Evidence based medicine is broken

Evidence based medicine is broken? As internist we don't think so, but... there is a real world

Roberto Nardi, MD, Internal Medicine, Bologna, Giovanni Scanelli, U.O.C. di Medicina Interna Ospedaliera - Azienda Ospedaliero Universitaria di Ferrara “Arcispedale Sant’Anna-Italy

Doctor Des Spence, just in "From the Frontline" section of this Journal, pointed out that Evidence Based Medicine (EBM) broke its original mission under the influence of the pharmaceutical industry, which has encouraged - more or less explicitly- a creeping disease mongering, resulting in over-diagnosis and overtreatment1 and consequently in waste of health care resources. In fact, we spent the last twenty years introducing instruments of good clinical guidelines, diagnostic and therapeutic clinical pathways, and EBM practices. But much work is still needed to bridge the gap between what we have to do and what actually happens. Before that, a few preliminary questions emerge: is EBM compatible with patients of the real world? Are we confident that the "statistically significant" differences of clinical trials, reported in selected patients, are actually really helpful to patients at the front of the daily bed-side clinical practice? Internal medicine (IM) patients are mostly elderly, with multiple complex co-morbidities, usually chronic. The complexity of these patients involves the intricate entanglement of two or more systems (e.g. body and disease, familial-social-economic and environmental status, coordination of care and therapies) and this requires comprehensive, multi-dimensional assessment2,3. Unfortunately, in a context of uncertainty and not evidence, the evidence of EBM is in many cases not well defined, not definitive and sometimes even contradictory, but the bedside decisions of the physician must be black or white. Uncertainty and decision-making in hospital IM patients require a wise clinical judgment competence, by a critical assessment of the results of clinical trials, both in terms of selection of included/excluded cases and methodology in considering the results, and not only from a mere statistical point of view. Our patients need a comprehensive assessment in order to define the highest priorities. In such way we believe that EBM has, in itself, some inherent limitations. In evaluating the results of randomized clinical trials, we need to consider not only their statistical significance of results, but also their clinical relevance, in accordance with the principle of Minimal Clinically Important Difference (MCID). In interpreting the results, we have to consider whether or not the MCID has been taken into account before applying to our therapeutic decisions the results of any trial, e.g. in the implementation of very expensive drugs, such as those for cancers4. We agree that clinical Research should focus on what we don’t know, mostly in the real world.

• Competing interests: We have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
• Provenance and peer review: not externally peer reviewed.
• mail addresses: nardidoc48@gmail.com; g.scanelli@ospfe.it

References

1. Spence D: Evidence-based medicine is broken. BMJ 2014：348：g22
2. Nardi R, Scanelli G, Corrao S, et al. Co-morbidity does not reflect complexity in internal medicine patients. Eur J Intern Med 2007; 18:359-68.
3. Nardi R,Berti F, Greco A, Scanelli G et al, Complexity in hospital internal medicine departments: what are we talking about?, Ital J Med 2013; 7 :142-155
4. Nardi R, Berti F, Fabbri LM, Di Pasquale G,Iori I et al, on behalf of the FADOI and their Friends in the Appropriate decision making Project Group (FFA-PG) in hospital Internal Medicine wards, Toward a sustainable and wise healthcare approach: potential contributions from hospital Internal Medicine Departments to reducing inappropriate medical spending, Ital J Med 2013; 7: 65-81

We thank Des Spence so much for pointing out such prominent problems in today’s health systems1, and indeed, with those solved, we should expect a better healthcare. But at the same time, we don’t agree with the comments he made on Evidence based medicine (EBM), which might mislead readers’ understanding of EBM. Hence we’d like to discuss a little bit more about EBM for its honour.

“Today EBM is a loaded gun at clinicians’ heads”, Des wrote.1 We would clarify that EBM is really a gun, but it points at disease rather than clinicians’ heads, helping us to conquer diseases. As it’s a science focusing on protecting and improving our human beings’ health.2,3 If so, what’s the real so called “gun at clinician’s heads”?1 The answers are the various conflicts of interest in the medical process and unscientific clinical routines caused by medical staff’s non-systematic knowledge.

