By Vince Giuliano
There appears to be a Great Divide in the world when it comes to health, manifest most clearly in Western Countries and in the US in particular. The divide is between two major paradigms of thinking, philosophies, methods and institutions used to maintain health and treat diseases. On one side of the divide we have what today is popularly called Health Care. On the other side of the Divide we have the paradigm I will call Wellness – which is actually the current form of Folk Health.
This blog entry updates and amplifies on the theme of my May 2011 blog entry Shift to the wellness-longevity paradigm. I reiterate some of the key points in that blog entry and focus particularly on the dynamics that keep the Great Divide in place. I discuss how new scientific knowledge of certain plant-based substances can contribute to bridging the Great Divide. And I express concern about how that can happen.
This is a long blog entry and if you want to go first to conclusions and suggestions you can scroll down to the final section entitled Wrapping it all up – bridging the Great Divide.
The two paradigms of Health Care and Wellness encompass behavior patterns, educational approaches, major institutions, government policies and agencies. The divide is to some extent also between old and new, between East and West, and between how a person decides on what to do about his or her wellness and health. It involves who people trust for health advice, and between what educated people think they are supposed to do and what they actually do.
Though operating in very different spheres, there is some evidence that these two paradigms are increasingly overlapping and moving together. I believe this is a very good thing. In this blog entry I discuss the strengths and weaknesses of each paradigm. I talk about how the two paradigms complement and require each other, and how the process of bringing them together might be accelerated. My primary reference here is the situation in the US, although similar patterns exist in other advanced countries.
First, let me outline the paradigm of Health Care as I see it. Health Care is based mainly on Allopathic Medicine and goes on to encompass vast institutions. Representing about 17% of the gross national product in the US, healthcare and its superstructure include doctors, nurses, dentists, hospitals, medical and nursing schools and clinics, pharmaceutical and biotech companies and institutions like the FDA and the NIH. At the periphery lie health insurance companies, nursing homes and secondary care facilities, government bureaucracies and countless university and private laboratories and research institutions.
The numbers involved in US health care are mind-numbing. The latest CDC report Health United States 2011 lays out some of them. Cost to the US economy of healthcare was $1.2 trillion in 2000 and $2.1 trillion in 2011 and rising at an unsustainable rate. Direct cost of care was $4,122 per individual in 2000 and $6,797 in 2011. And these costs do not include suffering from diseases, lost time from work for individuals and employers, loss of productivity, and care provided by unpaid caregivers.
The Health Care system facilitates progress in many important dimensions. But the relationships among central players also limits progress in overall public health
What drives or limits progress in Health Care? What is the source of innovation? What inhibits innovation? The answers are complex and multi-facetted, but I think they lie mainly in the interaction among three central groups of players: 1. MD doctors and the medical schools and boards that train and discipline them, 2. The pharmaceutical, biotech and medical technology industries that convert research knowledge into practical drugs and educate doctors about these, and 3. Government agencies, especially the FDA which sets the rules for how new drugs are developed and released to the public. Only doctors and a few other highly licensed practitioners can prescribe legally-sanctioned drugs. An individual can’t just go to the drugstore and buy them as in some countries. The doctors and the public are educated about new drugs by advertising, promotional activities, and “detail men” paid for by the pharma companies – activities that may cost hundreds of million dollars for one drug. Usually, more is spent on marketing and distribution than on the R&D required to develop a drug. New drugs are developed typically through the course of an 8-15 years period of research and development, culminating with Phase 1, Phase2 and Phase 3 clinical trials. These trials are overseen by the FDA and alone may cost from one to several hundred million dollars. Between R&D and marketing the cost of researching, developing and getting out a new drug may exceed a billion dollars. No wonder that big drug companies aim new drugs at massive markets and the business model is like that for blockbuster movies. There are “fast track and accelerated” FDA approval provisions for “orphan drugs” aimed at rare diseases, but even getting one of these developed and to market may cost $100 million dollars and it may require over 5 years to do so.
