by Dr.Harald Wiesendanger– Klartext
What the mainstream media is hiding
Less than 6% of all conventional medical treatments are based on reasonably reliable scientific findings; only 1 in 3 has sufficiently known side effects. These embarrassing figures are the result of a thorough evaluation of over 1,000 research reviews. The claim that “alternative” medicine cannot be trusted because it lacks “evidence” is therefore a case of the pot calling the kettle black.
If he were Saint Peter, he would only let two types of doctors into heaven, namely accident surgeons and dentists, once quipped British medical historian Thomas McKeown (1912-1988). In his eyes, these were the only ones who really contributed to alleviating suffering. In his opinion, the real advances in public health—longer life, better quality of life—were not due to the achievements of modern medicine, but to broad social and economic progress, higher living standards, especially better nutrition, better hygiene, and a life without constant fear, hardship, and danger.
That was in the mid-1970s, as recounted in McKeown’s provocative book The Role of Medicine. (1) And today, half a century later? A team of 12 authors has determined in a comprehensive meta-review—an evaluation of over 1,000 overviews of medical studies—just how weak the backbone of so-called “evidence-based medicine” continues to be. (2)
Arrogant conventional medicine with a weak backbone
The reviews covered all areas of medicine, from pediatrics to gerontology, from psychiatry to surgery, from pharmaceuticals to diets. They came from Cochrane, an independent, non-profit organization founded in the early 1990s by epidemiologist Archie Cochrane, in which a global network of scientists systematically summarizes medical research to enable doctors and health policymakers to make well-informed decisions. To this end, Cochrane’s research groups and centers create and maintain systematic reviews and meta-analyses that evaluate the state of evidence on medical interventions and, in some cases, diagnostic issues—including methodology, bias risks, and the significance of the overall evidence. Strict rules apply to the handling of conflicts of interest—purchased science should be excluded. The results are published primarily in the Cochrane Library. It now comprises more than 9,000 reviews.
From this huge collection of material, the research team selected 1,076 reviews published between 2008 and 2021, covering a total of 1,567 medical interventions. The most important inclusion criterion was that an intervention was compared with a placebo, no treatment, or standard therapy.
To assess their quality, GRADE was used: a common procedure that assigns a “confidence label” to each outcome in systematic reviews: high, moderate, low, very low.
Take, for example, the Cochrane review on statins, commonly prescribed drugs that reduce “bad” LDL cholesterol in the blood by inhibiting cholesterol production in the liver to lower the risk of heart attacks and strokes. On this topic, the Cochrane Library contains the Rapid Review by Health Quality Ontario. Here, GRADE evaluates two outcomes:
– Major coronary events, e.g., non-fatal heart attack + coronary deaths;
– Stroke: fatal + non-fatal stroke.
How does GRADE “calculate” this? Because these are particularly high-quality studies—RCTs, randomized controlled trials—GRADE initially starts at ‘high’ for each outcome.
Then GRADE asks for each outcome: “Do I need to go down a level (or more) because of problems?”
The five typical test points are: Risk of Bias, Inconsistency (inconsistency of results), Indirectness (lack of direct transferability to the question), Imprecision (wide uncertainty ranges; too little data/events), and Publication Bias (positive studies are more likely to be published than negative ones).
For outcome A: “Heart attack/coronary deaths”: 10 RCTs. Risk of bias: “serious limitations (-1)”. Why was it downgraded by one level? In several studies, the randomization of participants and their blinding were not clearly documented; it is not certain whether the groups were really formed “fairly.” One study was not blinded and evaluated “on-treatment” (those who drop out count less/differently) – this can distort effects. Two studies were terminated strangely early – this can make the benefits look “too good.” Otherwise, no restrictions. Publication bias: undetected. Quality: MODERATE.
For outcome B: “stroke.” 7 RCTs. Risk of bias: also “serious limitations (-1),” plus imprecision: “serious limitations (-1).” Why? Strokes rarely occur during the course of studies. The data is too sparse to be certain. → Quality: LOW.
The result: Only 5.6% of all medical interventions had a statistically significant “HIGH QUALITY” outcome.
In contrast, 58% of the reviews examined were of ‘LOW’ or even “VERY LOW” quality, with a further 30% being “MODERATE.”
“This modest efficacy profile,” the Walach/Ioannidis group notes, “is offset by the side effects. Only in 577 or 37% of all interventions were the side effects documented so carefully that they could be recorded in the reviews.” The extent to which medicine causes harm therefore remains unmentioned far too often.
Their conclusion: “In any case, we now know that a little more skepticism in dealing with the medical narrative of salvation is not only appropriate and factually correct, but actually the more enlightened and better-informed attitude.”