Overdiagnosis and overtreatment are the issues EBM aiming to solve. EBM takes doctors’ individual clinical expertise and experiences as well as the patients’ predicament, value and preference into account,4 and it means to be against all false and impropriety medical behaviors. The desired outcome of EBM is the truth or we can call it the reliable evidence, not the mentioned wrong or fake information produced by researchers or pharmaceutical factories, which even could not be considered “evidence”.

We could not settle the problems Des put forward unless we find out the real cause. It’s a fact that there are so many behaviors coated as EBM for profit, however, this is not the problem of EBM itself. Similarly, can we judge nuclear energy as guilty because some people attempt to use it for nuclear war besides its usefulness for electric power generation? Further more, the key point is that EBM is just a science for truth of medicine. We should not ignore its value or even criticize it when some people seek profit by headed their inveracious or unscientific production as evidence-based, for example, some of the pharmaceutical companies.

Opinion likes“So the drug industry and EBM have set about legitimising illegitimate diagnoses and then widening drug indications” is really serious misunderstanding on EBM.1 The “thing” combined with drug industry to produce fake evidence could not be called EBM, but a liar masked as EBM. As a science for truth and the wellbeing of humans, “the real EBM” should not be blamed like this and should not pay for people’s battle of profits.

False evidence is some fake things for profit, which is opposed by EBM. However, how many of us can clearly know the truth when some information is tagged as EBM? It is important for us to distinguish between the real EBM and the fake one, which includes those who claimed them as EBM and those who was misunderstood as EBM. Meanwhile, we should be aware that medical issues’ own complexity could be the other main cause of the problems. EBM is right a way to facilitate people to overcome medical questions.

We can summarize the above discussion by saying, the undesirable phenomenon related to pharmaceutical industry, clinical researches and guidelines, overdiagnosis and overtreatment are the results of people’s pursuit of interests and our limited cognition of diseases, and EBM itself has nothing to do with that. On the contrary, EBM is born to solve such problem.

Have we properly and fully used our medical knowledge? Why does skill level vary among different doctors? Why are there so many overdiagnosed or overtreated cases when it could be avoided? Why can not the best evidence be applied to the clinical practice? Perhaps the fact is just as J A Muir Gray’s saying, “Knowledge is the enemy of disease. The application of what we know will have a bigger impact on health and disease than any single drug or technology likely to be introduced in the next decade.”5

Better knowledge, better health. It is the theme of the 21st Cochrane Colloquium held in Quebec city of Canada. We believe that evidence-based medicine will have a better development, which could be better to protect the health of human beings.

Competing interests: None declared.

References:

1. Spence D. Evidence based medicine is broken. BMJ 2014;348:g22
2. Guyatt GH. Evidence-based medicine. ACP J Club March/April 1991:A-16.
3. Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992;268:2420-5.
4. Sackett DL, Rosenberg WMC, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71-2.
5. Muir Gray JA. The Future of Evidence Based Medicine is Evidence Based Patient Choice. Chin J Evidence-Based Med 2005;5:180-4.

I would like to exorcise the demon represented by industry and assure you that we have several other demons, just look through our door...

The fact is that without the drug companies, we would not have many of the drugs that have allowed some more years on our life expectancy. However, the health of people in different countries does not necessarily depend only from drugs. Much of the population still die from problems like hunger, lack of sanitation, violence, accidents, etc...

It should be keep in mind that the logic of a pharmaceutical industry is the logic of any other industry, it must produce drugs with high potential to the market, in which case, is extremely competitive. The industry point of view, that is correct, does not consider the analysis of public policies in each country (only for profit), and how healthcare is, only how big is the market, the profits to be reached. The industry wants to sell too much to the highest number of people.

