In part I of this series, I explained what I believe evidence based medicine (EBM) should be: the equal use of clinical experience and external evidence to make the best decisions about the care of patients. In this interpretation of EBM both clinical experience and external evidence are important and necessary.
Clinical Experience <—-> External Evidence
Unfortunately this interpretation is rarely used in current discussions of EBM. Instead we find this version of EBM widely promoted.
1. Randomized, controlled studies
2. Other studies
3. Clinical experience & “consensus” opinion
Under this interpretation, the value of evidence is now ranked. Double blind, placebo controlled studies are given the highest value, followed by a variety of other studies, and lastly clinical experience and consensus views from committees, associations, and experts. Instead of external evidence and clinical experience being given equal weight we now find that clinical experience is considered the least valid (and valued) form of evidence.
This form of EBM is often used to disparage and discredit alternative or non-mainstream therapies with the refrain, “there’s no / not enough evidence” because the only evidence considered worthwhile is that produced from studies, and especially from double blind, placebo controlled studies. The reports of hundreds or thousands of doctors and hundreds of thousands or millions of patients are brushed aside with the comment “anecdotal” as if that means they have no value.
To run a well conducted scientific studies, especially double blind placebo controlled studies, requires scientists to be hired, the study designed, subjects recruited, screened, and selected, the trial run for weeks, months, or years (in some cases), the data collected, analyzed and then published. All of this isn’t free and in fact costs a tremendous amount of money.
The government does sponsor some studies, but the current budget allocated for studying alternative therapies is pathetically small. The majority of studies are funded by private companies, and in a capitalistic society the goal of business is to make money. Studies funded by private companies are not done to prove whether a therapy is effective or not, but ultimately to prove that their therapy (being studied) is effective so that the results can be used to promote that therapy, and make money.
For example, a pharmaceutical company comes up with a drug they believe might have potential, they patent it which gives them exclusive rights to sell it for a period of time. This ensures that if the drug is shown to be useful they will be the only ones who can sell it and therefore they will be able to make a lot of money with it. The company will then fund scientific trials to prove that it is effective and bring it to market.
In contrast, something like vitamin C is cheap and widely available. It is a natural substance and so cannot be patented. If a company paid for a study on vitamin C and found it beneficial, anyone selling vitamin C could use the study to promote their brand of vitamin C. The company that spent the money to have the study done would not have any advantage because they cannot patent and hold exclusive rights to vitamin C. In fact the sponsoring company would be at a disadvantage because they spent the money to have the study done, while competitors could use the results of the study for free.
Pharmaceutical companies run the majority of trials on medical therapies, and because they cannot own natural therapies most natural therapies are not studied. Further, as many natural substances may be replacements or alternatives for drugs, pharmaceutical companies have a further disincentive to conduct trials on natural substances. The only studies they would have interest in running are those that prove that natural substances don’t work or are inferior to their products.
Therefore as alternative practitioners we find that the majority of our therapies are not studied in scientific trials, because there is no profit in doing so. Most supplement companies, alternative medical societies, associations, and schools are small and don’t have the millions of dollars needed to run the studies to “prove” that the therapies work. Evidence from practitioners and patients is discounted as anecdotal and therefore “worthless”.
Under this version of EBM, the conventional community claims there is no evidence to support the use of alternative therapies. However, if we turn this same standard upon the conventional community, we find they have little evidence to support many of the practices and therapies they use. By some estimates, up to 80% of conventional practice do not have sufficient studies behind them to justify their use under this version of EBM. Most MDs rely on evidence presented in scientific journals, what they are told by pharmaceutical representatives about medications, their own clinical experience and the consensus opinion of their colleagues and medical associations to provide evidence for the use of their practices and therapies. The majority of this evidence is considered lowest tier evidence under this version of EBM.
It is my belief that this version of EBM sets unrealistic and non-usefully high standards for what can qualify as evidence to justify therapies and practice, and by doing so denies patients effective care. In part III of this series I will lay out the form of EBM that I use in my practice and how I feel it best serves my patients.
What are your thoughts and opinions on EBM? We’d love to hear them. Feel free to share them below.