Posts Tagged ‘indicted’

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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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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