The Chief Scientific Officer of Infectious Diseases Diagnostic based in the United States, Dr. Dougbeh Chris Nyan has urged stakeholder in the Liberian health sector to prioritize the training of expertise, making reference of laboratory personnel, and the recruitment of expertise from among the Diaspora pool of healthcare professionals, research scientist, and other medical experts to provide training to local laboratory personnel if the country health is to be improved.
Serving as Keynote Speaker at the 3rd Annual Medical Laboratory Professional Week, on the 27th of April 2017 at the Monrovia City Hall, Dr. Nyan also urged the Liberian Government to make available substantial financial support in the national budget for science, research, and medicine (healthcare) as other developing countries are surging ahead, so there can be no justifiable reason and excuse to suffocate lab development, noting that establishing and tightening of governmental regulatory requirements on diagnostic tests and trials for the attainment of safeguards and quality of diagnostic tests.
Below is the full text of Dr. Nyan’s Speech at the occasion:
I am profoundly honoured by your invitation to participate in and serve as speaker of this important scientific meeting. This event marks the 3rd assembly of pathologists, laboratory technicians, doctors, and other medical professionals from the national and international healthcare communities. What I find particularly pleasing is that this event is organized through a Liberian (truly African) initiative. This suggests that Liberians and other Africans have always recognized their own problems and have always sought to discuss and find appropriate solutions befitting the prevailing conditions and circumstances on the Continent in general and in its individual countries in particular.
Almost every professional here may be fully aware that the situation of medical laboratory diagnostics in Liberia and most of Africa is very challenging. These challenges exist not because laboratory personnel and technicians in Liberia do not have the interest in performing good diagnosis, but largely because of certain factors which include: the limited material resources, lacked of well-equipped laboratories with state-of-the art equipment, the lack of more trained manpower needed to performed this critical task, lack of advanced training opportunities, and limited national budgetary allotment for healthcare in general and diagnostic laboratories in particularly. Thus, laboratory technicians are frequently challenged to work under conditions that seems to impede excellence and stifle the production of reliable test results needed for critical clinical decision making. Generally, these limitations and drawbacks ultimately lead to the mismanagement of patients and weakens the fight towards reducing disease burden.
Far before the December 24, 1989 civil war which lasted for about 14 years, Liberia had in place some institutional framework that provided guidelines and some regulatory services, however inadequate it might have been. But, the decade-long instability, the Ebola crisis, and the destruction of these institutions have set Liberia back in the health care sector, and particularly in the sphere of medical laboratory diagnostics. Now in the post-war reconstruction and rebuilding process, one is apt to ask as to what is preventing national policy-makers from giving much needed attention and substantial support to laboratory diagnostics in Liberia. We are apt to ask, because of the concrete circumstances prevailing around us. For example, during an evaluation retreat held by the Liberian Ministry of Health in July/August 2016 at the Golden Gate Hotel, a field health care worker reported in his presentation that in a rural population that was presenting with a necrotizing skin disease, they symptomatically suspected that these patients had Buruli ulcers. Buruli ulcers, you will note, is a chronic, debilitating, necrotizing disease caused by Mycobacterium ulcerans. But, these health care workers could not definitely confirm the diagnosis due to the lack of PCR (polymerase chain reaction) diagnostic capability. My question was why in this day and age is a simple diagnostic test such as PCR not available to these Ministry of Health workers, particularly for Buruli ulcers? I believe that you are now asking yourselves the same question. And said question could form part of the discussion during our discussion session of this meeting.
Then also, there is either the lack of or the enforcement thereof the appropriate standards for evaluating diagnostic tests, such standards which are required in order to provide best-practice guidelines for assessing the performance, the operational characteristics, and the results of diagnostic tests used for particular infectious diseases or for a patients’ blood-panel and blood-chemistry, etc. In this case, I can make specific reference to the Widal Test (an agglutination test developed in 1869 by Georges Widal) that is routinely used for diagnosis of typhoid fever in Liberia. It is well scientifically documented that the commercial antigens used in the Widal Test for Salmonella typhi diagnosis are not standardized. Furthermore, this Widal Test is prone to cross-reactivity with other organisms or non-typhoid infectious agents, thus giving false positive laboratory results.
This has led to mis-diagnosis, and over-use of the antibiotics such as Chloramphenicol and other antibiotics. So, with this questionable accuracy, why is the Widal Test being so heavily relied upon for diagnosis of typhoid fever when developed countries have practically abandoned the use of Widal for diagnosis of typhoid fever? With this situation, I propose that the use of the Widal Test be evaluated by the government of Liberia and studies done in order to assess its utility in the country any further.
More to this end, Liberia, like other resource-limited countries, is also confronted with the lack of regulatory controls on the quality of diagnostic tests. As such, the clinical management of patients could be critically compromised. This deficiency of regulatory control on diagnostic tests and handling of test-samples or specimens could render the Liberian biomedical and diagnostic system flawed, so much so that outside institutions and entities could come into the country, take advantage of this regulatory deficiency and operate without being appropriately checked. This is a national security issues, you know.
