Evidence for the failings of a profit-driven medical system is demonstrated in the USA. Roy Upton explores the role of herbal medicine in America’s healthcare system.
The American healthcare system
Evidence for the failings of relying strictly on a research- and profit-driven versus a practitioner driven medical system is no better demonstrated than in the health care statistics of the United States. In 1998, Schuster et al. reported that in almost all aspects of health care, the US is failing. These failings encompass the spectrum of services from preventive, acute, and chronic care; from infants to the elderly; or the health care delivery system of a single city or the country overall. Patients are either not receiving the care they should be receiving or they are receiving inappropriate care that is related to both under treatment and over treatment, as well as the inappropriate use of pharmaceutical medications. Similar findings were reported by numerous other authors (e.g., McGlynn et al. 2003) and organizations over the past decades, demonstrating these patterns have not changed.
By all measures of individual and social health, America is ranked among the worst of all similarly developed nations (Shellard 2000; WHO 2000; Woolf and Aron 2013). In infant mortality, a general marker of overall societal health, the US ranks an appalling 31 (based on 2008 data; Heisler 2012) in the world behind virtually all similarly industrialized nations. In 2000, the WHO ranked the US a dismal 37th in overall health care systems.
In a similar ranking by the Commonwealth Fund (2011), the US was far behind other nations in terms of healthy lives, quality, access, efficiency, and equity of health care delivery services and 19th of 23 nations surveyed in healthy life expectancy at age 60 (Commonwealth Fund 2008). Perhaps most importantly, the report noted a “strikingly consistent and pervasive pattern of higher mortality and inferior health in the US, beginning at birth”; that this pattern of poorer health was evident at all stages of life, from infancy to childhood, to adolescence to young adulthood, to middle and old age, and could not be explained by disparities in social demographics. Those who could afford health care and were financially well off fared little better than those less fortunate. More unfortunate is that some of these findings have been reported for decades (such as the persistent high rates of infant mortality) and yet no meaningful change in the system occurs. The failings of the American system is similarly evidenced by the disproportionate negative impact COVID-19 has had on the American population, where more people have died per capita than any other nation.
Primary care pioneer Barbara Starfield (1932–2011), highlights that the majority of those countries with the best health statistics have a strong primary care infrastructure and that better outcomes are correlated with primary care services (Starfield 2000). Primary care providers can be described as ‘patient centric’. This in contrast to the predominant reliance on specialists in the US, which can be described as more ‘research centric’. The WHO has a long history of recognizing traditional health care practitioners as primary health care providers, but many countries, like the US, lack acceptance or full integration of traditional healing practitioners into their national health care systems. The advantage of integrating traditional healing practices into a national health care system was highlighted by China’s full integration of traditional Chinese medical practices, and specific codification of herbal formulas for the treatment of SARS in 2003. When herbal medicines were integrated into the treatment of SARS, the death rate due to SARS dramatically declined (Chen and Nakamura 2004; Yang et al. 2020). Similar protocols and use of herbal medicine were fully integrated for various stages of COVID-19.
No improvements in health statistics can occur without a fundamental change in the philosophical basis by which health and healing is approached. As long as the militaristic approach of search and destroy is employed as the primary therapeutic paradigm, big guns represented in powerful pharmaceuticals and high tech interventions will continue to yield the extremely poor health statistics reflected in the American system.
Over diagnosis, over treatment, iatrogenis
Medical diagnostic technology that leads to a cascade of subsequent treatments is partly responsible for the relatively high rate of iatrogenesis in the US (Starfield 2000). Such diagnostics are predominantly research-driven and represent how lack of a patient-centered focus results in negative health outcomes. This is no more evidenced than in policies regarding prostate-specific antigen (PSA) screening and mammograms. For almost two decades in the US, annual PSA screening was recommended for healthy men over 50 years of age despite the lack of robust scientific evidence for a benefit (see Albertsem 1996; Woolf 1994). Literally millions of men were screened annually at an annual cost of $447 million to America’s Medicare program alone (2009) (Ma et al. 2014). False positives and detection of slow growing (indolent) tumors resulted in aggressive surgical or radiation treatments that caused serious harm including urinary incontinence, erectile dysfunction, pain, infections, hospital readmission, and death (Moyer 2012). It has only been more recently that a number of studies specifically looking at the benefit-risk assessment of routine PSA testing over the last 20 years determined that the moderate to high risks of PSA screening and the ensuing cascade of treatments as described by Starfield (2000) far outweighed the low to moderate benefits of PSA screening (Carter et al. 2013). Annual screening resulted in high levels of false positives that led to unnecessary biopsies that carry a risk of bleeding, infection, pain, urinary symptoms, and hospitalization (Loeb et al. 2012; Nam et al. 2013). Because of this, PSAs are no longer recommended for most of the demographics for which it was previously used. Routine mammograms followed the same trajectory and were, and among many, remain, a research-driven and profit-motivated technology (Epstein et al. 2001).
