US health care

Healthcare – More than Reform Is Needed: Jian Gao, PhD March 2, 2024

Healthcare – More than Reform Is Needed: Jian Gao, PhD March 2, 2024

Health reform has a long and tumultuous past – the first attempt of national insurance coverage by President Theodore Roosevelt was 111 years ago in 1912. Despite numerous tries over the last century, successes were few and far between except for the enactment of Medicare and Medicaid under President Lyndon Johnson in 1965 and the Affordable Care Act (ACA) under President Barack Obama in 2010.

Compared to other industrialized countries, American healthcare is the most expensive and fragmented system riddled with poor access, inequality, overtreatments, greedy/predatory pricing and/or billing practices, along with excessive administrative costs. Take our next-door neighbor Canada for example, the US spends twice as much as Canada does per capita on healthcare, yet life expectancy in Canada is 3.4 years longer, and infant mortality rate is 22% lower.¹ Let alone other waste, the US incurs 17% more administrative costs compared to Canada, as Dr. Himmelstein and Dr. Woolhandler have shown, mainly due to the disjointed and dysfunctional payment schemes.²

The goals of the attempted reforms are to increase health insurance coverage or access to care, simplify the payment system, reduce cost, and improve quality of care. However, these noble goals remain elusive thanks to the insurmountable roadblocks: opposing political ideologies on care coverage and how it should be paid, and powerful healthcare organizations fighting tooth and nail to maintain the status quo for continued economic gain and even windfalls through lobbying, political donations, and disinformation campaigns.

The intricacies of these problems are vividly depicted by several piercing books:
The Truth About the Drug Companies: How They Deceive Us and What to Do About It (2005), by Marcia Angell.
Inside National Health Reform (2011), by John McDonough.
Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care (2013), by Marty Makary.
An American Sickness: How Healthcare Became Big Business and How You Can Take It Back (2017), by Elisabeth Rosenthal.
The Hidden History of American Healthcare – Why Sickness Bankrupts You and Makes Others Insanely Rich (2021), by Thom Hartmann.
The Price We Pay: What Broke American Health Care – and How to Fix It (2021), by Marty Makary.
Sickening: How Big Pharma Broke American Health Care and How We Can Repair It (2022), by John Abramson.

The American health system is indeed broken as illuminated by these scholarly researched books – on the one hand, many are lacking access to care; on the other, the waste is mindboggling. Worse still, we have collectively turned a blind eye to an even more insidious problem which is a fundamental driving force behind the dysfunctional health system causing immeasurable human suffering.

A Deeper Problem in Medicine Itself

While the waste in healthcare is well studied and recognized, the immeasurable cost, human suffering inflicted by the skyrocketing chronic diseases, appears to be normalized and obscured by “breakthroughs” and “gamechangers” of treatments glorified by the medical establishment and in news media. According to the CDC, 6 in 10 adults in the US have a chronic disease, and 4 in 10 adults in the US have two or more chronic diseases – 90% of the nation’s $4,100,000,000,000 in annual healthcare expenditures are spent in treating chronic diseases. These are not just abstract numbers – they mirror the magnitude of unbearable human tolls which are largely unnecessary.

Chronic diseases in particular are hitting the younger generation harder and harder – obesity, diabetes, asthma, allergies, autoimmune diseases, mental disorders like depression and autism, and cancer. Take autism for example, the incidence has increased 417% from 1 in 150 to 1 in 36 children in just 20 years from 2000 to 2020 according to the CDC. Inevitably, parents are worrying about whether their child will have a normal life, anxious about another asthma attack or allergic reaction, agonizing over if antidepressants would induce violent or suicidal behavior, dreading if chemotherapies would work, the unknown long-term side effects of various drugs and treatments, and if the cancer will come back. And the worst of all is for parents to attend the funeral of their own child.

Given the calamity humankind is facing, we must reflect: how did we get here? And how can we fix it?

