Editor’s Note: Over the next several months, Mad in America is publishing a serialized version of Les Ruthven’s book, Much of U.S. Healthcare is Broken: How to Fix It. In this blog, he addresses the difference between basing a medical system on clinical belief versus one based on scientific evidence. Each Monday, a new section of the book is published, and all chapters are archived here.
“It’s not what you know that kills you. It’s what you know for sure that ain’t true.”
—attributed to Mark Twain
What are some of the sources of much of the poor quality and costly healthcare in the U.S. today?
We are currently spending over $3.6 trillion dollars a year on U.S. healthcare (17% of GDP and climbing). Except for what I will refer to as Blue Ribbon Medicine, a great deal of the medical care delivered in the U.S. today is what I consider to be both inappropriate and of poor quality. I know mine is a minority opinion. The vast majority of people, including those in the medical profession, are very pleased with the quality of healthcare today, but despite this there is general agreement that healthcare is too expensive. We spend more money on healthcare than any other country in the world, and the fact that we rank behind Cuba in infant mortality rate still does not seem to make people consider that the U.S. might have both a cost and a quality problem.
According to the Centers for Medicare and Medicaid Services, U.S. health expenditures were at 3.6 trillion dollars in 2018 or $11,172.00 per person or 17.7% of Gross Domestic Product (GDP) and projected to rise to 19.7% ($6.2 trillion) of GDP in 2028! The Peterson Center of Healthcare reports that the U.S. is spending twice as much per person as the Organization for Economic Co-operation in 34 member countries and, in the U.S., we are well below the average member in life expectancy at birth, infant mortality, unmanaged asthma, unmanaged diabetes and safety in childbirth. The Peterson Center reports that, in the U.S., 30% of total healthcare spending goes to unnecessary, ineffective, overpriced and wasteful services. In chapters 2 through 6 I will report on research that suggests the 30% figure is likely to be an understatement of the degree of wasteful spending.
The yearly $3.6 trillion dollar U.S. healthcare bill is only exceeded by the approximately $3.8 trillion dollar a year U.S. malpractice awards for medical errors!1
This latter statistic has led many to believe that they have found the solution to the U.S.’s healthcare cost problem: that is, to simply cap malpractice awards to a maximum of $250,000 for pain and suffering. Such bills have already been enacted in several states. A good case can be made that malpractice litigation actually reduces subsequent medical errors but such a “solution” deals with the effect of the problem and not the cause, the medical errors themselves!
This last is what I will refer to frequently as back end medicine, treating many health problems on the back end rather than the front end—the latter often being much more effective and much less expensive than a great deal of the “back end” medicine of today. Blaming greedy lawyers for our healthcare cost problem comes under the same category as blaming modern medical advances, the expensive new technology and medicines to identify—and at times—cure diseases, and other common “red herrings” in the healthcare industry. Such assumed causes for our healthcare cost problem only distract us from an examination of the real causes, which will be addressed in many of the following pages.
Cost & Quality
After a twenty year or so review of the health outcome literature, combined with my clinical experience as a psychologist and an arranger of behavioral healthcare for large self-insured employers, the above words of wisdom by Mark Twain are certainly relevant to both the quality and cost problems in healthcare today. Most readers will accept my thesis that we do have a cost problem but will argue with my point that we have a major quality problem in U.S. healthcare as well. I will make a case that we can fix the cost problem by fixing the quality problem!
Most people would rate the quality of U.S. healthcare as excellent—perhaps the finest in the world—and would wish that we could maintain the excellent healthcare quality and, at the same time, lower its cost. However, in examining the sound scientific research on health treatment outcomes, I will present research evidence that our cost problem in healthcare is derived largely and directly from many current healthcare practices that are:
- at times little or no better than a placebo effect
- of little value in relation to cost, and of poor quality
Yet these same treatments are considered gospel by most physicians, the media, and the public at large. These segments of poor but popular healthcare might be considered some of the “sacred cows” of modern medicine, health practices and policies that enjoy almost unanimous acceptance by physicians and their patients but, in Mark Twain’s words, are treatments “that ain’t true.”
In the past, one of the sacred cows of healers and physicians (and their patients as well), was bloodletting, perhaps the most popular and accepted practice of healing which lasted for more than 3,000 years and on occasion well up to the 20th century! In the U.S., during the 1918 flu epidemic, bloodletting was still in use to treat the disease. Bloodletting was said to treat effectively several dozen or more health problems, from gout to the black plague, much as modern medicine tells us that an SSRI (selective serotonin reuptake inhibitor) antidepressant treats effectively six or seven behavioral health problems (or “diseases” as they are now called) that plague many Americans.
