The FDA Approved a Drug for a Disease That No Longer Exists – But Here’s Why
On July 13, 2018, the FDA announced the approval of a new treatment for smallpox.
Considering the fact that we saw the eradication of smallpox back in 1980, this may sound like a surprising decision. After all, why in the world is research and development going into producing a drug to treat a disease that no longer exists?
Interestingly enough, the decision is not because there is a threat of a naturally-occurring outbreak of smallpox. Rather, the treatment is being produced to address a long standing concern that smallpox could be used as a bioweapon.
“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D. ” Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”
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New Smallpox Treatment… Just in Case of Terror Attack
The effectiveness of the treatment, TPOXX (tecovirimat), was established using studies conducted in animals infected with viruses closely related to smallpox. The researchers used the survival rate at the end of the studies to measure effectiveness.
At the end of the treatment, more animals treated with TPOXX remained alive compared to the animals treated with placebo.
The next step was to review the safety of TPOXX in 359 healthy volunteers without a smallpox infection. The most frequently reported side effects were headache, nausea and abdominal pain.
Based these results, TPOXX was approved under the FDA’s Animal Rule. This allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
The Bottom Line
Given the approval of this new drug, one key question automatically comes to mind: Are we really under threat of a smallpox bioterrorism attack?
The World Health Organization notes that is impossible to assess the risk of a smallpox release intended to deliberately cause harm. And in modern times there has never been a bioterrorist attack, even though concerns over such an event have been around for decades.
In the meantime, 2 million TPOXX treatments are reportedly already in the hands of the government for stockpiling.
- FDA approves the first drug with an indication for treatment of smallpox. FDA News Release. July 2018.