a sunny day…

Posted on Thursday 3 April 2014

And so I’m at a coffee house in Black Mountain, NC on a beautiful sunny day and I pull out my iPhone for a bit of free WiFi, after a morning visiting with relatives, and I’m stunned. Yesterday’s article on Paxil Study 329 was pretty great [Controversial Paxil paper still under fire 13 years later], but today’s news is more substantial. Today, the EU voted [Europe votes for clinical trial transparency]:
It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against.
AbbVie, one of the two U.S. companies trying to stop Europe’s drugs regulator from releasing previously secret clinical trials data, said on Thursday it had withdrawn lawsuits against the watchdog. The decision follows a move by the London-based European Medicines Agency [EMA] to accept a new set of redacted documents submitted by AbbVie, along with the company’s rationale for removing certain commercially confidential information. "A significant portion of data will be disclosed while protecting the information that is commercially sensitive," AbbVie said in a statement. "As a result, AbbVie has withdrawn its lawsuits." The EMA said the "very limited redactions" would have no significant impact on the readability of the clinical study reports that were at the centre of the litigation.
It is, indeed, a sunny day…
  1.  
    wiley
    April 4, 2014 | 1:10 AM
     

    That is a ray of sunshine. 547 in favour and 17 against— we couldn’t get a vote like that in Congress; but some reform at the FDA could get us closer.

    If all good and even-handed psychiatrists lobbied the F.D.A. and the President to tighten up regulations on drug companies then maybe we could get our watchdog to demand more from drug companies. It would, at the very least, cost a whole lot less than suing the drug companies every time they go out of bounds. As long as they all have to play by the same rules, it will be easier to reign them in.

  2.  
    berit bryn jensen
    April 4, 2014 | 9:36 AM
     

    The sun is shining here too, spring flowers are popping up, and I am as happy as I can be. Congratulations everyone and thanks to the overwhelming majority of EU parlamentarians voting in favour of transparancy.

  3.  
    April 4, 2014 | 2:03 PM
     

    Hurray for common sense!

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