1 Boring Old Man

When I started nosing around, I found all kinds of interesting and strange things. There was wide variability in efficacy among countries and doses.

The FDA reviewer recommended against approval, but was over-ridden by the FDA committee [see ought to know by now…, in the shadows…, wait…]. The Director of the FDA wrote a special report justifying that action. The «published» study was coordinated by the shakiest of clinical research centers [see hiding uptown…, hiding uptown [more]…].

I didn’t give Latuda® much thought after that. I had noticed in their signature before-and-after ads that Latuda®  apparently moves the part from one side of the head to the other like a mirror. So when one of those ads popped up, I always noticed. But otherwise, Latuda® was off my radar. And then it was February 2014, and I looked at the American Journal of Psychiatry and there were two articles about Latuda® Clinical Trials in the same issue and there  was an editorial about it. You guessed it, a Bipolar Disorder indication. Then, I wrote [from or both…]:

This month’s American Journal of Psychiatry has two articles reporting clinical trials on Lurasidone [Latuda®] as either monotherapy [Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study] or as an adjunct to mood stabilizers [Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study] in Major Depressions associated with Bipolar Disorder. The trials were both sponsored by Sunovion Pharmaceuticals, were both registered on clinical trials.gov on the same day, and share a number of their many trial sites [NCT00868699 (71 sites) & NCT00868452 (55 sites)]. All except the last author for both articles are Sunovion employees «7 authors each»… Dr. Sachs directs a Mood Disorders clinic at Mass General. Dr. Calebrese directs one at Case Western Reserve. Both are consultants for Sunovion and multiple other pharmaceutical companies.

Tuesday, after a long morning working in the clinic, I was awakened from a recovery nap by a mid-afternoon phone call. It was the FDA calling. The lady on the phone told me she’d seen I’d made other requests, but they were for "older drugs" [I wasn’t liking how this was sounding so far]. She said it was different for recent approvals. I didn’t follow all of what she was saying, but she seemed to be trying to dissuade me from pursuing my request. She said it had to go through several processes one of which was "disclosures" and there might be a charge. Did I still want to stay in the queue? By this time I was awake enough to say, "Sure. How long is the usual wait?" She said "18 to 24 months. You know, we get over 3000 requests every year." long pause. I said "Okay" [having given up with taking out my frustrations with big systems on small bureaucrats long ago]. But when I was fully awake and thought about it, I think I learned something, and have to revise my theory. My now fading enthusiasm for the FDA had been based on experiences where what I was requesting was old hat, and just required copying a disk from somebody else’s previous request. The fantasy that I could get the information on a recent approval in a timely fashion was naive. This drug is going to be well down the line in it’s patent life before I ever see that report, just like before.

There’s a point to this narrative. I went looking for how Latuda® was doing on the market. What about sales? That took me to various business sites, and somewhere on that road I read that Latuda® prescriptions were up 29% since the Bipolar approval. I finally ended up on the Dainippon Sumitomo Pharma Co., Ltd. site [Sunovion is owned by this Japanese firm]. And going through the yearly financial reports, I came up with this table [ballpark figures]:

It looks like it’s headed for "Blockbuster" status next year [$1 B/YR]. So here’s a late-comer that dribbled out of the pipeline just as the spigot was being turned off. It’s competing with its atypical predecessors and the first generation antipsychotics, all of which are available as less expensive generics. And it’s at the bottom of the efficacy list in the only meta-analysis that I know of that includes it [see the mother of meta…]

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And yet it got through the FDA with an 11th hour intervention by the FDA Director. It had three published Clinical Trial articles and an editorial that made it into the prestigious American Journal of Psychiatry. So it seems to be having an unusually charmed life, and is selling like hotcakes. As I said, these Sunovion people really seem to know how to sell some drugs [Sales Force Report: A Walk on the Sales Side].

That point I said I was aiming for is that while Latuda® is zooming up the ladder in sales and usage, I’m measuring my ability to find out about its safety and efficacy literally in years. So long as that’s the case, it’s going to be the pharmaceutical industry’s sales force that will exert the major influence on which drugs are prescribed – rather than the plain clinical facts. There’s no reason in the world for the FDA data seen by the reviewers to need anything except a postage stamp to get it to anyone else qualified to take a look. If there’s commercially confidential information on a drug, don’t put it in the material submitted. If there’s data that needs to be anonymized, do it before the submission. The FDA has more important things to do than calling some old man in the middle of a perfectly good nap to try to talk him out of wanting what he wants. Leave the keeping secrets business for the people in Langley Virginia where it makes sense…

Afterthought: When I looked back over this, I realized I left out something that belongs here. I think new has a high value. There are plenty of patients who have cycled through many of the available meds and are shopping for something new. And Latuda® came after an empty space – was the last something new on the block punctuating the dry pipeline meme. And I would recommend reading that article on drug rep technology [Sales Force Report: A Walk on the Sales Side]…