Eli Lilly settles with U.S. Gov't for $1.42 billion over illegal Zyprexa off-label marketing

payoutYes, you read that right. Eli Lilly has reached a settlement for $1.42 billion with the U.S. government over the illegal off-label marketing of Zyprexa. The company also pleaded guilty to criminal misdemeanor charges. Basically this is how I see it:

U.S. Gov’t: Eli Lilly, you did a bad, bad thing by doing illegal things. Pay a fine, please, and then you can go.

Eli Lilly: Okayyyy. [reluctantly hands over $1.42 billion to the government]

U.S. Gov’t: [slaps Eli Lilly on the hand] Now, don’t you ever, ever do this again!

It’s a record settlement for a whistleblowing case. According to Philip Dawdy at Furious Seasons, Eli Lilly has paid over $2.7 billion in settlement payouts so far. (With certainly more to come.)


Loose Screws Mental Health News

Let’s start off small and build up, shall we?

A blog I came upon, Providentia, has a post on the suicide rate in Kentucky over a 10-year period. Male schizophrenics have the highest rate of suicide. The leading methods of suicide in the state are firearm use, overdose, and hanging.

Mary WinklerMary Winkler, the preacher’s wife who killed her husband, has been moved from jail to a mental health facility, where she will serve the remainder of her three-year sentence.

East meadow, a poster on the drugs.com message board, asks about Lexapro’s correlation to suicide. Her sister committed suicide while on Lexapro and questions whether the Lexapro might have affected her in that way. As a former Lexapro user, I can empathize with the change in her sister’s behavior.

The Depression Calculator: see how much depression is costing your company and see if treatment is worth your while. I went through it for kicks and basically, I walked away feeling like it cost too much to hire someone with depression, especially if I were running a small business. Blah.

Apparently, bipolar disorder is covered under the Americans with Disabilities Act (ADA). Starbucks is settling an $85,000 lawsuit with Christine Drake, a former Starbucks employee who suffers from bipolar disorder. It seems that Drake’s first manager was willing to work with her “psychiatric impairment” and allow her to gain “extra training and support.” Then, get this:

“But, during her third year, new management told her she was “not Starbucks material,” refused to continue the accommodation and ultimately fired her for discriminatory reasons, the agency alleged.”

Starbucks probably put up one helluva fight, but in the end, they’ve tried to put a good face and good spin on the situation:

Starbucks agreed to pay Drake $75,000 and donate another $10,000 to the Disability Rights Legal Center, which provides legal representation for low-income people with disabilities facing discrimination, as part of the settlement.

“The facts of this case illustrate how relatively minor accommodations are often all that disabled people need to be productive members of the work force,” said the EEOC’s San Francisco district office director, Joan Ehrlich. “It is important that all of Starbucks’ managers understand their legal duties regarding disabled employees and provide them with the tools necessary to succeed. This is in everyone’s best interest.”

Ms. Drake, who seems to be more than capable of handling a job well, has probably eeked out several years of a barista’s salary from the Starbucks suit.

I’m amused, but it’s not necessarily a good thing.

RisperdalJohnson & Johnson is gearing up to put Risperdal for children on the market. I’m sure other blogs have beat me to the punch on this, but I just came across this info and found it absolutely retarded. (But what do drug companies care?)

The FDA has approved “expanded use” for Risperdal in teenagers who suffer from schizophrenia and the short-term treatment of bipolar mania in kids ages 10-17. I’m leery enough about antidepressants in kids let alone antipsychotics.

“J&J said the agency has not requested the company perform any additional studies, implying that it need only agree with the FDA on acceptable labeling for the expanded uses in order to gain final approval.”

I wasn’t sure what “expanded use” was so I looked it up. This was the best I could come up with:

“Applications for a new or expanded use, often representing important new treatment options, are formally called “efficacy supplements” to the original new drug application.”