In the 19th century, some of the sacred but later debunked treatment myths were children’s soothing syrup (narcotics), the curative powers of mercury (mercury does not help one’s brain at all), calm your cough with heroin, and urine therapy (yes, drinking one’s urine). In the 20th century and today we have had and have more than our share of fake treatments, such as you shouldn’t sleep after a concussion, you shouldn’t wake a sleepwalker, to more dangerous sacred cows including lobotomies, leucotomies, infecting the patient with malaria to cure one’s schizophrenia—and, if that doesn’t work, hydrotherapy for schizophrenia—and other current sacred cows of medicine that will be discussed.
Since the 1950s, there has been no letup in popular but fake treatments such as a pill will cure one’s depression, anxiety, schizophrenia, chronic pain (etc., etc.) and others I will discuss, such as epidural steroid injections are an effective and safe way to cure back pain (Chapter 6). In examining the scientific research on these and other popular treatments to be addressed one will find that the science at times finds little or no efficacy and often side effects that are injurious to one’s health as well, yet these bogus treatments thrive despite the absence of any proof.
Of all of the varied sources of poor-quality healthcare, none is more egregious (and anti-scientific) than the endemic use of off-label drugs to allegedly treat a host of health problems without FDA approval. I read somewhere that 20% of all prescribed medicines are used off-label, but I suspect off-label use is substantially higher. If an FDA-approved drug does not treat the health problem, I suspect most physicians turn to the off-label route.
At this point if you think I am a strong supporter of the FDA approval process, you would be quite wrong in some respects. In addition to the research to be discussed, I will present a strong argument that the current efficacy standard in general for FDA approval for any drug or therapy is too modest and a much higher efficacy standard is needed if we are ever to have better healthcare at lower cost. With a higher efficacy standard than the current one for drugs and non-drug treatments, the market would remove a number of popular, but currently inferior and bogus health treatments, totaling many billions of wasted—and often injurious—healthcare dollars.
We have had healers and physicians for over 3,000 years (including many physicians today) recommend (and still recommend) so many fake cures such as bloodletting for the plague, today’s SSRI to cure your depression, and epidural steroid injections (10 or so million a year) to cure your back pain! The healing in primitive cultures and too much of modern medicine are both characterized by false thinking, namely “I gave Mary bloodletting for her plague and she was cured,” or today’s “I gave Mary an SSRI for her depression and she got better.”
Any treatment to patients in distress who are given bloodletting—or any other wrongful modern therapy—are being given a dose of hope. When the healer gives the patient hope, despite the efficacy or non-efficacy of the therapy, the patient often gets better to a degree, probably because hope decreases the patient’s stress and perhaps stimulates the immune system, which helps our body fight the sources of the stressful symptoms.
This erroneous belief in the magic of the treatments is especially found when the treated health problem is self-limiting, i.e., gets better with or without treatment! We can’t depend on patient (or provider) satisfaction with the treatment to prove its efficacy, and if we do as we are now doing, we will continue to have many treatments with very limited or no efficacy and often serious side effects as well. With regard to Mary’s supposed cure of the plague through bloodletting, her doctor may have misdiagnosed plague for the flu and the bloodletting “cured” her flu, which typically remits without any treatment at all.
Clinical Belief vs. Science
We will discover that many current and very popular treatments have no real efficacy beyond their placebo value, or the clinical benefit is marginal and often not worth the adverse side effects of the therapy, or there are proven alternative treatments available. I submit that treatment efficacy and safety should be determined by the application of the scientific method and not anecdotal “evidence” such as patient and provider satisfaction with the therapy.
Unfortunately, my reading of the research finds that too much of modern medicine is based on the latter rather than the known science that is already in the health literature but seemingly “buried” from most physicians and the general public. Science and not anecdotes by “believers” should drive everyday clinical practice and this is the source of much of the inappropriate and poor healthcare of today. For example, while seeking treatment for my own back pain/disability problem, including an attempt to get a waiver from my insurance company policy of mandatory steroid injections before authorization for back surgery, my experiences have strengthened my belief that too much of healthcare is governed by clinical belief rather than science.
How do we get more science rather than propaganda to shape current healthcare delivery? I believe all of the existing health entities—providers, health insurance companies, the FDA, the pharmaceutical industry, and managed care—cannot and will not make needed changes to improve the quality of healthcare and to lower the cost as well. We will have to invent a powerful new entity that has the guts to bring about “drastic” changes in basic health policies. I will describe such an entity in Chapter 7. Yes, there is fortunately a door to better healthcare at lower and more affordable cost, but from the outset the current health establishment is closed to any needed changes and will fight those like me who argue for change.
