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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Another Sack of Raving Nonsense Is Slated For Publication | Main | And Now Some Politics »

June 12, 2009

Selling Zyprexa

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Posted by Derek

Well, this doesn't look good for Lilly. A huge pile of court documents has been unsealed in the ongoing lawsuits about Zyprexa's off-label promotion. The company has already paid some serious fines, and is now fighting it out with insurance companies and other plaintiffs who are seeking to recover their costs. Several states are suing them as well; those cases are still on their way.

Bloomberg News was given a lengthy list of internal company statements that will surely be difficult to explain in court. These were provided by one of the plaintiff's attorneys, Hagens Berman Sobol Shapiro LLP, so it's hardly a neutral selection (as Lilly is saying in response). But it's going to be interesting to see what sorts of explanations the company has for these. On the one hand, you have this:

In 1998, Lilly went back to the FDA seeking approval to market Zyprexa to those battling Alzheimer’s, the most common form of dementia, the company said in its 2003 request for a meeting on a proposed label change. Lilly withdrew its bid to promote Zyprexa for Alzheimer’s cases in 1999, according to the document.

In a November 2000 memo to Lilly salespeople, company executives said the dementia marketing initiative was abandoned because the FDA questioned Zyprexa’s effectiveness in treating the ailment.

“It was withdrawn due to vagueness on the FDA’s part regarding a definition of efficacy,” Lilly officials said in the document.

In a 2003 memo to FDA regulators citing the clinical studies, Lilly researchers acknowledged the death rates among older dementia patients on Zyprexa in the reviews were two times higher than their counterparts taking placebos.

Deaths among the patients taking Zyprexa in the studies were “significantly greater than placebo-treated patients (3.5 percent v. 1.5 percent, respectively),” Lilly officials said, according to the unsealed documents.

The studies didn’t find Zyprexa was effective in treating dementia, the company acknowledged in this document.

Lilly recognized this earlier, according to a 2002 document entitled “Zyprexa in serious mental illness (65 plus years) -- A Strategy Review.”

“The treatment of serious mental illness for people over the age of 65 has been identified as a growing opportunity for Zyprexa,” the authors wrote. “Unfortunately, attempts to gain the data to support an application for an indication in the treatment of dementia have to date been unsuccessful.”

But on the other hand, we have:

Lilly’s long-term care unit also saw Zyprexa sales rise 2.9 percent in the second quarter of 2002 as sales of Risperdal, Johnson & Johnson’s rival antipsychotic, fell, according to the 2002 marketing plan.

At that time, long-term care sales made up about 20 percent of Zyprexa prescriptions, according to the summary. Of that number, 65 percent were written for nursing-home patients.

Overall, prescriptions for older patients were the “2nd biggest money-producing segment” for Zyprexa in the U.S., according to a Feb. 15, 2002, e-mail from Lilly researcher Peter Feldman to Denice Torres, the company’s global marketing director.

In that e-mail, Feldman said company officials were saying in internal memos that they were going to stop studying Zyprexa’s potential health benefits for elderly consumers.

That would risk “killing the goose that lays the golden eggs to save on poultry feed costs,” Feldman said in the unsealed messages.

Torres assured him older consumers would continue to be a prime target for Zyprexa sales, according to the e-mail.

“Elderly remains an important aspect of target PT and affiliate focus,” she said in the message.

Increased Zyprexa sales to elderly patients also won Lilly’s long-term care unit praise in a 2003 newsletter unsealed as part of the documents.

“For two consecutive years, you have been on top and have turned in above-plan performance,” Grady Grant, Lilly’s national sales director, wrote in the newsletter. “I look forward to working with you as we set our sights on overtaking Risperdal as the number one antipsychotic in the marketplace!”

Lilly says these are cherry-picked quotes taken out of context. I'll await seeing what context they can be put in that will make them look less like. . .what they look like now.

Comments (19) + TrackBacks (0) | Category: Regulatory Affairs | The Central Nervous System | The Dark Side


COMMENTS

1. RB Woodweird on June 12, 2009 9:37 AM writes...

“Unfortunately, attempts to gain the data to support an application for an indication in the treatment of dementia have to date been unsuccessful.”

Ex-squeeze me and WTF? How do you decide that your drug should be good to treat a condition, then try to find data to confirm that? That is religion, not science.

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2. Anonymous on June 12, 2009 11:56 AM writes...

Apparently Lilly is in trouble for ghostwriting as well...

http://www.bloomberg.com/apps/news?pid=20601202&sid=a5OeWzHgCtFo

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3. LJ on June 12, 2009 1:17 PM writes...

