If every patient learned to overcome their reluctance to ask questions, progress in the application of evidence based medicine would improve.
Also, I just returned from a medical meeting where Dr Prasad was guest speaker Just read the book, open your eyes, and LEARN We Expect Medicine To Progress In An Orderly Fashion, With Good Medical Practices Being Replaced By Better Ones But Some Tests And Therapies Are Discontinued Because They Are Found To Be Worse, Or At Least No Better, Than What They Replaced Medications Like Vioxx And Procedures Such As Vertebroplasty For Back Pain Caused By Compression Fractures Are Among The Medical Advances That Turned Out To Be Dangerous Or Useless What Dr Vinayak K Prasad And Dr Adam S Cifu Call Medical Reversal Happens When Doctors Start Using A Medication, Procedure, Or Diagnostic Tool Without A Robust Evidence Baseand Then Stop Using It When It Is Found Not To Help, Or Even To Harm, PatientsDrs Prasad And Cifu Narrate Fascinating Stories From Every Corner Of Medicine To Explore Why Medical Reversals Occur, How They Are Harmful, And What Can Be Done To Avoid Them They Explore The Difference Between Medical Innovations That Improve Care And Those That Only Appear To Be Promising They Also Outline A Comprehensive Plan To Reform Medical Education, Research Funding And Protocols, And The Process For Approving New Drugs That Will Ensure That Of What Gets Done In Doctors Offices And Hospitals Is Truly Effective This a great book to realise what goals are important to really improve the quality of life of our patients As a primary care doctor who writes a great deal about our health care system and the waning doctor patient relationship, I fell in love with this book instantly It is well written for a broad audience, and clearly demonstrates why patients and doctors are often pursing medical interventions that are of no value From faulty statistics to magical thinking to perverse economic incentives to poor medical education, the authors use crisp language and real world examples to show specifically what is wrong and how to fix it As a patient who has to negotiate the health care system, this book is a valuable guide to help you protect yourself and obtain optimal care And as doctors who practice in the system, the book helps us to understand why our instincts and what our patients tell us are often correct than what the pundits and protocols tell us A great book Great book Amazing how many medical treatments come into use based one a small number of promising results, which are sometimes found to be the result of the placebo effect or spontaneous improvement This is NOT empirical science I hope the authors work helps to move medical school training from its over emphasis on basic sciences to an empirical What Really Works approach This book is an eye opener I have taken scans of about a dozen pages so far that have groundbreaking passages that I want to share with friends, family, and doctors Also contains an extensive Appendix containing all of the medical reversals that the authors found in their research.
The book reports how why doctors continue to used medical practices, sometimes for decades, that are later shown to be of no benefit to their patients Time and again, we learn that a new practice will help extend life, then that it does not Estrogen replacement therapy after menopause, placement of coronary stents to open narrowed blocked coronary arteries, cupping topical suction, lobotomy Vioxx, flecainide, losartan, routine mammography for women in their 40s The authors assert that while there are instances of good hypotheses failing to live up to expectations such should happen in a lab controlled clinical trial not in clinical medicine They believe medicine can do a better job recommending practices that actually work.
Medical reversal disbelief is strongest when involving how people feel eg vertebroplasty, coronary stents for the first three years , arthroscopic knee surgery to repair degenerative meniscal tears 700K year ,Seven states in the career of a medical innovation, pre Evidence Based Medicine EBM , per John McKinlay A promising report in which a medical innovation is publicized based on its promise 2 The innovation is adopted 3 Patients and payers accept the innovation as standard 4 Data begin to become available however, those supporting the innovation come only from insubstantial studies that support the innovation in the most superficial way 5 The RCT makes an appearance 6 Then denial, if its use is not supported entrenched interests deny the innovation may not be effective 7 Acceptance.
While EBM has filled journals, they often avoid big questions or favor one side such that they are not useful.
Surrogate end points are objective ones that can be easily and directly measured eg improved bone density vs fracture rates, lowered blood pressure vs decreased rate of strokes, antiarrhythmic drugs decreasing the number of premature ventricular contractions but not survival after a heart attack, hospitalization rates However, they are invisible to the patient.
Summarizing to this point, we have seen reversal for practices meant to make us live longer when evidence supporting that practice was weak or flawed this included times when the evidence relied on surrogate end points For practices meant to make us feel better, we have also learned how powerful the placebo effect is, and noted reversals when treatments were later tested using appropriate controls, such as sham procedures.
Screening recommendations have also be reversed In many reversals involving screening are the worst kind they are performed on healthy people and thus affect an enormous number of them who simply want to stay that way An ineffective screening test can turn millions of healthy people into patients Recommendations for PSA tests, mammograms for women in their forties, Pap smears, etc have all been revised.
