FDA actively blocking fast Ebola detection technology in America
Common sense would lead you to believe that the U.S. government would be doing everything in its power, now that Ebola has reached American shores, to combat the deadly virus. But if you assumed that, you would be mistaken.
Most people don’t know that there is an Ebola screening machine; it is currently available to the U.S military, and the military is using it now. So why aren’t U.S. hospitals using it? Because government guidelines prevent hospitals from doing so.
According to military news site Defense One:
It’s a toaster-sized box called FilmArray, produced by a company called BioFire, a subsidiary of bioMerieux and it’s capable of detecting Ebola with a high degree of confidence — in under an hour.
Incredibly, it was present at Dallas Presbyterian Hospital when Ebola patient Thomas Eric Duncan walked through the door, complaining of fever and he had just come from Liberia. Duncan was sent home, but even still, FDA guidelines prohibited the hospital from using the machine to screen for Ebola.
Government bureaucracy preventing its use
The machine sells for about $39,000 a piece and is capable of screening for the genetic markers of a number of respiratory, gastrointestinal and other pathogens, and that includes the Ebola virus. However, it has to have the correct “kit” in place.
And right now, current guidelines from the Food and Drug Administration prohibit hospitals — including the Dallas hospital where Duncan was treated and where two of his nurses became infected — from getting that kit. “That’s despite the fact that it can provide results with higher than 90 percent certainty and it’s one of the machines that the military is currently using to screen for Ebola in Africa,” Defense One reported.
The FilmArray works by performing polymerase chain reaction tests to see if Ebola is present, based on a set of genetic markers. A company official told the military news site, “It will take the Ebola cells, break them open, expose the [ribonucleic acid] in the Ebola and match those with a target we’ve identified.” The device works using either blood or saliva samples.
A Utah-based firm that manufactures the disease-detection technology, BioFire Diagnostics, confirmed to Defense One that Texas Health Presbyterian did indeed have a FilmArray machine — for as long as two years, possibly — sitting on a shelf when Duncan presented himself to the emergency room.
But in order to use the machine, hospitals must agree to do so only for research purposes instead of actually using it to diagnose incurable diseases like Ebola.
What is the reason for this lunacy? The military site explains:
The FDA rules in what are called “research use only” machines are far more lax than for machines that must provide clinical diagnosis. According to representatives from BioFire, even after the FDA approved the use of the machine for Ebola screening and allowed workers at the hospital to acquire the proper kit for Ebola testing, a 10-20 day “validation” procedure would kick in before they could change the machine’s use from diagnostics to research — and the results would have to go to the Centers for Disease Control for confirmation.
Device used to diagnose first two American Ebola patients
Proper controls or just more inane government bureaucracy? It’s not as if the machine’s Ebola diagnostic kit hasn’t already been proven; after all, it is currently being used by U.S. troops in Africa.
To add further insult to injury, Defense One reported that FilmArray was the device used by medical officials at Emory University Hospital to diagnose the first two American Ebola patients, Kent Brantly and Nancy Writebol (Emory is where Amber Joy Vinson, the second nurse to become infected by Thomas Eric Duncan in Dallas, is being treated).
In a recent paper, published in the journal Lab Medicine, the Emory medical team wrote, “Polymerase chain reaction (PCR)-based microbiological analyzer (BioFire FilmArray [BioFire Diagnostics, Inc, Salt Lake City, UT]) designed to detect a panel of viral, bacterial, fungal, or parasitic pathogens, many of which might be found in patients returning from a resource-poor region and might complicate care. Among other pathogen-specific markers, this instrument detects Ebola viral RNA, a capability that we believe could have value for monitoring progression of and recovery from Ebola infection in this setting.”
Learn all these details and more at the FREE online Pandemic Preparedness course at www.BioDefense.com