conclusions about evidence-based medicine 25 years in

COVERING UP EVIDENCE OF THE GREAT EVIDENCE-BASED MEDICINE COVERUP

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“The idea of Evidence Based Medicine (EBM) is great. The reality, though, not so much.”  Nephrologist Jason Fung from an April issue of Medium (The Corruption of Evidence Based Medicine — Killing for Profit)
Last July, the Lancet published a scientific article, Progress In Evidence-Based Medicine: A Quarter Century On, which made the statement, “EBM’s enduring contributions to clinical medicine include placing the practice of medicine on a solid scientific basis… and the development of the methodology for generating trustworthy recommendations.”  Today I am going to show you that this is simply not true.  Or at least not true in the way most people think of the word’s common use.  Today I’m going to show you that Evidence-Based Medicine, while cloaking itself in the robes of science, has, in far too many cases, been anything but scientific.  If you know what to look for, EBM’s disguise is as easy to see through as those campy Groucho Marx getups (cheap plastic glasses, cheap plastic nose, cheap plastic mustache).

A decade ago this coming December, Evidence-Based Medicine was defined by three MD / Ph.D types in the journal Acta Informatica Medica (Evidence Based Medicine – New Approaches and Challenges) as……

“The conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. It is a movement which aims to increase the use of high quality clinical research in clinical decision making. EBM requires new skills of the clinician, including efficient literature-searching, and the application of formal rules of evidence in evaluating the clinical literature. The practice of evidence-based medicine is a process of lifelong, self-directed, problem-based learning in which caring for one’s own patients creates the need for clinically important information about diagnosis, prognosis, therapy and other clinical and health care issues. It is not ‘cookbook’ with recipes, but its good application brings cost-effective and better health care. The key difference between evidence-based medicine and traditional medicine is not that EBM considers the evidence while the latter does not. Both take evidence into account; however, EBM demands better evidence than has traditionally been used”

Ten years later, costs are through the roof, and when there are potential profits on the table, you can’t blindly trust anything you read coming out of the biomedical field.  For proof, take a gander at the second largest blog category on my site (just behind FASCIA), titled, as you might expect, EVIDENCE-BASED MEDICINE.  After all, it was just three years before this that John Ioannidis, a Harvard-educated MD / Ph.D who is currently a professor of medicine and bio-statistics at Stanford, published his now famous study in PLoS One that has since become the single most downloaded document in the history of science, Why Most Published Research Findings Are False.

“There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field.  Published research findings are sometimes refuted by subsequent evidence, with ensuing confusion and disappointment. Refutation and controversy is seen across the range of research designs, from clinical trials and traditional epidemiological studies to the most modern molecular research. There is increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims. However, this should not be surprising.

Bias should not be confused with chance variability that causes some findings to be false by chance even though the study design, data, analysis, and presentation are perfect. Bias can entail manipulation in the analysis or reporting of findings. Selective or distorted reporting is a typical form of such bias.  Conflicts of interest and prejudice may increase bias. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable.”

Read that again and let it soak in.  Ioannidis is talking about FINANCIAL CONFLICTS OF INTEREST, INVISIBLE & ABANDONED RESEARCH, as well as the the way in which raw data is looked at and dealt with (the other day I showed you how the FDA has been purposefully making the data on SILICONE BREAST IMPLANTS look much better / safer than it really is).  A year ago next month I showed you what a world ruled by science looks like (HERE).  If something cannot be “proven” in a study — particularly an RCT or Randomized Controlled Trial (in RCT’s, people are randomly chosen to to be the control; they get the PLACEBO, or be in the experimental group; they get the drug, device, food, etc that’s being tested) —- then in the minds of those ruled by science, it can’t possibly be true.  And in biomedical sciences, if something is not true, don’t be surprised when you see it labeled as “QUACKERY“.

