Since the first outbreak of Ebola in 1976, the global pharmaceutical industry has invested little in Ebola research. All previous outbreaks have been sporadic, self-limiting and have occurred in poor populations – generating little, if any, commercial appeal for developing treatments. That is now changing.
The current outbreak, which is the worst on record and responsible for at least 4,500 deaths, is generating unprecedented interest among pharmaceutical companies and research institutions.
For instance, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) based in the USA are for the first time directly coordinating research efforts aimed at developing an Ebola treatment.
The Bill & Melinda Gates Foundation has made its largest ever donation towards a humanitarian cause by donating 50 million US dollars to support Ebola control efforts.
Pharmaceutical companies that had made prior investments in developing Ebola treatments are now seeing an opportunity to advance their products. Tekmira Pharmaceuticals Corp, which started developing an Ebola drug in 2010 and was planning to test it only in animals, now has the opportunity to demonstrate efficacy of its drug in humans and seek marketing authorisation.
Mapp Biopharmaceuticals and Chimerix Inc are also testing their products for the first time in humans. The current outbreak is thus presenting pharmaceutical companies with patients desperate for treatment.
This haste is also seeing other companies that were not previously active in Ebola research getting actively involved. According to Merck's head of vaccine division, the company is now screening its drug library for drugs that may be effective against the virus. CSL Ltd, an Australian-based company that makes plasma therapies, is contemplating taking up a request from the Bill & Melinda Gates Foundation to make plasma treatments.
While there is enhanced interest in finding a cure for Ebola, the big question remains: will these efforts yield effective treatments in good time and in sufficient quantities for the current epidemic?
Efforts to find treatments seem to be too late for the current outbreak. The World Health Organisation (WHO) is instead focusing on short-term approaches such as the use of blood plasma from Ebola survivors as treatment. WHO has actually issued guidelines on the use of these plasma therapies in West Africa.
Development of plasma therapies is challenging. The process involves collecting blood from people who have survived Ebola attacks, purifying the blood to generate "hyper-immune" products that are transfused into Ebola patients. According to CSL's CEO, whereas developing plasma therapies for Ebola is technically feasible, it is logistically difficult.
The company will have to collect large volumes of blood in West Africa, ship the blood to its facilities in Switzerland for processing and send the finished product back to West Africa – a process that is logistically challenging owing to material transfer regulations between countries. Plasma therapies will not be available until mid-2015.
The availability of drugs from Tekmira, Mapp and Chimerix for clinical use will not be soon due to the limited supply and long production times of these drugs. For instance, Tekmira's TKM-Ebola is in "limited" supply according to the company's CEO.
Further, the company needs to modify the drug to match the specific Ebola virus strain that is responsible for the current outbreak – a time-consuming process.
Stocks of Mapp's drug (ZMapp) were exhausted in August this year. Mapp is working to make more of the drug but the process, which involves modifying tobacco leaves to produce the drug, is technically complicated and takes several weeks.
Another challenge is the ethics related to performing clinical trials for Ebola treatments. The conventional use of randomised controlled trials (whereby a group of volunteers is given the test drug and another group is given a dummy drug) is not ethical in the present Ebola outbreak.
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Developing alternative trial designs that are acceptable to patients and regulators is proving to be a difficult and lengthy process. What about vaccines? There are various trials going on with potential success.
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