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

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

[Publius Valerius]

Does he get his money back from the pharmacy?

He still got the drugs and likely got the benefit of their use, so why should he get his money back?

[agrace]

If one cries false witness against the truth, does that make it false false witness?

Ironically, I’m a homeschooler too, so I AM sitting at home doing my googling. But my research extends far beyond random internet searches and comes rather from personal experience and tons of documented research - peer journals, FDA reports, drug trial publications, books written by field-respected psychiatrists, and the personal testimony of both doctors and drug reps - they themselves say that they are trained to talk up the good and dismiss the bad - typical marketing practices, but the thing is, in these cases, they’re talking about people’s lives.

And my axe, which I freely acknowledge rests loosely in my grip, was crafted in an Eli Lilly laboratory and sold to my spouse by his well-meaning doctor.

[bdeaner]

the most compelling evidence that you are largely a propagandizer rather than an enlightener are the huge piles of bricks now standing virtually empty all over the country, built in the era when there was no “BIG PHARMA,” called state hospitals, where that supposedly less beguiled populace housed its mental patients for decades .

< Actually, they've just been replaced by group homes. Chances are, you have a few in your neighborhood, often with 24 hour staff caring for these people. No question, a much more humane situation than the state hospitals. But these people are not going back and having productive lives after years on anti-psychotic medication.

I'm not a propagandizer, and challenge you to show me how my facts are wrong. The science is on my side.

It's actually kind of laughable to say I'm the propagandizer, rather than Big Pharma. You don't see psychologists advertising their treatments every 5 minutes during prime time television shows. Your statement seems pretty naive in that light.

Here are some facts for you:

In the 1970s, the National Institute funded three trials that compared traditional drug-based care to experimental forms of care that involved selective, minimal use of antipsychotic drugs, and each time the experimental group had better long-term outcomes.

In a long-term study of patients discharged from Vermont State Hospital in the 1950s and 1960s, Courtenay Harding determined that thirty years later, one-third had completely recovered. And all of those ex-patients had stopped taking antipsychotic drugs.

When the World Health Organization compared outcomes for schizophrenia patients in rich countries to those in poor countries, it determined that outcomes were much, much better in the poor countries. In the poor countries, the WHO reported, only 16% of patients were regularly maintained on antipsychotic drugs.

In 2007, researchers at the University of Illinois reported that 15-years after initial diagnosis, 40% of the schizophrenia patients who had weaned themselves from antipsychotic medications were “in recovery,” versus five% of those who were on the drugs.

Now you tell me who is the propagandizer -- me or Big Pharma? Would you allow your son or daughter to be put on these drugs?

[gusopol3]

I have no real desire to be argumentative. You have certainly developed your point of view through the school of experience. I would point out though, that there is a non-medicated population of mentally ill in the US that is readily accessible— they live under bridges, “out in the woods,” and in city parks at night.

[bdeaner]

there is a commandment about bearing false witness. These kind of statements come directly from NYT and so forth who have certainly established their objectivity,and certainly many such statements are directed at home schooling also, as home schoolers, like certain corporate sectors including pharmaceuticals, were perceived by the left to be bulwarks of the Republican electoral coalition, and therefore were to be degraded by all means available, including people sitting home and Googling with some sort of axe to grind.

I am not a home schooler, nor do I sit at home Googling because I have an axe to grind. I am a professional whose business it is to research these things, and as an expert in the field, I am speaking to the evidence. It would be much more convenient for me to go along with the status quo, rather than to raise these concerns -- it doesn't do me much good professionally, except make enemies I don't need. But I have to speak to the truth in good conscience. I have no other motivation.

Even if I did have some alterior motive to research these issues, your argument nevertheless is ad hominem and therefore lacking a rational basis. You attempt to dispute the facts by attacking the messenger. It doesn't change the facts.

If you want to dispute the facts, dispute the facts. Until such time, you are just blowing wind.

[bdeaner]

He still got the drugs and likely got the benefit of their use, so why should he get his money back?