Medicine (often referred to as orthodox, conventional, or mainstream medicine) is at its best when it comes to treating trauma, acute conditions, or disorders that surgical procedures and medical devices can alleviate – millions of lives have been saved by those ingenious interventions. However, as to treating the so-called chronic diseases, medicine has been on a hopelessly wrong path. Except for the treatments of infectious diseases and hormone replacements, nearly all drugs are designed to alleviate the symptoms by blocking or suppressing some physiological processes in the body without addressing the root causes. If you have hypertension, take pills to reduce the blood volume or expand the vessels. If you have type 2 diabetes, take drugs to make your liver produce less or to excrete more sugar. If you are obese, remove a part of your stomach. If you are diagnosed with autoimmune diseases, take immunosuppressants to weaken your immune system. If you suffer from mental disorders, take pills to change the chemistry in your brain. If you have cancer, kill the cancer cells along the normal ones.

It cannot be more obvious: chronic diseases became rampant because the root causes are not addressed. To be clear, most doctors pursuing medicine are dedicated to helping people, yet unfortunately they are confined to a drug-centered practice focusing on symptoms rather than the root causes.

Medicine Needs a Fundamental Transformation

Truth be told, medicine does not need a reform – it needs a revolution: stop the cookbook practice focusing on the symptoms of chronic diseases and start to treat the root causes.

!!!!!!!!!!Drugs Are Not the Solution for Chronic Diseases
We, the public, media, politicians, and even our doctors, have been collectively indoctrinated by the medical establishment including big pharma and other special interests to believe chronic diseases are largely unavoidable due to our genes, age, or lifestyle, certainly incurable, and the only solution is pills. As a result, we as a nation have become a giant Rx bottle – according to the Department of Health and Human Services, 8,743,000,000 prescriptions were dispensed in 2021 – 26.3 prescriptions per person on average in America.³

No matter how they are marketed and labeled, few prescription or over-the-counter drugs (except for those such as thyroid hormone or insulin used to compensate for damaged or failed organs) are not toxic, which is acknowledged by all drug companies in their direct-to-consumer advertising. Although the side effects of some medications are tolerable, others are insidiously dangerous if not deadly. Those who bare the most horrific side effects are the patients suffering from mental disorders who take prescription drugs to alter their brain chemistry, the patients with autoimmune diseases who swallow pills to suppress their immune system, and cancer patients enduring chemotherapies.

Anyone insisting prescription drugs are benign for long-term use should so demonstrate by taking a few of them for a year or two. Few are willing to do that. Here is an actual exchange I had with a neurologist a few years ago: “If you think these drugs are safe, why don’t you try them for six months?” I challenged him. “That is stupid,” he angrily replied.

We are deeply grateful to the dedicated scientists who create drugs which can drastically extend the life span of the patients with rare genetic disorders or improve the quality of life for those with irreversible organ damage. And we should not take for granted the drugs that can save lives for acute manifestations or flare-ups. Take immunosuppressants for example, they are life savers for those with acute autoimmune disorders or organ transplants.

Nevertheless, we must understand drugs are not the long-term solution for common chronic diseases. Not only do they not fix the root causes, but they are in fact counterproductive in the long run – they insidiously create other disorders, and more drugs are needed to fix the new problems – a vicious cycle.

You may wonder, how is it possible? After all, before getting on the market, all prescription drugs must pass three phases of randomized controlled trials (RCTs) to demonstrate their safety and efficacy for FDA’s approval.

Well, the process appears to be rigorous, but what’s assessed is deceiving. New drugs (e.g., antidepressants, immunosuppressants, and chemotherapy) are only required to be compared with a placebo for short-term symptom improvement. Long-term outcomes, especially all-cause mortality, are rarely assessed, if at all. Even if 5-year outcomes were compared, the results would mean little because the incubation time of many debilitating and deadly conditions potentially induced by the drugs is much longer than 5 years. For example, it takes more than 10 years for heart diseases and cancer to develop as will be discussed shortly. More importantly, the drugs are compared to placeboes, not the treatments targeting the root causes. And they are not even required to compare with the drugs already on the market which are typically much cheaper and equally if not more effective. Prescription drugs have become a giant money game with all the rules stacked in Big Pharma’s favor.^4-8

All in all, no drugs can cure the common chronic diseases – they are not designed or intended to do so in the first place. Worse still, there is always a price to pay for palliating symptoms by blocking or suppressing natural physiological processes in the human body.

