Target: Margaret Hamburg, Commissioner of the Food and Drug Administration
Goal: Facilitate hastened development of drugs and vaccines to treat patients of the current Ebola epidemic
The head of the World Health Organization recently warned that the Ebola outbreak in West Africa is outpacing efforts to control it. Scientists are hard at work trying to find a drug to treat Ebola virus patients, though researchers have recently encountered significant procedural hurdles. It is critical that the FDA prioritize Ebola drug research in order to mitigate the current Ebola epidemic.
Over 1,300 people in West Africa have contracted the Ebola virus since March; it is the deadliest outbreak to date, surpassing an occurrence that featured 602 cases of the virus in 1976 (the year of the virus’ discovery). In recent months, more than 50 percent of the infected have died, and concerns about the possibility of a pandemic are on the rise after a Liberian patient reportedly transferred the virus to Nigeria by air travel.
As of yet, no drug or vaccine has been approved, but several are in development. The most promising of these is Tekmira Pharmaceuticals’ TKM-Ebola drug, which has been highly effective in eliminating the virus in primates. Earlier in 2014, Tekmira began clinical trials to determine the drug’s safety in treating humans, and 14 research participants successfully tolerated the drug. However, in July 2014, the FDA put a hold on the trials, citing the need for additional data regarding the mechanism of cytokine release (Tekmira maintains that the mechanism is well understood).
The FDA must fast track Ebola drug research in light of the growing epidemic. By signing the following petition, you will encourage the FDA to act swiftly to encourage the development of a drug that can allow health care workers to obtain control over this alarmingly proliferous epidemic.
Dear Ms. Hamburg,
Concern is on the rise surrounding the current outbreak of Ebola hemorrhagic virus in Sierra Leone, Guinea, and Liberia, as health care workers lose control over the epidemic. As an agency with tremendous influence over the development of drugs and vaccines, the FDA is responsible for promoting public health. By keeping a hold on the study of Tekmira Pharmaceuticals’ TKM-Ebola drug, the FDA is preventing what could be a significant step towards overcoming the virulent epidemic that has already claimed over 1,300 lives.
By placing a hold on the TKM-Ebola drug, trials of which have consistently yielded promising results, the FDA is wasting precious time. As each day passes, more individuals are put at risk of contracting the virus. Ebola hemorrhagic virus has ruinous impacts not only on human life, but on economic welfare as well. It has been estimated that the affected countries will experience billions of US dollars in losses because the virus is concentrated in several agricultural regions.
It is the FDA’s responsibility to protect and promote public health, but by blocking further development of the TKM-Ebola drug, it is doing quite the opposite. There is, in fact, precedent for drug research fast tracking in emergency cases; in 2013, a researcher who was exposed to Ebola received experimental treatment. I urge you to fast-track Ebola drug and vaccine research in order to confront the extraordinary threat posed by the Ebola virus.
[Your Name Here]
Photo credit: Centers for Disease Control and Prevention via Wikimedia Commons