While early detection with mammograms benefits a small subset of the population, the very act of compressing breasts between two plates and subjecting breast tissue to the cumulative DNA-damaging effects of radiation increases women’s risk of breast cancer; some estimates accounting for up to 20% of breast cancers in the US (Epstein et al. 2001 and references therein). Despite mounting evidence of questionable benefit (see Miller et al. 2014) and substantial risk of mammograms, as of February 2014, 75% of American women reported having received a mammogram in the past year. In the United States alone, approximately 37 million mammograms are performed annually at a cost of approximately $100 per mammogram. It can be considered that routine PSA and mammography screening are almost identical in their over-diagnosis, over-treatment, marginal benefit, enormous cost, and substantial risk.
Such practices represent medicine at its worst and are a complete antithesis of the common medical dictum of Primum non nocere (first do no harm), often attributed to Hippocrates and still integral, in theory only, to modern medical ethics. More significantly, these examples of research-driven technologies represent an insidious aspect of the modern health care system as every major cancer association as well as local and national government agencies strongly supported the use of the aforementioned screening tools for the majority of the adult population despite a lack of clinical evidence of benefit and despite significant mechanistic and observed evidence for risk. The negative impact of such research- and economic-driven policies is clear. However, more importantly, these are poignant examples of how much of what is considered technologically advanced medicine is not based in sound clinical science, but rather research-based science.
A primary criticism levied against herbal medicines, and other traditional healing practices, is their lack of scientific proof of efficacy based in modern pharmacological research. However, much of traditional herbal medicines and traditional healing practices in general, are precisely based on human clinical outcomes codified in human experience for hundreds or thousands years. This is not to say that traditional healing knowledge is complete, safe, effective, and appropriate for all people all of the time, or does not have limitations and knowledge gaps. This merely reflects a different knowledge base that has been a consistently evolving foundation of human healing since the beginning of human existence, and at the very least, should be given the same respect, honor, and use as technologically advanced therapies that only have decades of largely experimental use.
Table 1: US Health care statistics compared to 13 other countries
| Outcome | Ranking of 13 countries* |
|---|---|
| Average for all health indicators surveyed | 12 |
| Low birth-weight % | 13 |
| Neonatal and infant mortality | 13 |
| Years of potential life lost | 13 |
| Postneonatal mortality and life expectancy at one yr old for females | 11 |
| Postneonatal mortality and life expectancy at 1 yr old for males | 12 |
| Life expectancy at 15 years of age | 10 |
| Life expectancy at 40 years of age (males) | 9 |
| Life expectancy at 40 years of age (females) | 10 |
| Life expectancy at 65 years of age (females/males) | 7 |
| Life expectancy at 80 years of age (females/males) | 3 |
| Age adjusted mortality | 10 |
Source: Starfield B. 2000. Is US health really the best in the world? JAMA 284(4): 483-485.
Table 2: Mortality due to iatrogenic causes in the US
| Cause | Mortality |
|---|---|
| Deaths from unnecessary surgery | 12,0001 |
| Medication errors in hospitals | 70001 |
| Other hospital errors | 44,000-98,0002 |
| Deaths from infections contracted in hospitals (annually) | 80,0001 |
| Deaths from non-error, adverse effects of medications (annually) | 106,0001 |
2 Kohn LT, Corrigan JM, Molla Donaldson S (editors). 2000. To err is human: building a safer health care system. National Academies Press, Institute of Medicine and National Research Council. 287 pp.
Pharmaceutical medications: A huge price to pay
In addition to the philosophical differences between traditional and conventional medical practitioners and the economics that drive medical practice, is the problem of having a system that relies predominantly on pharmaceutical medications. There is no doubt that pharmaceuticals save lives, especially in acute crisis. The advent of antibiotics, while solidifying a search and destroy militaristic philosophy as a primary approach in health care, was responsible for saving tens of millions of lives. Morphine, while representing an inherent split between whole plant-based medicines and active constituents, is an incredibly effective painkiller, that, due to its potential for diversion to opium and heroin, is no longer allowed in the public domain as a plant-based medicine as it once was. And, the story of pharmaceutical development can easily be written to focus on the positive attributes modern drugs have contributed to human health (e.g. The Inside Story of Medicines) (Higby and Stroud 1997). But despite many great successes in the world of pharmaceuticals, ironically many of which were derived from plants (e.g., aspirin, morphine, and vinca alkaloids), there is a tremendous price that current and future societies pay for their effects.