A lesson: “evidence” against HCQ
The “Surgisphere” scandal at the beginning of the coronavirus pandemic is a prime example of how “evidence” can be manipulated to discredit unpopular views and practices. Previously, numerous doctors had reported astonishing treatment successes with HCQ in Covid-19; even US President Donald Trump promoted it. Promptly, on May 22, 2020, a study appeared in The Lancet—one of the world’s most respected medical journals—claiming that HCQ does more harm than good to Covid patients—indeed, it increases the risk of death by 100% for those infected. This was allegedly the result of an analysis of the medical data of 96,032 patients from 671 clinics on six continents. Fact checkers worldwide referred to the impressive figures, and mainstream media spread them uncritically. The effect was resounding: in many countries, HCQ studies that had already begun were subsequently discontinued.
Later, it turned out that the data had been falsified. The company Surgisphere, from which the data originated, was never able to prove that the “1,200 hospitals around the world” actually existed. When Andrew Gelman, a renowned statistician from Columbia University, took a close look at the Surgisphere data, he came across something absurd: The study claimed that 73 COVID deaths had occurred in surgical hospitals in Australia—but by April 2020, the whole of Australia had recorded fewer than 102 COVID deaths; most of these had occurred in nursing homes, not in hospitals.
Which 1,200 hospitals did the Surgisphere data come from? The study did not name a single one. Investigations revealed that many of them did not even exist or had never heard of Surgisphere.
After a letter of protest from over 200 medical professionals, statisticians, and ethicists, Lancet withdrew the study. To this day, it remains unclear who commissioned and financed it in the first place. Only “conspiracy theorists” seem to care about clarifying this.
Much of clinical research is useless.
Ioannidis, a physician, epidemiologist, and biostatistician who is one of the world’s best-known science researchers, has long been skeptical of the mantra-like invocation of “evidence-based medicine” in the medical profession. (3) He considers the EBM ideal to be correct and necessary. However, the evidence that is cited can be systematically distorted. It is often not found neutrally, but produced, filtered, and marketed. All too often, it is contaminated by incentive systems and conflicts of interest. Influential randomized studies have often been conducted by/in favor of industry. For example, a drug may show an impressive effect on a laboratory value, such as LDL and HbA1c, in several studies. In guidelines, this then sounds like “strong evidence.” Ioannidis would ask: Were endpoints that are relevant to patients sufficiently collected: death, heart attack, quality of life? Are the studies large enough, independent enough, transparent enough? Or was the “EBM stamp” pressed onto a narrow, marketable excerpt of the evidence? Some findings are simply unreliable—multiple times distorted, too small in scale, too generously evaluated.
Much clinical research is useless, not necessarily because of “wrong” results, but because its design, relevance, and transparency are insufficient to truly improve decisions. Ioannidis does not criticize “too little research,” but rather too much research with too little information gain.
What Ioannidis does not question, however, is the concept of “evidence” itself. Derived from the Latin noun “evidentia,” it means visible, clear, obvious. Are scientists alone capable of clearly seeing what can restore and maintain our health? Is there nothing more insightful than the type of studies included in reviews and meta-analyses—especially RCTs, randomized controlled trials? Is what never appears there negligible?
Slaughtering the sacred cow
As befits a sacred cow, it does not live without a home. No, befitting its status, it resides on the top floors of a building that is hardly less significant to modern medicine than the Trinity is to Christianity. From their first semester at university, medical students become accustomed to trembling with awe at the mere sight of this structure: the “evidence pyramid.” For a branch of medicine that is guided exclusively by “evidence” obtained through research, it illustrates what doctors should base their assessments, decisions, and actions on; what counts as serious “evidence”; and how much weight they should give to different types of evidence.
According to this, the least importance is attached to in vitro studies, or, to put it bluntly, “test tube and Petri dish research,” for example with isolated cells. Animal experiments are considered to be of higher value. These are followed by: expert opinions, expressed for example in editorials, conference proceedings, and textbooks; individual case reports; entire case series in which a sample of patients with a specific disease is observed; and case-control studies, in which such a group of patients is compared with another group consisting of healthy individuals. Cohort studies carry even greater weight; they follow one or more groups of individuals who share a specific characteristic, such as vegans, singles, or smokers, over a longer period of time, either prospectively or retrospectively.
The sacred RCT cow looks down haughtily on them all. The only studies considered even more respectable than individual controlled studies are “reviews,” systematic overviews that summarize the results of numerous such studies, and meta-analyses, which statistically evaluate a large number of RCTs.
You don’t have to spend days poring over this pyramid before you notice three oddities. First, it excludes qualitative studies, even though such work can provide insights and insights that no quantitative approach can match.
Second, there is no room for patients in this structure. Does it not matter how they subjectively experience a treatment or medication, how they describe changes in their symptoms and well-being, discomfort and impairments, and the effects of therapy on their entire lives? In any case, none of this counts as the “evidence” that “evidence-based” medicine considers necessary. This is, to say the least, strange. What else should be the standard of good medicine if not the benefit it brings to patients—according to their own personal assessment?
