FDA Stands Ready For Ebola Treatments, But Research Still Underdeveloped
Due to the unpredictability of the disease and its limited market, Ebola research has been, until now, under-represented. The most recent outbreak in West Africa, termed the largest in history, has infected 1,323 people and is responsible for 729 deaths since February, and that number is growing. While West African leaders scramble to contain the disease, the FDA announced this week that it ‘stands ready’ to work with drug-makers to fast-track Ebola drugs.
Until recently, this disease, first identified in 1976, has claimed fewer than 1,000 lives per year. In comparison to Malaria, which claimed 627,000 in 2012, the Ebola numbers seem small. Though some preliminary research into an Ebola vaccine and treatment exists, interest and investment by large pharma companies has been limited. The bulk of research has been funded by the U.S. government, with few studies progressing past animal testing.
Another obstacle to the development of a vaccine is Ebola’s unpredictability. Even if a vaccine were to be developed, there is no way of predicting where the next outbreak might occur. Previous outbreaks have occurred in the Democratic Republic of Congo and Uganda. The current outbreak is concentrated in Liberia, Sierra Leone, and Guinea.
Dr. John Dye, chief of the viral immunology branch of the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), told the New York Times, “Ebola is like lightning strikes…Is it realistic to think we could vaccinate the entire continent of Africa?”
This leads some experts to conclude that a vaccine is not the answer, and that the bulk of energy and investment should be used to find a treatment for those already infected. The disease, however, is extremely fast-moving, and it’s difficult to intervene once the symptoms manifest.
While Ebola has no cure, one Canadian pharmaceutical company, Tekmira has come the closest to developing a successful treatment, TKM-EBOLA. TKM-EBOLA is the result of four years research, a 140 million dollar contract with the U.S. Department of Defense and represents the first Ebola research to proceed into human clinical trials.
Some argue that TKM-EBOLA should be taken directly to Africa, implemented, and tested at the source of the outbreak under a special authorization known as “Compassionate Use,” while others argue that a drug at such an early stage of development should not be qualified.
“Deploying TKM-EBOLA in the current outbreak would have benefits for both the drug developer and patients,” wrote Dirk Haussecker, an independent consultant in the field, and creator of The RNAi Therapeutics Blog. “You could argue that it is ethically more troubling testing a new compound in healthy volunteers when actual patients are available.”
As of July 21, Tekmira was not prepared to release the drug for this purpose. In a statement released by the company, they wrote that they were “mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa. TKM-Ebola is currently an unapproved agent and the regulatory framework to support its use in Africa has not been established at this time.”