The Curious Case Of Lauren Stevens And Exhibit 329…


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Comment left on Cafepharma website by (what I am assuming to be) – a GSK whistleblower: “…

http://www.cafepharma.com/boards/archive/index.php/t-561668.html

“you didn’t go to the Lauren Stevens trial in Maryland May 2011. Email presented into evidence of ANDY’s work in Wellbutrin Marketing. He is gone before too long!…”


“… Under the marketing stewardship of VP-General Manager of Marketing Andrew Witty… “(Adage 1997)


usa stevensEmailwitty
   Lauren Stevens is a former vice president and in house lawyer for GSK. She is now retired.
She was indicted twice for her work for GSK (as part of their defense for promoting Wellbutrin off label). Wellbutrin was one of several GSK drugs (along with Paxil and Avandia) which formed the basis of a major whistleblower complaint which led to GSK’s infamous 3 Billion dollar fine for mass fraud in 2012. You can read about the whistleblower complaint here, and there is a lot of legal analysis of the Lauren Stevens trial (in Maryland) online.
Stevens was acquitted on both indictments, (the second time in Maryland), however (according to this article) the prosecuting lawyer, Sarah Bloom, still believes that the “DOJ acted properly in bringing criminal charges against Stevens” and furthermore “Bloom contended that Stevens’s notes demonstrated that she knew she was lying to the government and understood that this was unlawful behavior.”

“Bloom made it clear that she stands by her decision :Stevens was “not held responsible for giving advice… she was held responsible for making false statements… knowingly making false statements to the government is a crime.”

   Although I find it interesting that Lauren Stevens was acquitted twice despite ‘alleged’ complicity in lying to the FDA about the (illegal) off label promotion and marketing of GSK’s Wellbutrin, what I find even more intriguing is the e-mail from (current) GSK CEO Andrew Witty which turned up as an exhibit (329) in this case against Stevens in Maryland. What info does this e-mail contain?

   The exhibit (329) dated 6/12/1998 is titled ‘E-mail from A.Witty re: speaker training inquiry’.
Apparently, Andrew Witty was head of GSK’s marketing department around 1997/98- and if so- then it would be safe to assume that he was aware of the promotional activities surrounding various Glaxo drugs at this time (including Wellbutrin).
How much he was aware of, in terms of off-label prescribing- is not known at this point in time, however perhaps the content of this e-mail at the Lauren Stevens trial could reveal more?
I’d certainly be interested to know what Witty’s role entailed for GSK in 97/98? and also:
Why was a 1998 e-mail from (Glaxo CEO) Andrew Witty used as an exhibit in the Lauren Stevens trial in Maryland?

The mysterious e-mail from Andrew Witty at the Lauren Stevens trial… what does it contain?
awitty

   It seems to me, that the Lauren Stevens trial was nothing but a charade. The public needed to see that at least one executive was being pursued for this 3 Billion dollar white-collar crime felony, and Stevens was the token sacrificial lamb. Furthermore, not only did she symbolize the ‘pound of flesh’ but her acquittal also set a legal precedent which means that in the future, in house- pharma-lawyers, won’t be brought to trial, no matter how knee deep it looks like they are in an alleged cover up, because the Stevens acquittal will be invoked as a benchmark for further acquittals down the line. Genius isn’t it?
The department of justice won’t want to ‘appear’ to embarrass itself again, therefore I reckon it will hesitate before attempting to dare to bring a high level executive from Big Pharma to book. In other words, it’s unlikely that any pharmaceutical executives or lawyers will ever be tried again.