This statement is the apex of ignorance. Did you read the article? Or even the response to the article? The drugs were used to treat a condition that the drugs were not meant to treat. How the heck does he "benefit"? That's the point of the suit -- that the drugs were marketed off-label for ailments they are not designed to treat. So all the patients get is the horrible side effects with no benefits. So, yeah, you can bet on the coattails of this lawsuit, there will be a lot more coming down the pike.

[bdeaner]

I have no real desire to be argumentative. You have certainly developed your point of view through the school of experience. I would point out though, that there is a non-medicated population of mentally ill in the US that is readily accessible— they live under bridges, “out in the woods,” and in city parks at night.

So, you admit that the release from state hospitals was not an indication of cure by drugs. Many ended up on the street, which simply goes to demonstrate my point.

[Publius Valerius]

How the heck does he "benefit"? That's the point of the suit -- that the drugs were marketed off-label for ailments they are not designed to treat. So all the patients get is the horrible side effects with no benefits.

I know what off-label marketing is perfectly well, but I'm not sure that you do. A drug might very well have benefits that are not approved by the FDA, and an attempt to "sell" a doctor on those benefits is what's called off-label marketing.

For instance, one of the off-label uses for this drug is alleviating nausea. So in addition to its approved use--anti-psychotic--it happens to also alleviate nausea. Only the FDA hasn't approved it as an anti-nausea medication. But whether or not the FDA has approved it as anti-nausea medication doesn't change the nature of the drug, and that it does, in fact, suppress nausea.

So what goes on with off-label marketing is that the prescription drug salesman is out at doctors' offices and telling them all about how this is a great anti-psychotic drug or whatever. The doctor says fine, fine, I'll prescribe it to my patients that need that. Then the salesman says something like, "hey, by the way, this drug also happens to alleviate nausea. Not saying you should prescribe it for that, but I just thought you might like to know."

Then a patient comes in and is having trouble with constant nausea and the doctor prescribes the drug. Nausea ends, because that's what the drug does--alleviates nausea. Patient is happy--nausea is cured. Doctor is happy, because his patient isn't nauseated any longer. Drug company is happy because it sold more drugs. FDA is sad because off-label marketing threatens its role as the great drug Oracle.

[gusopol3]

Would you allow your son or daughter to be put on these drugs?

in a heart beat, or my mother, father, etc. I wouldn't dispute you on the fact that the initial presentation of symptoms for which a diagnosis and treatment are rendered may be more transient than expected, no matter how classic the presentation. Something akin to presenting in the ER for chest pain and rolling up to the ward for MI, all the while the true diagnosis is MB (MeatBall). Of course the time frame is much longer, maybe unjustifiably so. Until we get a crystal ball, the effort needs to be made in many cases.

[gusopol3]

cure by drugs

cure?

[gusopol3]

your argument nevertheless is ad hominem

this was not an ad hominem argument. However, the argument that physicians are easily beguiled by a sandwich is.

[agrace]

My point regarding physicians is this - well-meaning family doctors prescribe new drugs to patients based on presentations they receive from drug reps they trust. Being busy practicing medicine, they have no time to do extensive research into every new pharmaceutical product that comes down the pike, and expect that the info they are given by the manufacturer through the reps they see is accurate.

My husband’s GP, a wonderful Christian doctor, did not readily recognize that anxiety symptoms in my husband were caused by the very drugs he was prescribing to treat anxiety and instead thought they were indicative of another condition all together. He was also unaware that withdrawal from said antidepressants could take much longer than the standard “two-three weeks” (as touted by pharmaceutical companies, who won’t even call it withdrawal and have coined it “discontinuation syndrome”) and instead, two months later, sent my husband for bloodwork and neuro exams; then he was amazed by the fact that my husband experienced symptoms while he sat in the waiting room before his CAT scan, which, needless to say, was negative.

My husband also saw a psychiatrist who insisted that because he had been on an advisory board during development of Cymbalta, there was no way in the world that what my husband experienced while on Cymbalta was caused by the Cymbalta, despite peer journal articles, FDA warnings, and info on the drug insert itself.

The fact is (and a recent study demonstrated this), the majority of doctors who practice general medicine have no idea of the documented harmful effects of psychotropics, and not many more in the psychiatric profession do either.

Maybe you could present some facts of your own, rather than accuse others of false witness and ad hominem attacks.