Well, I didn’t know what efficacy supplements were so I looked that up too:

“The legislative history indicates that this provision was directed at certain types of efficacy supplements (i.e., supplemental applications proposing to add a new use of an approved drug to the product labeling).”

So – correct me if I’m wrong – it sounds like the studies performed that led up to this “expanded use” are not as rigorously evaluated by the FDA as the initial studies that allowed the drug to be released on the market in the first place. It just seems like a company and the FDA simply need to agree on “acceptable labeling.” So if we’re following the theory that I’m still correct, the FDA doesn’t follow up on the clinical trials performed on these children, they just agree with J&J on the “acceptable labeling.” Doesn’t that thought make you feel all warm and fuzzy inside about your health?

Christopher PittmanOn the subject of children and psychotropic medications, 12-year-old Christopher Pittman shot and killed his grandparents and then set their house on fire in November 2001 all while on an adult dosage of Zoloft. It looks like the drama is still playing out in June 2007.

According to CourtTV.com, Pittman suffered from hallucinations while on the 200 mg dose and while in jail, displayed symptoms of mania.

“Three years after the killings, Pittman was tried in adult court and convicted of murder. He was sentenced to 30 years in prison. He was then 15 years of age.”

No doubt Pittman should be held responsible for what occurred, especially if he admitted to the killings (which he did). However, the situation raises a few questions. First of all, why was he on 200 mg of Zoloft when he was TWELVE? Why wasn’t he considered mentally ill and placed in a mental health facility? I could go on and on. While Pittman “did the crime and needs to do the time,” why isn’t the doctor who prescribed this not present in any of the reported stories? If this incident was 2001, it can only be worse for antidepressants and other psych meds today.

Eli Lilly settles with 18,000 people!

Holy crap.

In a stunning move by Eli Lilly, yesterday they agreed to pay $500 milion to settle lawsuits from 18,000 people who said they'd developed diabetes among other health problem on Zyprexa.

According to the company, 1,200 lawsuits are still pending.

Furious Seasons is doing some extensive blogging on this.

More on Zyprexa

More on Zyprexa, folks. It just isn't going to go away.

NYT reporter Alex Berenson, continuing his stellar coverage of Zyprexa's risks and exposing Eli Lilly's deceitfulness, has uncovered a recent case of a man who died using Zyprexa. John Eric Kauffman has a complicated medical, which might have led to his death. However, he was a mentally ill patient on Zyprexa and as a result of his death, Eli Lilly must report his death to "federal regulators," which it is required to do under law. However, despite his heavy smoking, he gained 80 lbs. on Zyprexa – which possibly led him to develop heart disease and become sedentary after being active most of his life. His mother says that Zyprexa did help him stave off the psychosis of his bipolar disorder, but his mother wonders if the risk was worth the early death of her son. Kauffman at 41 years old weighed 259 lbs. at the time of his death. He was 5' 10".

Which leads to the question of whether mentally ill patients should choose between taking Zyprexa – which CAN help mentally ill people – and dealing with its significant side effects or risk not taking Zyprexa when other medications won't work. In light of all this, should a doctor even continue to prescribe Zyprexa after seeing its awful side effects but left with no other choice (given that a patient is treatment-resistant to most medications)?

Eli Lilly's response to this continues to be appalling:

"Zyprexa is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives."

It may be true that it helps people "regain control of their lives," but as for being a lifesaving drug – that's unlikely. Zyprexa has been shown to induce diabetes, obesity, hyperglycemia, and now, heart disease and death. I commend Australian regulators for looking into the details of Lilly downplaying the risk of Zyprexa and hope that they will make the information public – a different course than what the U.S. federal government seems to be taking. Lilly's 2006 settlement with patients who developed diabetes and other health problems is pure evidence that despite their constant denials, Lilly's hiding something in an effort to make profits.

My prediction: The FDA will eventually slap a black-box warning on Zyprexa, warning patients that it makes them more prone to diabetes and its other ill health effects.