Research

Research

Medical Research - An Evidence Based Approach to Global Health

~Written by Mike Emmerich, Specialist Emergency Med & ERT Africa consultant (Contact: mike@nexusmedical.co.za)

https://twitter.com/MikeEmmerich_

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:

  1. Research must be evidence based with LOE-A as the gold standard
  2. Research must be driven by independent clinicians, scientists and medical policy makers
  3. 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.”

Disease Outbreak, Economic Development, Government Policy, Health Systems, Infectious Diseases, Vaccination, Research, International Aid

Politics and Medicine

~Written by Mike Emmerich, Specialist Emergency Med & ERT Africa Consultant (Contact: mike@nexusmedical.co.za

https://twitter.com/MikeEmmerich

"Medicine is a social science, and politics is nothing else but medicine on a large scale"—Rudolf Virchow

Politics is defined as "organised human behaviour", thus we can postulate that Medicine is micro managed organised human behaviour, at times right down to the molecular level. If we examine the Ebola outbreak/s (globally) and how it is being managed on a macro (politics) and micro scale (medicine) we can begin to see the cracks in the system, and hopefully then move to addressing these cracks, before they begin yawning chasms that are not repairable.

The region (Liberia, Sierra Leone and Guinea) has had success (we could add Nigeria and Senegal to the successes) and failures in both areas. Neither is Spain and the USA exempt from this analysis as can be noted from the various press releases (government and medical) over the past few months.

Since the first outbreaks in 1976 (Sudan and The DRC) till the current one in West Africa; care has generally been palliative and symptomatic, questions have often been asked during this period; What of a vaccine and/or other means of treating the infected patients? There was a report in the British Sunday Times (12/10/14), cited a Cambridge University zoologist as saying that “it is quite possible to design a vaccine against this disease” but reported that applications to conduct further research on Ebola were rebuffed because “nobody has been willing to spend the twenty million pounds or so needed to get vaccines through trial and production”. Globally this has been one of the failures of the pharmaceutical companies, and most probably even the WHO, for not pushing harder over the years to get this in motion.

In her 1994 book /The Coming Plague: Newly Emerging Diseases in a World Out of Balance http://lauriegarrett.com/#item=the-coming-plague, //Laurie Garrett warned that there are more than 21 million people on earth “living under conditions ideal for microbial emergence.” http://www.independent.co.uk/arts-entertainment/science-mutating-microbes-1601604.html Garrett when on to win the Pulitzer Prize in 1996 for reporting on Ebola. In 1995 Joshua Lederberg, the American molecular biologist said: "The world is just one village. Our tolerance of disease in any place is at our own peril. Are we better off today than we were a century ago? In most respects, we're worse off. We have been neglectful of the microbes, and that is a recurring theme that is coming back to haunt us."

Jump forward to the 23^rd of September 2014, US President Obama issued an unprecedented ‘Presidential Memorandum on civil society http://www.whitehouse.gov/the-press-office/2014/09/23/presidential-memorandum-civil-society’ recognising that: Through civil society, citizens come together to hold their leaders accountable and address challenges that governments cannot tackle alone. Civil society organisations…often drive innovations and develop new ideas and approaches to solve social, economic, and political problems that governments can apply on a larger scale./

If we look at the current crises in West Africa civic leaders are what is missing, hence the inability to track and trace potential infected persons, motivate communities to change risky behaviours (handing of the deceased), agitate with government to create better health care systems, this all adds fuel to the fire of the current epidemic.

Have we listened and learnt as governments, NGO's and Multinational Pharmacare companies since then?

Despite Medical Advances, Millions Are Dying, this is a banner from 1996, not 2014! from the WHO, which was "declaring a global crisis and warning that no country is safe from infectious diseases, the World Health Organization says in a new report that diseases such as AIDS, Ebola, Hanta, Mad Cow, tuberculosis, etc., killed more than 17 MILLION people worldwide last year”.

As Laurie Garrett wrote in her the closing section of her book, The Coming Plague, /“In the end, it seems that American journalist I.F. Stone was right when he said, ‘Either we learn to live together or we die together.’ While the human race battles itself, fighting over ever more crowded turf and scarcer resources, the advantage moves to the microbes’ court. They are our predators, and they will be victorious if we, Homo sapiens, do not learn how to live in a rational global village that affords the microbes few opportunities. It’s either that or we brace ourselves for the coming plague.” Time is short.

The Ebola outbreak in West Africa is “unquestionably the most severe acute public health emergency in modern times,” Dr. Margaret Chan, the director general of the World Health Organization, said Monday 20/10/2014). We do seem to be going in circles... circa 1995.. have we learnt nothing from history.

Sooner or later we learn to throw the past away History will teach us nothing ~Sting – Musician, singer-songwriter
Where have all the people gone, long time passing? Where have all the people gone, long time ago? Where have all the people gone? Gone to graveyards, everyone. Oh, when will they ever learn? Oh, when will they ever learn? ~Pete Seeger - American folk singer and activist