I have great friends working in the pharmaceutical industry, including some graduated from our institution, and I respect them very much. They work with high quality products and sell extremely well in our country. They do the job. Their industries pay the fees and taxes like any others but, do not promote the development of any of their drugs in Brazil, only the sale, and obviously they have a good profit. They are happy and believe strongly in their living model, continually criticizing Brazil's creeping bureaucratic system and we all know what that means...

Brazilian pharmaceutical industries have only recently benefited due to expiration of some patents, due to the use of reverse engineering processes and due to our biodiversity potential. We are walking a promising way in biologics products. Our economy is changing and after the global crisis of 2008, we still have a reduced market. We are lagging behind, slowly evolving...

Now, whose responsibility is it to coordinate public health policies? Who should invest in domestic industry? How often does the private sector come to the university for drug development projects? Who should decide whether or not a particular drug enters our country? What are the necessary medicines for our people? Who should know what is right or wrong for each patient? Questions? Problems? Thousands of them? Which are summarized in low government investment, low innovation, poor infrastructure, few cultural and social resources...and much corruption.

Obviously, the pharmaceutical industry lobby is immense. But which segment is not? How do you guys think U.S. congressmen or senators and congressmen in Brazil are elected? With cash savings? Millions of dollars of pharmaceuticals, armaments, oil, high tech and other industries feed politics. In Brazil, it is even worse... Our population ignores the facts.

In every field of human action this problem will occur, whether motivated by money or another motivator for conflict. This is inherent to the human race.

When I present the data about misconduct or interest conflict in class, I share the same surprise I had the first moment that I read it, however, I know the difficulties of fighting for a better and more humanistic world. I dare say that it borders on impossible, and always has been.

What to do? Cry, rebel, go to the Himalayas?

No!

I firmly believe that change occurs with knowledge. The oldest and acculturated civilizations have greater power than us to influence policies and decisions on all aspects of citizenship in an emerging and developing country.

Thus, we doctors, teachers, students, have a duty to multiply our knowledge, create and disseminate best practices of our professional practice and act as citizens to our patients, trying to give them the best and scientifically correct knowledge. We have an obligation to maintain our honesty and combat practices that are known to harm our fellow people. I think that EBM needs this focus.

When we are facing a big problem, almost always the solution can be quite simple. Faced with this immense problem related to conflict, money, politics, influence, lobbying, corruption, lies, etc., is not the solution the simple exercising of our best practices, carefully, with more and best knowledge, with criticism?

From a reading of Kant about moral reflection: "I should never act except in such a way that I can also will that my maxim should become a universal law."

I am so sorry for confusing you with the other Dr David Haslam. I hope you will accept my sincere apology for this error. I'll ask the BMJ to delete my rapid response.

May I bring to your attention something which I think illustrates the weakness of EBM in its present form. My 85 year old mother was in poor health with poor sleeping, fatigue, weakness, aches and pains (including chest pains), and falls. She was on 12 different medications, including anti-hypertensives, a statin, aspirin, drugs for Parkinson's disease, GTN spray and inhalers.

Her GP is thorough and surely had good reasons for starting these drugs based on chapter and verse knowledge of EBM. However my mother's health steadily deteriorated.

Then over a period of just a few weeks her health improved dramatically - how? She stopped all her drugs except for one of the medications for Parkinson's disease, began eating a plant-based diet and taking a vitamin D supplement (5000 units on alternate days) and vitamin B12. Her aches and pains (including chest pain) disappeared, sleeping improved, she has very good mobility with no more falls, and she is once again able to do her own housework and gardening.

It seems unlikely that we'll ever see an RCT to investigate the possible benefits of discontinuing one or more medications in patients suffering from polypharmacy. Major dietary interventions are probably impossible to investigate using RCTs. My mother's health worsened in spite of her GP's careful application of EBM, and dramatically improved with a more holistic approach that took account of basic physiological needs.

I understand that NICE will issue new guidance on vitamin D during 2014. I hope that it will take a serious look at plant-based nutrition as well (Kaiser Permanente published a favourable review of plant-based diets in its spring 2013 journal).