Big Pharma must be the most evil of all businesses. Filled to the brim with sociopaths and do-baders! At least the evil oil companies provide you a relatively cheap, reliable product. It demonstrates your typical pharma exec is amoral and there is no code of personal conduct or sense of societal responsibility. Just make $$$ any way you can.

More on Zyprexa

http://www.bloomberg.com/apps/news?pid=20601109&sid=aTLcF3zT1Pdo

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4. Anon on June 12, 2009 10:35 PM writes...

It IS possible that Lilly's right and these are out of context quotes. It is possible that Bloomberg is willing to gamble with its reputation (upon which a lot of the value of the company rides) to gain some on-line readership. But I doubt it. Given what I've seen working in the industry and what we've seen in the marketing FUBARs of the past several years, this is unfortunately all too easy to believe. That probably says a lot all by itself.

Oh, and as for the oil companies, they make no bones about their monopolistic tendencies. We've come to expect it from them. That wasn't the case with pharma. Notice the tense of the verb used.

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5. it's over on June 13, 2009 9:25 AM writes...

yet an other example of big pharma grabbing at straws to try and survive. They deserve exactly what they're getting these days

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6. DC on June 13, 2009 7:42 PM writes...

It's hard not to have mixed feelings about pharma at the moment.

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7. Daniel Haszard on June 14, 2009 9:00 AM writes...




"FIVE at FIVE"

The Zyprexa antipsychotic drug,whose side effects can include weight gain and diabetes, was sold for "children in foster care, people who have trouble sleeping, elderly in nursing homes." Five at Five was the Zyprexa sales rep slogan, meaning 5mg dispensed at 5pm would keep patients quiet.
Google * Eli Lilly Zyprexa * and read the links,this is for a product that we put in our children's bodies.This drug company has a reputation a little better than a mafia drug lord.

BTW-I took Zyprexa it gave me diabetes and was as addictive as tobacco.How so?
Because withdrawal is accompanied by severe insomnia for 6 weeks.It was harder to quit Zyprexa than cigarettes.
Awful stuff and $10 a pill

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8. Lucifer on June 14, 2009 4:19 PM writes...

Get a prescription for Zyprexa!

//It's hard not to have mixed feelings about pharma at the moment.//

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9. S Silverstein on June 14, 2009 9:45 PM writes...

"Cherry picked and taken out of context" are hackneyed expressions pharmas should probably stop using. When I see them, I prepare to take anti-vertigo drugs, because I know neutron star-level spin will likely follow.

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10. Hap on June 15, 2009 9:16 AM writes...

If you can't come up with a plausible context within which the quotations make sense (assuming that words aren't being elided - the dreaded "creationist quote mine"), then using the claim that quotes are taken out of context seems like a bad PR strategy. Or if such a plausible scenario involves universal dosage of psychotropic drugs.

If pharma management is so competent, how have they managed to take an industry that makes life-saving and -lengthening drugs and one that had been financially successful and turned it into GM ca. 1995, and which now has the public status of oil companies, banks with large subprime mortagage or credit card businesses, or lawyers with leprosy? Spinning gold into straw is an amazing feat, just not one that anyone actually wants to see.

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11. What happened to Science? on June 15, 2009 1:27 PM writes...

So, I used to think that this was a blog by and for folks with a bit of scientific inclination. Perhaps I was mistaken?

Lilly was targeting dementia in the elderly in their trials, which then showed a higher mortality rate. Note that Zyprexa can be administered for multiple indications beyond dementia, and that nothing in the "data" provided by a very biased party (plaintiff lawyers) suggests anything about Zyprexa's poor performance outside of dementia.

Yet the information cited in the next paragraph to show Lilly's evil intent relates only to treating the "elderly" at large. Does dementia make up 70% of the elderly patients being prescribed Zyprexa? Or is it 0.7%? How relevant is this information to the understanding of the drug at the time these decisions were being made? We aren't given the data in this post to decide that. If this were a discussion about bench chemistry, Derek would have been laughed out of the lab for drawing conclusions based on crap statements like those assembled by the lawyers. As for the posters, most of them would have been taken out behind the lab building and asked not to come back.

Why is it that internet postings about how best to responsibly treat patients with prescription pharmaceuticals inevitably make me think that Maury Povich or Jerry Springer would do a better and more useful job of addressing the subject?

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12. Derek Lowe on June 15, 2009 2:39 PM writes...

The post is mostly a straight quote from the Bloomberg story, of course - as I make clear. And I'm willing to give Lilly a shot at explaining this, as they'll be doing in court.