From Symptom-centered to Root-cause-focused Medicine

The human body is an intricate complex system where all parts work together rather than independently. And most often, the symptoms and their root causes are in different places. For instance, the triggers of depression or dementia are most likely not in the head; and what causes the plaque buildup is not necessarily in the heart. Yet, our medicine is overspecialized by body parts, which further foments the treatments focusing on symptoms rather than root causes.

To halt the relentless march of chronic diseases, medicine must abandon its paradigm of a pill for an ill and focus on the root causes rather than the symptoms. To do so, medicine itself needs fundamental changes. First, medical schools need to build a new curriculum for primary care focusing on tests and treatments for root causes of common chronic diseases: environmental toxins or factors including food sensitivity and infections (e.g., mold infections are often overlooked), micronutrient deficiency, gut disorders (dysbiosis and intestinal permeability), and stress.

Fixing root causes does not appear to be as ‘scientific’ or ‘medical’ as are patented expensive pills tested by randomized controlled trials (RCTs) and approved by the FDA. Nevertheless, treating root causes is the only way to prevent or reverse chronic diseases. No pills designed to alleviate symptoms will heal chronic diseases today or tomorrow.

Medicine needs to put properly trained primary care doctors in the drivers’ seat – take charge of patient care in a truly holistic way – fix the root causes rather than dispense pills. Primary care physicians should not be paid by how many patients they see; rather, they should be fairly compensated based on their expertise and their patients’ long-term outcomes. Obviously, the number of primary care doctors needs to be drastically increased.

To change from the prevailing drug-centered to root-cause-focused practice, medicine does not need to start from scratch. A lot can be learned from alternative medicine, especially Functional Medicine (FM).

What is FM? The Institution for Functional Medicine states “Functional Medicine is a systems biology-based approach that focuses on identifying and addressing the root cause of disease.” FM was founded in 1990 by Jeffrey Bland, PhD, a biochemist. In 1991, he and his wife Susan Bland established the Institute for Functional Medicine (IFM) to educate clinicians about FM. In 2009, IFM formally started a Certification Program. In 2020 and 2021, IFM had more than 18,000 registrations for training programs. Over 1,800 practitioners have been certified to practice FM across the country. And many of them are MDs who had practiced mainstream medicine before embracing FM to fix their own health problems.

FM is not perfect, far from it. But mainstream medicine needs to put its pride aside and objectively look at what FM has achieved – countless patients suffering from ‘incurable’ debilitating and even life-threatening maladies have recovered under the care of FM practitioners.

Rather than recognizing and learning from what FM has accomplished, the medical establishment launched merciless attacks – “Functional medicine. It sounds so…scientific and reasonable. It’s anything but. In fact, functional medicine combines the worst features of conventional medicine with a heapin’ helpin’ of quackery.”⁹ And FM is “an indecipherable babble and descriptive word salad.”¹⁰

To be fair, the critics are not all wrong. There are certain degrees of pseudoscience and even quackery at the practitioner level in all different forms of alternative medicine including FM. For instance, for the same disorder, one practitioner allows no animal products (e.g., meat and dairy) at all in patients’ diet, while another practitioner asks patients to eat more animal protein and fat. Both claim their protocols are science-based and no recovery should be expected unless strictly following their protocol. Obviously, the two protocols cannot both be scientific. FM as an organization needs to do a better job resolving inconsistent practices like this.