[gusopol3]

They’ve made billions because they spend millions on marketing, not because they actually work.

this is a false statement. Your implication that physicians continue to prescribe medications that they see not to be working, not withstanding your husband's ordeal, is ludicrous. Your husband's symptoms may have been marginal to indicate use of the drug. To the extent that marketing efforts are persuading physicians to use drugs in people who don't really need them, yes , I agree with you, just as many "colds" don't need antibiotics, and "don't work" for those cases. On the other hand, these medications do work for very seriously ill people , and the kind of slander that some of the far-reaching statements of the kind that appear on this thread against "BIG PHARMA" are extremely deleterious in health care.

[agrace]

By the way, you said

in a heart beat, or my mother, father, etc.

I don't have any idea what your profession is, or from what, if any, specialized authority you speak on this subject, but with all due respect I implore you, as one who has been through hell with another on these drugs, do extensive research before allowing yourself or a loved one to get started on any kind of psychotropic.

And while I have you again, along the lines of prescribing off-label, antidepressants are now the most prescribed class of drugs in the US, with an estimated 10 percent of total population on some kind or another (this statistic doesn't even include other psychotropics).

A personal, off-label anecdote - as a result of dealing with the aforementioned hell, I went to my own dr for stress-related back pain, and got a prescription for what I assumed was a muscle relaxant, because he said "I'll give you something to help with the stress and the muscle tension."

Imagine my surprise when I filled it and found that it was Doxepin, another antidepressant. Do you think I took it? :)

[gusopol3]

Doxepin

Generics not capitalized among the cognoscente. Be careful of those centrally acting muscle relaxants that are not designated "psychotropics," they can put you down a lot faster. Some kids stole some mailorder baclofen off somebody's front porch a few years back, passed it around at a party , and I think three of them died.

[agrace]

I’ll readily admit that I operate from a jaded perspective. However, I have yet to read of independent studies which conclude conclusively that these drugs, by and large, are helping people.

Maybe you could cite some.

[bdeaner]

I fully understand what off-label marketing means.

A hammer is used for nailing things together. I can use a hammer to put you to sleep if I wack you in the head with it. Doesn't make it a good idea. The FDA is there to protect idiots from wacking people with hammers, figuratively speaking -- and even in that case, the FDA is only minimally protective, because the hammer consultants are all being paid by the company that makes the hammers.

Any physician who precribes an anti-psychotic for nausea needs a swift kick in the pants.

[bdeaner]

this was not an ad hominem argument. However, the argument that physicians are easily beguiled by a sandwich is.

Yes, your argument was entirely ad hominem. She raised an issue of the influence of Big Pharma on psychiatry, and you attacked her Googling habits. Not a very good argument.

[bdeaner]

in a heart beat, or my mother, father, etc.

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? Would you allow your three-year-old to take it for "childhood and adolescent bipolar disorder" based on a 15 minute office visit to a GP?

Of course the time frame is much longer, maybe unjustifiably so. Until we get a crystal ball, the effort needs to be made in many cases.

Due to dwindling resources among physicians, most do not take the time to do a proper assessment before psychiatric diagnosis. I see it all the time.

Empirical evidence exists which shows that if you take a child to a psychiatrist, the chance that the child will be medicated is above 90%. Something is wrong with this picture.

[bdeaner]

cure?

Well? You implied that psychiatric drugs liberated the insane from the asylum, due to "cure." Did you consider what the long-term cost has been for this short-term outcome -- an outcome which at best amounts to minimally manage their symptoms? Irreversible motor disorders, akithesia, obesity, diabetes, blurred vision, flat affect, loss of motivation, in general poor quality of life, et etc ... but hey they can live in a group home with 24 hour supervision. Woopty-friggin'-do. Little gain, major cost. And have we really explored the alternative to medication? No. Not for psychosis. It hasn't been systematically explored, and yet somehow third world countries show much more improvement in their psychotic populations -- before the introduction of psychiatric drugs into the culture--than in well developed countries like the U.S. If the drugs were really treating the symptoms in a desirable way, then how do you explain this finding? How do you explain the fact that people with psychosis who get off the drugs do better in the long-term -- are more likely to recover from psychosis -- than those who comply with treatment?