Eli Lilly to pay $1.4B for off-label drug marketing

Capital Journal ^ | January 16, 2009 | Capital Journal Staff

[bdeaner]

PIERRE — State Attorney General Larry Long announced Thursday that South Dakota has joined with other states and the federal government and reached a $1.4 billion settlement with Eli Lilly and Co., to settle allegations it engaged in an off-label marketing campaign that improperly promoted the anti-psychotic drug, Zyprexa.

Eli Lilly will pay the states and the federal government a total of $800 million in damages and penalties to compensate Medicaid and various federal health care programs for harm suffered as a result of this conduct.

South Dakota’s total settlement recovery is $1.4 million. Of that amount, South Dakota will keep $475,000, which represents the state’s share of the Medicaid loss, with the remainder going to the federal government for its share.

Between September 1999 and Dec. 31, 2005, Eli Lilly willfully promoted the sale and use of Zyprexa, primarily through a marketing campaign called “Viva Zyprexa,” for certain uses which the Food and Drug Administration had not approved.

Eli Lilly’s activities in the “Viva Zyprexa” campaign promoted Zyprexa not only to psychiatrists, but also to primary care physicians, for such unapproved uses as the treatment of depression, anxiety, irritability, disrupted sleep, nausea and gambling addiction.

In implementing the campaign, Eli Lilly also provided remuneration and other things of value to physicians and other health care professionals.

As a result, Eli Lilly caused physicians to prescribe Zyprexa for children and adolescents, dementia patients in long-term care facilities, and in unapproved dosage amounts, all of which are uses that were not medically accepted indications for which state Medicaid programs would approve reimbursement.

As part of the settlement, Eli Lilly will enter a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General which will closely monitor the company’s future marketing and sales practices.

This settlement is based on four cases that were filed or consolidated in the United States District Court for the Eastern District of Pennsylvania by various relators — private parties that filed actions under state and federal false claims statutes.

The South Dakota Medicaid Fraud Control Unit and the South Dakota Department of Social Services assisted in recovering the settlement money.

[quickquiver]

Also, if I remember correctly, the state pays (or paid) around $500.00/month to the drug’s manufacturer per patient for the treatment.

[gusopol3]

the child will be medicated is above 90%. Something is wrong with this picture.

if true ,agreed

[gusopol3]

You implied that psychiatric drugs liberated the insane from the asylum, due to "cure

not true, disagreed.

[gusopol3]

and you attacked her Googling habits.

not true. Disagreed. I never said she was Googling anything. There was neither innuendo nor implication that this phrase applied to her.

[gusopol3]

psychosis who get off the drugs do better in the long-term they are the third that don't relapse. Many , many who go off antipsychotics relapse and have multiple $10-50,000 hospitalizations to show for it.

[gusopol3]

oops. psychosis who get off the drugs do better in the long-term

they are the third that don't relapse. Many , many who go off antipsychotics relapse and have multiple $10-50,000 hospitalizations to show for it.

[bdeaner]

Many , many who go off antipsychotics relapse and have multiple $10-50,000 hospitalizations to show for it.

Yes, that's right, but do you know why? The evidence suggests this is a rebound effect from the anti-psychotic, not a return of the orginal symptom-formation. It's called WITHDRAWAL.

[gusopol3]

same thing happened in the pre-drug era. The illnesses are serious. It’s tragic that you choose to minimize them .

[Publius Valerius]

The FDA is there to protect idiots from wacking people with hammers, figuratively speaking

That's absurd. There are tons of off-label benefits for drugs, and those types of treatments and not only improve the quality of life for some people but save lives. Heck, one of the off-label uses of viagra is to help premature babies breathe.

Drugs should help patients. If they can, great. I'm not interested in some bloated government agency telling me I can't take a drug that hundreds of thousands of other people take without incident AND will improve my quality of life just because the FDA hasn't declared it "effective." That's bull.

[Publius Valerius]

Would you let them take it for nausea, as someone suggested above is a valid use of an anti-psychotic, even though this is an off-label use?

Yes.

[bdeaner]

Yes.

WHY in the WORLD would you do THAT?

[bdeaner]

The illnesses are serious. It’s tragic that you choose to minimize them

Who is minimizing the symptoms of psychosis? Not me. I'm saying that the drugs that we are using to treat psychosis, in many cases, cause more harm than good -- although, in certain cases, the potential harm may be outweighed by the benefits.

Please don't put words in my mouth. I never minimized psychosis at all. What I said is that there is evidence which suggests that people with these illnesses do better IN THE LONG RUN if they do not take medication for the symptoms. In the short run, they do better. But at what cost?

[Publius Valerius]

WHY in the WORLD would you do THAT?

If it works, I don't care. When I take a drug, the questionis whether it works to fix the problem for which I'm taking it. If I have hypertension and my doctor prescribes viagra, I only care whether it will work to fix my hypertension. Don't care that it's also an ED drug. Does it correct my hypertension? Yes? Great. Did the FDA approve it for hypertension? Don't care.

[bdeaner]

If they can, great. I'm not interested in some bloated government agency telling me I can't take a drug that hundreds of thousands of other people take without incident AND will improve my quality of life just because the FDA hasn't declared it "effective." That's bull.

There wouldn't be a need for such a government agency in a perfect world. But it ain't a perfect world. Psychiatrists are vulnerable to manipulation by economic and other incentives by those who do not have the best interest of the patients in mind. Ideally, the FDA serves those interests, albeit not always very well -- but it is better than nothing.

[bdeaner]

There are tons of off-label benefits for drugs, and those types of treatments and not only improve the quality of life for some people but save lives.

When the drugs have very little side effects, I have no problem with using drugs for off-label purposes. It is a matter of cost-benefits analysis. But I see very few reasons to use anti-psychotic medication for anything other than psychosis and mania that has not responded to other, less damaging treatments FIRST.

But I agree that off-label marketing is completely inappropriate and should not be legal. The Lilly case is a good precedent that will protect a lot of people. Moreover, I think all marketing of prescription drugs to a general population should be banned. It's unethical in the same way it is unethical for psychologists to advertise their services (this is part of our code of ethics, by the way).

[Publius Valerius]

Psychiatrists are vulnerable to manipulation by economic and other incentives by those who do not have the best interest of the patients in mind. Ideally, the FDA serves those interests, albeit not always very well --

You might have a point if the drug wasn't approved, but it has been. The FDA has said that it's "safe." The only question is whether the drug company has bothered to spend the tens of millions of dollars in order to get the FDA to acknowledge something that the whole rest of the world knows: in the case of Viagra, for instance, that it is effective for treating hypertension.

Everyone agrees that Viagra is effective for treating hypertension. The FDA has said that Viagra is safe; indeed, it's taken by probably millions of people around the world. If my doctor and I agree that Viagra is the best treatment for my hypertension, why shouldn't he prescribe it for me?

[bdeaner]

If it works, I don't care.

You don't care about side effects? We're talking about drugs that PERMANENTLY and IRREVERSIBLY alter the structure of your brain. And you'd like your kid take this for nausea. Wow.

[Publius Valerius]

You don't care about side effects?

That's a decision for me and my doctor, not a federal agency in Washington, D.C.

[bdeaner]

That's a decision for me and my doctor, not a federal agency in Washington, D.C.

Believe what you want to believe, but, from my perspective, you seem to have a very naive trust in physicians. Good luck with that.

[Publius Valerius]

Good luck with that.

Thanks. So far, I'm batting 1.000. Can't say the same for the FDA, though.