Regardless, the principle of FM is sound and does have the potential to revolutionize medicine. However, it cannot do so in a black box. FM and all other forms of alternative medicine need to demonstrate its effectiveness – only patient testimonies are not enough. As will be discussed shortly, although randomized controlled trials (RCTs) are not the right tool to assess the efficacy of alternative medicine, at the minimum, alternative medicine including FM needs to report some basic statistics: how many are treated, how many are healed or cured, and how many are not. For the greater good (too many people are suffering too much from chronic diseases), FM needs to take the lead in minimizing pseudoscience and increasing transparency. If you cannot measure it, you cannot improve it.

Taken all together, to transform medicine in treating chronic diseases, FM focusing on root causes is a good starting point.

Evidence-based Medicine – A Giant Camouflaged Roadblock to Transformation

We must practice evidence-based medicine, the medical establishment proclaims. Ironically, all the evidence under the sun plus the brightest and smartest have led medicine to a universal practice – prescribing drugs to palliate the symptoms by blocking or suppressing some physiologic processes in the body. Is there no evidence at all supporting treatments going after the root causes except for genes and lifestyle? Do not forget, genes and lifestyle are not the main drivers behind the soaring prevalence of chronic diseases in the last 80 years.

Given that the direction of medicine is guided by evidence, we must understand how evidence is generated and used. The following discussion may appear to be tedious, especially for policymakers and policy researchers, but failure to understand it will continue to imprison medicine in the symptom-centered paradigm.

Randomized Controlled Trials (RCTs) – The Gold Standard

For testing safety and efficacy of drugs (e.g., antibiotics, antidepressants, antipsychotics, and antihypertensives), RCTs are indeed the best tool if well designed and executed.

Before 1962, RCTs were not the dominant method in evaluating drug safety and efficacy – pharmaceutical companies promoted their drugs largely based on expert testimonies and case reports. RCTs gained its prominent status thanks to an international scandal coming to light in 1961. During the late 1950s and early 1960s, a drug called thalidomide, initially introduced in 1953 as a tranquilizer, was widely prescribed to women in 46 countries to alleviate anxiety, insomnia, and morning sickness. By 1961, it became apparent that a tragedy was at hand – women who were pregnant or subsequently became pregnant while taking the medication were at very high risk of having stillbirths or births with severe deformities.

In response to the manmade medical disaster, Congress enacted the Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act in 1962, mandating “adequate and well-controlled investigations” of new drugs for approval. By 1970, the FDA started to interpretate the amendments as requiring RCTs for approvals of new drugs.¹¹ Thus, RCTs have officially become the gold standard in medical research generating evidence.

Many believe RCTs revolutionized medicine and there is truth in that. Expert testimonies and case studies can be mistaken in whole or in part, even large observational studies can often produce misleading findings with deadly consequences. Take the famous Nurses’ Health Study for example, which has been run by world class experts at the Harvard Medical School and School of Public Health. The study found women taking estrogen, a sex hormone supplement, reduced their risk of coronary heart disease by about 50-70 percent. Propelled by two articles of the findings published by the New England Journal of Medicine (NEJM),^12,13 an estimated 15-20 million women were put on estrogen therapy (also called hormone replacement therapy or HRT) by 2001 for health benefits. Shockingly, a large RCT called Women’s Health Initiative (WHI) later found women taking estrogen significantly elevated their risk of breast cancer, heart disease, and stroke,¹⁴ which resulted in many deaths – an article by New York Times Magazine states “A reasonable estimate would be tens of thousands.”¹⁵

What led to the deadly misleading result in the Nurses’ Health Study? It was the usual suspects – membership bias as well as other uncontrolled confounding factors. In a nutshell, the participants in the study who took HRT were different from those who did not. Those under HRT were in better health because they were better educated, wealthier, more health conscious, and received better preventive care, which masked the ill effect of HRT.