But your objections don't hold up well. Zyprexa is approved as a stand-alone drug only for schizophrenia and bipolar disorder. I think that it's a reasonable assumption that dementia makes up rather more than your "0.7%" of the scripts for the drug in the elderly population.

And if it isn't tolerated well in elderly patients, then it doesn't seem to matter much what the intention is when it's given. Looking at the prescribing information, it seems like most of the recommendations are for 10 mg/day dosing. What's going to change?

If Lilly has good reasons for all this, then I'll most certainly blog about them. But I don't run a site that only cheers on the industry (although, since I work in it, I have a favorable bias, for sure).

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13. What happened to Science? on June 15, 2009 2:52 PM writes...

So, I used to think that this was a blog by and for folks with a bit of scientific inclination. Perhaps I was mistaken?

Lilly was targeting dementia in the elderly in their trials, which then showed a higher mortality rate. Note that Zyprexa can be administered for multiple indications beyond dementia, and that nothing in the "data" provided by a very biased party (plaintiff lawyers) suggests anything about Zyprexa's poor performance outside of dementia.

Yet the information cited in the next paragraph to show Lilly's evil intent relates only to treating the "elderly" at large. Does dementia make up 70% of the elderly patients being prescribed Zyprexa? Or is it 0.7%? How relevant is this information to the understanding of the drug at the time these decisions were being made? We aren't given the data in this post to decide that. If this were a discussion about bench chemistry, Derek would have been laughed out of the lab for drawing conclusions based on crap statements like those assembled by the lawyers. As for the posters, most of them would have been taken out behind the lab building and asked not to come back.

Why is it that internet postings about how best to responsibly treat patients with prescription pharmaceuticals inevitably make me think that Maury Povich or Jerry Springer would do a better and more useful job of addressing the subject?

Permalink to Comment

14. CMCguy on June 15, 2009 2:58 PM writes...

#9 S Silverstein perhaps pharma should stop using the expression "Cherry picked and taken out of context" only if politicians and journalist (and lawyers) would actually stop doing this so often that their biases show through.

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15. milkshake on June 15, 2009 3:05 PM writes...

I am surprised that given the "rich" side-effect profile of their drug they would even try to market it for the elderly patient population.
Closely-related clozapine has a worrisome history of complications, and so do other antipsychotics

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16. Hap on June 15, 2009 3:08 PM writes...

1) If you're going to ask "What happened to science?", wouldn't it be a good idea to have some before you run smack? Unsupported assertions and blind faith don't add up to science. Sorry.

2) When you advocate prescribing something to people in whom it has a higher rate of side effects, you ought to have something that shows the drugs works well enough to be worth the risk. Since they stopped investigating those benefits (claiming that they didn't want to "kill the golden goose"), that sure sounds like the benefits weren't sufficient (sort of like Robert Gates's comment during an Iran-contra briefing that he didn't want to know any more about the topic - how did he know that he didn't want to know, exactly?) to justify their sales emphasis. If they had the data to justify the risk, you would have figured salespeople might have been told about it, just in case someone asks. (If you were honest, you might actually explain that it may cause more side effects, but is worth it because it is more effective, but that's a lot to ask, perhaps.) Either way, in some form, the data justification which mitigates the side effects ought to be public somewhere (but, not surprisingly, not in your rejoinder). Otherwise, it looks rather like they continued to actively push a drug at people in whom it had a higher risk of harm than other users and in whom it didn't have an added benefit. Why is that criticism offbase, again?

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17. Hap on June 15, 2009 3:16 PM writes...

Why would anyone want politicians and lawyers to stop using "taken out of context" as a defense? It has the obvious rejoinder of "And that context would be...?" Just allowing the mind to wander should bring plenty of contexts to mind, none of which are likely to be complimentary to the people/companies employing this defense.

If some group of evil or stupid people wants to cover themselves in napalm and asks me for a light, I see no reason not to give them one, just so long as I can stand at a safe distance when I do so.

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18. incha on June 15, 2009 4:08 PM writes...

I know this doesnt look good for Lilly, and it really annoys me that there are folk somewhere at the top (in the marketing department?) who are making unethical decisions to market for indications where there is little or no clinical data that supports them.

My question is, why does noone ever question the doctors. Ultimately Lilly did not give these patients the drugs, their doctors did. If there is no clinical evidence that these drugs are effective for the patients, why are they prescribing them? They earn some serious cash, but sometimes it seems like the public would be better making their own decisions about what to take.

Also, why is it still possible for companies to be sued when it clearly states the side effects on the label. