There has been a major breakthrough for the Food and Drug Administration this past week involving the treatment of the smallpox virus, by approving the oral antiviral TPOXX.
A Dangerous Threat
If you are familiar with the smallpox virus, then you will know that it has been on the radar of concern for healthcare professionals and beyond since 1980. One of the major concerns of smallpox is the threat of bioterrorism, to be used as a weapon in attacks. Now, in the year 2018, the FDA has made major steps to approve the risk that smallpox brings.
“While circulating smallpox is no longer a threat, there are concerns that the virus could be used to threaten health and safety through bioterrorism.” Healthcaredive reports.
Smallpox affected many people in the 1980s, oftentimes even leading to death. This caused healthcare professionals to find a cure for the virus. This resulted in a vaccine given to those in the military or those who worked in labs. Since smallpox affected mostly everyone who came into contact with it, researchers knew that more had to be done.
“Smallpox has devastating effects, which begin 10 to 14 days after infection with symptoms of fever, exhaustion, and headache. The pus-filled sores that result from smallpox can eventually lead to permanent scarring, and the disease can also cause loss of large areas of skin, encephalitis (inflammation of the brain) and blindness.”
A Modern Cure
It all started after September 11 at the National Institue of Allergy and Infectious Diseases, through a collaboration with the Biomedical Advanced Research and Development Authority. Research began in order to work in order to work safely with smallpox vaccines while diluting them.
“Siga Technologies of Corvallis, Oregon, developed TPOXX (tecovirimat) under a federal biomedical defense contract, and the FDA provided it with fast-track and priority review designations.”
TPOXX was developed and tested on non-human primates after being infected with viruses that resembled smallpox through a lethal infection. Humans were involved in the testing as well, as 359 healthy humans were evaluated after being injected.
The FDA reported that the most common side effects were a headache, nausea and abdominal pain. Animals treated with TPOXX lived longer compared to those who were not injected with TPOXX. This was made possible through the FDA’s Animal Rule which allows well-controlled animal studies to be done under the FDA’s approval.
The FDA & The Future
The move to accept TPOXX through the Federal Drug Administration is a big step for healthcare and the public’s safety.
“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D.” The FDA reports.
It will be interesting to see how this will affect the healthcare market, including providers, and patients alike.
Healthcare leaders are working tirelessly to improve patient access to care, reduce costs, improve the quality of care, and answer growing patient demands.
New technology like Telehealth, Artificial Intelligence, Augmented Reality, Robotics, 3D Printing, and more are enhancing the patient experience. This October, The Millennium Alliance is bringing together CIOs from North America’s leading Health Systems to discuss how the industry is digitally transforming with the influence of these technologies.