RCTs are designed to minimize or eliminate membership bias and other confounders by randomly assigning the participants to the treatment and control groups so the characteristics of the participants in the two groups are approximately the same except for the treatment. RCTs indeed can be the gold standard if two key requisites among others are satisfied: (1) truly double-blind and placebo-controlled (the participants do not know they are receiving the real treatment or placebo, and neither do the investigators during the study), and (2) the causal relationship between the treatment and the outcome is largely one to one (e.g., diuretics for hypertension). The first requisite has been well recognized although its consequences are often swept under the rug, but the second one, as crucial as it is, has been overlooked as will be discussed below.

Obviously these two requisites can be readily met for most RCTs assessing drug efficacy except for sometimes the study participants become aware of their group assignment (treatment or control) from the presence or absence of side effects.

In short, when the treatment or intervention can be packed into a ‘pill’, RCTs can be the gold standard.

Randomized Controlled Trials (RCTs) – Manufacturers of Misleading Evidence

In contrary to assessing the efficacy of drugs, however, RCTs are the wrong tool in evaluating the effectiveness of treatments targeting the root causes of chronic diseases.

First, most treatments or interventions targeting root causes cannot be packed into a pill for double-blind and placebo control in RCTs. Second and more importantly, a chronic disease is often the result of multiple triggers working together, and thus multiple treatments targeting all potential triggers are necessary to show any effect.

When the intervention cannot be packed into a pill, RCTs can easily produce very costly misleading results due to noncompliance and contamination. Trials on dietary fat and heart diseases during 1950s-1990s are great lessons.

Heart disease was largely unnoticed until the 1920s when suddenly and mysteriously deaths from heart attacks skyrocketed. By late 1940s, coronary heart disease (CHD) sprouted into the number one killer in the US. Relatively young otherwise healthy people including businessmen and doctors dropped dead at the prime age of 40-50 at an increasingly alarming rate, striking enormous fear into the public.

Thus, the race to search for the cause(s) and cure(s) was on. Numerous observational studies (e.g., the famous Seven Countries Study) and RCTs found dietary saturated fat (SF) was the culprit (for detailed discussion, read Road to Health, chapter 4). By the 1970s, the low-fat diet, promoted by the government agencies, professional societies, physicians, media, and even the food industry, was largely accepted by the public as the strategy to fight heart disease. However, the critics believe the low-fat policy was not science-based – they protested that the findings from observational studies were correlations, not causations; and the RCTs, although showing saturated fat detrimental to the heart, were too small and flawed with their design.

To settle the controversy once and for all, in 1972, the National Heart, Lung, and Blood Institute (NHLBI) funded the largest RCT focusing solely on CHD, known as MRFIT (Multiple Risk Factor Intervention Trial). The goal of the study was to test if mortality from heart disease could be reduced by decreasing serum cholesterol via limiting SF intake, lowering blood pressure, and cutting back cigarette smoking. The participants in the treatment group received group and individual counseling on a fat-modified diet, high blood pressure reduction, and smoking cessation. The participants in the control group went on with their lives as usual. After seven years of hard work and a total cost of $110 million ($804 million in today’s dollars), in 1982, the study published its much-anticipated findings.¹⁶

The result was disastrous – there was no appreciable difference between the two groups in mortality, let alone statistical significance. Consequentially, the null finding became the official launch pad to attack the low-fat diet policy. The critics of the low-fat diet claimed and still claim the finding of a landmark RCT, the gold standard, has definitively demonstrated SF is harmless and even healthy.

Did the $110 million RCT prove SF harmless? No, not at all. And it did not prove SF detrimental either. It proved nothing. It was a total waste except for generating more misinformation and confusion.

How and why? Apart from other problems, the Achilles heel of this type of RCT is the intervention or treatment cannot be packed into a pill. As a result, noncompliance and contamination ensue. The noncompliance was obvious – the total cholesterol level in the treatment group barely budged – it dropped from the baseline average of 253.8 mg/dL to 235.5 mg/dL after 7 years of intervention. Apparently, the participants in the treatment group did not lower their fat intake much. Keep in mind, it is an established fact that for most individuals high SF intake raises the total cholesterol level and vice versa – the controversy has been whether high cholesterol causes heart disease (see chapter 4, Road to Health, for details).

