~Written by Mike Emmerich, Specialist Emergency Med & ERT Africa consultant (Contact: firstname.lastname@example.org)
A question posed by Jessica Taaffe on twitter, who is a TWIGH panelist, is my inspiration for this weeks blog. The question posed was: If you were to list three major research gaps for access to medicines what would they be? I posted 2 comments to that statement, the 140 characters per tweet, was not enough to fully weigh into the matter, so I am using this weeks post as a soapbox to expand further.
Firstly you might be asking what does this have to do with global health? In a nutshell, it has a huge impact, access to medicines, is dependent on the research that underpins it, it is the foundation on which medicine that we use stands. How firmly it stands depends on the strength of the research. If the road travelled to arrive at the end product is not evidence based (we will discuss the vagaries of this shortly), we then run the risk of having a flawed product, or even in some cases a product that never sees the light of day, (see my blog on Politics and Medicine).
The two comments I posted to twitter stated that evidence based medicine must be driven by independent clinicians, scientists and medical policy makers. Furthermore I stated that /Levels of Evidence A/(LOE - A) must be the benchmark. We cannot just be led by the large multinationals (Pharma and Medical Device Industries), they can most certainly push money into research, but the parameters of that research must be in the hands of independent clinicians, shared decision making can and must play a key role. This is a huge challenge but must be addressed, we need to claim back the labs and work alongside the drug and medical device industries.
So what is evidence based medicine http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349778/?page=1, why is it important and why do I say the we need to adhere to LOE -A?
Evidence based medicine grew out of critical appraisal, when Gordon Guyatt took over as the director of the internal medicine registry programme at McMaster University. He wanted to change the program so that physicians managed patients based not on what authorities told them to do but on what the evidence showed worked. It then appeared in an article in “The Rational Clinical Examination” series in Journal of the American Medical Association (JAMA)in 1992.
The strength of evidence is assessed by a specific grading system which, in fact, is quite simple. It combines a description of the existence and types of studies supporting a certain recommendation.
-Level of evidence A: recommendation based on evidence from multiple randomized trials or meta-analyses -Level of evidence B: recommendation based on evidence from a single randomized trial or non-randomized studies -Level of evidence C: recommendation based on expert opinion, case studies, or standards of care.
So the highest standard to attain is LOE – A, is this always the case? In 2009, a very interesting paper http://jama.jamanetwork.com/article.aspx?articleid=183453 was published in JAMA, assessing the strength of evidence underlying the American College of Cardiology (ACC) and the American Heart Association (AHA) practice guidelines. They were reviewing recommendations to see if they were based on strong levels of evidence (LOE – A) and how much is based on "expert” opinion.
In only 11% of the guidelines published was LOE – A the benchmark, and most of the current guidelines included more than 50% of LOE – C as the standard! The authors correctly concluded that “expert opinion remains a dominant driver of clinical practice, particularly in certain topic areas, highlighting the need for clinical research in these fields”. I am sure if we had to review other areas of medical research we will be in a similar ballpark.
I can cite numerous examples from my own area of speciality where we have used certain drugs for years, with no studies definitely stating that they were beneficial to the patient, but there use was continued because of expert opinion, what drove that expert opinion is open to debate.
The Internet has also allowed incredible access to masses of data and information. However, we must be careful with an overabundance of "unfiltered" data. As history, as clearly shown us, evidence and data do not immediately translate into evidence based practice.
This is where the Cochrane Review stands the test of time, as it enable the practice of evidence-based health care, where health care decisions can be made based on the best available research, which is systematically assessed and summarised in a Cochrane Review http://www.cochrane.org/cochrane-reviews. Cochrane Reviews are systematic reviews http://www.cochrane.org/about-us/evidence-based-health-care of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care http://www.cochrane.org/about-us/evidence-based-health-care.
In closing then, to come back to the original question; what three major research gaps for access to medicines:
- Research must be evidence based with LOE-A as the gold standard
- Research must be driven by independent clinicians, scientists and medical policy makers
- Research needs to be taken back to the labs and institutions who will research what is needed globally.
We would need large NGO's such as the WHO and the European Research Council (amongst others) to monitor and guide where research needs to be focussed. We need to thank all scientists, inventors, and researchers who are motivated by the need to know, the thrill of discovery,and the desire to make a positive contribution to mankind as a whole and acknowledge the right of people to the common ownership of medicines/vaccines etc. which are as basic to their common and individual well being, as to life itself.
As the cognitive linguist George Lakoff http://www.huffingtonpost.com/george-lakoff/empathy-sotomayor-and-dem_b_209406.html puts it, “Empathy is at the heart of real rationality, because it goes to the heart of our values, which are the basis of our sense of justice. Empathy is the reason we have the principles of freedom and fairness, which are necessary components of justice.”