The May 2013 issue of the Journal of the Federation of American Societies for Experimental Biology published a study titled Evaluating the Evidence for Evidence-Based Medicine: Are Randomized Clinical Trials Less Flawed than Other Forms of Peer-Reviewed Medical Research? that looked into the validity of RCT’s by reviewing almost 18,000 of them to see whether or not they were of a high enough quality to make it into a “review” or “meta-analysis“.  And while their conclusions were not as dire as Ioannidis’ 90%, almost 40% were “excluded from review for an identified flaw.”  And yet the RCT continues to be the standard that I am bound to.  Why should I have a different standard than say a drug company?  Allow me to show you in a clear and concise manner.

As a chiropractor, I treat my patients using CHIROPRACTIC ADJUSTMENTS as well as a form of TISSUE REMODELING that leaves signs that are more than just ‘tell tale’ (it causes some bruising; see link).  The endgame is clinical results that are both quick and effective (HERE and HERE for instance are dozens of examples).  But how in the world could you possibly test what I do against a “sham” (placebo)?  A tongue-in-cheek study that was published in a 2003 issue of the British Medical Journal (Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systematic Review of Randomised Controlled Trials) did a great job of making this very point.

“As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.”

Funny but completely true.  It’s why 12 years prior to this piece in the BMJ, their editor, one Richard Smith, published a SCATHING EDITORIAL titled Where is the Wisdom? The Poverty of Medical Evidence, pulling back the curtain and revealing that only 15% of medical treatments are supported by any evidence, and maybe worse (but maybe even less surprising), only 1% of the studies published in journals is “scientifically sound“.  The December 2009 issue of the Journal of Evaluation of Clinical Practice (We Hold These Truths to be Self-Evident’: Deconstructing ‘Evidence-Based’ Medical Practice) put it this way, when talking about RCT’s….

“EBM’s strict distinction between admissible evidence (based on RCTs) and other supposedly inadmissible evidence is not itself based on evidence, but rather, on intuition.  Evidence-based medicine (EBM) claims to be based on ‘evidence’, rather than ‘intuition’. However, EBM’s fundamental distinction between quantitative ‘evidence’ and qualitative ‘intuition’ is not self-evident. The meaning of ‘evidence’ is unclear and no studies of quality exist to demonstrate the superiority of EBM in health care settings. This paper argues that, despite itself, EBM holds only the illusion of conclusive scientific rigour for clinical decision making, and that EBM ultimately is unable to fulfill its own structural criteria for ‘evidence’.  In plain language, we deconstruct EBM’s paradigm of ‘evidence’, the randomized controlled trial (RCT), to demonstrate that there cannot be incontrovertible evidence for EBM as such. We argue that EBM therefore ‘auto-deconstructs’ its own paradigm, and that medical practitioners, policymakers and patients alike ought to be aware of this failure within EBM. According to EBM’s own logic, there can be no ‘evidentiary’ basis for its distinction between admissible and inadmissible evidence. Ultimately, to uphold this fundamental distinction, EBM must seek recourse in (bio)political ideology and an epistemology akin to faith.”

Faith“?  This is exactly what renowned pediatrician, DR. ROBERT MENDELSOHN, argued in his 1979 masterpiece, CONFESSIONS OF A MEDICAL HERETIC.  EBM’s waters were muddied even further when just a couple of weeks ago, a third of the board of the COCHRANE COLLABORATION, the world’s premier organization for reviewing biomedical data and creating large meta-analysis, resigned over issues of bias and financial COI in the field of biomedical research that came to a head with a poorly done vaccine coverup (HERE).  Interestingly, it was the same issue of the journal the previous quote comes from that asked the question (“Who Decides?“), leading me to pen an answer in a post I titled WHO DECIDES THE EVIDENCE IN EBM?  In order to completely understand said answer, we need to go back and look briefly at EBM’s history.

Back in the 1960’s and 70’s groups within medicine, mostly academics, began a quest for better science by gathering more and better data in hopes of creating greater statistical accuracy.  Ideas for EBM were fermenting because of a perceived “Expert-Based Medicine” approach in medicine.  In other words, the doctor was the expert, and his knowledge and integrity were not only unquestioned, but unquestionable. BMJ editor, Richard Smith, wrote in 2014’s EBM – An Oral History that, “Young physicians realized that they could challenge their seniors in a way that was not possible with expert based medicine. It was liberating and democratizing. Evidence based medicine quickly became popular, Sackett believes, for two main reasons: it was supported by senior clinicians who were secure in their practice and happy to be challenged and it empowered young physicians—and subsequently nurses and other clinicians.”  I’ll go a step beyond that.

EBM has also proved instrumental in empowering the general public.  How?  With the advent of the world wide web, not only do doctors and nurses have medical research at their fingertips (not to mention, expert commentary and opinion), so does John Q Public.  And while there are plenty of physicians who like the idea of “EMPOWERING” non-physicians with knowledge that a short time ago could only be accessed by those in the medical field, there are plenty that accuse these sorts of asking too many questions or “meddling” in affairs they have no understanding of.  In many cases we have over-corrected, not putting enough emphasis on expertise, while overemphasizing research — research which as I have shown you repeatedly, is overwhelmingly flawed and biased.  Listen to the cherry-picked findings of Dr. Michael Accad, from a 2016 edition of The Health Care Blog (The Paradox of Evidence-based Medicine)…..

“Beyond the proper use of statistics, they demanded that clinical studies be designed properly, and they anointed the randomized double-blind clinical trial (RCT) as the supreme purveyor of medical evidence. Others, like Ian Chalmers and the folks at the Cochrane Collaboration developed methods of ‘meta-analysis’ whereby different trials and studies on a particular question could be analyzed in aggregate.  By the late 1990’s, however, it became clear that EBM was having two major effects, and the promotion of clinical judgment was not one of them. On the one hand, EBM gave rise to ‘guideline medicine and cookbook recommendations that would soon provide insurers and government agencies a method to gauge ‘quality of care’ on a large scale and to tie performance to that quality. On the other hand, the methodology also played into the hands of large pharmaceutical companies who, through the implementation of large clinical trials, could now identify small effects that physicians would feel compelled to apply to large populations of patients.  The benefits the pharmaceutical and medical device industry reaped through the use of the mega-trial, was a tough pill to swallow. Many in the EBM movement were not particularly thrilled to see their pet methodology be at the service of major corporations, but they were hard-pressed to be able to criticize them on that basis.  It’s like a paradox: the more we insist on scientific reliability, the less certain our knowledge seems to become. As I mentioned before, I believe this paradox arises in part because we are bent on applying to medicine quantitative methods that are more suited for the study of falling stones and quarks than for the proper understanding of human beings.”

Fascinating — especially the way that EBM has been used to hijack MEDICAL GUIDELINES — something I’ve bee hollering about for years.  The word “hijack” means to commandeer or take over something that doesn’t belong to you such as a plane, ship, bus or other vehicle by force.  Other things can be hijacked as well.  Conversations, relationships, agendas.  EBM’s agenda has, according to Dr. Ioannidis, been hijacked.  Case in point, the article he wrote for a 2016 issue of the Journal of Clinical Epidemiology titled Evidence-Based Medicine has Been Hijacked…. 

“As EBM became more influential, it was also hijacked to serve agendas different from what it originally aimed for. Influential randomized trials are largely done by and for the benefit of the industry. Meta-analyses and guidelines have become a factory, mostly also serving vested interests. National and federal research funds are funneled almost exclusively to research with little relevance to health outcomes. We have supported the growth of principal investigators who excel primarily as managers absorbing more money. Diagnosis and prognosis research and efforts to individualize treatment have fueled recurrent spurious promises. Risk factor epidemiology has excelled in salami-sliced data-dredged articles with gift authorship and has become adept to dictating policy from spurious evidence. Under market pressure, clinical medicine has been transformed to finance-based medicine. In many places, medicine and health care are wasting societal resources and becoming a threat to human well-being. Science denialism and quacks are also flourishing and leading more people astray in their life choices, including health.”

