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Avanir Pharmaceuticals, Inc. Message Board

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  • rayonman1 rayonman1 Jan 19, 2013 12:59 PM Flag

    Nuedexta and impulse control

    "The scientific method requires formation of hypotheses based on observations. Those hypotheses are then experimentally tested. The present study includes relevant observations that absolutely support a hypothesis that PBA may be a wider spectrum of disorders. Not sure why you'd call this aspect unscientific."
    Because the "support" you are referring to above is so small as to be effectively lacking.
    The wording of the abstract, the way they ignore the junk science they are presenting (12 patients, uncontrolled, retrospectively being treated, (presumably successfully) for PBA, with a soft endpoint of how much impulsive/compulsive shopping they are doing and talking about changing the very definition of the condition is all unscientific.
    I can tell you have read many abstracts and research papersin your career so just allow me to remind you to read the abstract from a purely professional scientist point of view (I'm just trying to help here) and be overridingly mindful of how conservatively scientific papers and abstracts are usually worded (and appropriately so).
    Scientific papers and abstracts discuss the limitations of the study (although in this case, the "limitations" are so huge that to talk about them would be much bigger than the abstract itself :-) and they don't talk about a garbage study redefining the definition of the illness or recommending it be tried as management of the condition or as is "potent pharmacotherapy".

    There are so many flashing red signals here that no benefit of the doubt should be given about "ambiguous" wording. The wording about "management" is inappropriate enough that it just does not belong there. I agree with you that they were trying to be "purposefully ambiguous" with their "management" wording and I hope you agree with me that they crossed the line to inappropriateness and it was because of commercial bias. In my opinion, their abstract crossed lines to being unprofessional and unscientific and I suspect it was not unwitting. I suspect it was for the serious MOTIVE of commercial off-label promotion of the drug as a hired doctor.

    I am sure you would agree that they should have commented that treating PBA itself could lessen depression and thereby lower obsessive/impulsive shopping. But if they had done that, it would have diminished their calls for redefining the disease and using the drug and I suspect that is why they omitted this obviously necessary commentary as well as other obviouisly necessary commentary about the myriad severe of the "study".

    I think it is fair to surmise this clinical abstract, while barely appropriate to even present at a medical meeting, is being used as a little advertising booth for inadvisable off-label use of Nuedexta at the American Academy of Neurology meeting.
    In my opinon, I can only surmise Avanir management is too greedy and unethical to realize these commercial efforts by physician proxy diminishes Avanir's credibility amongst physicians and investors.
    As an example, I suspect the same greedy, unethical and unscientific thinking prevents the CEO from ever mentioning that about 30% of the severe PBA in the STAR trial had a complete remission with placebo when he crows about how something like 51% in the Nuedexta arms had complete remission. Before anyone jumps to say how the CEO is not a scientist, he has at least two physicians working for him and surely he would run his presentation by them for medical comments. I can only surmise it has been pointed out to him by at least one of his physician employees that he should mention this placebo efficacy but he does not and instead always clues his audience that he is a conniving stock promoter. It is just foolish.

    A scientific approach would have been to acknowledge how poor quality this clinical data is and to have a brief suggestion of doing a small prospective randomized placebo controlled Phase 2 study in traumatic brain injury patients with impulsive or compulsive shopping problems but who do not have PBA (but definitely NOT with Avanir's money, PLEASE) and that study would have to see if there is an efficacy signal.
    That is all that is warranted mentioning here by the "study" authors.
    But I'm sure Avanir's CEO is "delighted" with the abstract.

    OnlyF, I think especially after being burned by accepting Avanir's huge expansion of claims of the PBA population that you would be more careful touching anything Avanir influences, like this "study" and what you basically acknowledge is its inappropriate suggestions and conclusions.
    This "study" is not the least bit "important," to use your word.

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    • But if they had done that, it would have diminished their calls for redefining the disease and using the drug and I suspect that is why they omitted this obviously necessary commentary as well as other obviouisly necessary commentary about the myriad severe limitatons of the "study".

 
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