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Ebola, the failure of the global pharmaceutical industry to solve the crisis

18.08.2019
Article from AFRIC Editorial
Ebola, one of the deadly virus in the world that continue to torment West Africa has its turn on Democratic Republic of the Congo (DRC) yet again. The July 2019 declaration of Ebola outbreak in the DRC as a Public Health Emergency of International Concern (PHEIC) sparked debate across the world and among the ethicists, economists, and health policy experts, on the world’s preparedness to combat and proffer a solution to this virus coupled with well-funded research and development that leads to medically certified vaccines. Considering the unprecedented EVD.

outbreak in West Africa (2014-2016), both its scale and impact, the remedy should have been fast tracked not to only treat but to prevent the resurgence of EVD.
The outbreak of the Ebola virus epidemic has a tendency of exposing the underbelly of many Africa’s healthcare systems. They are often poorly funded, severely neglected and in some cases virtually non-existent. The disease’s virulence has overwhelmed health systems which before Ebola lacked basic equipment and facilities, medical staff and supporting infrastructure. When West Africa confronted the most severe and most complex outbreak of EVD in 2014, there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. This resulted in more than 28600 Ebola cases with 11300 deaths recorded. What a shame that so many had to die to prompt the acceleration of research and development of a vaccine against a disease as deadly as Ebola?

Fast forward to 2019, total number of probable, confirmed and suspected Ebola cases exceeds 2800, with 1900 deaths as at 18 August 2019 in DRC according to WHO statistics. In as much the as the outbreak is centred in DRC for now, it rivets the attention worldwide of clinicians, virologists, public health experts, industry, regulators, and the lay public alike.

There seem to be great strides on Human Immunodeficiency Virus (H.I.V) world over, why then is EVD continuously declared epidemic and pandemic? Why does it seem that the world is well prepared for war than for such deadly virus? “We always say we go to war with a virus. But the world is not as well-prepared for [an] epidemic as they are for war,” exclaimed Dr. Margaret Chan, director-general of the World Health Organization after the 2014 West Africa outbreak.

Vaccines and treatments in 2019

There is no cure or specific treatment for the Ebola virus disease that is currently approved by world health authorities for market, although various experimental treatments are being developed. It’s quite interesting to note that the standard of care for treatment of hemorrhagic fevers, of which EVD is one, ‘has not changed appreciably since the 1950s’

Is Ebola a neglected disease?

Prior to 2014, fewer than 2400 cases of Ebola had been reported since 1976, when EVD was first identified in Zaire (now DRC) and South Sudan. The sheer rarity of Ebola and the unpredictability of outbreaks doubtlessly slowed the development of targeted vaccines and treatments. Could it be that producing vaccines or drugs for a disease that predominantly affects developing countries is not a lucrative business?

Some school of thoughts attribute the lack of a business case to pharmaceutical companies for investing in the development and licensing of an Ebola vaccine – a cost that was likely to run into hundreds of millions of dollars.

The fact that Ebola is solely endemic to Africa has likely also played a role. It has been lamented, for example, that a vaccine would probably exist today if Ebola affected many people in high-income countries, making research and development financially attractive to drug companies. Given that development of drugs and vaccines is both expensive and cumbersome, and that the people who would most benefit from the development of Ebola therapies live in extreme poverty, it is difficult to attract investors. Those affected by Ebola are widely seen as a vulnerable population whose health needs have not been met by the market economy though the right to life is a universal human right and access to medicine is a fundamental component of that right.

One is tempted to assert that existing or emerging viruses that cause diseases like EVD are neglected if they affect poor nations and that neglect has a tendency of exacerbating global health inequalities and directly implicating questions of distributive justice. Thus, there is a moral and ethical dimension to the 2014 West Africa and 2019 DRC EVD outbreaks—and to the lack of vaccines and therapies that, in part, allowed the virus to spread. Complicating this analysis, however, is the notion that some believe that governments and others have provided substantial funding for Ebola research but only to the extent they perceived Ebola to be used as a biological weapon.

Some suggest that ‘disproportionate resources’ have been deployed for Ebola research and control as compared to other neglected diseases. As a result of this investment, progress was made in understanding the Ebola virus and in developing potential therapies. Nevertheless, two clinicians from the U.S. Centers for Disease Control and Prevention (CDC) observed that ‘from the perspective of those most at risk of [EVD], progress has not been experienced’

Observations from the 2014 West Africa and 2019 DRC outbreaks

The following difficulties were encountered in ensuring a timely identification and response from WHO perspective:

  • Insufficient monitoring
  • The global security approach oversight
  • Delays in the identification of epidemics: weak surveillance system and alert mechanisms
  • Delays in declarations of epidemics
  • Failing to respond: (a) tension between prevention and emergency response; (b) practical and political constraints; (c) lacking the tools—the failure of the research and development framework

Pharmaceutical Industry incentives

Meaningful research into an Ebola vaccine started over a decade prior to the 2014 outbreak. Results were promising albeit slow. Scientists in the US and Canada had vaccine samples that proved to be effective in protecting primates from Ebola, but they had not advanced far enough to be tested on humans. And in any case, the impetus behind the research was not to save lives in developing countries: ‘The funding you could get five years ago to make an Ebola vaccine was not to prevent outbreaks in Africa, unfortunately, but to defend North Americans against a potential bioterrorism attack,’ explained Adrian Hill internationally renowned scientist based at Oxford University, who heads up the Jenner Institute for public sector vaccine development. The Jenner Institute received funding from the WHO in 2014 to accelerate research and development of new vaccines and fast-track testing of existing Ebola vaccines on humans, in response to the outbreak.

‘If we depend on the [pharmaceutical] industry entirely, we are just going to follow the industry’s priorities which may not align with the priorities of society at a particular time,’ says Gary Kobinger, Director of the Centre for Research in Infectious Diseases at Laval University in Canada, who led the development of the Ebola drug and vaccine at the Canadian National Microbiology lab. Kobinger concludes that it’s for countries that have money to come forward and put money to support these projects.

As much as WHO need to scale up funding for Ebola, the world cannot continue to live in a system that only reacts after an outbreak. Other diseases that have lost funds to Ebola could become the Ebolas of tomorrow. Research and development of vaccines for Ebola and other neglected diseases cannot be left in the hands of pharmaceutical companies. The primary incentive for any company is arguably profit maximisation; thus, there could be little business sense in producing a drug that will not yield economic dividends.

Recommendations

There is need to work towards a system that aims not only to respond, but to prevent. It is now imperative to restructure a completely dysfunctional R&D system within the control of WHO, which for years has been driven by rich countries and the diseases of the rich.

A more holistic and equitable approach to be adopted where rich and poor countries would come together to pilot new, cost-effective, innovative forms of drug development where both sides share equal responsible for implementation. Done well, it could be revolutionary – no more charity-based, reactive-to-pandemic drug development.

Article de la rédaction AFRIC

Photo Credit : google image/illustration

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