It won’t change a damn thing

It won’t change a damn thing

Earlier this week the FDA issued revised guidance on … wait for it .. improving the accuracy of conventional finger stick glucose monitors. According to a press release;

“The Food and Drug Administration is released final guidance describing studies and criteria that are recommended when submitting premarket notifications 510(k)s for blood glucose monitoring systems (BGMSs) for prescription point-of-care use in professional healthcare settings.

The FDA also released separate, similar guidance for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter home use.”

To this we say who cares. While this news likely will warm the hearts of the diabetes blogging community who have been pressing for more accurate glucose monitors it won’t change a damn thing. It will not improve patient outcomes, there is no evidence, yes those pesky facts again showing that patients achieve better outcomes with “more accurate monitors.” It will not make patients test as frequently as they should. It will not in any way change the dismal market dynamics for BGM. A market which is headed for obsolescence.

The fact is, yes we just love those pesky facts, when it comes to glucose monitoring CGM is where its at. It is CGM that will become the standard. So quite frankly this news really isn’t news at all.

Consider some additional facts as according to this guidance meter accuracy is supposed to improve from the current standard of +/- 20% to wait for it … +/- 15% – yes a whopping 5% improvement. So under the new standards a reading of 100 either is 85 or 115, instead of 80 or 120, yep that’s progress my friends.

There are other items besides improved accuracy in the guidance but again who cares. This is like the government issuing new standards for land lines when the world has moved onto mobile phones. There might be a few old soles who still have land lines but not many. In a few short years there may be some patients who still use an old school point to point finger stick monitors but not many.

So let’s rejoice the FDA has solved a problem that didn’t need to be solved in the first place. Kudos to the agency for listening to the diabetes community then wasting time and taxpayer’s money for new regulations that won’t change a damn thing. Congrats to the diabetes community for pressing this non-issue and showing once again who clueless you really are. Keep in mind this is the same community that now wants the government to intervene because patients out of pocket cost for insulin are too high. The same community that has blamed insulin manufacturers for this problem when they don’t understand or ignore those pesky facts.

We can only imagine the out of pocket of insulin if the government steps. While out of pocket costs seem high today after the government gets involved watch out, today’s prices will look a bargain by comparison. Keep in mind that these are the same genesis who put together the Affordable Care Act, which in turn created these high deductible plans which everyone complains about. These are the same genesis who won’t let insurance companies compete which would only drive prices down. And the same genesis that created competitive bidding for diabetes testing supplies but won’t do the same for drugs which only save Medicare even more money.

Now we don’t think the Affordable Care Act should be repealed, that might make a good sound bite but nothing the government does is repealed with the notable exception of prohibition. Fix the program take what’s good and keep it and then fix what’s broken.

It would also be helpful if payors, PBM’s all the middlemen involved with insulin were required to disclose not just the discounts they are receiving from insulin companies but the rebates too. This transparency would show all these people who blame insulin companies for the high out of pocket cost of insulin just how off base their blame is.

Seriously folks there are some very real problems facing patients with diabetes, glucose meter accuracy is not among them. But let’s not let those pesky facts get in the way. As Momma Kliff used to say; “Funny thing about facts they do ruin a well thought out fantasy.”