Why do you think Ioannidis’ last sentence is true?  Easy; it’s the backlash against what today is passing for science.  With few biomedical studies able to be reproduced either by other research teams or the original team of researchers (the very hallmark of the scientific method), what are we supposed to think (HERE)?  In the earlier words of Dr. Accad, the science has become a paradox, with the medical community seemingly doing whatever they want, despite what peer-review may show; something we see over and over again.  The classic example is FLU VACCINES that have so little evidence backing their use, yet are being foisted on millions of people in the name of saving lives and pandemic prevention.  But it isn’t the only one, not by a long shot.  HERE is a list of dozens of others.

The problems, folks, are rampant.  Earlier this year, Dr. Eric Patashnik, writing for Vox (Why American Doctors Keep Doing Expensive Procedures that Don’t Work) revealed the answer to the question posed by his title (money) then stated, “The proportion of medical procedures unsupported by evidence may be nearly half.”  A telling study in the field of diabetes treatment (An Evidence-Based Medicine Approach to Antihyperglycemic Therapy in Diabetes Mellitus to Overcome Overtreatment) appeared in the January 2017 issue of Circulation.  After revealing that wasteful medical care costs in excess of $750 billion annually, these authors suggested that in order to “prevent overtreatment, the researchers propose that intensive blood-sugar treatment should not be a universal goal of patient care for those with type 2 diabetes, which affects more than 29 million people in the United States.”  So, even though we are not following it, real peer-reviewed care of T2D LOOKS LIKE THIS, and furthermore, research has shown that diabetes drugs are doing little more than addressing surrogate endpoints (HERE)?  Examples problems in EBM are endless, but let me show you a few more.

  • “The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful”  Past editors of the New England Journal of Medicine, Drs. Arnold Relmen and Marcia Angell, from a 2002 article for New Republic titled America’s Other Drug Problem: How the Drug Industry Distorts Medicine and Politics

 

  • “Instead of revolutionizing care, EBM therefore threatens to bring about stagnation and bland uniformity, derogatorily characterized as ‘cookbook medicine.’ Ironically, EBM may also result in a lower standard of safety by deskilling practitioners. Instead of using clinical judgment, practitioners will be encouraged to follow protocols that treat all patients as essentially interchangeable. Providers will therefore be poorly equipped to contend with the variations between patients they will encounter in actual clinical circumstances. Even more problematically, traditional health care professionals may be replaced by less expensive, less skilled workers, who may be incapable of operating effectively in diverse situations.”  Taken from a 2005 issue of Health Affairs (The Promises And Pitfalls Of Evidence-Based Medicine)

 

  • “Evidence-based medicine has been defined as ‘The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.’ There are two major assumptions in this statement. First, it is assumed that the evidence is in fact the best. Unfortunately this is not necessarily so, and published evidence is affected by bias, sponsorship, and blind faith in mathematical probability which may not be clinically relevant. Second, the evidence is population based and may not be applicable to the individual, and blind adherence to this concept may cause harm.”  From professor and surgeon, Dr. David Muckart’s 2013 article in the South African Medical Journal titled Evidence-Based Medicine: Are We Boiling the Frog?

 

  • “In a system where half of all clinical trials never see the light of publication, doctors are merely ‘imagining that we’re practicing evidence-based medicine.'”  Renowned EBM critic, Dr. Ben Goldacre, as quoted in an interview for a 2013 issue of Medpage Today with Kristina Fiore (Is Evidence-Based Medicine Only an Illusion?).  He’s talking about the phenomenon known in the profession as INVISIBLE & ABANDONED RESEARCH.

