The Ebola virus disease outbreak in West Africa continues to rage on, with 1848 suspected cases and 1013 deaths (54.8% fatality rate). Treating EVD typically consists of symptom management, as there aren’t many approved medications available for use. However, there are a number of yet-unapproved medications to treat EVD that are in various stages of testing, including the ZMAPP serum given to Dr. Kent Brantly and Nancy Writebol before their transfer to Atlanta.
The World Health Organization (WHO) convened a meeting with representatives from 10 countries on Monday and unanimously determined it would be ethical to grant “compassionate use” of some of these unproven medications in order to combat this outbreak. A statement was released today (August 12) but the full report will be made available August 17.
The obvious risks of using medications that have not been approved are that they won’t work or may have potentially catastrophic unforeseen side effects. Drug development is an extremely long process in order to ensure the best treatment possible. Following successful testing in an animal model, a treatment can potentially move forward to human clinical trials. The first phase deals only with safety, identifying all side effects from the drug. Phase II begins to determine any efficacy, while therapeutic value and long-term effects are studied during Phases III and IV, respectively.
The committee stressed that strict ethical guidelines must be followed when administering these medications. The criteria “include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community,” according to WHO's statement.
Additionally, the committee stresses a “moral obligation” for open access to all of the data accrued during this time period. In order to bolster the integrity of the information collected, health officials should takes steps to ensure that the medications are administered as similarly to clinical trails as possible.
It has not been made entirely clear within the released statement which medications will be selected for use first or where they will be accessible. Medications that have not been approved are also not produced in large quantities, so there will likely be issues with availability. Once an unregistered intervention has been given to patients, its performance will determine whether or not it continues to be used. Additionally, the first medications given under these circumstances will also determine if and what other treatments are introduced.
Desperate times call for desperate measures, and hopefully introducing compassionate use drugs will be beneficial to containing this outbreak. The information gained from these impromptu trials could even expedite the formulation and development of a drug that is able prevent future outbreaks.