Another problem is contamination. Apparently, the participants in the control group also changed their diet – their average serum cholesterol also dropped from 253.5 at the baseline to 240.3 at the end of the study. During the 70s and 80s, the media coverage about fat, cholesterol and heart disease was wall to wall – it was hard not to be swayed.

After 7 years’ intervention, the difference of total cholesterol level between the treatment and control group is next to nothing: 4.8 out of 250 mg/dL. How can anybody expect any meaningful mortality difference between the two groups due to the reduction of cholesterol? Nevertheless, the null finding became the bedrock of the SF-cholesterol-harmless theory – the landmark RCT says so.

As if MRFIT were not confusing enough, NIH (National Institutes of Health), without learning anything from MRFIT, funded another large-scale trial called Women’s Health Initiative (WHI) with a price tag of $625 million ($1.4 billion in today’s dollars). WHI failed even more miserably than MRFIT. Started in 1991, WHI ran three components or separated studies: Dietary Modification Trial (DM) with 48,835 participants, Calcium/Vitamin D Supplementation Trial (CaD) with 36,282 participants, and Hormone Therapy Trial (HT) with 27,347 participants.¹⁷

For the DM trial, after 6 years, the treatment group on average consumed 2.9% less SF than the control group, the total cholesterol of the treatment group was only 3.26 mg/dL (out of 224 mg/dL) lower than the control group, and the LDL and HDL were 3.55 and 0.43 mg/dL lower respectively in the treatment group.¹⁸ Obviously, the NIH and the researchers who designed the study kept doing the same thing but expected different results.

Once again, the DM trial in WHI proved nothing but further generated more misinformation confusing the academics, medical communities, policymakers, the media, and the public. Although it was another big waste, at least the DM trial did not directly kill people. But the HT trial became a WMD (weapon of mass destruction) – the first round of findings published in 2002 by JAMA led to some 50,000 premature deaths.^19,20 Ironically, it was the HT trial that demonstrated the misleading findings of the Nurses’ Study which killed thousands as just discussed above. Now, how could it be possible the HT Trial, the ‘whistleblower’ against the Nurses’ study, went on to kill 50,000 more women?

Unlike the DM trial, estrogen therapy or replacement can be packed into a pill and the trial was double-blind and placebo controlled. What happened was the HT trial violated the external validity – the finding was only valid for the participants in the study but not for the general public.

The HT trial did find women taking estrogen and progestin had significantly higher risk of breast cancer, heart disease, and stroke than women taking a placebo. The risks were so high that the 15-year trial was abruptly stopped three years earlier than originally planned. Almost instantly, estrogen became taboo. Doctors and patients alike tried to avoid estrogen as much as they would avoid a plague. By 2011, estrogen replacement therapy in women aged 50-59 dropped a whopping 79 percent.^21,22

Unfortunately, the backlash against estrogen therapy proved to be deadly – leading to 50,000 or so unnecessary deaths of women, estimated by the researchers at Yale University.²³ What happened was the original 2002 HT trial published in JAMA only studied women with an intact uterus. For the population with an intact uterus, estrogen and progestin did increase health risks. However, the 2011 WHI follow-up study has clearly demonstrated estrogen reduces health risks of those with hysterectomies (surgical removal of the uterus).²⁴ Tragically, the initial result was over-generalized to all women including those with their uterus removed, and for ten years nobody came out to clarify the over-generalization.

This goes to show evidence-based medicine can be deadly if the evidence is wrong, even if generated by double-blind and placebo controlled RCTs. And probably RCTs are even more dangerous because few dare to question or challenge findings from RCTs, the gold standard.