Firstly, pharmaceutical medications are represented to the public and health care professionals as proven to be safe and effective according to scientific methods. This is not entirely true. In 2009, the pharmaceutical giant Pfizer, plead guilty to a felony charge and agreed to pay $2.3 billion in fines for fraudulently marketing select drugs. This was the fourth fine levied against Pfizer for similar infractions since 2002 demonstrating that fraud within at least one pharmaceutical giant is a recurring theme. In recent decades, a large number of the most recognized pharmaceutical companies have paid similar fines, most for fraudulent marketing practices and some for violations of good manufacturing practices (GMPs). Such practices reflect relatively gross violations of federal law. The research and development side of pharmaceutical development is much more nuanced and insidious as has been highlighted in recent writings such as Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. This expose was written by Peter Gøtzsche, a co-founder of the highly prestigious independent evidenced-based Cochrane Collaboration. Another, The Truth About Drug Companies: How They Deceive Us and What To Do About It, was written by medical doctor Marcia Angell, former editor in chief of the New England Journal of Medicine. Both works, written by long-term editors of arguably two of the most prestigious medical journals in the world provide clear and evidence-based examples of broad-based bias and fraud in the world of medical literature. These authors demonstrate clearly that published clinical research is positively biased to the sponsoring companies, provide examples of gross fraud by medical writers claiming to conduct trials that were never conducted (reviewed in Gupta 2013), and report that negative findings are often not publicized, allowing for a drug to be released on the market with the mistaken belief that it has been scientifically demonstrated to be safe and effective.
The consequence of poor science and fraud in pharmaceutical drug development is significant. There are numerous examples of heavily marketed drugs that were removed from the market due to serious, sometimes fatal, adverse effects including Oraflex, Propulsid, Rezulin, and perhaps the crowning jewel of this collection, Vioxx, a widely prescribed arthritis drug that was withdrawn from the market after disclosures that the pharmaceutical manufacturer Merck, withheld information from patients and physicians about the potential for Vioxx to increase the risk of heart attacks and stroke. Vioxx use resulted in between 88,000 and 140,000 cases of serious heart disease. Most significantly, cautions regarding the safety of Vioxx were put forth by epidemiologist David Graham, who at the time was the Associate Director of the Food and Drug Administration’s (FDA) Office of Drug Safety. In formal testimony given before the US Senate Committee on Finance, Dr. Graham provided poignant testimony stating that policies within FDA were insufficient to protect the public from drugs, which carry unacceptable risks, stating;
“I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless… Finally, the scientific standards CDER [Center for Drug Evaluation and Research] applies to drug safety guarantee that unsafe and deadly drugs will remain on the US market.” (Graham 2004).
In a follow-up interview with Dr. Graham, Congressional representatives asked specifically what within FDA needed to be fixed, Dr. Graham replied:
“FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed.” (Carozza 2005).
While such testimony can be viewed as representing only an individual opinion, similar findings were reflected in a US Government Accountability Office (GAO 2006) report that stated:
“FDA lacks a clear and effective process for making decisions about, and providing management oversight of, post market drug safety issues.”
The fallacies of the scientific validity of the US drug approval process is further promoted to the American public in equally infactual ways. In a 2013 article in the Journal of General Internal Medicine, authors Faerber and Kreling, reported that 60% of prescription drug ads and 80% of over the counter drug ads were found to be misleading or false. The study found 43% of the claims in direct to consumer (DTC) drug ads were “objectively true” while 55% were “potentially misleading” and 2% were “false.” Most DTC prescription drug ads reportedly spend more time on benefits than negative side effects and 84% of regulatory letters sent by the FDA from 1997 to 2006 cited the companies producing those ads for minimizing risks and/or exaggerating effectiveness of drugs. For example, one study found that although 19% of DTC ads mentioned lifestyle changes as an adjunct to medication, none mentioned them as an alternative to drug treatment (Frosch 2007). Thus, promoting a drug in consumer advertisements as the solution to a specific health problem, rather than emphasizing life-saving lifestyle changes, disincentivized viewers from making healthy lifestyle changes and fostered the belief such changes are ineffective or unnecessary (Shaw 2008).
DTC drug advertisement, which is illegal in most all countries with the exception of the US and New Zealand, rarely focuses on public health messages about diet, exercise, addictions, social issues, and other treatments that may be more cogent to wellness than pharmaceutical interventions (Almasi et al. 2006). Healthy lifestyle modification can result in fundamental changes in an individual’s health status, is free of side effects, and free of cost. Unfortunately, such practices are very bad for business, which circles back to the economic aspect of American medicine, that it is a business. Unfortunately, what happens in America does not stay in America. The consequences of deceptive drug development and approval practices carries over to other nations.
The relevance of all this to traditional healing practices, especially herbal medicine, is two-fold; first is that research, economic, and regulatory agendas are heavily biased to pharmaceutical development based on research findings that are often flawed at best and fraudulent at worst, versus being patient centric and outcomes oriented. Second, no single herbal medicine or collective of herbal medicines in the history of the world has resulted in the magnitude of public harm as drugs such as opioids, Vioxx or Rezulin or the collective of pharmaceutical drugs. Yet, despite hundreds or thousands of years of clinical and empirical data with herbal medicines, their use is often restricted or limited based on claims of their “unknown dangers” simply because modes of action have not been fully articulated according to modern conventional drug standards.
