A solution that was too expensive

So I got this guy who is the poster boy for Brittle Diabetics. Ok, ok, ok, ok. I know. I know. Now-a-days there isn’t supposed to be any such thing as brittle diabetics. But like the Loch Ness Monster, Big Foot, and little grey aliens—if you see one in the flesh it really doesn’t matter whether they are supposed to exist or not, right?

For those of you who just arrived at the party, “brittle” was a term used long ago to classify someone who’s BGL is nearly impossible to control. Weird spikes with no cause. Unexplained crashes. Wild swings that make no sense.

In reality everything under the sun has an explanation. It may just to too obtuse to be obvious. Mercury is in retrograde, the moon is in Leo, the wind is from the east and the barometric pressure is rising so the poor guy has a hypo.

Hey, the human body is a complex environment and our best tools and medicines are stone knives and bear skins compared to the elegant complexity of a properly functioning endocrine system!

I’m somewhat brittle myself. I think, in reality, I’m just hyper-sensitive. Especially to anything with even a decent amount of carbs. I can just walk past The Old Spaghetti Factory restaurant in Denver and my BGL will spike. Probably the carb molecules in those wonderful smells wafting through the air…..

But back to the Poster Boy. His sister brought him to us a year or so ago after he survived a hypo-induced car crash. At that time he was on old-school mix insulin which was very poorly suited to his life style. Also, he was under huge stress, his wife of 25 years having left him for her boyfriend. An extraordinarily vicious divorce was underway.

To make a long story short (did I hear a collective snort from the blogosphere?), I have tried virtually every combination of diabetes drugs under the sun on this guy. We finally ended up at a modified Multiple Daily Injection plan. We had tried garden variety MDI with poor results. Side note: I’ve had good results putting T-2s on MDI, a treatment that historically is only used for T1s. Further proof that 1 or 2, we are all really the same tribe. He’s just not cut out for carb counting, and he’s very insulin sensitive. I had thrown in the towel on proactive use of fast-acting. I had him taking basal, trying to eat reduced carb and then correcting any screw ups with sliding scale. I wasn’t really happy with either the approach or the results. His morning fasting numbers might look like this:

45

348

132

118

212

…and so on. The only pattern being there was no pattern. I wasn’t very happy. Did I also mention that he commutes about 80 miles to come see us? And that his boss is a total ass hole who gives him a ton of grief about taking any time off for medical appointments?

Anyway, recently, after studying his latest BLG download in Co-Pilot, and after consulting my Ouija Board, and after praying for divine inspiration, I finally decided that the key to our trouble was the postprandials (after meal BGL readings and surges). I convinced myself that if we could fix the postprandials we could tinker with the basal insulin and everything would work out. Turns out I was right. But it did me no good, as you will soon see.

Oh yeah. Did I mention he’s also nearly stone-deaf? Our appointments are full of shouting, wild gestures and lots of scribbled notes. I find shouting into his left ear works best for me. His sister shouts into his right. Really, one of his appointments looks like a scene right out of a sit-com. Being a traditional polite Hispanic, he always nods, smiles, and pretends to hear me. I now make him repeat to me any critical instructions.

So about four weeks ago I’m sitting at my desk fiddling with my pen, desperately trying to come up with a solution when I remember we’ve just received Januvia samples. I’m pretty sure we are the last clinic in the world to get samples. No, wait, I think there is a one-man clinic in southeastern Paraguay that doesn’t have it yet. I’m pretty sure Kakistan is totally stocked.

Januvia is a somewhat new Merck diabetes drug. It belongs to the broad category of incretin drugs, the latest frontier of diabetes treatment. Merck reps caused quite a stir when it was first released by telling Docs that Januvia was “oral Byetta.” Which is not true at all. Byetta and Januvia both come at the same general problem, but from opposite sides.