As always its a win/win for Big Pharma and a lose/lose for those of us (victims/patients) on the other end of these misdeeds…


   Some comments left by an alleged whistleblower on the cafe-pharma website seems to indicate that perhaps the 3 billion fine for GSK, and the charade of the Lauren Stevens trial was nothing but one big whitewash… I think this could be true, but there are many pieces of this story which need to be explored…
…in order to get a complete picture of how all these pieces fit together we need to know- what’s in the e-mail? How much did Witty know about Wellbutrin when he was involved in the marketing department in 97/98? Why did the department of Justice not go back beyond 2000 in their investigation against GSK?
    Why did no executive go on trial?
These are questions which are begging to be answered.. and perhaps some journalist might consider following them up, if so, contact me on truthman30@gmail.com

   If there is anyone out there with a legal background (or perhaps who was involved in this trial etc) maybe they could e-mail me on truthman30@gmail.com and let me know how I can access the contents of this e-mail, and of course any other information would be greatly appreciated. You can send info anonymously, and everything will remain private and confidential.
I have had some great help over the years from various people from all walks of life, some have been whistleblowers, others just concerned members of the public, or ethical doctors, or just people having a hard time on (or coming off) Seroxat and I am always extremely humbled when I received any kind of contact, advice, tip offs or help etc. It is always greatly appreciated.

“The DOJ accused Stevens, who was acting as a liaison between GSK and the FDA, of lying to the agency in connection with GSK’s alleged promotion of the drug Wellbutrin for unapproved, or “off-label,” uses.  She was indicted last fall on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents.”… (May 11, 2011)


Wellbutrin XR is an important new medicine for doctors and patients in Europe,” comments Andrew Witty, president, GSK Pharmaceuticals, Europe. “Depression can be a crippling condition that is often difficult to treat. With its unique mode of action, Wellbutrin XR offers a real alternative to the depressed patient. We hope its profile will help patients stay on their therapy, which would address a significant unmet need in the area of antidepressants.”

(Andrew Witty) LONDON, UK — January 16, 2007


Avandia, for example, racked up $10.4 billion in sales, Paxil brought in $11.6 billion, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a data group that consults for drugmakers. “So a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business,” [Patrick Burns, spokesman for the whistle-blower advocacy group Taxpayers Against Fraud] said. The settlement covers improper Glaxo practices from the late-1990s to mid-2000s. Based on claims by whistle blowers — four Glaxo employees — prosecutors said the company tried to get doctors to prescribe drugs off-label by buying them spa treatments and lavish trips, and in the case of Paxil, helping to publish a paper in a medical journal that misreported clinical trial data.

(Time Magazine July 2012)


“…you didn’t go to the Lauren Stevens trial in Maryland May 2011. Email presented into evidence of ANDY’s work in Wellbutrin Marketing. He is gone before too long!…”


http://www.cafepharma.com/boards/archive/index.php/t-561668.html


http://www.washingtonpost.com/wp-dyn/content/article/2010/10/11/AR2010101105724.html

Sara Bloom: Fighting drug maker health care fraud

Assistant US Attorney Sara Bloom

Assistant US Attorney Sara Bloom (Sam Kittner/kittner.com – Sam Kittner/kittner.com)
The Partnership for Public Service

Monday, October 11, 2010; 7:59 PM

For many years, executives and sales representatives of pharmaceutical giant Pfizer engaged in a massive illegal scheme to promote four prescription drugs for unapproved uses and paid kickbacks to encourage health care providers to prescribe these and others medications.

During an intensive four-year investigation, Department of Justice (DOJ) lawyer Sara Bloom and her team of 25 agents, attorneys and analysts from across the federal government uncovered the full scope of Pfizer’s misconduct. They poured over thousands of documents, interviewed hundreds of witnesses, followed tips from whistleblowers, traced the flow of money and fought an army of corporate lawyers.

Bloom, drawn to public service 15 years ago because she “wanted to make a difference,” said the long investigation showed that the choice of “drugs that patients were being given was influenced by money and other things given to doctors.” She called this “a deeply offensive notion” that corrupts the marketplace and could endanger patient health.“She genuinely cares about public health and safety and is committed to prosecuting cases that will ensure that,” said Sternberg. “She is tireless, bright and talented.”


In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss.

The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments.

“This is absolutely precedent-setting — this is really going to set people’s hair on fire,” said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. “This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.”

The indictment accuses the Glaxo official, Lauren C. Stevens of Durham, N.C., of lying to the Food and Drug Administration in 2003, by writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens “made false statements and withheld documents she recognized as incriminating,” including slides the F.D.A. had sought during its investigation, the indictment stated.

Tony West, assistant attorney general for the civil division, said in a statement, “Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations.”

