{"id":44008,"date":"2014-02-15T08:00:52","date_gmt":"2014-02-15T13:00:52","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=44008"},"modified":"2014-02-15T03:08:38","modified_gmt":"2014-02-15T08:08:38","slug":"creepy","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/02\/15\/creepy\/","title":{"rendered":"creepy…"},"content":{"rendered":"\n

I really never took a business course or thought about marketing before I started writing this blog. I don’t even bargain with car salesmen. But I’ve learned a few things in the last couple of years. I didn’t understand indication creep<\/em> until a couple of years ago. I was sitting in a too-hot courtroom trying not to nod off and the witness [Tone Jones<\/a>] said "You can’t be a billion dollar drug in a 1% market<\/em>" [the prevalence for Schizophrenia is 1%]. I came alert with an AHA! experience. That’s why once they get FDA Approval, they start going for other indications. Here’s how that indication race looked a few years ago with the Atypical Antipsychotics [the year Latuda® came on the scene]:<\/p>\n

<\/p>\n

Without other diagnosis·specific indications, they can’t legally advertise. This is all pretty crazy, because nobody thinks these drugs are diagnosis·specific – at least nobody I know. But that’s the way the game has been played. Get the drug approved for a diagnosis, then spend the years of its patent life trying to get other indications for new ad launches. Towards the end of the patent, be sure to have a study or two in kids so you can get a pediatric extension.  If it’s a blockbuster, try to get a long acting version approved [Paxil CR®, Seroquel R®] or maybe a purified isomer [Lexapro®, Focalin®] or even a metabolite [Pristiq®].<\/p>\n

But back to indication creep<\/em>. According to the NIMH site, the prevalence of Bipolar Disorder is between two and three percent and the majority of episodes are depressive, so they add a market at least as big as the one they had. And we all know that Bipolar Disorder is way over·diagnosed. Let me say that one more time, Bipolar Disorder is way over·diagnosed. So their market grows even more because [did I mention] Bipolar Disorder is way over·diagnosed. And they covered their bases by the pair of studies – both monotherapy and adjunctive therapy, making it a clean sweep. But Johanna’s comment<\/a> to the last post points out a more subtle marketing ploy that is probably even more lucrative:<\/div>\n
\n
Funny you should mention the glossy-magazine-advertisement bit. I was just reading People Magazine yesterday, and came across a two-page spread advertising Latuda for bipolar depression (featuring a picture of a nice-looking 20-something woman with a vaguely hopeful expression on her face).<\/div>\n

<\/p>\n

Worse yet, the “safety information” had been carefully worded to repeatedly refer to Latuda as an “antidepressant<\/font><\/strong>.” People will be offered this drug for no better reason than “my antidepressant doesn’t seem to be working” — and will have no earthly idea what they are fooling around with. <\/div>\n<\/blockquote>\n
She’s exactly right. I hadn’t thought of that. It certainly happened with Seroquel XR®. They got approvals for the drug as an adjunct to antidepressants in treatment resistant Major Depressive Disorder and Bipolar Depression. The ads said may help in depression<\/em> and a proven option in Bipolar Depression<\/em>:<\/div>\n
<\/div>\n

And depressed people began showing up in the clinic on  Seroquel XR® being used as an antidepressant [with none of the criteria to meet these diagnoses except a depressed mood AKA unhappiness]. Now as Johanna discovered, that same strategy appears to be being picked up by Latuda®. The People Magazines in my doctor’s office are frayed and from an earlier historical epoch, so I hadn’t realized that Latuda® was being advertising there – but I’m  not surprised. I don’t exactly know what to call this variant of indication creep<\/em> – maybe grammatical sprawl<\/em>.<\/p>\n

The formal linking of these drugs to a DSM diagnosis based on clinical trials sounds good on paper, but in truth, it is not easy to defend – yet it’s the law of the land. But if only people actually meeting the DSM criteria were put on the drugs, we wouldn’t have anything like our current problem. I doubt that many people get a diagnosis of Schizophrenia made casually. But diagnostic precision goes way downhill after that. I mentioned that Bipolar Disorder is way over·diagnosed, but it doesn’t hold a candle to Major Depressive Disorder which is often diagnosed by a report that "I’ve been depressed<\/em>" with little else. So any way that a pharmaceutical company can get the word depression<\/em> into an ad is a major marketing success. I expect they were cheering at Sunovion when this months American Journal of Psychiatry<\/font><\/strong> came out.<\/p>\n

In September 2011, I wrote [echo<\/font> echo echo<\/font> echo<\/font> echo<\/font> echo<\/font> echo…<\/font> <\/a> ]:<\/div>\n
\n
Now comes the indication march proper [already in place well before the initial F.D.A. Approval]: <\/div>\n