Thirdly, it is surprising that the proven wealth of knowledge from centuries-old healing traditions is also excluded from the pyramid, as is medical experience, possibly gathered over several decades of practice with thousands upon thousands of patients. There is no question that they lack statistical relevance – nevertheless, they are anything but meaningless and negligible, but generally extremely instructive and informative. The empirical foundation of not only all successful “alternative” healing methods, but also a large part of conventional procedures, consists of countless case reports, whether documented in writing or simply stored as memories in the minds of practitioners and patients. They arose from direct contact with sick people and proved themselves quite well. Even I feel this way: when faced with the question of whether I should agree to a particular therapy, I am much more convinced by a large number of precise, largely consistent reports from credible sources than by the most elaborate multicenter double-blind study, especially one sponsored by industry.
In the therapy camps of my foundation Auswege, as in everyday medical practice, multimorbid patients with multiple illnesses and medications predominate; psychological stress, which requires empathetic attention and understanding, is always involved, at least in chronic cases. However, such people do not appear in clinical research because they would distort the results. University physicians, statisticians, and file researchers examine standardized test subjects with only one quantifiable health problem. How useful are therapy recommendations from this cloud cuckoo land of medical knowledge in medical practice? How, if not on the basis of a personal assessment of the individual case, does a doctor ultimately decide what is good for this real patient with multiple illnesses who is sitting in front of him right now, in his particular condition, under his unique circumstances, with his unique history?
The cult of “evidence-based medicine”: part of a general attack on doctors’ freedom to make decisions and choose therapies
The devaluation of case studies, as well as the experience based on them, seems to me to be part of a well-thought-out, long-planned general attack on medical freedom of decision and therapy. It aims to make our doctors fundamentally distrust what their eyes, ears, and brains tell them.
They are to renounce their practical reasoning in order to become the willing executors of “science” – and thus of those who have the power to exploit this institution for their own purposes. However, the best doctor is not the one who can recite the most studies of the highest level of evidence and implement them in accordance with guidelines – but one who observes attentively, asks detailed and communicative questions, thinks and feels empathetically, draws obvious conclusions from what they see and hear, takes special circumstances into account, and is wary of hasty generalizations. In doing so, they draw not only on acquired external knowledge, but also on a growing personal wealth of data gained from encounters with hundreds, if not thousands, of people seeking help over many years of practice, as well as from a mindful, reflective, and compassionate life in society.
What would happen if he relied primarily on this? For example, he would certainly only prescribe psychotropic drugs to people with mental health issues in exceptional cases, at the height of a serious crisis, in the lowest possible dose and only for a short period of time. For his own perception shows him in a shocking way what these drugs can do to the body and soul of those affected in the short or long term. If too many of his colleagues do the same, they jeopardize economic interests: the profits of one of the most powerful and lucrative industries on the planet. Medical experience can become a nuisance that damages business and threatens sales.
No less dangerous to the business of psychotropic drugs is what consumers experience when taking them. If the doctor had not insisted that they take them, most would stop after a few days because the side effects are so bad, or at the latest when the first chronic damage to body, mind, and soul sets in. Their personal experiences with psychotropic drugs are mostly disappointing to devastating. So steps must be taken to ensure that these experiences do not count. It should not matter that people suffering from depression and anxiety are three times more likely to mention psychological help than medication when asked about their preferred therapy. Does the drug make you unfocused, restless, aggressive, listless, and apathetic? Do you feel weak and tired? Do you sweat, tremble, and twitch, your muscles stiffen, you have cramps? Do you have constant headaches? Is your vision blurry? Are you gaining a lot of weight? Are you losing your sex drive? Are you becoming even more depressed and anxious, thinking about suicide more often than ever before, or reacting in other paradoxical ways? Are you becoming a stranger to yourself? It doesn’t matter, because there is excellent evidence that you must continue to take them and remain “compliant” and “therapy-adherent.”
Underestimating the experiences of both the patient and the practicing physician became the epitome of medical professionalism, just as a strange testing procedure gradually became the ultimate yardstick of clinical research, the true source of reliable knowledge: the “controlled study.” Originally conceived and limited to drug testing, it somehow managed to rise to become the “gold standard” for all types of treatment—regardless of the obvious absurdity that rages in the process. Because apart from the administration of drugs and the use of medical equipment, nowhere else in the field of helping and healing can the therapist and the therapeutic agent be neatly separated, as strict placebo control requires: words not from the speaker, gestures not from the gesticulator, touch, attention, and affection not from the one who gives them. Everywhere else, and especially in psychotherapy and all forms of social support, other testing procedures and quality standards would be far more appropriate, taking seriously what those being treated experience.
