Posts Tagged ‘Lauren Stevens’

Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

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

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

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Feds Want Glaxo Exec To Testify In Stevens Case

Monday, April 25th, 2011

Pharmalot – April 25, 2011

By Ed Silverman

gavel-flickr4The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice.

Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story).

The feds want Millar to be compeled to testify because his testimony “may be necessary to the public interest.” However, prosecutors expect that he would refuse to testify or otherwise provide any info on the basis of his privilege against self-incrimination, according to court documents (read this). As of this morning, the order compelling his testimony has not been filed with the court.

As indicated previously, the trial threatens to evolve into a spectacle where Glaxo execs and Glaxo lawyers – notably, the King & Spalding law firm that frequently represents the drugmaker – turn the courtroom into a finger-pointing match among people who once labored on the same side of the pharmaceutical battlefield (see here).

http://www.pharmalot.com/2011/04/feds-want-glaxo-exec-to-testify-in-stevens-case/

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American Psychiatric Association’s Interests in Conflict

Friday, December 31st, 2010

CounterPunch New Year’s Edition
December 31, 2010 – January 2, 2011

by Martha Rosenberg

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted “no conflicts of interest” and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified.

The meeting’s Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau.

Doctors on other speaker bureaus like Shire’s Ann Childress and Wyeth’s Claudio Soares gave presentations and workshops that — surprise! — extolled company drugs.

And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff’s book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book’s preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Schatzberg was investigated by the Senate in 2008 which found “a lack of consistency” between what he earned from drug companies and what he reported to Stanford where he continues to head the psychiatry department. He owns $6 million of stock in a company he co-founded, Corcept Therapeutics, which sought FDA approval for a psychiatric drug despite Schatzberg’s APA position.

Nemeroff, for his part, left Emory University in disgrace after a 2008 Congressional investigation unearthed $1.2 million in drug industry income, his $9 million NIH grant was terminated (a rare occurrence) and he was banned from further NIH grants for two years. But he resurfaced as head of the psychiatry department at the University of Miami in 2009 after the medical school dean, Pascal Goldschmidt, was assured by crony Thomas Insel, director of the National Institute of Mental Health (NIMH), that Nemeroff could still draw NIH money, according to the Chronicle of Higher Education. It was payback for when Nemeroff got Insel a job, say observers. Nemeroff still sits on NIH scientific panels reviewing others’ grant applications, ensuring further cronyism.

Ghostwriting, of course, solves the “Company-Says-Company’s-Product-Is-Great” problem and increases the chance of a paper’s publication in a journal. It helps “authors”‘ careers and may even spur their individual prescribing habits since studies show doctors prescribe more of a drug they are paid to promote.

But the consumer version, unbranded advertising, is also effective: radio and TV commercials posing as public service announcements that push “awareness” of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES) and drive worriers to sites where they can self-diagnose with simple quizzes.

Meanwhile, the consumer version of bought doctors is “Astroturf” or patient front groups like the “grassroots” National Alliance on Mental Illness (NAMI), investigated by Congress for drug industry links. These bought patients flash mob the FDA with sob stories when an expensive drug is up for approval and lobby Medicaid to not substitute less expensive drugs, inflating entitlement program and insurance premium costs for industry’s benefit.

In the war against drug industry duplicity, company employees are increasingly reporting misdeeds thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement sums, in some cases. And last month the Justice Department filed the first criminal, not civil, charges against a the drug industry operative, Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. But as long as politicians like former Louisiana Rep. Billy Tauzin, who headed the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to parlay a career’s worth of knowledge and relationships to sell product, the government is essentially fighting itself.

Read the article here: http://www.counterpunch.org/rosenberg12312010.html

For more information on the APA/Conflicts of Interest see:

CCHR: American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits http://www.cchrint.org/2010/05/21/apa-leaders-called-upon-to-cut-drug-company-ties-and-put-the-lives-of-children-ahead-of-personal-profits/

CCHR: DSM Panel Members Still Getting Pharma Funds http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/

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Former GSK lawyer indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug

Tuesday, November 9th, 2010

WZCO.Com, November 9, 2010

Ex-Glaxo lawyer indicted for role in U.S. drug probe

WASHINGTON (Reuters) – A former lawyer for pharmaceutical giant GlaxoSmithKline Plc has been indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug, the U.S. Justice Department said on Tuesday.

The lawyer, Lauren Stevens, was indicted on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo’s promotion of the drug for weight loss, which had not been approved by the Food and Drug Administration.

“Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” said Tony West, head of the Justice Department’s civil division.

The Justice Department did not name the drug or Glaxo, but the company confirmed she had worked in its legal department but retired. A legal directory described Stevens as a Glaxo vice president and associate general counsel.

A lawyer for Stevens was not immediately available for a comment.

The case emerged after the FDA sought information from Glaxo in 2002 about its promotion of the drug.

A Glaxo spokeswoman declined to comment about any FDA probe of marketing of its drug for an unapproved use.

Such charges against corporate executives in these kinds of instances are rare. Justice Department officials could not immediately recall a similar case in recent years.

Stevens knew the company had sponsored programs to promote the drug for unapproved uses, including payments to doctors to give hundreds of talks to other doctors, according to the indictment.

The indictment also accused Stevens of withholding slides that were used by doctors who were paid by Glaxo to promote the drug and that she prepared a memorandum about the benefits and risks of providing the information to the FDA.

The obstruction charges carries a maximum sentence of 20 years in prison, while each false statements charge has a maximum sentence of five years in prison.

(Reporting by Jeremy Pelofsky; editing by Andre Grenon)

http://wkzo.com/news/articles/2010/nov/09/ex-glaxo-lawyer-indicted-for-role-in-us-drug-probe/

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