People are the Data in Clinical Trials

September, 26, 2021 | 2 Comments


  1. more revealed and the Fid hypothesis theory…

    Posted on Thursday 11 October 2012

    a GSK watcher of note] …

    With Transparency Pledge, Glaxo Makes Promises No Other Drug Company Has


    by Matthew Herper


    In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs.

    What Witty is saying he will do now goes way beyond anything even Eliot Spitzer asked for. Glaxo would put in place a system by which independent researchers could request the data about what happened to individual patients in its clinical trials, and would be granted access if an independent group of experts thought the idea had scientific merit

    One obvious detail to worry about: the panel of experts, convened by Glaxo, who will decide which independent scientists get access to the company’s data. Will the panel allow critics, like Nissen, to look at this patient-level data, as the this information is known?
    “We’re not asking that panel to make judgements on the value of the questions being asked,” says Vallance. “We’re asking that panel to take a view on the scientific validity. So the answer to that question is yes, someone like Steve Nissen would be able to access patient-level data if he had a protocol that would answer a scientifically valid question robustly.” Vallance also warned, however, that it would be “anti-public health” for researchers to trawl the data for side effects without clear questions, because it would lead to unwarranted side-effect scares. But he said that even in the case of Glaxo’s best-selling asthma drugs, which some doctors warn can sometimes hurt patients, what he wants are the real answers. “We are not looking to hide something about our medicines,” says Vallance. “If it is a scientifically valid question, answered robustly and comes up with an answer, I think we need to know that answer.”

    A timeline that suggest that this hypothesis might be elevated to the level of theory:

    “New York Attorney General Eliot Spitzer sued Glaxo in 2004 for not disclosing negative data that linked Paxil to suicidal thoughts in children. As part of a settlement, GSK agreed to post all the results of its clinical trials on a company Web site.”

    GSK complied with a partial posing of the data in 2004, summary data rather than patient level data

    August 2, 2012: “When I scrolled down, it had changed. There was Study 329, the famous one [Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial], but after all the narrative summaries, it had a list of Appendices [Appendix A through H]. I’d never seen them before and as I opened them, I realized that what I was seeing was the raw data – HAM-D scores/Subject/Item/Week and all the other various rating scales. The page said ‘Updated on Thursday 2 August 2012‘ down at the bottom.”

    a GSK watcher of note] …

    So I wrote everyone I could think of who were onto the Study 329 story asking about the change, and I was told by Dr. David Healy [author of Pharmageddon] that Peter Doshi had noticed that it was missing and had alerted the NY AG that the Appendices [Data] weren’t posted. It was apparently part of an order in the Paxil suit in NY [settled in 2004] that they post all the data. And after a bit [6 months or so], there it finally is.

    So, back to Paxil Study 329. Peter Doshi noticed that the raw clinical data from GSK’s Paxil Study 329 was missing from the web site above [Paroxetine and pediatric and adolescent patients] and questioned whether it was fulfilling the settlement requirements from the old 2004 NY GSK suit. I don’t know the details of how it came to be, but here on August 2, 2012, the data has finally been posted [after another $3B suit just settled against GSK also related to this study] – 11 years after the publication of the article and 8 years after data transparency was prescribed by the New York settlement. Better late than never I suppose, but way earlier would have been infinitely preferable.

    “All Drs I saw afterwards were of the opinion the drug could not have done this.”

    watcher of note] …

    recovery&renewal Retweeted

    Katinka Blackford Newman @antideprisks…

    @davidhealy @Reduxreloaded

    of note] …

    (It doesn’t expalin what is to be done with the data – would be usefult o pharma companies for one – Tell us the secret Javid -it’s not nice to treat the population just as data/research fodder .

    UK government could face legal action over huge, secretive health database
    Exclusive: Lawyers acting for openDemocracy have written to health secretary Sajid Javid demanding transparency over database originally run by Palantir ast month the government ended a controversial deal to handle adult social care data with US ‘spy tech’ firm Palantir.

    This data is instead set to be held in a new system called Edge, which will be run internally by the Department of Health and Social Care – but built by British defence contractor, BAE Systems.
    Caroline Molloy
    11 October 2021, 2.56pm

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