 

  • “Large trials designed to achieve marginal gains in a near saturated therapeutic field typically overestimate potential benefits (because trial samples are unrepresentative and, if the trial is overpowered, effects may be statistically but not clinically significant) and underestimate harms (because adverse events tend to be underdetected or underreported).”  A 2014 issue of BMJ (Evidence Based Medicine: A Movement in Crisis?) discussing, among other things, the phenomenon of UNDER-REPORTING ADVERSE EVENTS

 

  • For one thing, the ‘evidence based’ brand has been co-opted by special interests (such as companies that make medicines) to further their commercial interests. Companies often define both the disease and its evidence-based treatment: female sexual arousal disorder (treat with sildenafil); male baldness (treat with finasteride); low bone density (treat with alendronate). It’s almost like what counts as a disease (or a disease ‘risk factor’) depends on whether there is evidence for a drug to ‘treat’ it.  From a 2014 issue of ScienceNews (Evidence-Based Medicine Actually Isn’t)

 

  • “What is the Evidence Based Medicine problem?  They include: Publication bias, which means that if researchers find that an intervention had little or no effect, then those studies are less likely to get published. In other words, not publishing negative findings. Overconfidence of studies that rely on statistical p-values of 0.05. This could lead to false positives as well as false negatives.  Lack of replication since many important studies are not repeated, or even ‘repeatable’, by other independent researchers to verify the results. Some major studies that have been replicated have found surprisingly different and even contradictory results.  Small study size and underpowered methodologies. The lower the number of subjects in the study, the less likely the results are true.  Selective outcome reporting, manipulation of data/fraud and financial conflicts of interest. The greater the financial interest, the less likely the study will be true.  The greater the flexibility in designing studies and in definitions, the less likely the research findings are to be true.  The reward systems within medical research, particularly in academia, incentivizes quantity of publications over quality of research.  When I first read his article, I was a bit shocked and in disbelief that Evidence Based Medicine could possibly be this wrong. The article left me begging the question, what now?”  From a 2014 article for Students 4 Best Evidence dot com by Danny Minkow titled The Evidence Based Medicine Problem and what to do About it

 

  • “Over the past 20 years or more, the concept of evidence-based medicine (EBM) has increasingly been accepted as the gold standard for decision making in medical/health practice and policy.  EBM has been widely criticized by many disciplines including clinical practice, epistemology, health sociology, and implementation science. Moreover, in recent years, previously supportive EBM researchers argue for a ‘renaissance’ of the movement that follows and applies their original broad principles and multidisciplinary values, specially regarding the components of EBM related to shared decisions with patients and to expert judgment, built of evidence and experience. The main argument is that, in spite of its benefits, EBM could have also had important negative consequences for healthcare delivery, policy and financing. Examples of this include (1) failing to manage complexity, the individual’s needs; (2) the quantity of research studies and the variable quality, which has become impossible to manage and in some cases lack clinical significance; and (3) the medicalization of life, namely creating new diseases for non-specific complaints and the use of the evidence-based ‘quality markers’ to widely promote drugs and medical devices.”   From the November 2015 issue of Health Research Policy and Systems (Evidence-Based Medicine: Is it a Bridge Too Far?)

 

  • Way back in 2013, Harvard researchers published a study in JAMA Internal Medicine based on 24,000 cases of spine problems between 1999 and 2010 showing that the vast majority of doctors ignored clinical guidelines on back pain treatment already in existence and continued to prescribe heavy-duty narcotics even though they really knew better.  So it’s not unreasonable to wonder what’s going on here. Is this a phenomenon that’s really specific to back pain and the doctors who treat it? Or are we looking at a more widespread, endemic problem in medicine? The myriad ways in which doctors ignore medical guidelines.  Why do doctors ignore the guidelines?  Doctors are of course prone to confirmation bias like the rest of us. Confirmation bias refers to our tendency to look for and pay attention only to information that confirms what we already believe.  There are other known reasons that doctors ignore evidence, like financial incentives  to do more tests and procedures or conflicts of interest involving pharmaceutical and medical device company payments that influence practice. But these reasons, while all valid, are only part of the story…….  CHERRY-PICKED from Drs. Sara and Jack Gorman, authors and owners of the website, Critica (The Trouble with Evidence-Based Medicine)

Nowhere do we see the dichotomous paradox of EBM more than when we look at STATIN DRUGS.  Come back later this week for part II of this topic as I show you what the “Best Evidence” really says about statins.  If you like our site and find yourself spending more time than you intended, be sure to like, share, or follow on FACEBOOK as it’s a great way to reach those you love and care about most.

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