The science says there is only one proven way to truly determine a drug or treatment efficacy, and that is through double-blind, randomized drug/therapy placebo-controlled scientifically sound clinical trials, which is the path for FDA approval. Medical care in general, often because of very limited efficacy of the treatment over the placebo effect in both psychiatric and “medical” drugs, has been attacking this standard of proof and have turned to other means to establish the so called “real” efficacy of many of their favorite treatments.
A major and very popular “alternate” path to medical truth is the Open Label study in which a controlled comparison or placebo group is simply avoided entirely! This, of course, proves to be a non-science satisfaction study, which as far as science is concerned is not worth the paper it is written on. This open label “research” study, if not a scientific achievement, was a marketing achievement, which in one case spurred 120 published articles extolling positive antidepressant drug findings, such as that 65% of the patients remitted their depression!
Antidepressant drug sales soared as the result of such publicity directed to general and family physicians who prescribe the vast majority of psychiatric drugs. However, the main government study was fortunately under the freedom of information act, which allowed independent researchers to access the study data and to reanalyze the data, the results of which told a quite different story (as will be described in Chapter 2). Unfortunately, as happens so many times in healthcare, marketing ruled out over science and antidepressant sales escalated!
Much of 20th century medicine smugly looks back at the “pre-science” days of medicine and says the days of mythical and debunked treatments are over! I assure you at the outset that the days of fake treatments are still alive and well. Moreover, I strongly suspect the days of mythical cures will never be over because there seems to be something in the human spirit that wants to believe, and once belief sets in the believer often strongly resists any change in the belief despite any evidence to the contrary, which we will observe many times throughout these pages. We will see that this wanting to believe exists throughout society (including modern healthcare) and is no respecter of age, gender, intelligence, education or profession. As we shall see on many occasions when someone challenges the conventional wisdom (e.g., a healthcare whistle blower) these persons are attacked because they dare to question the accepted truth! I know because several times in my career I have challenged the then currently accepted healthcare wisdom, and needless to say I was not given a warm welcome by those believers who took offence by my failure “to go along” and dare to question the “truth.”
Many of today’s sacred cows of medicine are indeed true (the current antibacterial drug cure for infection, for example), but I will focus on those sacred cows of medicine that are not supported—and are contrary—to the existing sound scientific research. I use the term sound health research because in many of the following pages I will show that much of what passes for accepted health research is of poor quality and that we must approach any piece of health research with skepticism and armed with a good deal of expertise in knowing how to examine the research data to determine its truth or falsity.
Unfortunately, the average physician practitioner has no training or expertise to evaluate the merits of a piece of health research and depends on others (e.g., the drug company) for their science education. Additionally, practitioners are very gullible about endorsing false conclusions from substandard research, which often appears in very prestigious health journals. Since current medical care is largely the dispensing of prescriptions, the average medical practitioner is very vulnerable to persuasion by the drug detail person who is just passing on what he has been told about the “research” behind the drugs he or she is selling.
I will point out dozens of research outcome studies in which the conclusions about the treatment are not only not supported by the data but on examination are contradicted by the data! I will point out that many of these later false studies enjoyed (and enjoy) widespread popularity among providers and often resulted (and result) in poor, expensive and very harmful care.
Here I am just touching upon the prevalence in modern healthcare of non-FDA approved off-label drug use, that is, an FDA-approved drug (for one condition) that is used to treat one or usually several other health conditions because physicians believe the off-label drug is effective. This popular and egregious practice is an abandonment of science and harkens back to the days of bloodletting and must be stopped if we are ever to have better healthcare. I am not opposed to hunches that an approved drug may also be effective in treating other health problems, but let’s put this hunch or hypothesis to a scientific test to determine its truth or falsity before using the drug off-label.
I might point out that Ph.Ds. in psychology (which I am) are trained in statistics, science, and the scientific method and are trained to both conduct sound research and evaluate the soundness of the research of others. Physicians, although principally trained in the biological and physical sciences, are practitioners and are not trained to conduct or evaluate the research of others and are susceptible to endorsing scientifically substandard research, especially if the research is consistent with their clinical opinion about the drug or therapy.
I warn the reader to be especially skeptical of drug industry sponsored and funded health research even when carried out under contract by research professionals who are not a part of the sponsoring industry. One would hope that professionals doing research for a fee would not let their findings be influenced in any way by monetary considerations (and the expectation of future drug contracts). However, contrary to these hopes, and as we shall see, experience suggests that we cannot count on this. In several cases to be pointed out, the questionable “positive” conclusions about the therapy in the study even seem to reach the level of outright fraud in a number of examples to be discussed later.
To see the list of all references cited, click here.
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