In studies of CT scan screening for lung cancer in those between ages 55 and 80 with a heavy smoking history is the only screening test to date that makes you live longer and even here am many as 96% of abnormal findings are false alarms In studies of colorectal cancer with 30 years of follow up, for every 10,000 people, 192 die of colon cancer in the unscreened arm, vs 128 in the screened arm However, looking at overall mortality, 7,109 out of 10,000 die in the unscreened group vs 7,111 in the screened group not a significant difference.
Most experts agree that all cancer screening leads to some amount of over diagnosis When we screen for prostate cancer, we end up treating about 40 cancers for every cancer that will kill For mammography, the best studies suggest that if a mammogram finds breast cancer and it is treated, there is a 13% chance this will have saved a life.
Each year in America, we spend hundreds of billions on screening tests and their downstream costs In 2011, two articles were published, finding that gown and glove precautions did not decrease transmission of VRE or MRSA in ICUs an intervention generating additional costs w o benefits However, gown and glove precautions were adopted largely on the basis of single center, before and after studies The proof from such a study tends to be tenuous because that center may be idiosyncratic a unique demographic of patients or bacteria, or an unusually enthusiastic proponent who changes the culture in ways not reproduced elsewhere Before and after studies are also problematic, and the initial data behind most systems interventions However, one s intervention is never the only thing changed Hawthorne effects and per the author, we have yet to see a very large, well done randomized trial confirming that eg a checklist is truly what makes the differences Another rapid response teams for cardiac arrests were demonstrated in the 2005 MERIT trial in 23 Australian hospitals to not improve patient outcomes Yet, gown and glove precautions and RRT are widely accepted, despite not working Door to balloon time was considered an important objective A 2013 study found that between 2005 and 2009, door to ballon times were significantly reduced across the nation the number of patients waiting longer than 90 minutes decreased from 40.
3% to 16.
9 Mortality, however, was unchanged Explanations perhaps we were not targeting the right metric instead focus on total time , or decreasing door to balloon time might be an example of diminishing returns A final example in 2001 a single center unblinded RCT found that lowering blood sugar levels to normal levels could improve survival in a SICU A novel strategy because one of the body s responses to critical illness is to raise blood sugar levels This quickly became a new standard until a 2009 multicenter 42 hospitals RCT found the practice increased deaths by 2.
6 percentage points at 90 days.
Prasad then points out that while doctors often recommend treatments that do not work, patients also do on their own Glucosamine and chondroitin 700 million in 2004 a 2006 RCT found no difference in pain this was followed by a 2010 review of data from 10 different trials that reached the same conclusion Echinacea nearly 20% of Americans reported using Echinacea in the past 30 days, mostly to reduce the duration of cold symptoms A 2005 RCT study concluded it did not reduce symptom duration this was later supported by 7 randomized trials only one of which reduced symptom duration compared to a placebo The authors also examined 12 studies that looked at Echinacea to prevent colds none of the studies showed an effect Acupuncture is a popular treatment for pain, dating back over 3,000 years An effort to summarize all research analyzing acupuncture published Western Chinese, and Korean scientific literature between 2000 2009 concluded there is little truly convincing evidence that acupuncture is effective in reducing pain, and also enumerated a few examples of acupuncture causing real harm.
Use of multivitamins in a 2009 study of 161K women found no link to declines in cancer, heart disease, or mortality a 2013 review of randomized trails found no clear benefit on overall survival, heart disease, or cancer.
Recent analyses of randomized trials found that calcium and vitamin D supplementation does not reduce risk of fractures among healthy women, and the U.
S Preventive Services Task Force recommends against the supplements On the other hand, we ve known that calcium and vitamin D supplementation increases kidney stones, and a 2010 group of researchers added heart attacks as another potential side effect.
When it comes to dietary habits, studies are less like science and like an opinion poll Most diets are never tested in a randomized trial, and when they are, the main outcome of study is usually short term weight loss In PREDIMED an RCT evaluation of the Mediterranean diet, using randomly assigned patients at high risk for a cardiovascular event found one had to treat about 90 people with the diet for 5 years to prevent one stroke yet no mortality differences.
In 2005 John Ioannidis wanted to measure the proportion of important findings in medicine that were later contradicted He started with studies referenced over 1,000 times published during the years 1990 to 2003 Of those, 45 found a medical intervention effective, and of those 16% were later found ineffective, another 16% less effective than initially believed, 44% supported in future studies, 24% never tested again The authors did their own research, using articles in the 2009 NEJM of the 35 studies examining current standards of care, 46% showed current standards as ineffective They then extended their study to NEJM articles between 2001 and 2010 Reversals were found in 40%, 38% reaffirmed the benefit of a new practice, and 22% were inconclusive A project of the British Medical Journal Clinical Evidence completed a review of 3,000 medical practices and found 35% effective, 15% harmful unlikely to be beneficial tradeoff, and 50% of unknown effectiveness.
