a bottom line…

Posted on Saturday 14 September 2013

In all of the offers of cooperation about data transparency in Clinical Trials that have been made by the pharmaceutical companies in response to the various campaigns, there is one deal-breaker at the core of every proposal:

The pharmaceutical company itself chooses what is to be released

That is, in fact, the problem in the first place. They’ve already been choosing what is released in multiple subtle ways, and the net result of the process has been, by any account, an absolute disaster:
  • They choose what is released when they don’t publish negative studies.
  • They choose what is released when they don’t register or report their trials as required.
  • They choose what is released when they have guest authors signing on to their articles.
  • They choose what is released when they hire medical writing firms to write papers.
  • They choose what is released when they use the tools of analysis to obscure.
  • They choose what is released when they monitor the publication from start to finish.
That’s the essence of the complaint – that the publications are so heavily filtered and controlled by the sponsor that the scientific truth of the published article[s] is regularly impossible for a reader to determine – even with a close reading.

I just erased several paragraphs that reiterated the various proposals of GSK, of the EFPIA, of Neal Parker of AbbVie, etc. They are filled with reasons for the pharmaceutical companies to object to data transparency or to try to pass off data sharing in its place – some are forced rationalizations, some are faux humanitarian arguments, and some actually reasonable concerns. I erased them because I’ve decided that it’s a trap to even argue. So long as their reasons lead to the conclusion that…

The pharmaceutical company itself chooses what is to be released

… it’s an unacceptable argument, no matter whether it’s reasonable or not, simply because it leaves them with the perogative to continue to cheat and distort without anyone being able to check their work. There are plenty of ways to protect the interests of research subjects and protect the company’s business interests that don’t leave them the option of continuing to flood our literature with distorted Clinical Trial reports signed by non-participating academic key opinion leaders [whose medical  licenses should have been revoked some time ago].

So when you read these various counter proposals or listen to the likes of Neal Parker of AbbVie, simplify things for yourself. If the bottom line is …

The pharmaceutical company itself chooses what is to be released

… reject it on the spot and wait for the next offering or simply move ahead. There are a few absolutes in life, and this is one of them…
  1.  
    September 15, 2013 | 5:10 AM
     

    Nice job Mickey.

  2.  
    Steve Lucas
    September 15, 2013 | 10:19 AM
     

    There is an old concept in sales called diversion. Here the person doing the selling tries to divert the conversation and focus the time of those involved on an issue they either cannot win or is not important. Pharma is a sales based industry and will return to its roots when dealing with a problem.

    They will claim to be dealing in good faith all the while ignoring the real issues. These people bottom line everything and there is no emotion to any decision. When people die or are injured it is their fault. When the drug does not work the problem is they need a higher dose.

    People dealing with pharma need to understand that they do not care, it is all about sales and how do I get my bonus. Money is how you keep score and until someone is put in jail they will continue what they feel is a winning strategy.

    Steve Lucas

  3.  
    a-non
    September 15, 2013 | 11:40 AM
     

    “The pharmaceutical company itself chooses what is to be released.” Mickey

    This conflict of scientific objectivity vs fabricated “evidence” was inevitable and will continue to be an issue in the future. The money simply won’t substitute the data.

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