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prelapse: but there’s more

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firemonkee57

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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…


http://1boringoldman.com/index.php/2015/05/12/prelapse-but-theres-more/
 
Frost

Frost

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Sounds like evergreening to me...

I mean, that doesn't automatically mean that it doesn't work, but whether it's legitimately superior to its predecessor probably needs to be independently evaluated before people start spending vast sums on the shiny new (patented) drug rather than the soon-to-be-cheap aripiprazole.
 
Kerome

Kerome

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Plus the fact that he's doing studies on first episode sufferers, who according to some sources shouldn't even be on antipsychotics, is even more dodgy.
 
Frost

Frost

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Even diagnosing schizophrenia on the basis of a first-ep psychosis is questionable, I wouldn't have thought you'd want to include them in a proper drug efficacy study...

The sceptic in me wonders if he's picked people in PEP because they've probably got a better short-medium-term prognosis than people with well established schizophrenia.
 
Frost

Frost

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I note that in that post you (assuming you're the author) state that:

I lifted one of their figures and added the results from these Brexpiprazole studies for comparison
I'm unsure of your level of scientific literacy, judging from that post it's reasonably high, so I don't know whether you've taken the following into account or not but it's worth pointing out. Apologies if you have and I just end up coming across as condescending.

The graph is of 'Overall change in symptoms' for each drug. This means that there are two problems when it comes to directly comparing the results of different studies (on top of the usual things you need to control for when comparing study results).

#1 Which symptoms each study actually measured as outcomes. I'd imagine most have similar symptom lists, but it's worth making sure that you're not inadvertently comparing say, 'hallucination severity' and 'duration of episode'.
#2 How comparable the techniques of measuring ^^ are between studies. Some will use self-answer questionnaires, some will use clinician judgement of response, some will use proxy measurements... etc. Are the techniques employed by different studies to measure the same outcomes actually directly comparable? If not, statistical magic needs to be done in order to compare them.
And then of course there's #3, which is the stuff you always need to look for when comparing the results of studies. Are they all RCTs? Is each paper internally valid (bias, confounding, etc)? Are the studies of similar methodological quality (similar/high-quality blinding techniques, statistical analysis tricks, etc)? And so on.

Essentially it boils down to 'Are they asking a comparable question using a comparable group of people and measuring similar outcomes in similar ways?'.

What this means is that you can't just take a graph out of a meta-analysis, which has already done all the legwork to ensure the above criteria are met, and throw in data from other studies alongside it without accounting for these things.



Also, the graph kind of implies that the half-way point (in this case -0.5) is the point at which treatment is favoured over placebo. Even just thrown in there, all of the brexpiprazole data (albeit minus 95% CIs) sits underneath the 0 mark actually required to consider a treatment effective compared to placebo. It also says nothing of how well-tolerated it is compared with the more efficacious drugs such as clozapine - if a less 'powerful' drug can hold a given person's symptoms, and with less side effects than the more 'powerful' drug, then why give the more powerful one?


Sorry if this comes off as attacking you, it isn't meant to. It's also not supposed to come off as a defence of brexpiprazole, a compound that seems to me rather like an evergreening attempt unlikely to post much/any real benefit over its parent compound. I just think it's important to consider things in their entirety before writing them off or accepting them.
 
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