Post-Ebola reforms: ample analysis, inadequate action
BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j280 (Published 23 January 2017) Cite this as: BMJ 2017;356:j280All rapid responses
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The absence of scientifically sound and globally acceptable guidelines on using experimental therapies during public health emergencies like the Ebola outbreak is a cause of concern [1]. It has been suggested that such guidelines should also facilitate accelerated evaluation of experimental therapies during public health crises [2].
However, any guideline on experimental therapies should include guidance for issues related to a possible surge in demand for expanded-access of investigational therapies proved to be statistically more effective in accelerated trials. For example, will these experimental therapies found to be effective in accelerated trials get permission for mass production to make them available to patients outside controlled trials? If yes, will the product developers be able to mass produce and make these therapies available during the public health emergency itself? If no, how would these accelerated protocols be justified? Further, the ramifications of an inability to provide experimental therapies proved to be effective in such accelerated trials to dying patients outside controlled trials need to be kept in mind.
It is paramount to be extra cautious and vigilant in framing guidelines for experimental therapies as the same can be misused to rapidly test & try multiple therapies during public health emergencies, and create more mistrust among an already suffering population.
1. Moon S, Leigh J, Woskie L, Checchi F, Dzau V, Fallah M, et al. Post-Ebola reforms: ample analysis, inadequate action. BMJ 2017;356:j280.
2. Borio L, Cox E, Lurie N. Combating Emerging Threats-Accelerating the Availability of Medical Therapies. N Engl J Med 2015;373:993-5.
Competing interests: No competing interests
Reference is made to the report on Post-Ebola reforms: ample analysis, inadequate action, published on 23 January 2017. We appreciate its clear picture of what has been achieved and the gaps that need to be filled.
We agree: most of the 11,000 Ebola deaths in West Africa could have been prevented had the world been better prepared, but profoundly so. To prevent most deaths during the next Ebola outbreak, affected countries need resilient health systems that extend to rural areas, a sensitive early warning system coupled with rapid response capacity, and a focus on communities as the first line of defence in detecting and responding to outbreaks and emergencies. Countries also need access to effective and affordable vaccines, diagnostics, and treatments, outstanding laboratory and logistics capacity, and safe and abundant treatment centres.
The world has a long way to go before reaching such a level of preparedness, with funding shortfalls repeatedly cited in the report as a main reason for inadequate action. However, as the report concludes, “substantial reforms are under way and deserve support.” Considerable progress has been made in several areas. Some new instruments and partnership models show great promise.
The WHO emergencies programme, launched in August 2016, is playing a central role in coordinating a number of activities with partners. Early warning and rapid detection systems are being strengthened, and procedures are in place to activate established mechanisms for coordination that work well in humanitarian crises during outbreaks of infectious diseases. A formal process of quality control for the training and verification of emergency medical teams is strengthening the global health emergency workforce, offering vetted surge capacity during outbreaks. Member States, at all levels of economic development, are prioritizing peer-reviewed assessments of their core capacities to implement the International Health Regulations. Our main concern is the lack of assured financing and technical assistance to fill the gaps identified during these assessments.
The January Executive Board confirmed that the Pandemic Influenza Preparedness Framework, set up in 2011, works as a bold and innovative preparedness tool that puts virus sharing and benefit sharing on an equal footing. To date, the Framework has secured access to around 350 million doses of vaccine as preparedness for the next pandemic; partnership financial contributions from industry, amounting to more than $110 million, have been largely invested to build surveillance, laboratory, regulatory, and other capacities in developing countries.
This is one successful model for better preparedness, and there are other encouraging signs. The WHO R&D blueprint, developed in response to lessons learned during the Ebola outbreak, has been immediately applied to expedite the development of new medical products for Zika virus disease. It aims to cut the time needed to develop and manufacture candidate products from years to months. As noted in the report, the Coalition for Epidemic Preparedness Innovations, which draws on the blueprint and the WHO list of priority pathogens, holds great promise for developing vaccines ahead of epidemics. But, as always, the world needs much, much more to move from ample analysis to adequate action.
Political attention nearly always wanes as time passes and a crisis loses its sting. We must not let this happen. By ensuring a joined-up approach to global health security, supported by predictable and adequate financing, the international community can once and for all internalize the lessons learned from Ebola and other recent outbreaks, making the world permanently safer for future generations. In these uncertain times, one thing is sure: the volatile microbial world will deliver many more surprises.
Competing interests: No competing interests
1. We heard a great deal about:
Fruit bats and bush meat in general, as the virus resrvoir. True, the virus has been found in fruit bats.
But, is there a single report of the virus having been isolates from any of the bush meat that finds its way in to the European countries? (I include the UK in Europe.)
It is difficult to believe that the West African population has swallowed the advice to keep away from bush meat. Do the authors have any information that bush meat has disappeared from the cuisine of the West Africans?
2. There have been a very few reports of the virus being detected in semen for as long as six months.
Are there any studies showing that this is exceptional? Of it is exceptional, has anyone worked out the immunological reasons why only SOME survivors harbour the virus in the testes for such long time?
3. Clinical Ebola came and went.
Could it be that there are co-factors, eg, other viruses, which are essential for what is a zoonosis, to cross the species barrier?
I would be obliged if some one could throw a beam of light on these three ( to me) dark areas.
Competing interests: No competing interests
The recurrence of Ebola outbreaks in endemic areas by transmission from animal reservoir to humans tells us that we have not seen the last of this deadly virus. In addition, there is some evidence that the virus itself has a tendency to relapse in some patients who have recovered from the initial infection.
Although we do not as yet know where the Ebola virus hides away from the immune system and what triggers its reactivation, there is no doubt about the ability of the virus to relapse as we have learnt from the well-known cases of two patients: a British nurse, Pauline Cafferkey, and an American doctor, Ian Crozier. Both Cafferkey and Crozier were relatively young (39y and 44y), had severe illness and high viral load. Further studies will tell whether such influences have significance in predicting potential cases of relapses. Thus the fear factor of “the virus returns” needs to be addressed.
However, until such time as we are able to elucidate the underlying mechanisms responsible for virus relapses and further studies on the host reservoir interaction are done, we need to focus on public education and awareness. We need to educate public on essential basic information about this deadly virus including its infectivity, mode of transmission, symptoms recognition, incubation period, spread of disease and sensible precaution to protect themselves and others. In this day and age, the importance of public education and awareness about Ebola cannot be exaggerated.
Dr Sayed Subhan Bukhari MBBS (Hons), DGUMed, MSc, FRCPath, Cert Mt
Consultant Clinical Microbiologist
University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary
Leicester LE1 5WW
Email: sayed.bukhari@uhl-tr.nhs.uk
Mr Shaun Livsey
Biomedical Scientist in Microbiology
University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary
Leicester LE1 5WW
Email: shaun.livsey@uhl-tr.nhs.uk
Competing interests: No competing interests
In recent years the reappearance of many insect-borne diseases, particularly from mosquitoes, is challenging to communities and health care systems. The development of resistant mutations variant in pathogenic organisms and vectors, along with the increased susceptibility of human beings and environmental influences, are a few factors now influencing the spread and the severity of vector-borne diseases like Ebola. So collective coordinated preventive measures at all levels among countries are the need of the hour to tackle and prevent these diseases in the near future and forever.
Competing interests: No competing interests
Clarification of Potential Competing Interests
Dear Editor,
The initial version of this article did not state any competing interests. I am writing to clarify that I had consulted for Astra Zeneca, served on the boards of Medtronic and Alnylam. I terminated all relationships with industry in July 2014 when I joined the Institute of Medicine. I received deferred compensation from Medtronic which was placed in a blind trust.
I do not believe the above relationships are relevant whatsoever to the publication and thus should pose no conflict. However, I am writing to clarify this information in the spirit of transparency.
Sincerely,
Victor J Dzau
Competing interests: No competing interests