One of the odder health indictments to come down the legal pike in a while alleges that a drug company lawyer impeded a Food and Drug Administration inquiry into the marketing of a prescription drug.
Glaxo's world headquarters in Brentford, Middlesex, U.K.
The government doesn't often press criminal charges against a drug company official for messing with investigations into sales of medicines for uses that never passed muster with the FDA. But this morning we learned the government is moving ahead with just such a case.
The details get even more curious because the indictment, which you can read here, protected the lawyer's employer under the pseudonym "K-Corp" and only identified the medicine as "W-Drug."
According to the government, the company sold the drug, an antidepressant approved only for treatment of major depression in adults, for unapproved uses, including weight loss.
The feds do say the lawyer is named Lauren Stevens and that she's from Durham, N.C.
The Boston Business Journal reported Stevens worked for GlaxoSmithKline. And there's a public LinkedIn page for a Lauren Stevens, indicating she's a vice president & associate general counsel at the company.
In an e-mail to Shots, a Glaxo spokesman confirmed Stevens did work for the company. "She is now retired," the spokeswoman wrote.
Shots called Ropes & Gray's Brien O'Connor, one of the lawyers representing her, for comment. He sent us this 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 FDA. She looks forward to the day when a judge and jury can hear the true facts in this case, which will show that she has done absolutely nothing wrong.
So what did Stevens allegedly do to stymie the FDA? The feds have charged her with one count of obstructing an investigation, one count of concealing and falsifying documents to influence a federal agency, and four counts of lying to the FDA.
The heart of the case concerns the company's use of outside doctors to talk up the mystery drug. The DOJ statement gives these highlights:
Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The drug, Glaxo confirms, was Wellbutrin SR, and the company is cooperating with the government in the case.
A Justice Department spokeswoman in Boston said by e-mail that she couldn't comment on why the name of the company wasn't revealed.