Medical doctors are highly trained, regulated and respected in our society. They function within practice frameworks prescribed by law and by rule-setting professional associations like the American College of Cardiology, the American Association for Thoracic Surgery, the American Academy of Pediatrics, etc. Few doctors will administer or prescribe treatments that have not gone through the FDA approval process and that are not mainline in their professional subspecialty. One reason is that straying beyond FDA and association-approved medications engenders a risk of ruinous lawsuits. If a treatment prescribed is not an established standard of medical practice and someone claims to be harmed by that treatment, the doctor is at risk of ruin. Use of standard and government approved drugs provides badly needed legal coverage in case of such commonly-occurring lawsuits. Another reason, sadly, is that doctors, being extremely busy as they are, may simply not know about highly effective alternative treatments in Wellness which have been highly researched and found effective but which are not FDA sanctioned. Physicians get much of their drug information not from reading research journals but from pharma company representatives that are constantly calling on them. As a result, I believe there are numerous effective alternative treatments that are locked out of medical practice. By-and-large, allopathic physicians do not know about them. They live in limbo.
Health Care is basically a repair-oriented industry
The main context of Health Care has been repair rather than regular maintenance. For the most part, patients invoke Health Care to fix a problem when it manifests itself. You have a sore throat or a serious pain, you see a doctor.
The most serious problem with the repair-oriented paradigm of Health Care is that by the time a serious degenerative disease problem shows up, it is frequently too late effectively to do anything about it. Too many aging-related diseases like Alzheimer’s disease, Parkinson’s disease, ALS and many cancers are simply not curable. And for them a diagnosis is like a death sentence. Early-detection biomarkers for more and more of these diseases are being identified and there are a number of simple preventative maintenance interventions that can be applied to forestall actual diseases from emerging, even when there is a genetic risk factor for them. However, the concept of Preventative Medicine is only now starting to receive semi-serious attentions. For most of us, Preventative Medicine within the Health Care paradigm means relatively superficial checkups. Blood pressure and pulse is checked at every office visit to a doctor. An annual physical exam involves a few blood and urine tests, the doctor thumping us and looking in our orifices, asking us a few questions. Once every few years there might be a cardiogram, chest x-ray, mammogram, colonoscopy or other diagnostic procedure. For seemingly healthy people however, even aging ones, predictive biomarkers for specific deadly age-related diseases are not looked for.
In the blog entry Shift to the wellness-longevity paradigm, I contrast our Health Care with healthcare for commercial airliners. For airliners, healthcare is mainly about constant checkups and preventative maintenance, not about repair-after-breakdown. An airliner must be inspected before each flight and is subject to a strictly enforced schedule of preventative maintenance required by law. Imagine what it would be like if airliners were in a healthcare system like us humans are – where repairs are initiated only when a problem becomes clearly manifest. For an airliner this could mean an engine stopping or catching fire in mid-air or a flat tire that is only discovered when taking off. The idea is very scary and our airline accident death rate would be many times what it is now.
In all fairness we can’t do preventative maintenance on the body like done on airliners because our system of biomarker indicators for health problems is too primitive, we can’t be taken apart, and we can’t readily have our parts swapped in and out. However by moving in the direction of regular preventative maintenance we could do a lot better than we are doing now.
The term Health Care itself is misleading because the paradigm of Health Care actually cares a lot more about trying to cure problems of health than it cares about maintaining individuals or a population in a healthy state.
How well is Health Care doing?
The answer depends on the perspective. Health care is responsible for many achievements. Sophisticated technologies have been brought to bear on a massive scale, such as the use of MRI machines for diagnosis and interventional radiology for performing surgeries without cutting. A few formerly incurable diseases are now curable, although the treatments are sometimes draconian. More cancers are being cured. People who are walking around would have been dead without triple bypass surgeries or the use of special drugs that address certain deadly and rare diseases. Orthopedic procedures such as knee, hip and shoulder replacements keep many people functional and moving, and there is progress in developing robotic appendages. Measures of health such as longevity, diseases of all causes, infant mortality and disease incidences and cure rates have generally continued to improve year-to-year . See ref for details.
Yet, the US with by far the highest per-capita expenditure for health care, trails many other countries in terms of most key health indicators The WHO Statistics document tells the story, Given that we are the bastion of Health Care and spend so much on it, Why does the US rank as the 49th country in the world in terms of infant mortality(ref)? Why have we dropped from being ranked 23th in 1960? Why are we not even in the top 20 countries when it comes to life expectancy when we ranked 7th. in 1960? And the same pattern exists for most other health statistics related to specific diseases and conditions. Our performance ranks down with that of third-world countries while, all at the same time that we spend at least twice as much per healthcare per capita than in other countries.
Despite hundreds of billions spent by the Health Care establishment on research and ineffective drugs over the years, most of the degenerative diseases of old age like Alzheimer’s Disease, Parkinson’s Disease, solid tumor cancers and diabetes and other metabolic diseases remain mainly incurable. And as the population ages and lifespans become longer, these diseases become more and more important.
