Comment left on Cafepharma website by (what I am assuming to be) – a GSK whistleblower: “…
“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!…”
“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.”
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…
…“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.”
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.
“…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!…”
Sara Bloom: Fighting drug maker health care fraud
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.
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.”
“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.”
“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.”…
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: