Glaxo Attorney Indicted for Obstructing the FDA - Wellbutrin XL

It is good to know the FDA is trying to do more about the dangerous off-label marketing problems.

 

http://www.pharmalot.com/2010/11/pharma-lawyer-indicted-for-obstructing-the-fda/#more-27688

 

By Ed Silverman, Pharmalot

 

Lauren Stevens, a former Glaxo attorney, has been charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and five counts of making false statements to the FDA, according to an indictment issued by the US Justice Department. The feds note Stevens is based in Durham, North Carolina, where GlaxoSmithKline has offices and a Lauren Stevens is listed as a vp and associate general counsel on LinkedIn (see this). We await comment from Glaxo. UPDATE: A Glaxo spokeswoman confirms Stevens was its employee, but is now retired.

 

This marks one of the rare moments when the federal government seeks to prosecute an executive in connection with off-label marketing. Although the feds have negotiated eye-popping settlements with various drugmakers, some of which have also pleaded guilty to misdemeanors or felonies, none of these recent deals included charges against individuals. Consequently, there are now efforts under way to ban healthcare execs found guilty of fraud from doing business with federal healthcare programs (see this).

 

The indictment states that in October 2002, the FDA asked for info about promotion of a prescription drug, as part of an inquiry into off-label marketing. UPDATE: In March, Glaxo disclosed in a filing with the Securities and Exchange Commission (see page 173) that the feds inquired about its response to an October 2002 letter from the FDA’s Division of Drug Marketing, Advertising and Communication requesting info about the alleged off-label promotion of Wellbutrin SR.

 

The feds charge that, in response to the FDA inquiry, Stevens signed and sent a series of letters from the drugmaker to the agency falsely denying off-label promotion took place, even though she knew, among other things, that the drugmaker had sponsored numerous programs where the drug was promoted for unapproved uses (you can read the indictment here).

 

The feds go on to say Stevens knew numerous docs had been paid to give promotional talks to other docs that included info about unapproved uses. In one example, a doc was paid to speak at 511 promotional events in 2001 and 2002, while another spoke at 488 events during that period. The docs, however, are not named. Meanwhile, Stevens allegedly did not provide the FDA with slide sets used by the paid docs, even though the FDA asked for the slides and Stevens previously promised to send them along.

 

And this is interesting: The feds allege a legal memo was prepared for Stevens that spelled out “pros” and “cons” of sending the slides to the FDA. One negative: the slides would provide “incriminating evidence about potential off-label promotion of (the drug) that may be used against (the company) in this or in a future investigation.” so instead of providing the slides, Stevens offered that the company’s responses to the FDA’s requests were “final” and “complete.”

 

Each of the obstruction charges carries a maximum penalty of 20 years in prison, while each false statement count carries a maximum penalty of five years in prison. The drugmaker is not being charged with a crime.

 

“There is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth,” Carmen Ortiz, US Attorney in Boston, says in a statement. “Federal agencies such as the FDA cannot protect the public health if the entities and individuals they regulate provide false information and conceal the true facts.”

 

“This indictment shows that we will investigate those responsible for unlawful acts done on a company’s behalf. When individual employees are identified, they will be held accountable for their illegal activity. Individual employees now know that concealing information from the government, obstructing investigative activity and making false statements to federal investigators will be investigated and prosecuted,” says Richard DesLauriers, Special Agent in Charge, FBI, Boston Division, in the same statement.

 

UPDATE: Brien O’Connor, Stevens’ attorney at Ropes & Gray, sends 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.”

 

 

 

I hope she gets time.

"The drug maker is not being charged with a crime".

 

Big Pharma is one of the most protected industries on the planet.. the blinders go up, generally because people unquestionably believe the drugs are "science-based"...

 

Kat

 

I would like a detailed explanation as to why the drugmaker is not being charged.  Are they innocent based on some technicality? Or, did their investigation 'prove' that the drugmaker had no clue about the off-label marketing being done by their reps? And, if so, how did they 'prove' that?