Health Care is not the major factor in determining health of a population. Wellness appears to be more important.
The conclusion seems inescapable. There is great concern today in improving the efficiency of health care, controlling health care costs, speeding up the FDA approval process, eliminating unnecessary medical procedures, developing better medical records, etc.. These could be very good things to do. However, improving the efficiency of Health Care is not going to be enough. By itself the Health Care paradigm is incomplete, broken and in key respects obsolete. Unless other initiatives are taken, health care costs are likely to continue to spiral upwards and our relative health performance as a country is likely to spiral even further downwards. . We have to do something else, and I believe the place to look for that something else is in the Wellness paradigm.
Wellness – Folk Health
Wellness, Folk Health, has deep historical roots and includes but is not confined to Folk Medicine. Wellness is not focused on sickness but rather on maintenance of health and longevity. It is comparable to preventive maintenance where steps are taken to prevent debility or sickness sufficiently in advance so that actual debility or sickness becomes relatively scarce. While important aspects of wellness are captured in the traditional Health Care idea of preventative medicine, wellness-longevity goes much further in expectations for ever-enhanced longevity, personal productivity and transformed lifestyles.
As I see it, Wellness encompasses all health-oriented activities that take place outside of the health care (allopathic medicine) establishment. Wellness includes all the things people do as individuals to keep themselves healthy including eating healthy food, fastening seat belts, watching their weight, exercising regularly, using air and water purifiers in their homes and consuming dietary supplements. And Wellness includes public health initiatives.
Historically, the most striking gains in health and population longevity have been due to public health initiatives. In recent history for example, automobile injury deaths and rates of certain cancers have declined due to safer cars and anti-smoking campaigns. AIDS educations has been another important health-promoting factor, as is the use of mosquito netting in the third world to control malaria. Over the last 200 years water treatment and sewage systems have been major contributors to longevity. Some public health gains have been the results of other technological developments. The replacement of horses with automobiles eliminated fecal materials in the streets and reduced bacterial contamination in cities, and modern oil and gas furnaces eliminates the cancerous clouds of smoke from wood burning fireplaces that once hung over our cities. Catalytic converters and other emission-control measures are reducing smog in cities that contributes to pulmonary problems. And today anti-obesity campaigns and public awareness programs about diabetes are kicking in.
Folk medicine, a subset of Wellness, is still the mainly practiced form of medicine in many parts of the world, and is surprisingly vital and growing today, even in the US. “The term folk medicine refers to healing practices and ideas of body physiology and health preservation known to a limited segment of the population in a culture, transmitted informally as general knowledge, and practiced or applied by anyone in the culture having prior experience. — Folk medicine may also be referred to as Traditional medicine, Alternative medicine, Indigenous medicine, Complementary medicine, and Natural medicine(ref).” It is often called holistic medicine. Practiced in almost every country in the world, Folk Medicine has very deep roots in ChineseMedicine and Indian Aryuvedic Medicine. Each of these is thousands of years old and has involved the passage of knowledge from generation to generation primarily by oral means. These and other forms of folk Medicine tend to look at diseases more in terms of perturbations of whole-body systems than in Health Care which is more reductionist. Most forms of Folk Medicine practiced throughout the world are heavily focused on herbal treatments. Folk Medicine is usually passed on by an oral tradition and its practitioners may be trained or be self-declared. They can be known by such names as healers, shamans, bush doctors and curanderos.
Image source. “Dhanvantari (धन्वंतरी), known as an avatar of Vishnu is the Hindu god associated with Ayurveda”
Image source. Contemporary Chinese pharmacy
Folk Health is mainly focused on disease prevention, staying healthy and longevity, and only partially on disease repair. Folk Medicine tends to be concerned with both health maintenance and treating diseases, in most cases viewing the two as intrinsically related. Often, Folk Medicine as well as other practices of Folk Health have strong spiritual and mental wellbeing components. In the US for example, many practitioners of yoga and meditation view themselves as being important contributors to Wellness.
Folk health today – called “wellness”
I believe Wellness is alive and thriving in the US and Western countries with ever-new forms of expression. Like traditional Folk Health it is largely separate and independent from Health Care. Like traditional Folk Health the major focus is on wellbeing, general health and longevity.
