulterated herbal products as a particularly serious threat to consumers in international markets as demand puts pressure on supply. And treatments involving physical manipulation or intervention, although far less commonly used, are gaining in public popularity and are therefore also judged in need of regulatory supervision.

But the general thrust of this concern is to make CAM respectable. Regulatory structures are emerging in most developed countries, especially where CAM therapies already form part of a state-sponsored offering. CAM treatments have made sizeable inroads into the primary care provision of state funded health systems around the world as the cost of mainstream medicine has soared. Although the UK’s National Health Service has been rowing back on its CAM offering over the past few years, around half of general medical practitioners recommend some alternative therapies to patients. Even when offered free or at low cost, these treatments have been seen to represent a big saving on the drugs bill.

The herbal products industry, by far the biggest segment of the CAM market, has been braced to receive the EU Directive on Traditional Herbal Medicinal Products. From the end of April this year, all herbal remedies have to be in compliance. Broadly, those that have been on the market for 30 years (before 2004) must hold a Traditional Herbal Registration (THR). Products that have been on the market for less than 30 years before 2004 must obtain either a product license or market authorization. There are many grey areas and layers of complexity to negotiate here, but how the rules apply depends on whether or not products are classified as botanical under food law; are available only from herbal practitioners, or make no medicinal claims.

In January 2009, the UK industry received a new regulator, the Complementary and Natural Healthcare Council (CNHC). This is partly funded by the UK government, partly by the charitable Prince Charles Foundation for Integrated Health. The Council, which registers anyone signing up to its code of conduct who can show evidence of training and evidence of insurance, very quickly recruited more than 10,000 members, although most therapists also sign up to their own, therapy-specific, trade organisations. Memberships may be relatively costly, but are generally seen to be worthwhile for the cachet they may confer.

Australian academic, Dr. Hans Baer, suggests that CAM is one of the ways the Australian government has been using to contain healthcare costs, supporting training programs in chiropractic, osteopathy, Chinese medicine and naturopathy in public colleges and partnerships between private CAM colleges and public universities. CAM training is much cheaper than conventional medical training and, even better, the government does not have to fund the use of CAM therapies by patients. Users have to pay out of their own pockets or through private insurance.

CAM is not, therefore, automatically the cheap option for users. And director general of the United Nations sponsored World Health Organisation, Dr. Margaret Chan, says the success of the business is an indictment of inadequacies in the delivery of conventional treatments: “This is not the poor man’s alternative to conventional care”, she says. “Recent studies conducted in North America and Europe indicate that these remedies tend to be used most in groups with higher incomes and higher levels of education. In many cases, the costs are not covered by medical insurance schemes. The use of these complementary and alternative therapies has become a multi-billion dollar industry that is expected to continue its rapid growth”.

All this has sharpened the alarm and resentment of many in the orthodox medical professions who see CAM as nothing more than a gigantic confidence trick on the suffering masses that governments have no business to encourage. Their case can be summed up as follows:

• To categorize medicine as either conventional or alternative is grossly misleading. There is only medicine that works and medicine that does not.
• Any therapy that passes rigorous evidence-based testing and is proved by this method to be safe and effective may become a conventional treatment. Other therapies remain “alternative” simply because there is no evidence that they work.
• When they appear to work, it is simply the result of a psychological ‘feel-good’ response to receiving some care and attention - the placebo effect – and serves simply to delay people in seeking out proper medical attention, a delay that could be fatal.
• CAM proponents seem to have little or no interest in applying scientific method to their treatments by submitting them to independent clinical trials and testing. Instead, they continue to rely on anecdote and speculation.
• CAM practices remain unchanged despite the massive expansion of human knowledge and understanding of physiology, particularly over the past century. This ages-long stasis can only be seen as indicative of, at best, resistance to constructive thought and, at worst, willful, dangerous or even criminal ignorance.

