Wondering why all the latest and greatest diabetes technology seems to get launched only in Europe these days? Wait, it gets worse...
Did you know that 40 different countries around the world have approved new Low-Glucose Suspend (LGS) technology — which allows a CGMS-augmented insulin pump to automatically shut off basal insulin when it detects a BG reading below the target range, an amazing safety feature! — yet FDA is still not anywhere close to being on board? The technology has been available overseas in the form of Medtronic's VEO system for over two years now. Yet the FDA has only recently issued "guidance" on LGS in this country — and in a form that will thwart the availability of this lifesaving technology for years to come, according to JDRF.
Yikes! How frustrating! Want to know why? Because they are experiencing something called "Safety Paralysis" in which they've become so risk averse that they bog down everything in layers and layers of new pre-approval requirements.
But before we get into that, we'd like to thank JDRF for their unceasing efforts pushing for this new technology.
Late last fall, we reported on the FDA's hearing on the Artificial Pancreas Project, much of which actually revolved around Low-Glucose Suspend technology. JDRF was insistent that FDA outline clear recommendations "to ensure the safe and effective testing of artificial pancreas technology in real-life situations" so that the value of LGS could be clearly documented.
This month, the FDA finally released the draft of their guidelines document and opened it up for comments until Sept. 20, 2011. JDRF, of course, led the charge in voicing our community's concerns:
"JDRF believes that, as currently written, the proposed low glucose suspend guidance document is unreasonable and will delay the availability of lifesaving technology to people with type 1 diabetes who need it."
In this PDF document, JDRF lays out three main concerns:
1. The clinical study pathway in the FDA proposed guidance is excessively burdensome and will require large, multi-year pre-market studies (slow! expensive! unnecessary)
2. No "adequate clarity" is provided on use of continuous glucose monitors (CGM) in LGS studies (some standardized commitment to the use of CGM in clinical studies is the only way to legitimize results)
3. Restriction on "equivalent components" in LGS systems studied is crippling (not allowing researchers to swap out components without a separate clinical trial on each new technology piece is going to immobilize further research)
JDRF showcases the vital (and oh-so-obvious-to-us) point that insulin itself is dangerous! "Too much insulin can cause dangerous low blood sugar and seizures, coma, or death," therefore systems that can protect us from an accidental overload are crucial! The risk of receiving less insulin for a short period of time is low compared to the alternative.
So whhhyyyy is the FDA dragging their feet on this?
Because, as eloquently explained by medical device expert Karen Talmadge at the DiabetesMine Innovation Summit last week, that organization is very polarized. They tend to experience "pendulum swings" of over-ambitious approvals, and then back to mega-risk-adverse mode, otherwise known as "Safety Paralysis" or "Analysis Paralysis." With some highly publicized drug scandals recently, they'd rather approve as little as possible at the moment, and not take any risks.
This doesn't mean that there aren't any good people at FDA, or that they aren't working hard. It just means we patients have to sit tight while this risk-adverse Zeitgeist passes over. OR... we can keep hammering on them, and raising our voices until they get the message that in some cases, potential risks of using a medical device are lower than not using the device, and just letting the illness run its course!
If you want to learn more about how to follow FDA's moves, see fellow D-Blogger Bernard Farrell's excellent roundup here.