We would love to say the HT trial is a mishap – lessons are learned and move on. But the misuse of RCTs continues to engender dangerous misinformation in different ways. Take for example, a recent large scale double-blind and placebo-controlled trial with 25,871 participants was conducted to assess the effect of vitamin D supplementation (2000 IU daily) on prevention of cancer and cardiovascular disease. The study was done by researchers at Harvard University and published in 2019 in the New England Journal of Medicine. It does not get much more prestigious and influential than that. If you, like most in the medical field including doctors, only read the conclusion in the abstract, here it is: “Supplementation with vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events than placebo.”²⁵

This can be readily interpreted by the media, the public, and even doctors as “vitamin D supplementation just produces expensive pee.” However, a close look into the article would spot serious problems.

For unknown reasons, the study participants were overall not vitamin D deficient – the average serum vitamin D level was 30.8 ng/mL at the start of the study, which was not a good representation of the vitamin D level in the general public. Studies have shown 23-42% of the US population are vitamin D deficient (<20 ng/mL), and the prevalence is much higher among the elderly, institutionalized, or hospitalized.^26-30 And the latest data from the National Health and Nutrition Examination Surveys (NHANES) published in 2022 shows nearly two-thirds of the US population with their vitamin D level below 30 ng/mL.³¹

More importantly, a study conducted by German researchers published in the Journal of Nutrition demonstrated “An inverse association between serum 25(OH)D and mortality was observed only for participants with vitamin D insufficiency or deficiency and was strongest for the latter.”³²

Given vitamin D has receptors in each cell of the human body, regulates over 2,000 genes, and its deficiency induces or contributes to almost every disease from depression to cancer, and to COVID-19 infection,^33-39 the ramifications of the misguided conclusion published in the top medical journal can’t be overstated.

Furthermore, even if the study participants were vitamin D deficient, it would be next to impossible for a trial with a 5-year follow-up period to detect the effect of 2000 IU vitamin D supplementation on cancer or cardiovascular events – the incubation time for cancer and heart disease is long – it is estimated the average latency period for hematologic cancers such as leukemias and lymphomas is 51 months and the average latency period for solid tumors is 110 months.⁴⁰For coronary heart disease (CVD), it is 10 years or more.⁴¹

Most importantly, chronic diseases including cancer and CVD are typically multifactorial,⁴² and vitamin D is just one of the causal factors for those who are deficient in it. No one should expect vitamin D alone can prevent cancer and CVD or stop them if they are already in the ‘pipeline’.

Despite all the flaws, the vitamin D trial did find a 17% decrease in deaths from cancer in the group taking vitamin D supplements, which is supported by other studies.^43-45 Curiously, the 17% decrease in mortality was not reported in the abstract of the article. Given the fact that few medical journal readers including doctors would scan beyond the abstracts, the damage done by the misguided conclusion in the abstract is far reaching.

Unfortunately, the misuse and overuse of RCTs are beyond sporadic or random – by and large, RCTs systematically produce misleading findings when assessing the efficacy of treatments targeting root causes, which has trapped medicine into a symptom-centered practice.

Chronic diseases are typically multifactorial.⁴² One disorder is often the result of multiple triggers or root causes, and for the same disorder, the root causes can be different from person to person. Typically, treatments of root causes require longer intervention time and cannot be packed into pills for double blind and placebo control in RCTs, which makes compliance impossible and contamination inevitable.

Take for example, despite the fact many have their health problems such as autoimmune diseases and mental health disorders resolved after implementing gluten/dairy free diet, RCTs would most likely find gluten/dairy free diet ineffective.

Why? As just mentioned, most chronic diseases are a result of multiple risk factors working together. For the randomly selected study participants, gluten and dairy are unlikely to be the only culprits causing their health problems. The condition could be a result of sensitivity to other foods (e.g., nuts and shellfish), stress, intestinal permeability, dysbiosis, and thousands of manmade chemicals as well as heavy metals accumulated in the body. When the participants are treated with gluten/dairy free diet, only a small portion of the study participants whose condition is principally driven by gluten/dairy will experience positive results. Consequentially, the RCT will most likely find the gluten/dairy free diet ineffective because the positive effect in some participants would be averaged out by the null effect of other participants.