In short, those who sell CAM therapies are fools, frauds or both. But are so many millions of regular consumers the willing victims of charlatans? And are policymakers recklessly exposing their voters and taxpayers to healthcare rackets? There can be no clear cut answers, at least until these treatments undergo serious scrutiny and, maybe, not even then.

In the meantime, CAM proponents have plenty of criticism to level at orthodox medical practitioners, with some support from the WHO’s Dr. Chen, who says: “What explains the sharp rise in the use of complementary and alternative medicines? Some commentators in journals such as the British Medical Journal, The Lancet, and the New England Journal of Medicine interpret this trend as a biting criticism of high-technology, specialized medicine, despite all its well-documented merits. Medical care has become depersonalized; some would even say “hardhearted”. In most affluent countries, the number of family physicians and primary care doctors continues to decline. The trend towards highly specialized care works against a sympathetic doctor-patient relationship. In too many cases, the patient is no longer treated as a person, but rather as an assembly line of body parts each to be managed, often with great expertise, by an appropriate specialist. In the views of at least some commentators, the rise of alternative medicine is a quest for more compassionate, personalized, and comprehensive health care”.

CAM proponents argue that although scientific method may represent the triumph of intellectual rigor over superstition, it is far from incorruptible. First, its application can be complex, difficult and expensive. Research projects may be badly designed and poorly executed; it is hard to design bias out of clinical trials, especially as so many are based on people already in hospital or undergoing long-term medical care. Poor controls can fatally skew data and even double blind trials can turn out not to be. But even when data quality is beyond reproach, it is still open to misinterpretation. Equally, research based on literature review and historic data analysis is another skilled job that easily can be muffed.

There is the constant suspicion, too, that the relationship between medical practitioners and the big pharmaceutical companies is unhealthily close when patient data is so commonly used in trials and surveys and when pharmaceutical sales representatives make regular ‘house calls’ to primary care centers.

And then, concerns abound over scientifically tested and “proven” remedies, about which there appear suddenly to be serious second thoughts. Two examples spring instantly to mind: first, the mass medication of millions of UK citizens with statins. These drugs are among the world’s top-selling treatments, widely used on otherwise healthy middle aged and older people to lower blood cholesterol levels and, it is thought, thereby greatly reduce the likelihood of their developing heart disease.

But a recent review of research by the Cochrane Heart Group at the London School of Hygiene and Tropical Medicine indicates that although statins reduce death rates in those who suffer from heart disease, there is scant evidence to justify using them on people at low risk of developing the disease. Further, little work has been done on the long term side effects of this medication, which people are expected to take for the rest of their lives, although evidence has already emerged of serious side effects, including liver problems and kidney failure.

Similarly, the jury is out – again – on another drug massively prescribed in low dosage as a preventive treatment against strokes, heart attack and, possibly, some cancers. This time it is the very old drug, aspirin. Again, new studies suggest that aspirin may not be helpful to people who have no history of heart problems and should not be prescribed to healthy individuals. Aspirin has long been known to cause internal bleeding in some people. There are further worrying aspects of these cases:

• Both drugs have been used to mass medicate millions of people who are not ill.
• The stated aim is to prevent the later suffering of people, but there is also the inescapable incentive to lower costs. Healthcare bean counters around the world are bound to favor this approach over the much more expensive treatment of existing heart diseases and strokes, but the present trend is exposing well people to greater risk than many would willingly choose.
• Although all practitioners acknowledge the obligation to do no harm, orthodox prescribers cannot be sure that they are doing no harm when using drugs in this way, any more than can a CAM practitioner who has no understanding of modern physiology.

All this serves to fuel the unsettling thought that users of orthodox medicine are little more than guinea pigs in vast experiments to find ways to save costs in state provision and turn profits for pharmaceutical companies. But on the positive side, the fact that the state of knowledge is constantly being increased and updated demonstrates the immense dynamism of scientific medical research. It is fair to assume that any real breakthroughs in our state of understanding will not come from any traditional or CAM therapy.