Ms. Stevens has assembled a high-powered legal defense team. “She’s pleading not guilty,” said Reid H. Weingarten, one of her lawyers, who previously represented Bernard J. Ebbers, former chief executive of WorldCom, and Mark A. Belnick, former Tyco counsel. “We’re going to trial and looking forward to it, and we fully expect her to be vindicated.”

Brien T. O’Connor, a lawyer with Ropes & Gray, said in a statement, “Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with F.D.A.”

Ms. Stevens, who is 60, could not be contacted Tuesday. No one answered her home telephone.

She is retired, according to Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. Ms. Rhyne said the company was cooperating fully with a federal investigation into allegations of illegal sales and marketing of Wellbutrin. Last year, it set aside $400 million to resolve the case, which is still pending.

Two weeks ago, in an unrelated case, GlaxoSmithKline agreed to pay $750 million to the government to settle civil and criminal complaints that it sold tainted or ineffective products from a large manufacturing facility in Puerto Rico.

The theme of the drug-law industry conference last month was “more individuals, more often.” In a presentation, Eric M. Blumberg, a deputy chief counsel at the F.D.A., warned: “If you are a corporate executive — or counsel advising such a client — do not wait for the first case to decide now is the time to comply with the law.”

“Once you threaten somebody with jail, people really start paying attention,” said Frances H. Miller, a Boston University law professor and expert on health care policy. “This fits in that framework of sending very high-profile messages very fast.”


http://www.bloomberg.com/news/articles/2011-04-27/ex-glaxo-lawyer-went-too-far-u-s-says-at-opening-of-obstruction-trial

“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” said Patrick Jasperse, a Justice Department lawyer, during opening statements today in Greenbelt, Maryland, federal court. “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.”


http://www.lexology.com/library/detail.aspx?g=82b8f230-f356-4348-9c51-305262124b60

“Judge Titus found  that…Now, even if some of these statements were not literally true, it is clear that they were made in good faith which would negate the requisite element required for all six of the crimes charged in this case.”…

http://www.cbsnews.com/news/lawyer-says-feds-are-conducting-a-sweeping-investigation-of-gsk-as-a-whole/

Lawyer Says Feds Are Conducting a “Sweeping Investigation of [GSK] As a Whole”

Last Updated Apr 22, 2011 12:35 PM EDT

Federal prosecutors have asked a judge to grant immunity to a GlaxoSmithKline (GSK) executive in return for his testimony against one of the company’s top lawyers. The move comes as the accused lawyer revealed in court that she believes the feds have launched a wide-ranging, ongoing probe of the entire company via a grand jury in Boston.

The underlying case alleges that the lawyer, former vp/associate general counsel Lauren Stevens, made false statements to the FDA to conceal that GSK was illegally marketing the antidepressant Wellbutrin for weight loss and other unapproved uses. (Stevens previously had the indictment dismissed, but a grand jury reinstated it.) The feds’ strategy seems to be a version of “divide and conquer” — prosecutors want executives at GSK to know that they have two choices: Cooperate, and we won’t charge you; fail to cooperate, and we have a grand jury waiting to ask you difficult questions about how you sell drugs. Prosecutors want vp/strategic pricing, contracting and marketing James Millar to take the stand against Stevens. “It is likely that James Millar will refuse to testify or provide other information on the basis of his privilege against self-incrimination,” they told the judge. It is not clear from court papers what the feds believe Millar has to offer. In pretrial motions, Stevens’ lawyers set the stage by describing her prosecution as merely “one very thin slice of a very large Government investigation … concerning other individuals, other drugs and other time periods”: Stevens also took the unusual step of leaking the fact that a grand jury in Boston is conducting “a sweeping investigation of the company as a whole,” and the probe is ongoing: Grand jury investigations are confidential proceedings and although Stevens’ lawyers may not be bound by that confidentiality attorneys usually respect the secrecy of the process. It is not clear why Stevens wants this dirty laundry out in the open. In fact, it could harm Stevens’ defense — her former colleagues at GSK now know they may be targets of the probe and that prosecutors are offering get-out-of-jail-free cards in return for testifying against her. Related:

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