One major trend in wellness is that individuals increasingly are taking personal responsibility for their own health. There is no one strong group of respected healers, curanderos or bush doctors in our US society. But there are many groups with their individual wellness-related specialties like athletic trainers, specialized non-medical therapists of all kinds, dietary advisors and TV Wellness gurus, practitioners of homeopathy and naturopathy, and teachers of yoga, tai chi, massage, meditation and acupuncture. Signs of the Wellness paradigm are everywhere in our culture. For one thing, the value of regular exercise is being widely acknowledged: exercise and health clubs are thriving, more and more people are regularly “working out,” there are dozens of new forms of exercise and yoga for everyone to participate in.
Manifestations of the Wellness trend seem to be everywhere. Public policy and institutions are continuing to evolve to better support the health and Wellness trend. Cigarette smoking has already been banned in most public places, cigarettes are highly taxed and their use in the first-world is on the decline. Recently, and New York City has banned large-size sugary drinks in fast-food restaurants. Bike paths are augmenting roads in cities and old railroad lines are becoming hike-and-bike trails. There are hundreds of health and wellness apps available at little or no cost for smart cell phones and computer tablets. New condo buildings are constructed with built-in health clubs. Michelle Obama has launched a crusade against childhood obesity, “junk food” chains like McDonalds have been induced to offer healthier alternatives, and there is a focus on healthier school lunches. These Wellness activities are all supported by the Health Care establishment.
Dietary Supplements in Wellness
Another trend in Wellness is broader recognition of the importance of dietary intake for health and longevity. Supermarkets are offering organic and other forms of “healthier” foods and chains that offer premium healthier foods are thriving.
Dietary health-producing supplements is a large and growing business. “The global nutraceuticals (health-producing dietary supplements) market is projected to exceed US$243 billion by 2015, owing to consumer desire for leading a healthy life and increasing scientific evidence supporting health foods(ref).” According to a CDC report, at least 54% of Americans consumed dietary supplements in 2006 (the last year available)(ref). According to a 2012 medical newsletter: “Sixty-eight percent of U.S. adults take nutritional or dietary supplements, according to data issued Oct. 4 by the Council for Responsible Nutrition’s online Consumer Survey on Dietary Supplements. The council is a Washington-based trade association that represents dietary supplement manufacturers and ingredient suppliers. — seventy-six percent of those who use supplements say they do so regularly, compared with 18% of people who take supplements occasionally and 6% who use the products seasonally, data show.” And I suspect that more often than not, this consumption of such pills is without the consent or even knowledge of individual’s medical doctors. “The US continues to be the largest market for nutrients & supplements in the world in terms of retail sales. In 2010, the US nutrition and dietary supplements market reached USD 28.04 billion compared to USD 25.00 billion of 2009(ref).”
Herbal substances and Wellness
Although Folk Medicine can be practiced in hundreds of different forms and traditions, a common denominator appears to be usages of plant-based substances for healing and health maintenance. And I believe it is exactly these plant-based substances that can provides a needed bridge between Wellness and Health Care.
Remarkably, many of the most important medicinal herbs are found in many very different traditions of Folk Medicine. They have passed not clinical trials but instead multiple trials-by-culture over thousands of years. And for many categories of these Phyto (plant-based) substances, science has recently been discovering how and why they work in terms of gene activation.
These substance do not exist by accident. They have been carefully crafted by millions of years of plant evolution.
They are signaling molecules that govern multiple survival pathways in plants, regulating responses to light and dark, temperature, moisture, resistance to insects, etc. . In many cases the same molecular pathways are evolutionarily conserved in humans. So the substances can produce important gene-activation signaling and health benefits in humans too. Finally, many of the most important health-producing phytosubstances are readily available in foods we can opt to eat and in dietary supplements we can purchase.