But the real joker in the pack is that strange and powerful phenomenon, the placebo effect. This is the individual patient’s response to treatment – any treatment, be it active or dummy and to all medications, be they powerful drugs or just sugar pills. The placebo effect is still far from understood, but it is thought to be a conditioned response that stimulates the release of endorphins in the brain, which block pain and induce euphoria. This response is thought to have much to do with the patient’s faith in the treatment, confidence in the doctor and the subsequent lowering of anxiety. Subconscious associations between the experience of being treated and of recovery are also thought to be a powerful contributor to the placebo effect and may explain why sometimes sugar pills seem to work, even when recipients are told that they are being given sugar pills. The effect, then, is very real indeed.

So far, the consensus view is that the placebo effect is transitory and does not actually alter the course of a disease. Yet there is also some evidence that the placebo effect can trigger long-term physiological outcomes, possibly by kick-starting the body’s auto-immune response. So CAM proponents can now contend that even if their treatments work only as well as a placebo, that is an entirely acceptable outcome that need not be achieved by “lying” to a patient.

But placebos present a new worry to drug developers. They have been used in clinical trials of new drugs since the late 1940s: today no new drug can be deemed effective unless it outperforms a dummy drug, or placebo. But, reports the magazine Scientific American: “Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills”. The report continues: “The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests”.

The pharmaceuticals industry is now working to understand the placebo effect better, so that it can try to devise trials that clearly differentiate between the effect of a drug and the capacity for the human body to heal itself. Exacerbating the industry’s problem, reports Scientific American, is the trend for pharmaceutical companies to target the growing market for drug remedies for a range of disorders that are directly related to higher brain function - the very types of condition known to be most susceptible to the placebo effect.

Many practitioners, orthodox and CAM, believe that collaboration is the only way forward for both industries. In 2008 the WHO hosted a conference on traditional medicine in Beijing for representatives of 70 member states, intent on finding a workable accommodation between the modern western approach to medicine and the traditional medicine on which up to 80% of populations in the developing world rely. (WHO applies the term “traditional medicine” to that used by people within a particular culture; CAM is the traditional medicine of one culture which is borrowed by another, for example, India’s Ayurvedic system or China’s acupuncture and herbal medicine practiced in the United States or Western Europe.) The organisation has agreed to:

• Support and integrate traditional medicine into national health systems in combination with national policy and regulation for products, practices and providers to ensure safety and quality.
• Ensure the use of safe, effective and quality products and practices, based on available evidence.
• Acknowledge traditional medicine as part of primary health care, to increase access to care and preserve knowledge and resources.
• Ensure patient safety by upgrading the skills and knowledge of traditional medicine providers.

There is something for everyone here. Dr Chan says: “Traditional medicine has much to offer, but it cannot always substitute for access to highly effective modern drugs and emergency measures that make such a critical life-and-death difference for many millions of people. This is not a criticism of traditional medicine. This is a failure of health systems in many countries to deliver effective interventions to those in greatest need, on an adequate scale.

“Over a comparatively short period of time, modern medicine has developed powerful methodologies for proving efficacy, ensuring quality, standardizing good manufacturing practices, testing for safety, and conducting post-marketing surveillance for adverse effects. Many, but not all, traditional medicines have an inadequate evidence base when measured by these standards.

“As societies modernize, social expectations for health are rising all around the world. The scientific method is the process by which scientists, collectively and over time, endeavor to construct an accurate (that is, reliable, consistent and non-arbitrary) representation of the world. I believe that the strong calls we are hearing for a renewal of primary health care create an ideal opportunity to revisit the place of traditional medicine, to take a positive look at its many contributions to health care that is equitable, accessible, affordable, and people-centered.

“The two systems of traditional and Western medicine need not clash. Within the context of primary health care, they can blend together in a beneficial harmony, using the best features of each system, and compensating for certain weaknesses in each. This is not something that will happen all by itself. Deliberate policy decisions have to be made. But it can be done successfully”.

Well, maybe.