Unlike Liberia and other developing countries, this is exactly what the regulatory bodies such as the US Food and Drugs Administration (FDA) and its European counterpart do in the developed world. Mainly, these bodies set standards for evaluating diagnostic tests (and pharmaceuticals) that are widely used by manufacturers targeting markets in developed countries, but not necessarily applicable for diseases that are prevalent in the developing countries. Thus, this underscores the need for Liberia to establish regulations, standards, guidelines, and operating protocols as well as implement them consistently for all types of disease diagnostic testing and clinical trials now and for the future. Here, implementation as well as enforcement is cardinal to effecting regulatory control.
Let us be remind as this occurred during the Ebola outbreak of 2014 when every organization and country that came into Liberia (and, of course into Guinea and Sierra Leone) operated not according to any standardized system or regulations of the three affected countries (as there probably was none), but according to their individual laboratory diagnostic and infection-control protocols. And so, it was chaotic among participating institutions that came to help with the fight against the Ebola virus outbreak as to what to do or what not to do.
Hence, during the discussions about the Ebola vaccine trials (dubbed the PREVAIL Trial), Diaspora medical professionals of the three affected countries along with patient-rights groups advocated that the trials be conducted under ethical and internationally acceptable standards. An IRB (Instructional Review Board) was put in place, trial protocols were vigorous reviewed, and a DSMB (Data Safety Monitoring Board) was also put in place to review study data and guide the conduct of the trials. On behalf of all the Liberian professionals who participated in the conduct of that PREVAIL study, I can vouch that the Ebola vaccine trials were conducted under the most stringent and ethical internationally accepted standards that even took into consideration the local cultural value systems of the trial participants in the three affected countries.
Let us shift for a moment and take a look at the diagnostic laboratory (be it a biosafety laboratory level – BSL 1, 2, 3, or 4) and the criteria for a diagnostic test. In an optimum situation, we expect a laboratory to be conducive and accommodating for the lab personnel; to be equipped with the required instruments and tools to facilitate the diagnostic process; to be stacked with the chemicals and reagents needed for performing diagnostic procedures, and provide appropriate storage spaces and conditions for reagents and clinical specimens as well as proper disposal procedures. Importantly, a laboratory must be staffed with knowledgeable and experienced technicians with the capability to perform procedures in various aspects of diagnostics so that physicians are confident and trusting of results produced from these diagnostic laboratories. This is what we see in the advanced countries, unlike in developing countries, like Liberia where resources are limited and laboratory personnel hardly have the opportunities for improvement and advancement.
Now, when these required conditions are met, a lab is then accredited and personnel are certified. In this functional diagnostic laboratory we then begin to perform procedures based on established protocols and standard operating procedures (SOP). These diagnostic methods and procedures must then meet certain established characteristics which include: the specificity, sensitivity, and positive predictive and negative predictive values, and must be reproducible and produce reliable test results that will give the physicians the confidence in making confirmatory diagnoses on a patient’s case. Therefore, as diagnostic personnel, when using a particular diagnostic method or diagnostic device, we are compelled to ask ourselves the following questions about the performance characteristics:
- Is the test sensitive – that is, can it tell us if an infected person is truly infected?
- Is this test specific – that is (in the case of pathogen diagnostic, for example), can it truly rule out a non-infected person or can it detect a specific disease or pathogen without cross-reacting with a phylogenetically related pathogen?
- Is this test reproducible – that is, can this test give us the same results every time this test is performed with a set of appropriate reference standards by the same personnel or different personnel?
- Was this test evaluated against a “gold standard” test or approved test?
Thus, including other characteristics such as time taken to perform the test, ease of performing the test, stability of the test, these are among the major criteria that a diagnostic test must satisfy to lend a laboratory test its accuracy and reliability. Otherwise, the test will be question as was the case with a US-CDC developed Trioplex test.
In September 2016, the Center for Infectious Diseases Research and Policy of the University of Minnesota and the Science Journal reported that a leading scientist at the US Center for Diseases Control, Dr. Robert Lanciotii had challenged the CDC’s Trioplex Test for Zika, Dengue virus, and Chikungunya virus. He contended that the test is less sensitive and not reliable. Dr. Lanciotti specifically asserted that the CDC’s Trioplex test is about 40% less effective than the CDC’s Singleplex test used only for detection of Zika.
Dr. Lanciotti further raised alarms that the CDC’s Emergency Operations Center was withholding information from other public health laboratories in the United States about the sensitivity differences of these two test. Mind you! This CDC’s Trioplex test was being used to test for the Zika virus infection during the recent Zika virus outbreak in North and South America. As ethical and professional as he was, Dr. Lanciotti was penalized by his CDC bosses for questioning the reliability of the CDC’s Trioplex Test.
Then in February this year (2017), it was reported that the public health laboratory in Washington D.C. reported erroneous Zika test results (false negative results) of patients tested between July and December of 2016. The fact that physicians rely on diagnostic laboratories to enable them make their confirmatory diagnosis, this situation potentially erodes doctors’ confidence in such diagnostic laboratories and places patients’ health at risk. Looking at the situation in Liberia and other resource-limited countries, how will this situation play out? We can also discuss this topical example in our sessions.
Talking about the quality of diagnostic tests, let me give you an example of my own work and invention. My research team and I developed a rapid multiplex diagnostic test for various pathogens including HIV, some hepatitis viruses, Plasmodium – malaria, Ebola, Zika, West Nile virus, Chikungunya, Dengue, Trypanosoma, etc. For example, the test is capable of detecting and distinguishing between Ebola and Malaria infections as these two pathogens present with similar onset clinical symptoms which may present differential diagnostic challenges to a physician in the absence of a laboratory test. The test is 97% sensitive and 100% specific and can be perform in as little as 10 to 40 minutes with ease.
My test can give you a minimum of 3 results with a single test-run and was evaluated against a “gold standard”, FDA approved test (Procleix) in three separate studies that utilized actual human clinical specimens. This work has been validated and published in “Nature — Scientific Review”, “Clinical Infectious Diseases (CID)” and the “International Journal of Infectious Diseases (IJID).” We have patented this work and is pending field-trial. If time permits, I may present some of our data during our session in order to practically highlight some of the diagnostic characteristics we talked about earlier.
All I have said here this morning suggest that we need to develop the culture of evidence-based medicine. Diagnostic must be grounded in deep scientific knowledge and practice, must be accurate and reliable to aid clinicians in their critical decision-making process during patient management. This can happen when we maintain institutions that are dedicated to biomedical scientific research at the molecular level. This can happen and is possible when policy makers begin to think outside of the box and expand their horizon of thinking to address these healthcare necessities that can benefit the entire population. This can happen if the “limited resources” are properly managed, because I don’t think that the problem is with the resources being limited, instead proper management of “limited resources” is the problem in most underdeveloped countries such as Liberia.
Furthermore, instead of building-up such institutions and strengthening the existing ones, policy makers in Liberia tend to be eliminating them and constricting its own possibility of scientific advancement. By this, I am referring to the dissolution of the Liberia Institute for Biomedical Research (LIBR) which was established in the early 70s by Liberia’s visionary President, Dr. William R. Tolbert, Jr. This decision to dissolve the LIBR and incorporate it into the newly formed Institute of Public Health was a seismic blow against the building of evidence-based science and medicine in this country and further spells out a setback for Liberia’s biomedical scientific growth.
The LIBR, from the time of its foundation till the beginning of the 1989 civil war religiously devoted its functions to biomedical science research in collaboration with various reputable biomedical research institutions around the world. Look at other countries! For example, there is a reasons why the United States and China have the Center for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) as stand-alone entities. Here in Liberia, my call and advocacy for the establishment of a Center for Disease Control first in December 2005/2006 (during my un-paid volunteer teaching duties at the A.M. Dogliotti College of Medicine, University of Liberia), then on September 17, 2014 (during my testimony to the US Congress on the Ebola Crisis), and on July 26, 2016 (during my National Independence Day Oration) was to have a public health institution as a stand-alone entity that is primarily focused on public health issues with some research function of its own, while the LIBR continues to devote itself to intensive biomedical research – the driving force of modern and advanced medicine from bench to bedside. This much I can say and we can discuss during the Workshop Session: “The Importance of the Laboratory in Research.”
Finally, allow me to say that this conference is a well conceptualized programme and is well organized by Africabio Enterprise, bringing together all these great minds from the UN system, the US-CDC, very notable Liberian doctors, laboratory personnel, and public policy makers. I appreciate your attention and will leave this podium with the following general recommendations:
- There be a change in the mentality whereby the world governing bodies, donor agencies, and developed countries look down upon Africa and the developing countries in a negative way and most often proposed symptomatic remedies to diagnostics and health care, than treating the root causes of the problems besetting the Continent.
- Training of expertise (lab personnel) at the Bachelor and Masters level; conduct periodic certification of laboratory technicians after completing refresher courses in techniques and lab ethics.
- Recruitment of expertise from among the Diaspora pool of healthcare professionals, research scientist, and other medical experts to provide training to local laboratory personnel;
- Commitment by national governments of substantial financial support in the national budget for science, research, and medicine (healthcare). Other developing countries are surging ahead, so there can be no justifiable reason and excuse to suffocate lab development;
- Establishing and tightening of governmental regulatory requirements on diagnostic tests and trials for the attainment of safeguards and quality of diagnostic tests.
- Developing of national regulatory standards and guidelines for diagnostic tests, such guidelines that are suited for the array of diseases that are prevalent in a developing and tropical country such as Liberia;
- Define for the international and donor communities what the needs of Liberia’s and other developing countries are, and not what the donor agencies think Liberia and other developing countries need.
Thank you very much and may all of us work assiduously to promote advanced science and medicine for the benefit of humanity.