One example of a universal health-producing phytosubstances is Bitter Melon. See the blog entry Focus on Bitter melon. This plant (Momordica charantia) “is known as bitter melon, bitter gourd or bitter squash in English, and has many other local names. (including “which include kugua (Chinese: 苦瓜, pinyin: kǔguā, “bitter gourd”); parya (Ilokano), pare or pare ayam (Javanese and Indonesian), pavayka or kayppayka (Malayalam:പാവയ്ക്ക, കയ്പ്പക്ക ), goya (Okinawan: ゴーヤー) or nigauri (Japanese: 苦瓜; although the Okinawan word goya is also used in Japanese), paakharkaai (Tamil: பாகற்காய்), hāgalakāyi (Kannada: ಹಾಗಲಕಾಯಿ), ma’reah (Khmer: ម្រះ), kaakarakaya(Telugu: కాకరకాయ), করলা (korola) (Bengali), ampalaya (Tagalog), muop dang (Vietnamese: mướp đắng) or kho qua (Vietnamese: khổ qua). It is also known as caraille or carilley on Trinidad and Tobago, carilla in Guyana, cundeamor is a small variety very common in Puerto Rico (actually is the Momordica balsamina), “asorosi” or assorosie” in Haiti, and cerasee or cerasse in Jamaica and elsewhere in the Caribbean, including parts of South America (although is known in Portuguese as melão de São Caetano – and Spanish-speaking areas, however is known by the Okinawan or Japanese names in others regions). It is karela in Hindi – and Urdu-speaking areas, कारले (karle) in Marathi. It is known as तीतेकरेला (tite karela) in Nepali. In Suriname, it is known as sopropo. The fruit is called kudhreth narhy (kudret narı) in Turkey, faaga in Maldives, and karavila in Sri Lankan(Sinhalese). Additional local names include hagala kayi(ಹಾಗಲಕಾಯಿ) in Kannada, karla in Bengali and Marathi, kakarakaya in Telugu, and paakal-kaai (பாகற்க்காய்) in Tamil.)(ref). .
How could the same plant show up in so many different traditions of health and medicine ?. World commerce? To some extent perhaps. But, I think mainly not so since usages of the herb appear to predates significant international commerce. And the cultural forms of Folk Health that use the same herb can be very different. I think bitter melon and many other traditional herbs were discovered and incorporated into multiple folk traditions of health and medicine for one simple reason, they actually work to produce health. The most popular medicinal herbs happened to grow wild in a particular area, were consumed randomly by people who lived in that area, they were found to have particular health benefits, and this knowledge was passed down orally from generation to generation.
“Good” supplements and “bad” ones: Not all dietary supplements are equal, either according to research studies or large population tests. This leads some in the Health Care paradigm mistakenly to paint them all as bad.
Although in the public’s mind antioxidants, vitamins and plant and herbal substances may be part of the same mix of little green and brown bottles on the shelf of a drugstore or health food store, studies are showing that they are very different.
- Entries in this blog have gone into detail as to why indiscriminant consumption of classical antioxidants and vitamins like vitamins C and E, beta-carotene and vitamin A and folic acid may do nothing or even have negative health effects – they can interfere with operation of the body’s natural anti-oxidant defense system. And the free radicals that classical antioxidants go after are not necessarily bad; they are essential biological signaling molecules(ref)(ref). While at the same time a great many plant-based substances sold as supplements like curcumin and resveratrol have a hormesis-producing health effect due to their activation of Nrf2 which turns on hundred of natural anti-oxidant and health promoting genes(ref)(ref)(ref)(ref) (ref).
- Large-scale population research supports the same conclusion. But some scientists in the Health Care establishment fail to recognize the critical distinctions between types of supplements and paint them all as bad. For example, a October 2012 article in Gastroenterology and Endoscopy News reported: Use of Dietary Supplements May Raise Cancer Risk: by George Ochoa “Dietary supplements have little to no effect in preventing cancer and may actually increase cancer risk, according to a review published in the Journal of the National Cancer Institute (Martínez ME et al. 2012;104:732-739). Restricting their review to supplements that have been researched in sufficiently powered clinical trials or large observational studies, the authors focused on antioxidants, folate and folic acid, vitamin D and calcium. — Despite early evidence suggesting an anticancer benefit from antioxidants, clinical studies have not borne out that promise, the authors said. For example, b-carotene does not prevent recurrence of non-melanoma skin cancer (Greenberg ER et al. N Engl J Med 1990;323:789-795); b-carotene and vitamin A do not protect against lung cancer (Omenn GS et al. N Engl J Med 1996;334:1150-1155); vitamins C and E do not protect against total cancer incidence (Gaziano JM et al. JAMA 2009;301:52-62); and a-tocopherol, vitamin C, and b-carotene do not protect against total cancer or cancer mortality (Lin J et al. J Natl Cancer Inst 2009;101:14-23). — However, several trials have shown evidence of an increased cancer risk from antioxidants, the review authors, led by María Elena Martínez, PhD, at the University of California, San Diego, reported. One such study, conducted in a population at high risk for lung cancer, found a 39% increase in lung cancer incidence in the b-carotene arm compared with the placebo arm (Omenn GS et al. N Engl J Med 1996;334:1150-1155). — Similarly, the authors did not find evidence that folic acid and folate protect against cancer, whereas they did note evidence of increased risk for cancer from long-term folic acid supplementation. They found insufficient evidence to draw conclusions about vitamin D, and “diverse results” regarding calcium. — Many expert groups have reached a “general consensus” that “nutritional supplements have little to no benefit in preventing cancer,” the authors wrote.”
