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  • onlyfactsplease onlyfactsplease Jan 18, 2013 9:52 AM Flag

    Nuedexta and impulse control

    "If this were presented at a medical meeting" - It's about to be presented at the AAN meeting

    "it would fail the audience question of whether there was evidence of commercial bias" - but hopefully this highly speculative finding would be interpreted with the consideration that that bias may be present. That being said, I expect this is a poster presentation and there will be no pass or fail criterion.

    As is true with most abstracts, the methods used need to be picked apart. Esp. how the 12 patients were chosen (consecutive unselected series vs. chose because they had an effect) and how the "salubrious" effect was determined.

    As for conclusions they are only saying this unexpected finding deserves further consideration. They didn't say they found a "cure" for compulsive shoppers. That being said, I do think a positive bias is present in their wording. But I also think that the link to a possible effect should be pursued as should the entire concept of what may be an expanded/linked disorder of impulse/emotional control of which PBA may be one component.

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    • "As for conclusions they are only saying this unexpected finding deserves further consideration."

      This thing exudes unwarranted conclusions and bias.
      Note, for just one example, they are saying that dex/quin deserves "consideration for "management" of various neuropsychiatric behaviors associated with TBI" This is an unwarranted conclusion based on really poor "'data".
      Consideration of a Phase1/small Phase 2 study would be okay, but consideration for management is nonsensical given the extemely poor quality of the data presented.

      They say the "results" highlight dex/quin as potent pharmacotherapy for various neuropsychiatric behaviors secondary to TBI" I'm sorry, but this statement is just an affront and shows how biased they are. They seriously underestimate their audience.

      These 12 retrospective cases don't "support" any "hypothesis" about expanding the definition of PBA. This is really unscientific and inappropriate, in my opinion.

      "The results of this case-series highlight DMQ as a potent pharmacotherapy for various neuropsychiatric behaviors secondary to TBI, including PBA. Treatment of PBA with DMQ in all 12 patients had the unexpected, salubrious benefit of decreasing the frequency of compulsive shopping behaviors. CONCLUSIONS: DMQ deserves consideration for the management of various neuropsychiatric behaviors associated with TBI, including PBA and impulsivity. Initiation of DMQ therapy holds the promise to significantly enhance the quality of life for individuals with PBA and poor impulse control. The co-occurring inhibition of compulsive shopping behaviors in this sample further supports a recently suggested hypothesis that the operational definition of PBA secondary to TBI be expanded to formally acknowledge the primary impairment of impulse control within which these episodes of affective lability frequently occur."

      • 1 Reply to rayonman1
      • 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.

        Otherwise, as I agreed in my last post there is a positive bias. Clearly saying "highlight DMQ as a potent pharmacotherapy" is overstepping their results.

        The "deserves consideration for the management" is (probably purposefully) ambiguous. It could mean that the hypothesis should be tested and I'd agree. It could be a suggestion to use it off-label which would be unjustified.

    • "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.