I would love to hear the reasons addressing all of those questions.

the world is turning into 1984 by the day!

charge!

http://ethiopedia.com/world/600562

 

 

NOV

12

Former Glaxo Exec Faces Federal Charges Over Wellbutrin Marketing

2010-11-12

Federal prosecutors are pursuing criminal charges against a former GlaxoSmithKline vice president for alleged efforts to cover up illegal, off-label marketing of Wellbutrin.

On Tuesday, the U.S. Department of Justice (DOJ) issued a press release announcing that it was charging Lauren Stevens with obstructing an official proceeding, concealing and falsifying documents to influence a federal agency and four counts of making false statements to the FDA.

According to the indictment, Stevens attempted to hide the fact that Glaxo was promoting Wellbutrin for uses not approved by federal regulators. While it is legal for doctors to prescribe drugs for any uses they see fit, it is illegal for drug manufacturers to promote those medications for uses other than those approved by the FDA.

Stevens, now retired, was vice president of GlaxoSmithKline’s legal department at the time of the alleged cover up in October 2002. The indictment does not name the company or the drug involved, but Glaxo officials have confirmed that the issue is over Stevens’ handling of the FDA’s Wellbutrin investigation.

DOJ investigators say that Stevens signed and sent a series of letters to the FDA saying that Glaxo was not involved in off-label promotion of Wellbutrin, despite knowing that the company had paid physicians hundreds of times to do just that. Stevens told the FDA that the physicians had not been paid to speak on the drug’s behalf, but federal investigators later found out that one doctor had been paid to speak at 511 promotional events regarding unapproved Wellbutrin use in 2001-2002 and another had been paid to speak at 488 events.

Stevens also refused to turn over a set of slides that the FDA requested, and that she promised to provide. According to the indictment, a legal memorandum was generated inside the company that listed the pros and cons of turning over the slides, one of negatives listed was that the slides could be used as evidence that the company had been illegally promoting Wellbutrin.

When the FDA asked for the slides, Stevens did not turn them in, saying that the company’s response to the FDA inquiries and the evidence it had turned over was complete.

If convicted, Stevens faces a maximum of 20 years in prison for the obstruction charge, and five years in prison for each of the false statement charges.

Wellbutrin (bupropion HCI), which is manufactured by GlaxoSmithKline, was first approved by FDA as an antidepressant in December 1985. The drug was pulled a year later due to the high number of seizures associated with Wellbutrin side effects, but it was reintroduced in 1989 after federal reviewers determined that the seizures were dose specific and lowered the daily dosage of the drug.

Wellbutrin has come under closer scrutiny recently after a study published in May in the American Journal of Obstetrics & Gynecology suggested that there may be an increased risk of heart birth defects from Wellbutrin when the medication is taken during pregnancy.

Researchers found that mothers who were given Wellbutrin in their first trimester had double the chance of giving birth to a child with a congenital heart problem than mothers who did not take the drug. However, they were not able to establish a cause-and-effect relationship between the drug and the birth defects.

The charges against the GlaxoSmithKline executive may represent a possible shift in enforcement actions involving pharmaceutical companies, who have been fined billions of dollars in recent years over illegal marketing of drugs in violation of federal regulations. Executives at the pharmaceutical companies may increasingly find themselves facing criminal charges for their role in illegal actions taken by drug makers.

 

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"According to the indictment, Stevens attempted to hide the fact that Glaxo was promoting Wellbutrin for uses not approved by federal regulators. While it is legal for doctors to prescribe drugs for any uses they see fit, it is illegal for drug manufacturers to promote those medications for uses other than those approved by the FDA." (3rd paragraph).

 

As noted in the above paragraph, the FDA obviously knew that "Glaxo was promoting Wellbutrin for uses not approved by federal regulators".  It would be no surprise to me that Glaxo will not be charged in  this case.  Paying doctors  are the norm for not only this company, but for many other pharmaceutical companies as well.  Add in the caribbean vacations, etc....I'm not against the industry per se; it's what goes on behind the scenes, the dark side... 

 

So now the FDA is pursuing a former vice-president for criminal charges relating to basically the same thing as Lauren Stevens' charge.  Note that Ms. Stevens is a retired vice-president of the Company's legal department.  Would the FDA have charged these people if they were still in  the employ of the Company?  Who knows?

 

Kat