The quoted “general consensus” statement paints all nutritional substances as equal and is not at all justified by the research cited. This statement can be viewed as propaganda in a war the pharma industry is waging against the dietary supplement industry, a war I describe below. The public could benefit considerably from better and more authoritative information highlighting the distinctions among dietary supplements and their health benefits based on current research. Unfortunately, large numbers of Internet sites concerned with dietary supplements, particularly sites selling popular health books or supplements, completely blur those distinctions and promulgate now-obsolete research results as the truth. They irresponsibly continue to try to scare people about free radicals and taut conventional antioxidants as well as phytosubstances.
Much additional research is needed about dietary supplements
A great deal of knowledge now exists as to how a number of dietary substances work, what they do in terms of gene activation, and what their health benefits are. We now know, for example, that broad classes of polyphenols work via hormesis, activate the Nrf2 pathway which activates hundreds of anti-oxidant and other protective genes, and turn off NF-kappaB and its pro-inflammatory activities. See my blog entries cited below. But, unlike many proprietary drugs, plant extracts usually consist of many compounds which activate multiple biological channels. We are missing reliable systematic information as to which polyphenols are superior to others, which are short acting and which are long-acting, and what their hormetic range of dosage is, the range where health effects are maximized. We know that many such substances have poor bioavailability and we don’t really have good dose-response curves for humans.
When the question is asked “What dietary supplements should I take when; what is the best combination?” the answers can at best be roughly estimated. Finally, there is a serious issue of herb-drug interactions(ref) which also can benefit from additional research. So, much additional research on dietary supplements is required.
The dietary supplement industry can’t pick up the slack and do the required research on its products. By itself, it cannot develop and bring to market new innovative Wellness products based on research it has done on plant substances. It must depend on research of others.
The companies in this industry are not well-positioned to do the required research. It is mainly a low-margin consumer commodity product industry comprising tens of thousands of manufacturers marketing more than 29,000 products. Companies are mainly focused on manufacturing, marketing and distribution of me-too products. They mostly cannot afford and do not do any scientific research and only little product-oriented research. The idea of such a company spending $300,000 to a million dollars for a clinical trial of a single product is unthinkable.
Further, a supplement company cannot obtain major venture funding to bring a new plant-based product to market. Because it cannot patent such a product, it can’t protect itself from competitors sweeping in and selling the same product cheaper. What a few supplement companies have done, however, is develop proprietary counterparts of commodity phytosubstances like resveratrol and curcumin that are –or at least claimed to be –more bioactive. And they often package several substances together which they market under such names as “Men’s Formula,” “Power Weight Loss Formula,” or “Immune Strengthener.”
Natural substances, the mainstays of Wellness, cannot make the transition into becoming medicines in Health Care because they can’t be patented and owned by any company.
Therefore, no pharma company will spend the hundreds of million dollars required to put such substances through clinical trials. It’s that simple. And not being FDA-approved medicines, most doctor’s shy away from them
Supplement manufacturer trade associations have focused primarily on regulatory issues and legislation, though they are aware of and are interested in addressing some of the key issues facing this industry.
The IADSA (International Alliance of Dietary/Food Supplement Associations) is an umbrella association of food supplement associations with member associations in six continents. IADSA is structured to play an integrative role in a widely dispersed industry. “IADSA is the leading international expert association regarding the globalisation of food supplement markets and increasing regulatory challenges. Bringing together food supplement associations from 6 continents, IADSA aims to build an international platform for debate and a sound legislative and political environment for the development of the food supplement sector worldwide.” –“IADSA is primarily composed of member associations in the food supplement sector representing over 20,000 companies worldwide. As a member of one of these associations you become part of the global network, receiving information and documentation developed by IADSA and able to play a part in shaping future global regulation(ref).” Besides legislative activities, IDSA sponsors research and publications on major issues confronting the industry
For example, regarding the issue of arriving at standards for dosage, IADSA sponsored a 2011 publication Bioactive Food Components: Changing the Scientific Basis for Intake Recommendations. October 2011: “This publication proposes a new framework for recommended intake, enabling the incorporation of aspects of basic, pre-clinical and clinical research – including the Evidence Based Medicine approach of Randomized Controlled Trials (RCT) – but allowing for decision-making based not primarily on RCT but on the totality of the evidence. It suggests the need for human intervention studies of a smaller scale than those used to evaluate drug efficacy and safety, arguing that RCT used to establish the safety and efficacy of drugs is, alone, not an appropriate method for establishing recommended intakes for nutrients and other bioactive substances.