<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n<\/tr>\n<\/table>\n

<\/p>\n

They’re following in the footsteps of some of the greats, well warned about the shoals of false advertising and other sleaze by the antics of their predecessors. Their problem – the generics are here. Even just plain Seroquel went off-patent this week<\/font><\/strong><\/u><\/a> – so, at $14+\/pill for Latuda<\/font><\/strong>, it’s going to be an uphill climb. What they have going for them is that it seems to be weight neutral [so far]. What’s on the downside? It’s a decidedly weak sister [efficacy-wise]; it has an annoying EPS profile; and maybe, just maybe, people are finally tired of over-medicating and being over-medicated. But at Sunovion<\/font><\/strong>, hope springs eternal<\/a>…<\/div>\n<\/blockquote>\n
Sunovion<\/font><\/strong>®<\/sup><\/font><\/strong><\/em> Latuda <\/font><\/strong>Phase III Clinical Trials<\/font><\/strong><\/td>\n<\/tr>\n
NCT ID<\/sup><\/font><\/strong><\/td>\nTitle<\/sup><\/font><\/strong><\/td>\nRecruit<\/sup><\/font><\/strong><\/td>\nStartDate<\/sup><\/font><\/strong><\/td>\n<\/tr>\n
\n
<\/td>\n<\/tr>\n
NCT00868699<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression (Monotherapy)<\/sup><\/td>\nYES<\/sup><\/td>\n04\/2009<\/sup><\/td>\n<\/tr>\n
NCT00868959<\/font><\/strong><\/a><\/sup><\/td>\n24-week Extension Study, Bipolar I Depression<\/sup><\/td>\nYES<\/sup><\/td>\n04\/2009<\/sup><\/td>\n<\/tr>\n
NCT00868452<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression (Add-on)<\/sup><\/td>\nYES<\/sup><\/td>\n04\/2009<\/sup><\/td>\n<\/tr>\n
NCT01284517<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression<\/sup><\/td>\nYES<\/sup><\/td>\n11\/2010<\/sup><\/td>\n<\/tr>\n
NCT01358357<\/font><\/strong><\/a><\/sup><\/td>\nBipolar Maintenance Adjunctive to Lithium or Divalproex<\/sup><\/td>\nYES<\/sup><\/td>\n06\/2011<\/sup><\/td>\n<\/tr>\n
NCT01421134<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features – Flexible Dose<\/sup><\/td>\nYES<\/sup><\/td>\n09\/2011<\/sup><\/td>\n<\/tr>\n
NCT01423253<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features – Extension<\/sup><\/td>\nNot Yet<\/sup><\/td>\n09\/2011<\/sup><\/td>\n<\/tr>\n
NCT01423240<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features<\/sup><\/td>\nNot Yet<\/sup><\/td>\n10\/2011<\/sup><\/td>\n<\/tr>\n
\n\n\n\n\n\n\n\n\n\n\n\n<\/tr>\n<\/table>\n

<\/p>\n

If I were a marketing professor, I might find all of this pretty interesting and prepare a lecture analyzing the marketing strategy. But I’m not a marketing professor, and so what I see is experimentation on people who are sick, with the goal of increasing drug sales to other people who are sick. And I’m a doctor who has lived through this multi·decade·long era where each new drug that comes along is advertised as something special and unique, but doesn’t pan out and ends up in the another-one-of-those<\/em> file not too long after it goes off-patent and the indication creep and advertising storms pass.<\/div>\n","protected":false},"excerpt":{"rendered":"

I really never took a business course or thought about marketing before I started writing this blog. I don’t even bargain with car salesmen. But I’ve learned a few things in the last couple of years. I didn’t understand indication creep until a couple of years ago. I was sitting in a too-hot courtroom trying […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-44008","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44008","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=44008"}],"version-history":[{"count":17,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44008\/revisions"}],"predecessor-version":[{"id":44025,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44008\/revisions\/44025"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=44008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=44008"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=44008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Sunovion<\/font><\/strong>®<\/sup><\/font><\/strong><\/em> Latuda <\/font><\/strong>Phase III Clinical Trials<\/font><\/strong><\/td>\n<\/tr>\n
NCT ID<\/sup><\/font><\/strong><\/td>\nTitle<\/sup><\/font><\/strong><\/td>\nStatus<\/sup><\/font><\/strong><\/td>\n<\/tr>\n
\n
<\/td>\n<\/tr>\n
NCT00868699<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression (Monotherapy)<\/sup><\/td>\nDone<\/sup><\/td>\n<\/tr>\n
NCT00868959<\/font><\/strong><\/a><\/sup><\/td>\n24-week Extension Study, Bipolar I Depression<\/sup><\/td>\nDone<\/sup><\/td>\n<\/tr>\n
NCT00868452<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression (Add-on)<\/sup><\/td>\nDone<\/sup><\/td>\n<\/tr>\n
NCT01284517<\/font><\/strong><\/a><\/sup><\/td>\n6-week Study, Bipolar I Depression<\/sup><\/td>\nDone<\/sup><\/td>\n<\/tr>\n
NCT01358357<\/font><\/strong><\/a><\/sup><\/td>\nBipolar Maintenance Adjunctive to Lithium or Divalproex<\/sup><\/td>\nRecruiting<\/sup><\/td>\n<\/tr>\n
NCT01421134<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features – Flexible Dose<\/sup><\/td>\nRecruiting<\/sup><\/td>\n<\/tr>\n
NCT01423253<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features – Extension<\/sup><\/td>\nDone<\/sup><\/td>\n<\/tr>\n
NCT01423240<\/font><\/strong><\/a><\/sup><\/td>\nMDD With Mixed Features<\/sup><\/td>\nWithdrawn<\/sup><\/td>\n<\/tr>\n