Tracking citations to three major practices found not to work beta carotene to prevent cancer, estrogen to prevent Alzheimer s, and vitamin E to lower cardiovascular risk, researchers found that 10 years passed before the research community stopped referencing the flawed practice.
original analyses of prescribing estrogens for post menopausal women was cofounded by the self selected nature of those originally taking the supplements less likely to have a family history of heart disease, be hypertensive, have diabetes, or smoke they also were younger, drank alcohol, and consumed saturated fats.
A 2012 paper titled Empirical Evaluation of Very Large Treatment Effects of Medical Interventions Pereira, Horwitz, Ioannidis examined the proportion of medical trials showing a very large treatment effect eg 5X or They looked at over 228,000 trials and found only 9% did so Topics with large effects were less likely to be about mortality and likely to be about a laboratory value They then looked at other studies addressing the same questions as those demonstrating the very large treatment effect 90% of the time, the large treatment effects got smaller when one looked at other studies, thus strongly suggesting the largest magnitude of effect ae likely statistical flukes Across all the studies, only one had a large effect on mortality a method for oxygenating blood of newborns who cannot adequately breathe on their own.
RCTs have intrinsic error rates, added to by early termination of RCTs, publication bias,Industry sponsored studies are 4X as likely to reach a positive conclusion they are also less likely to be published presented, or published after a delay When companies hold back evidence device makers, drug formulators , the medical literature becomes selectively drawn from a much larger pool Tamiflu was thought to prevent transmission of the flue, decrease hospitalizations, and save lives an RCT found it decreased flu symptoms by less than a day while causing nausea and vomiting, did nothing to prevent transmission of the virus, reduce hospitalization or deaths Previously, Roche Tamiflu manufacturer had published its own meta analysis, and found large benefits Their study included only those proven to have influenza rather than those with influenza like illness and focused on those receiving the drug early different than typical use.
The FDA cannot consider cost as part of its deliberations, nor relative efficacy Then, in the early 1990s, the FDA pioneered an accelerated approval program allowing drugs for serious diseases with few treatment options to gain approval by showing benefit on a surrogate end point reasonably likely to predict clinical benefit The drug is then given a period of time to prove it benefits a important end point However, after a drug is approved, it is much harder to get participants to enroll in a study no one will pay for a trial if there is no prospect for large returns and after 20 years one third of these post approval confirmatory studies had not been completed.
What is also not acceptable is for a drug company to develop a drug for one indication and then market it for something else gabapentin is an egregious, but not the most recent, example In 1993, under the trade name Neurontin, it was approved to be used for the treatment of seizures when combined with other drugs Its maker, Parke Davis, then marketed it for eg bipolar disorder, pain disorders, etc AND as a single agent for seizures despite having previously being rejected for the latter by the FDA A 430 million settlement followed, but over 20 years later gabapentin is still not approved for most of the off label uses for which it was initially promoted Another reversal prone situation A bias to act now, data later also contributes to reversal, rapid reporting on new technology is another, along with direct to consumer advertising we re one of only two nations New Zealand that permit such An evaluation of DTC advertising found 10% of those with adjustment disorder symptoms and did not request a medication received one, vs 39% of those making a general request and 55% making a brand specific request Between 1999 and 2005, DTC advertising increased from just under 1 billion to over 4 billion Another a medical school emphasis on reductionism understanding the mechanism by which a drug purportedly works , instead of empiricism does the drug work.
Interesting take on the unholy alliance between physicians and drug and medical device manufacturers Turns out that the heroes in medical research are the scientists who come up with the latest and greatest, regardless of whether there are tenuous grounds to support their claims Those few medical scientists who study whether treatments or devices actually do what they are supposed to do, don t get nearly the same notoriety In a bigger picture way, this book gets you to think about the whole medical treatment model Many medical treatments are based on a mechanical theory of how the body works That being the case you would think that in all cases the placing stents to open blocked heart arteries would be beneficial However, carefully controlled studies have shown that stenting is not beneficial for those patients with controlled coronary artery disease and may even lead to complications Yet, in spite of the evidence, this practice continues.
Ending Medical Reversal advocates for evidence based medicine as the gold standard to which all doctors should aspire Prasad and Cifu explain to the lay reader how not all medical studies are equal, discuss the placebo effect, present an outline for a better curriculum for medical training and, I found most importantly, offer practical advice on how I can avoid being a casualty of a treatment based upon flawed data or reasoning This is a book that I look forward to rereading to ingrain these concepts in my mind It is so easy to believe that just because something is new and hyped, that it is better.
El sobrediagn stico y el sobretratamiento es algo que todos los m dicos, sobre todo los de familia, deben tener en cuenta a d a de hoy en todos y cada uno de sus pacientes.