Deadly Corona Lesson
How many SARS-CoV-2-infected people had to die because countless pieces of evidence from medical practice were underestimated? How many Covid deaths could have been prevented otherwise? As early as March 2020, one month after the WHO declared a global pandemic emergency, unconventional doctors desperately tried to make themselves heard: from Didier Raoult and Vladimir Zelenko (4) to the FLCCC group led by Paul Marik and Pierre Kory (5), Richard Bartlett, Peter McCullough (6) and Thomas Borody to Joseph Varon (7), Brian Tyson and George Fareed. Instead of leaving infected people waiting idly for vaccines, they treated them with combinations of off-label antiviral drugs such as ivermectin and hydroxychloroquine, antibiotics (azithromycin, doxycycline, clarithromycin) for concomitant bacterial diseases, anti-inflammatories such as quercetin, steroids such as prednisone, micronutrients such as zinc, vitamins C and D3, and other active ingredients. When used early on an outpatient basis, not a single one of thousands of infected individuals died, and hospitalizations were avoided. Even among severe COVID-19 cases, hardly anyone died.
But these findings were ignored, the doctors concerned were denounced as charlatans, discredited and ignored by mainstream media and fact checkers, rejected by professional journals, abandoned by professional associations, marginalized and threatened with the withdrawal of their licenses, in some cases slapped with horrendous fines or even put behind bars. Why is that? If word of the therapeutic successes had spread, they might have put a damper on the emerging multi-billion-dollar business with experimental injections.
Devaluing individual cases is part of the business model of the “research-based” pharmaceutical industry.
The glorification of the sacred RCT cow serves to devalue individual cases—and thus a major source of business-damaging arguments against swallowing drugs that are limited in their effectiveness, full of side effects, and expensive. Isn’t it strange and telling that the same luminaries who, since the 1960s, have been exaggerating the RCT procedure as the ultima ratio of therapy research in specialist articles and textbooks, at congresses, training and continuing education events, committees, and authorities have elevated the RCT procedure to the ultima ratio of therapy research, vehemently advocated treating people with health problems first and foremost with chemical substances? Is it a coincidence that these very opinion leaders of Western medicine, the most renowned spokespeople for conventional medicine, are almost without exception on the payroll of pharmaceutical companies? Only when we consider the close ties between the medical profession and industry does the triumph of the RCT model, which is impractical and prone to error and manipulation, become fully understandable.
As a doctor, to swim against the mainstream in this respect, to insist unwaveringly on one’s own experience with individual patient cases, even though no, precisely because it runs counter to supposedly reliable “evidence-based” knowledge: this may sometimes seem stubborn and negligent, but it is neither always backward-looking nor always ignorant, but often deeply wise and beneficial, in psychiatry even more so than in any other branch of medicine.
No, this is not a plea to turn back the clock.
(1) Thomas McKeown: The Role of Medicine: Dream, Mirage, or Nemesis?, London 1976; dt.: Die Bedeutung der Medizin: Traum, Trugbild oder Nemesis?, Frankfurt/Main 1982.
(2) Howick J, Koletsi D, Ioannidis JPA, et al.: „Most healthcare interventions tested in Cochrane Reviews not effective according to high quality evidence: a systematic review and meta-analysis“, Journal of Clinical Epidemiology 2022;148 doi: https://doi.org/10.1016/j.jclinepi.2022.04.017. Zusammengefasst hier: Harald Walach: „Meta-Review: Das Rückgrat der Evidence Based Medicine ist schwach.“
(3) https://pubmed.ncbi.nlm.nih.gov/28532611/, https://journals.plos.org/plosmedicine/article?id=10.1371%2Fjournal.pmed.0020124, https://pmc.ncbi.nlm.nih.gov/articles/PMC4915619/, https://pubmed.ncbi.nlm.nih.gov/11405896/
(4) https://drelef.org/zelenko/Vladimir-Zelenko-treatment.pdf, https://drelef.org/zelenko/Zelenko-memo-August-protocol.pdf
(5) https://jeffreydachmd.com/wp-content/uploads/2020/09/MATH-protocol-for-the-treatment-of-SARS-CoV-2-infection-the-scientific-rationale.pdf, https://www.hsgac.senate.gov/wp-content/uploads/imo/media/doc/Testimony-Kory-2020-05-06-REVISED.pdf, https://www.hsgac.senate.gov/wp-content/uploads/imo/media/doc/Testimony-Kory-2020-12-08.pdf
(6) https://pubmed.ncbi.nlm.nih.gov/32771461/, https://pubmed.ncbi.nlm.nih.gov/33387997/
(7) https://www.medscape.com/viewarticle/934114, https://jeffreydachmd.com/wp-content/uploads/2020/09/MATH-protocol-for-the-treatment-of-SARS-CoV-2-infection-the-scientific-rationale.pdf