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The Fatal Failings of Evidence Based Medicine

The medical system (and much of the culture) these days is focused on group outcomes, not individuals. Personally, I think that stinks.
In medicine, this failing comes from improper use of what was originally a good idea—evidenced based medicine (EBM). EBM was developed to help overcome anecdotal medicine, in which a seemingly successful therapy in one patient gets adopted by a physician as the “way to go” and then preached to his trainees as the management of choice, and over time becomes unexamined gospel. “Anecdote-based medicine” is a form of groupthink, and groupthink is bad in general and particularly bad for the patient sitting in front of us on an exam table.
There needed to be some way to help doctors realize that an individual patient response is not generalizable to others.
EBM evaluates groups of patients to determine statistical responses to interventions. It was created (initially) to help doctors determine whether an intervention is likely to work in an individual patient. In that way, it was originally kind of the obverse of anecdotal medicine.
It was originally a noble concept for fighting against groupthink.
Sadly, the government, insurance companies and big pharma all got behind EBM, and then distorted it for nefarious or foolish purposes. The goal of improving individual care was set aside. Few academic physicians noticed. As the opposite of generalizing an individual response to a population, EBM generalizes a population response to an individual. EBM has been distorted into a system that is the even worse groupthink!
This is how the distortion of EBM happened:
First, the government and academics started making guidelines and standards for treatment of various diseases in an attempt to provide “best practices” so that the problem of anecdotal medicine could be overcome.
However, these same academic guideline-writers commonly are hired by the pharmaceutical companies to give talks to other doctors about the companies’ drugs. They believe that the talks are unbiased because they are required to be “evidence based”. The paid speakers are convinced that their association with these companies does not bias them. After all, they are just giving a chance for big pharma to be heard, nothing more—not to influence or defraud the listeners.
Here’s the trick: the doctors to whom they are lecturing are not the people whom the marketing department of the pharma company is targeting. It is the speaker herself who is the target of the pharma company’s marketing department.
These speakers are “thought leaders”, selected by the pharma company in hopes that they will some day sit on a guideline writing committee. And after talking up a company’s drug’s good points throughout the country, the speaker will—through ego and repetition—swallow her own speeches: hook, line and sinker. Someday, the speaker will use her (influenced) best judgment to help craft the next set of guidelines. Once a drug is incorporated into the guidelines, the insurance companies and governments of the world not only pay for the drug, but in this day of nationalization of everything, often compel its use. A subsidized and even compulsory market is the ultimate goal of the pharma companies. (By the way, this is fascist). 
Big Pharma thus influences the disease management guidelines, despite and through the evidence based mentality. And they are motivated to get drugs that are profitable and still protected by patents into those guidelines, displacing drugs subject to price competition (and therefore cheaper for patients and less profitable for pharma).
The various empowered agencies coerce, subsidize and demand the adherence to disease-management guidelines and increasingly punish doctors who don’t abide by them. Guidelines morph into rulesHospitals use adherence to the guidelines as quality metrics. Government pays bills based on these metrics. Flocks of research nurses now study ways to maximize adherence to guidelines. Doctors, as has become their way, just do as they are told.
Yet, EBM is highly abusable and therefore guidelines should be questioned and never mandated. When looking at group averages as the outcome, studies can be twisted to make it appear that a drug is useful in a group of patients with a disease, even though it may work in only a small (and sometimes tiny) fraction of the individuals within the group.
The pharmaceutical companies are motivated to encourage groupthink. They don’t want doctors to think of patients as individuals. You see, if the doctors ever figure out that there is only a small percentage who respond to their drug, and that those who respond really have a different disease than those who don’t respond to the drug, then they will start thinking of their patients as individuals, and seek better diagnostics, and thereby reduce the market for the drug. And that’s no good for big pharma. COPD and asthma are examples of “diseases” that aren’t diseases at all but physiologic disturbances resulting from a large variety of highly different diseases that obviously should require very different therapies. But they have been groupthinked for the purpose of expanding the market for big pharma’s blockbuster drugs that have statistically significant benefits for group averages, even though those drugs work for only a subsection of the patients.
One lie that has been promulgated by the EBM system is “the bigger the study, the more reliable the data are and the better a drug is”. Utter hogwash.
A drug that is effective for a short term outcome should be provably effective with a study of less than 100 people. If it takes a 30,000 patient study to show a statistical improvement in a short-term outcome (like lung function in COPD), then you can count on there being something very squirrelly, such as an effect that occurs in only a small percentage of the patients, or a tiny and clinically irrelevant “statistically significant” effect.
When you see a huge study performed on a short term outcome variable, the company that is sponsoring studying knows full well that their drug is going to suck. They very carefully choose their study population and statistical methodology to maximize the chance that their group data will be “positive”. In such a fashion, they (we) use EBM groupthink against us all.
Now, EBM still plays an important role: when there is no reasonable way to individualize patient care because of the nature of the disease. You can’t do empiric trials on individual patients when it comes to cancer chemotherapy. So we rely on evidence from other patients as the best thing we’ve got, and try to use biomarkers to help focus the evidence. When the outcome is long in the future, statistics—not individual patient responses—may be all we have to provide guidance. That’s reality.
In COPD and asthma, however, and many other diseases that have highly measurable short term outcomes to monitor, the reality is that we have much better guidance available to us than EBM can offer. EBM should be but a minor tool. Instead, we should be doing anecdotal empiric trials on our individual patients with these diseases to see what works best for each person, both to help them feel better, and because empiric trials help to hone in on the diagnoses that underlie the physiologic disturbances we call COPD and asthma. EBM can guide which empiric trials to try first.
Of course we should not generalize one success in one patient to other patients (for that would be the other form of groupthink).
I hope we can combine the best of individualization (patient-based medicine) and the best of evidence based medicine by entirely disposing of the groupthink parts of each. But first, we have to be sensitized to see when groupthink is present. And in our culture, groupthink is now everywhere.
John Hunt, MD (www.readjohnhunt.com) is a pediatrician and author of the hilarious novel Assume the Physician as well as Higher Cause and Liberty.Me’s “Surviving Obamacare”.