Did they or didn't they?
Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.
Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.
Millar was head of GSK's marketing for Wellbutrin and remained insistent that GSK's promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.
GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.
In 2002, writes Law 360's Christopher Norton, "GSK became aware that the company's two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations."
Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK's Wellbutrin promotional stable.
It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.
It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It's also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included "off-label" use.
Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a "company approved" slide kit.
Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.
So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin... yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that - she was told to do so by one of GSK's lawyers!
The mind boggles at how this company operate.
It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.
The case against Stevens continues.
Her re-indictment can be viewed HERE
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