Peace and War between Health Care and Wellness
There is peace and co-operation
In important respects Health Care and Folk Health (Wellness) are at peace and cooperate with each other. In other respects they are at war. Example of the former are schools of public health and growing emphasis in medical schools and some clinics on preventative medicine, holistic medicine and complementary medicine..More Doctors are advising exercise and good diets, though many do not know what exactly to recommend. And some doctors are at the forefronts of public health initiatives. Finally, some insurance companies pay for and some HMOs offer access to “complementary medicine” treatments by non-MD practitioners.
It is slowly dawning on the US government and insurance companies that one dollar spent on wellness education may pay off ten-to-one or better in terms of reduced medical costs. An intestinal transplant is likely to cost $1,121,800, a heart transplant $787,000, and a bone morrow transplant $676,800(ref). And the figure for open heart surgery is $324,000. And these figures do not include costs of personal suffering or lost time, or costs to family members. These amounts, just for one procedure on one individual, can buy substantial programs of Wellness education that affect large numbers of people.
And then, there is war
An example of ongoing war between Medical Care and Wellness/Folk Medicine is the Pharma industry’s efforts to see laws enacted that establish much tighter FDA regulation over the dietary supplement industry – even going so far as to having many familiar herbal substances reclassified as drugs that would require clinical trials before they are made available to the public. I agree that the supplement industry in the US is currently under-regulated and that indiscriminant use of the substances it provides can lead to negative health results.. There is currently no requirement that effectiveness be established for any natural-product dietary supplement. Labeling requirements for dietary supplements are quite lax, and people often do not know what they are getting. Nobody checks. Supplement dosages or ingredients may be incorrectly labeled and not reveal contaminants such as heavy metals.
Further, certain supplements relating to athletic performance and weight loss have been shown to be outright dangerous. Scarcely a day passes without some news item about lack of effectiveness or negative effects of dietary supplements. An example is an October 15, 2012 story in amednews.com Dietary supplements often lack reliable evidence to support health claims. “Twenty percent of studied supplements made prohibited disease-fighting claims, an OIG report says. Some lacked disclaimers that benefits were not evaluated by the FDA.”
The Durbin Bill
However, in my opinion some of the efforts to regulate the supplement industry like the Durbin Bill (the “Dietary Supplement Labeling Act of 2011) have been over-reaching. They are threatening to put the supplement industry squarely under the FDA’s heavy thumb so this industry becomes tamed and reshaped as yet-another appendage of Health Care. “Currently, there is no requirement for pre-market testing for safety and efficacy for dietary supplements, and dietary supplement manufacturers are not required to register with the FDA or to report adverse events from product usage. — that may change if Senator Durbin’s proposed bill becomes law(ref)” The FDA already has some authority to assure product safety. The bill led to concern that some familiar substances like curcumin could be reclassified as drugs, handed to pharma companies for clinical trials, eventually packaged in proprietary formulations owned by drug companies, and then sold to the public by prescription for 20-50 times the current prices. All this would be enforced by law. This possible scenario is frightening to the supplement industry and also frightening of takers of dietary supplements who cannot afford to pay pharmaceutical-level prices for them. Is this scenario a serious possibility? I think it possibly is. In Germany, France, Sweden and Australia, herbs are classified and regulated as medicines, while in the US these herbs are almost all unregulated and freely available to the public(ref). So, there has been controversy over whether the Durbin Bill was a serious attempt to protect consumers or whether it is a power grab by the pharma industry(ref). Possibly it is both. All the natural product dietary supplement trade associations rallied against the bill and critical amendment to the bill was defeated May 24, 2012. Yet the legislative struggle between the pharma and dietary supplement industries goes on and is not likely to abate.
Wrapping it all up – Bridging the Great Divide
In summary, several forces are working to bridge the practical divide between Health Care and Folk Health/Wellness. I see the most important ones as:
- Wellness is in the air and manifesting itself everywhere, part of the evolution of our social fabric of our time.
- Elements of Wellness are slowly transforming Health Care. And there is a clear economic incentive for this to happen
- People who also rely on doctors are increasingly taking responsibility for their own wellness – be this via some form of exercise, diet, mental discipline, etc The Internet makes a wealth of wellness and medical information available. Individuals are taking all kinds of Wellness initiatives independently of their doctors.
