Viral Politics

Security, safety and rationality have been driving Ebola drug development for years

By Steven Kuehn, Editor in Chief

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As news began trickling out of West Africa regarding the latest Ebola outbreak, the global community’s awareness and alarm grew at a pace much faster than the previous major outbreak in 2007 and the one prior to that in 2000. Certainly the back chatter during these past outbreaks was similar among the more seriously engaged interest groups of the time but this summer, fueled by an even more insatiable 24/7 news cycle and the immediacy of social media Ebola became the cause célèbre for the summer with social political advocacies around the world pointing fingers at the “establishment” (otherwise known as Big Pharma and U.S. regulators) blaming them for not doing enough to bring the benefits of modern western medicine to the often poor, black and innocent victims of the disease.

Critics of the establishment seized on familiar bogeymen including capitalism, bureaucratic obstructionism, racism, cultural elitism and other similar institutionalized western societal scourges to browbeat the developed world into action, the heat of their righteous and moral indignation fanned by the news that western (code for “white”) doctors and medical missionaries were to be first in line for “experimental” but potentially life-saving drugs. The ethical issues the establishment’s response elicited are profound, so much so that the World Health Organization convened a special panel to discuss the ethical ramifications of administering experimental and “untested” drugs on humans. “We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,” says Dr Marie-Paule Kieny, Assistant Director-General at the World Health Organization (WHO). “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.” Indeed they did ask and on August 11, the panel they convened in Switzerland declared that it was “ethical” to administer untested therapies to humans in the context of such a deadly disease. According to WHO: “In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”

Let’s recall however, that research covering vaccine and antibiotic-based interventions for Ebola and its viral cousin Marburg are well established and ongoing with Big and small Pharma companies like Johnson & Johnson (Crucell), GSK, NewLink Bio, Sarepta, Tekmira and Mapp developing biopharmaceutical therapies to the point that most, if not all could go into traditional clinical human trials right now. How is it that these therapies are at this stage of advanced development when corporate greed, capitalistic avarice and profit motive are allegedly preventing the world from helping the helpless in Africa? That’s a rhetorical question, but it does seem to adequately support the supposition that the system, the “establishment,” has actively been pursuing a therapeutic response in spite of the poor economics and relatively small population of sufferers.

Regulatory reform (which did not occur overnight either) is also bearing fruit. August 7 Tekmira Pharmaceutical Corp. announced that the FDA verbally confirmed they had modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application to partial clinical hold, which now allows Tekmira to administer the therapy to individuals infected with Ebola virus. "We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so," said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals. "This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols."

According to Tekmira’s announcement, TKM-Ebola, is an anti-Ebola virus RNAi therapeutic developed under a $140 million contract with the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. “Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira's LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus.” Notable is the fact that Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola March 2014, predating the political pressure that emerged since the “The Summer of Ebola” began.

The point is that Ebola is indeed a danger to society, but proportionally there are bigger threats; take Malaria for example: one statistic tells us that disease kills someone on this planet every minute. So far, there have been somewhere north of 2,300 Ebola deaths over the last 15 years and while there currently is no “established” cure, not everyone who contracts the virus dies from it either. Its pandemic potential is also limited say researchers because Ebola has real trouble standing up to western hygienic practice and culturally established health care norms.

Yes, Ebola is a threat, but contrary to much popular opinion there has been a continuous, timely and proportional response by the world’s developed and prosperous societies to stop this disease. Yes, the system has flaws and its pace in pursuing a pharmaceuticals solutions may seem slow, especially when people are dying, but since the Ebola virus has been identified, there’s been real effort made by Pharma, government and regulators to stop it from becoming a threat we really have to fear.

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