Recently, when I was reviewing two RCTs for Brexpiprazole, a derivative of Abilify®, I found that each study had only one academic author for each. The rest were pharmaceutical company employees. Both articles had “editorial assistance” [AKA ghost-writers] from the same firm and both were funded and administrated by the drug’s sponsor – Otsuka. Looking further, the two academic authors were from the same Department of Psychiatry at Hofstra and both were associated with the Feinstein Institute. And the two studies were spread over 117 clinical sites all over the US and World [the spice must flow…]. So everything about the studies was industry generated. But there’s more. One of the Brexpiprazole academic authors was also the senior author on a recent Abilify Maintena® RCT and both of them were part of a free CME about Abilify Maintena® [machiavellian medicine lives…]. Otsuka is certainly getting its money’s worth from the Department of Psychiatry at Hofstra. But there’s more. One of the authors on everything I just mentioned, Dr. John Kane, is the Principle Investigator on the NIMH RAISE-ETP [Recovery After an Initial Schizophrenia Episode] Project as well as being Chairman of Psychiatry at Hofstra. That was last week.
But there’s more. This week, I read Johanna Ryan’s article [The Once and Future Abilify: Depot Injections for Everyone?] and found that Dr. John Kane is Principle Investigator on the PRELAPSE study I’ve been talking about here using Abilify Maintena® in first episode Schizophrenia. The study is going to be done by a new CRO, Vanguard Research, at the Feinstein Research Institute. Watch the video to hear Dr. John Kane, founder of Vanguard, discuss this PRELAPSE RCT and hear how the Vanguard network arose from the NIMH study [RAISE?]. Now look at this Newsday article describing the $28M deal to do this study.
Vanguard will manage a clinical trial evaluating Abilify Maintena®, a once-monthly injectable version of a blockbuster drug made by Otsuka America Pharmaceutical Inc. Vanguard is majority owned by North Shore-LIJ. Dr. John Kane, the health system’s senior vice president of behavioral health services, owns a minority stake.
So Abilify® is about to go off-patent, and we have all of this activity – and every bit of it has Dr. John Kane plastered right in the middle of things. The rule is supposed to be that there shouldn’t even be a possibility of Conflict of Interest. In this tangle, Conflict of Interest is all there is to see. This is going to be a short post, because I can’t think of anything to say. The PRELAPSE study is designed to carve out a new commercial indication for Abilify Maintena®, not for any valid clinical reason that’s apparent to me. This is the Academic·Industrial·Complex with Dr. John Kane and Otsuka at the helm at its worst. I rest my case on the evidence as presented…