Setting aside the fact that different patients may have different triggers for the same disorder, even if gluten were the sole culprit, RCTs could still produce null findings due to food cross-contamination and/or noncompliance. According to an FDA report,⁴⁶ some individuals’ immune systems adversely react to an intake of 0.4 milligrams of gluten per day (about 0.008% of a teaspoon, or 1/9 of a sesame seed). And some may cheat – a slice of pizza is too irresistible.

Furthermore, even if the intervention in a RCT is to target all the potential risk factors or root causes, noncompliance is a formidable foe. In addition to the challenges of food sensitivities, reducing stress and avoiding environmental toxins are easier said than done. It’s hard for someone who works on three jobs and can’t make ends meet to reduce stress, let alone meet all the other challenges in life. We all understand pesticides are detrimental to our health but not everybody can afford organic food. We know carpet and padding emit chemicals called endocrine disruptors, but many can’t afford hardwood flooring. We understand old and damp houses often have mold overgrowth causing health problems, but not many have the luxury to move to a new and dry home.

All in all, when it comes to assessing the efficacy of treating chronic diseases by targeting their root causes, RCTs are a square peg in a round hole.

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To summarize, the battle line between drug-centered and cause-focused medicine is drawn around how evidence is and should be produced. Unfortunately, the overuse and misuse of RCTs have trapped medicine in a giant pill bottle by generating misleading evidence.

Truth Is Simple

Truth or real evidence does not need to be complex. When it comes to healing common chronic diseases by managing their root causes, both the clinicians and patients know whether a treatment is effective or not – reporting basic data can go a long way: how many were treated, how they were treated, how many were cured, how many were improved, how many saw no change, and how many experienced side effects.

Of course, the reporting system cannot be an honor system. A rigorous auditing process must be established, and severe penalties must be imposed on fraud and dishonesty as a means of deterrence. In this regard, much can be learned from detecting/punishing insurance frauds.

Establishing such a reporting system is more feasible than ever thanks to the widespread implementation of electronic health records (EHR) due to the HITECH Act. Additional costs needed for the establishment and management of the reporting system can be financed by introducing excise taxes on all chemical products including drugs which created or exacerbated the chronic diseases epidemic in the first place.

Too many people are suffering from too many chronic diseases. For the wellbeing of humankind, medicine needs to chart a new course in treating chronic disease – follow the truth (real evidence) and treat the root causes rather than the symptoms.

But Money Is the Obstacle

We know where medicine should go, but the obstacles are too great to overcome. The tallest roadblock to the root causes is money, plain and simple. For the medical establishment, especially big pharma, “a lifetime of treatment is preferable to a cure,” wrote Dr. Elisabeth Rosenthal, MD, in her eye-opening book An American Sickness: How Healthcare Became Big Business and How You Can Take It Back.

Imagine a world without chronic diseases – the medical establishment would stand to lose trillions of dollars. For the potential losers, it is a ‘life and death’ struggle – no argument, and no smokescreen of ‘evidence’ and ‘science’ will be spared in fighting any shift to treating chronic diseases by identifying and addressing their root causes.

Realistically, nobody should expect a revolution in treating chronic diseases in mainstream medicine in the foreseeable future. Until then, take care of yourself and each other – avoid long-term use of prescription or over-the-counter drugs if possible and try to figure out the root causes.

References

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Himmelstein DU, Campbell T, Woolhandler S. Health Care Administrative Costs in the United States and Canada, 2017. Ann Intern Med. 2020 Jan 21;172(2):134-142. doi: 10.7326/M19-2818. Epub 2020 Jan 7. Erratum in: Ann Intern Med. 2020 Sep 1;173(5):415. PMID: 31905376.
Department of Health and Human Services, Assistant Secretary for Planning and Evaluation. Trends in Prescription Drug Spending, 2016-2021. Sep. 30, 2022. https://aspe.hhs.gov/sites/default/files/documents/88c547c976e915fc31fe2c6903ac0bc9/sdp-trends-prescription-drug-spending.pdf
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