OK, time for Incretin 101, the latest online diabetes treatment course from your hosts at LifeAfterDx (It’s high end reality internet!). In a nut shell, with T-2s, insulin resistance isn’t the only thing going on. Two incretins (hormones), GLP-1 and GIP are the air-traffic controllers of the pancreas. They help with insulin release and action. They also hold the liver in check so it’s not adding sugar to the problem. The Gs also play a role in hunger signals and digestion speed. Anyway, there is nothing wrong with GLP-1 and GIP in Type-2s. The problem comes in from a nasty little critter called DPP-4. It’s job is to mop up the Gs when they’ve done their job. Problem is, DPP-4 jumps the gun in most T-2s.

So there is a complex dance between GLP-1/GIP and DPP-4 that just begs for intervention. The choices boil down to adding more GLP-1 or slowing down the DPP-4. Either approach should work.

Byetta (the lizard spit drug!) was the first incretin drug to hit the market, and it took the supplement approach. It is correctly called an incretin mimetic. What that means is that it is an artificial incretin, much like analog insulins are modified versions of real insulin. Byetta is, in essence, supplemental GLP-1. It is a runaway “best seller,” and for good reason. Byetta is an amazing drug, one of the most effective diabetes meds for T-2s I’ve ever seen. The problem is, it is hard to get insurance companies to pay for it; and for some reason insurers view it as a drug of last resort rather than the first line defense it ought to be. Byetta actually restores first-phase insulin response. If you put all pre-diabetics on Byetta, full-fledged Type-2 diabetes would virtually vanish. As that makes a lot of sense, it will never happen.

Januvia takes the opposite approach, to “inhibit” the DPP-4 (we’re really gonna need better names for these incretins). Even Merck’s own studies don’t exactly blow the doors off of the competition, showing less than a 1% A1C drop. The Byetta crowd has really tried to trash Januvia, but a couple of folks in the biz that I have high respect for have reported good results to me, so I was open minded. I want every tool I can get my paws on.

In summary, both drugs focus on postprandial blood sugar. And everyone agrees that the T-2s can benefit from more GLP-1 after a meal. Byetta gives extra. Januiva inhibits the DDP-4 so that the native GLP-1 can do its job. Byetta is injectable. Januiva is a pill. Byetta has the delightful side effect that most patients lose a ton of weight. Januiva is weight neutral, meaning that most people neither gain nor lose. Just so you know, most folks put on weight when put on insulin. Some debate about whether or not this is caused by the medication or the fact the people feel freed up to eat what ever the hell they want to eat….

So desperate for a solution, and having nothing to lose, I gave my guy two weeks of Januvia samples and told him to only use the Novolog if he topped 300, which I fully expected him to do.

In two weeks he had not touched his Novolog. His sugars were actually stable. We needed to make a small adjustment to his basal, but he was in near perfect control.

I was impressed.

And pleased.

So we sent him on his way with a script and I closed the mental door on a difficult chapter. Now I didn’t need to worry about this guy any more.

Until the phone rang.

It was my patient’s sister. The patient had gone to his pharmacy. The co-pay for Januvia on his Blue Cross was $96 per month. She said he couldn’t afford it.

Fuck.

I went to our pharmacy guy to see what the wholesale cost of the drug was. Now we need to take another detour here. There is no one single wholesale price for any drug. The wholesale price depends who you are, and how much you buy, and whether or not you paid for hookers for the drug company executives. Unfortunately, we didn’t get our grant funds for hookers this year, so….

We have a unique pharmacy at my clinic. We don’t take insurance, it’s all cash-pay. But, as we are a federally funded non-profit (more accurately federally partly-funded) we get our meds at one of the federal rates. We are required to add an administrative handling fee, but do not make a profit of any sort on the drugs. Consequently we can sell some drugs to patients very cheaply, especially generics, and others… well….

And Januiva? The pharmacy guy reports that it starts at $400 for a month’s supply of the lowest dose, and goes up from there.

So my guy is screwed. If he were a welfare bum I could get him free drugs through patient assistance programs (PAP). If he were a rich oil executive he could afford it, or more likely he’d have a better Blue Cross policy that would have him only paying $15 for the med.

But he’s working class, and there is not a worse class to be in when it comes to your health care. So back to the drawing board. We’ll have to take him off the only medication that has worked so far.

So like Moses and Martin Luther King, Jr.; my patient got to see the promised land, but won’t get to go there.

Sucks.