Restoring Study 329: Correspondence with BMJ Jul 15 to Jan 16

April, 19, 2016 | 13 Comments


  1. “They do not illustrate that I have spoken favorably about GSK products”

    Here is Matthew Herper interviewing Sir Andrew on 18 Oct, 2013 “You can’t knock us off course” Witty following an interesting article on 2 and 3 Jul 2012

    Watch the earnest concentration on Matthew Herpers face and you will get the picture..

    GlaxoSmithKline’s CEO on the China Controversy, Transparency, and Big Pharma’s Reputation


    Rubbish, responds Glaxo CEO Andrew Witty. “We’re not at all surprised that there’s some controversy,” Witty tells Forbes. “Because there always is. People always have different opinions. Frankly, we didn’t think what was published was particularly comprehensive. We feel good about where we stand today.” And Witty remains committed to high-risk investments in high-risk drug programs.

    • Can This Man Make You Believe In Drug Companies? -……Cached
    Steve Forbes and Andrew Witty, … Matthew Herper Forbes Staff. Follow Following Unfollow. I cover science and medicine, and believe this is biology’s …

    So did Glaxo do anything right? All of the actions predated the tenure of current GlaxoSmithKline chief executive Andrew Witty, who has been trying to improve the company’s reputation. He has pushed forward with efforts to develop medicines for poor nations, including a malaria vaccine that Glaxo is developing with the Bill & Melinda Gates Foundation. He has also taken steps to remove incentives that made pharma salespeople so overzealous, no longer tying compensation to how much of a drug they can sell. In a statement, he said that employees have been removed from positions as a result of the changes and that new provisions will allow the company to take back compensation from executives if they don’t adhere to the company’s standards.

    Glaxo has done something else right, too: Witty actually managed, in the press release disclosing this settlement, something close to a full-throated apology. He said:

    “Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”

    Blind sided..

  2. “There’s a little thrill in knowing something no one else knows!”

    Hmm… That sounds more like a Wall Street trader’s thrill than a scientist’s. Maybe we should ask Martin Shkreli, the snot-nosed Pharma speculator who’s got everyone all upset at the industry. If he’s not too busy meeting with his defense lawyer.

    Not that scientists can’t gloat, of course! But traditionally, the thrill a scientist dreamed of was to be the *first one* to know something. The first human to gaze on some distant galaxy, or microscopic critter, or subatomic particle, or whatever. After which your next move was to check all your findings, take a deep breath, and send it off to the biggest journal possible. In other words: Tell the world.

    But hey, we’re in a new world, where research findings can be trade secrets. Especially negative ones. Maybe Martin Shkreli would be more at home at GSK than we could ever imagine … BTW, who’s the guy in the picture?


    “Here’s a tough experiment: what does it mean for transparency if we open our books but no one looks?

    If a tree falls in a forest, does it make a sound?

    GSK Retweeted

    GSK US ‏@GSKUS Apr 19

    We posted data from 1700 clinical trials but is anyone really looking? Our Chief Med Officer shares why it matters.

    Written by

    Murray Stewart

    • “If a tree falls in a forest, does it make a sound?” Only if it is heard by a quick-witted investigative journalist (ie Shelley Jofre). But how much effort does it take to get anyone to see the wood for the trees? (ie Restoring Study 329).

      Yes, Murray Stewart. “This boils down to a lack of trust in our industry—something we readily acknowledge”. (How dare these sandal-wearing microbiotic types, scientologists, psychologists, and other assorted oddballs, led by that heretic Healy, get in the way of rampant capitalism!!).

      But it’s not just the trials, is it Murray? Why not put up a page about GSK China? A full, frank explanation – including the circumstances under which the whistleblower, who cost the company several hundred million dollars, was quietly re-employed after the fuss had died down. Bet Blair Hamrick won’t be reinstated…he has nothing to offer.


  4. What makes Paradoxetine, any different…?

    BCTV: Six Years of Avandia
    Original broadcast date: Sunday, June 16, 2013
    Transcript of BioCentury This Week TV Episode 143

    Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA

    Dr. Murray Stewart, Senior Vice President Metabolic Pathways and Cardiovascular Therapy Area Head GSK

    Dr. Robert Califf, Director, Duke Translational Medicine Institute (DTMI) at the Duke University Medical Center

    Dr. Kenneth Mahaffey, Professor of Medicine and Associate Director, Duke Clinical Research Institute

    “DR. MURRAY STEWART: We welcome the opportunity for people to ask questions of GSK and approach. We don’t encourage, what I would call fishing expeditions that people just come and just browse through it. But if people have appropriate scientific questions, we’ll be setting up forums where people can come and ask questions and have access to the data.”

    DR. MURRAY STEWART: So I think, sometimes, meta analyses is answering a different question. But if you wanted to know clinical evidence, I think the hierarchy still suggests that a well conducted, randomized, control trial is the highest source of evidence.

    STEVE USDIN: Great. Well, thank you. Thank you very much, Dr. Stewart. Next, we’ll speak with Dr. Rob Califf of Duke University.

    “…it’s essentially a bell-shaped curve there.

    That is, those outer confidence limits like, let’s say it was 1.7, there’s a low probability that that’s the truth.”

    According to analysts from UBS, 13,000 suits had been filed by March 2010.[50] Included among those suing: Santa Clara County, California, which claims to have spent $2 million on rosiglitazone between 1999 and 2007 at its public hospital and is asking for “triple damages”.[51] In May 2010, GlaxoSmithKline (GSK) reached settlement agreements for some of the cases against the company, agreeing to pay $60 million to resolve 700 suits.[52] In July 2010, GSK reached settlement agreements to close another 10,000 of the lawsuits against it, agreeing to pay about $460 million to settle these suits.[53][54] [55]
    In 2012, the U.S. Justice Department announced GlaxoSmithKline had agreed to plead guilty and pay a $3 billion fine, in part for withholding the results of two studies of the cardiovascular safety of Avandia between 2001 and 2007. The settlement stems from claims made by four employees of GlaxoSmithKline, including a former senior marketing development manager for the company and a regional vice president, who tipped off the government about a range of improper practices from the late 1990s to the mid-2000s.[35]
    United States investigations

    GlaxoSmithKline was being investigated by the FDA and the US Congress regarding Avandia.
    The Senate Finance Committee, in a panel investigation, revealed emails from GSK company officials that suggest the company downplayed scientific findings about safety risks dating back to 2000. It was also alleged by the committee that the company initiated a “ghostwriting campaign”, whereby GSK sought outside companies to write positive articles about Avandia to submit to medical journals.[57] GSK defended itself by presenting data that its own tests found Avandia to be safe, although an FDA staff report showed the conclusions were flawed.[58]


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