Wednesday, October 27, 2010

Big Pharma - helping me - but screwing you over.

Got the results from the mixed meal tolerance test in Utah. A1c is 5.8. Awesomeness. C-peptide started out really low, but it went up to 2.7, which is really quite good. Honeymooning 21 months after diagnosis? Also awesomeness. My pancreas still works, baby, and even if it's not doing its job completely, I'll take what I can get.

The big news, though - the day I went up there, was the day the office learned that the drug company is pulling all studies of this drug. END. NADA. NOBODY ELSE GETS IT. I did Protege, which had already stopped enrolling because it was full, but Protege Encore? (same drug/same dosage) OVER. Subcue? (drug give with needles instead of infusion) STOPPED. Everybody was in complete shock, they couldn't figure out why. The official reason is that the efficacy goal wasn't reached.

HOW could this drug not be effective? The office I go to has the largest enrollment, and they've seen incredible results. 3 people off insulin, snacking on Snickers bars. Nobody's Lantus dose is over 12, and they've had many people drastically drop - like from 30 to 6. And yes, most people stay on insulin, but the main goal of the drug was to drop insulin usage and extend the honeymoon - which was totally happening. Maybe other sites were teaching their subjects differently - i.e. saying they didn't need to manage their diabetes, see if the drug does that - I don't know, but saying the drug is ineffective just blows my mind, and everyone else working with it.

It's also supposed to decrease the number of lows, and you want to know how many hypoglycemic events I've had in the last 6 months? TWO. And both times, I know the reason why (more exercise than usual). I am no longer terrified of going low - I mean, I still carry candy, but I hardly ever use it. That right there makes it worth it.

You know, in the beginning, I would Google all the time, trying to find people that were in the study, see what happened to them, and I would find little snippets here and there, 100% positive. I still do that, actually. And I did see on one board somewhere (and I can't find it now, which is driving me crazy) a comment from someone that struck me as paranoid. It was when Eli Lilly bought into the study (it used to just be MacroGenics, and it happened while I was enrolled) and he said something to the effect of "Eli Lilly always buys into Type 1 studies that look promising, says they aren't effective, and then kills them. Just watch. That's what will happen." And spookily enough, here we are. Eli Lilly was in charge, declared it ineffective, and killed all the studies with teplizumab.

It's almost enough to make me a conspiracy theorist. I mean, the dude predicted it. The press release (found here) says it was an independent committee, but hmmm....

(The office also found Eli Lilly much harder to work with. Reimbursements for travel and other payments started taking much longer to get.)

I don't know why a drug company would kill it, though. I mean, most people don't go off insulin. They still need the test strips, the needles, the insulin, the money makers for the drug companies. They just get an additional drug, which you think would be win/win for the drug company. Make diabetes MORE expensive, but with the added benefit of extended honeymoon/fewer lows/increased quality of life for the diabetic. But the whole thing stinks of money somehow - maybe they wouldn't get people to pay for the drug, after all, every doctor I've ever mentioned to that I took this, pauses for a second and says "that has got to be one expensive drug." So possibly they were worried they'd get it approved only to have it sit on the shelf as insurance companies and patients opt not to pay for it.

The whole thing just really really bothers me. I don't like the feeling of not trusting the data. What other drugs were stopped in the past and/or will be stopped in the future? I don't like that nobody else will get this drug, when I would totally recommend it to anybody newly diagnosed. I don't like feeling like the search for a cure has taken HUGE steps backwards, all because of the almighty dollar.

But hey, MY numbers are good. I'M lucky, I guess. But there should be more than just a handful of us.


  1. Wow, interesting. I'm afraid it is all about money, politics, and the complexities of running a billion $ corporation. It seems like somehow, with all the money out there,there would be an actual cure for diabetes, because more people suffer from it than any other disease other than heart disease, but I think that is the VERY reason there isn't a cure yet. Companies want to keep their target audience captive and dependent in any way they can. The drug you have been helping to test sounds like it would give too much independence and hope to diabetics. That hope could turn into a demanding population of diabetics who refuse to accept the statement they always hear: "Well, if you have to have a chronic disease, diabetes is the one to have because the modern advances make it so liveable." That is just the point . . . drug companies want their customers to be satisfied with the status quo and live long enough to keep the demand up, but they don't want us living too well . . . . Boy, I really sound like a pessimist to the max. Sorry! You just opened up a topic I feel so strongly about.

  2. Maybe if the drug companies were run by Type I diabetics - that's what we should do! Make sure all the big drug companies have a diabetic as the CEO and watch the advances start moving at lightning speed.