- The unquestionable authority of medical doctors is increasingly being challenged. Lay people are learning more and more about wellness. Lay people are starting to research their own illnesses on Internet. They use social media to learn about the experiences of others. They sometimes look to exercise trainers and others more than to their doctors for wellness information. And they are likely to barrage their doctor’s with hard questions or confront them with information that the doctor may not know about. Asking for second opinions is increasingly common.
- This blog, focused on health and wellness-research results that have largely not been embraced yet by Health Care, is another manifestation of the trend.
- Big pharma is increasingly turning to plant-based products for discovering chemicals that can be the basis of new drugs.
- Health Care used to have the advantage of pointing out that it had science on its side and that Traditional Folk Health had only folk tales and anecdotal evidence that could not be really trusted. That is no longer the case as shown by a great many entries in this blog which focus on the science behind herbal substances. It is quite the opposite. It appears that most practitioners of Health Care either do not know about or ignore in practice the science behind Health and Wellness.
For me personally, the most exciting shift relates to an important theme of this blog – hard scientific evidence that elements of Folk Health, particularly the use of certain foods and dietary supplements are supported by a wealth of current scientific research. Many traditional herbs have been extensively studied using the latest knowledge and tools of science. We now know not only that many substances work as shown by the test of time in multiple countries and social contexts, but we are clarifying how and why they work in terms of molecular biology and genetics. I have written blog entries reviewing a number of lesser known traditional herbal substances like curcumin, resveratrol, ginger, cat’s claw (ucaria tomentosa or Uncaria guianensis), bitter melon (Momordica charantia), epimedium and icarin, andrographis, rhodiola, dashen root (salvia miltiorrhiza bunge), fucoidan, cordyceps militaris, rosmarinic acid, caffeic acid, gambogenic and gambogic acid and grape seed extract. I have written a number of blog entries explaining how these substances work in terms of hormesis and Nrf2 activation(ref)(ref)(ref)(ref) (ref). I have written extensively about the advantages of phytosubstances(ref)(ref)(ref). And I have written about healthy foods like extra-virgin olive oil, blueberries, and dark chocolate.
There are many challenges still
- While Health Care is well organized and tightly regulated, Wellness is wild and open to everybody, including snake oil salesmen and practitioners that offer quack cures. And today the quest for Wellness sometimes leads people to trust offshore clinics that offer dangerous stem cell “therapies” as cures for just about everything. And, unregulated purveyors of dietary supplements often make misleading claims that certain products have research-proven health benefits when the opposite may be the case.
- Many available herbal substances may offer significant health benefits, but they are eschewed by Health Care and live in a limbo state as part of Wellness. As far as their use for our personal Wellness goes, we continue to be largely on our own.
- The general public is quite ignorant about the distinctions between classical vitamins and antioxidants, and plant-based substances. And this critical distinction remains blurred for commercial reasons and because of ignorance. So the public is barraged and confused by news reports and infomercials that say supplements are good for you and ones that say that supplements are bad for you.
- Much further research is needed to verify safety and efficacy and proper dosages of certain herbal substances, ones which clearly promote wellness and may have specific therapeutic values.
- Governments and foundations must pick up the tab for the needed research on phytosubstances; the supplement industry can’t do it and the pharma industry won’t. At present, there is no clear indication that that is going to happen on the needed scale.
- The public can benefit from additional forms of regulation of the supplement industry, probably along the lines suggested by the IADSA.
- Most people respect their medical doctors and look to them as a source of wellness advice. Doctors need to be better prepared and supported to fulfill this role by moving more heavily into Wellness. This process has been started but needs to be carried much further.
- It would be good if Health Care seriously embraced herbal medicine as a specialty. Elements of herbal medicine should to be taught in medical and nursing schools. Family doctors should be made familiar with a small subset of herbal substances for which research establishes safety and efficacy
Health Care and Wellness are both needed and can work better together
In a nutshell, Wellness is needed to insure general health and longevity; this cannot be achieved by Health Care alone. Health Care is needed to treat diseases and ailments and provide care for the sick; tasks far beyond the scope of Wellness. It is ridiculous for the two paradigms to be at war with one another and balances need to be established between them. Health care insurance companies, government and businesses that bear the costs of health care have enormous economic stakes in further integration of Health Care and Wellness. So do we as individuals. Let’s do it!
I am grateful to Melody Winnig for significant help in assembling the ideas for this document and creating the document itself.