refining our “No”…

Posted on Friday 15 November 2013

A couple of months ago, when I first heard the testimony of AbbVie’s lawyer Neal Parker at the Brussels Conference on Data Transparency by the European Medicines Agency, I was horrified – an emotion I don’t often feel [a deal-breaker?…]. He’s a fast talker and is obviously emotionally engaged in his topic, and I couldn’t follow his logic. I finally got around to transcribing what he said this afternoon so I could ponder it. This is the part that has stayed with me
    "It’s not constructive to look at categories of documents and say we’re going to release this, or we’ll release annex 1, 7, and 8 and a clinical study report. Because all three categories of information are interspersed throughout all these documents. And it takes a very, very fine analysis, which is on the burden, by the way, of the company to do to identify what’s sensitive. And you are right, a lot of summary information is in the label which is the product of all of our work, is in the blue stuff. It’s in the label. It’s in the [?]. It’s in the summaries the FDA releases. It’s all out there. It’s enough to give independent researchers the end part of our conclusions. But the detail of the give and take of the problem solving which is reflected in the narrative of some of these clinical study reports is internal sensitive information which is nowhere reflected in the label. The process of getting these products approved with the regulatory agencies is a give and take of issues, challenges, reworking of data in response to regulator’s concerns, or concerns that we have identified or raised ourselves, which needs to be explained or articulated in documents that we submit to regulators to get products approved. And if I’m a competitor to Abbvie, and I’m in a competitive landscape where there are a lot of products on the market, and I want to enter that market, the first thing I want is Abbvie’s clinical study report. Because I want to know what problems I am going to have to confront when I try to get a product approved, and that is a competitive advantage, and that’s why we consider this information, depending on the circumstance, CCI [commercially confidential information].
    [see a deal-breaker?… for the video (@19:00) and the BMJ news report]
The thing that reminded me to go back and transcribe Parker’s speech was the 2003 letter from the FDA to GSK in the last post [scarlet bullets…] where we read:
That simple little paragraph contains a couple of bombshell’s: Study 329 was negative – GSK and the FDA were in agreement on that point. And, by the way, so were the other two studies 377 and 701 – the sum total of all studies done on Paxil in adolescents who were depressed ever conducted.  How is it not useful to mention that? because good drugs fail clinical trials in depression sometimes? Essentially, GSK is getting the FDA to collude with them in keeping the lie published in Keller et al alive ["paroxetine is generally well tolerated and effective for major depression in adolescents"]. GSK knows it’s a lie. By getting the FDA to keep it out of the label that all Paxil studies for MDD in kids are negative, the teens treated by doctors informed by the Keller article stay in the dark. Particularly in a situation like this, that label should read something like, "While Paxil was efficacious in the treatment of adolescent OCD, it was not shown to be effective in pediatric patients with Major Depressive Disorder" [I'm skipping over the adverse effects issue for the moment]. A priest would call this a sin of omission.

When I read that 2003 FDA letter to GSK, I immediately thought of Neal Parker’s little diatribe where he was passionately struggling to make his point without giving any real life examples, talking in code, "a give and take of issues, challenges, reworking of data in response to regulator’s concerns, or concerns that we have identified or raised ourselves, which needs to be explained or articulated in documents that we submit to regulators to get products approved." What in the world does "reworking data" mean anyway? It’s "reworking data" that we’re trying to stop! And in the case of this FDA letter, I didn’t know that GSK and the FDA cut a deal to not mention that Paxil had failed all three depression in adolescence trials, and I’ve spent major hunks of my time digging around in a literature that I didn’t even know existed as a practicing doctor.

The pharmaceutical companies mount a number of arguments against blanket transparency in the Phase III Clinical Trials: Subject Confidentiality, Trade Secrets, Commercially Sensitive Information being at the top of the list. They want us to recognize their rights to have a "competitive  advantage." But in Neal Parker’s case, he can’t tell us what he’s talking about exactly. I think he wants us to agree that his company should be free to get the FDA to keep secrets or cut deals like this one. There’s no question that keeping the fact that Paxil is not efficacious in pediatric depression when there’s a major piece of literature out there that says it is gave GSK a competitive advantage, an ill-earned gain. Subject confidentiality is more ruse than problem. It’s drug company confidentiality that matters to them.

Trade secrets in the manufacturing process? Fine by me. Trade secrets in the effect the drug has on people? No thanks. A clinical trial subject who takes a medication "blinded" to whether it is active or not has made that choice. But [and here I go with more scarlet bullets again]:
  • To ask a help seeking patient to take a medication "blinded" to anything about that drug is an unreasonable request.
  • To ask me to prescribe it "blinded" to anything that’s known about its effect on people is an unacceptable request.
  • To ask that we allow regulators to cut deals like the one mentioned here with pharmaceutical companies is also an unacceptable request.
There may come a day when we actually thank Abbvie for filing this suit against the European Medicine Agency and Neal Parker for making his garbled little speech and raising our awareness to what his company actually wants – so we can be refining our "No" to what he’s asking for comprehensively…
  1.  
    wiley
    November 15, 2013 | 8:04 PM
     

    It’s like the same frame of mind with these gun nuts who show up in groups of a dozen or more in a restaurant parking lot, for instance, carrying rifles where four women are having lunch and discussing how to grow their movement to lobby for better gun regulations like better child safety protections.

    These gun toting people claim that this constitutes a “peaceful protest”, and that anyone threatened by their display is suffering from Hoplophobia— an irrational fear of guns.

    If those four women having lunch in that restaurant in the face of an armed “peaceful protest” were not being irrational and all, then they could tell that the people with guns weren’t preparing for the assault that they appeared to be gearing up for, they’d see that all the magazines those freedom loving peaceful protesters had were empty, and could trust that there were no bullets in any of the chambers, and would know that not of those patriotic Americans intended to harm or intimidate anyone because—

    shut up that’s why.

    It’s an understandable state of mind for a four year-old to struggle with; but adults, especially professional adults should know better than to say, “trust me because I say you can, and besides, there’s something wrong with you if you don’t.”

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