It looks like Lilly will be paying more than a billion dollars in fines for off-label marketing of Zyprexa, according to the 

Although approved for schizophrenia, Lilly sales reps were illegally pushing Zyprexa as a treatment for dementia and depression. It is unknown how many sales reps were involved, but documents show that reps were encouraged to inform doctors that the drug could be used for older patients with forms of dementia.


There has been a rash of complaints surrounding sales tactics recently. In late January, former Amgen sales reps accused the company of firing them for refusing to engage in unethical sales practices, including off-label marketing of Enbrel and gathering patient information for consumer marketing.

"There have been a series of prosecutions for off-label marketing over the course of the last decade, and part of the problem is that the laws are pretty vague so it's hard to follow what's going on," said Mark Herrmann, partner at law firm Jones Day. "Other companies have paid big amounts to settle these types of claims, and you still see the prosecutions.

"An awful lot of people will tell you that the laws are so vague that you can't figure out what you should be doing—and you can't stand the risk of prosecution, so you settle."

 broke the news of the Zyprexa settlement, but it was actually a member of Lilly's legal team that accidentally tipped the Gray Lady off to the news.

 yesterday that a lawyer at Lilly's outside firm Pepper Hamilton accidentally sent a memo with all the pertinent information regarding the settlement to Alex Berenson, a reporter at the 

 instead of the her co-counsel Bradford Berenson.

Articles

News Analysis

Lilly is in the midst of settlement discussions with federal prosecutors over the pharma company?s off-label marketing of the antipsychotic medication Zyprexa. If settled, Lilly could be shelling out more than $1 billion in fines.

Lilly Faces Billion-Dollar Settlement

Vioxx is the target of a grand jury probe, according to a report by the 

. The paper states that the US Attorney's Office of the District of Massachusetts is examining Merck's marketing practices to see if the pharma manufacturer engaged in off-label marketing of Vioxx.

The drug was pulled from the market when it was deemed a high risk for heart attacks and strokes. The company is in the process of shelling out more than $4.85 billion to settle lawsuits with people who were hurt from the drug. 

 that Merck will establish one fund worth $4 billion for heart attacks and another worth $850 million for strokes. The payment for each plaintiff will be decided on a case-by-case basis using a graduated-risk point system, including age and risk factors. The maximum restitution is estimated to be between $1 million and $1.5 million. 

 cited unnamed sources in its report, and Merck refused to comment. However, lawyers following the Vioxx situation told 

 that a grand jury probe is possible, though if it were ongoing it would be extremely secretive.

Merck is under investigation for allegedly pushing physicians to prescribe Vioxx for unapproved use. Federal investigators are scrutinizing Merck?s marketing and sales practices in search of shady business tactics.

Grand Jury Probe Targets Merck Marketing Practices

Last week, FDA issued a public health advisory notifying the public of additional warnings and changes in the prescribing information for Pfizer's Chantix.

According to FDA, severe mood swings and psychotic episodes are side effects of the smoking-cessation drug. Other warnings and side effects include:
 

Recurrence of a previous psychiatric illnesses 

Behavioral changes including depression, anxiety, and thinking about or attempting suicide

The changes in prescribing information stem from a flood of adverse reaction reports FDA received late last year. According to reports, the feds received nearly 5,000 complaints from Chantix users and families of users who claim the drug brought on drowsiness, aggressive behavior, and suicidal thoughts. Of the 5,000 reports, 55 included instances of suicide, and 199 included cases of suicidal thoughts.

The reports were brought on by the death of musician Carter Albrecht, who was shot and killed by a neighbor after Albrecht went into a psychotic rage outside the neighbor's front door. It was reported that Albrecht was taking Chantix and had consumed a large quantity of alcohol.

After the event was reported, consumers took to the blogs, posting hundreds of entries about their own experiences with Chantix (both positive and negative). 

 "It looks like FDA felt that there is likely a relationship [between Chantix and depression], whereas before the news was just about a finding that didn't have a cause and effect," Deutche Bank analyst Barbara Ryan said. "It's too early to see an impact, but this is one of those situations where you have an effective drug, and the more aware patients are of the side effects, the less alarming the issues will be." 

Pfizer boosted warnings and prescribing information on its smoking-cessation drug Chantix in response to an early safety review by FDA. Side effects such as depression, suicidal thoughts, and odder-than-normal dreams have been attributed to use of the drug.

Pharmaceutical Executive-02-06-2008

Lilly Faces Billion-Dollar Settlement

Grand Jury Probe Targets Merck Marketing Practices

Chantix Receives Additional Warnings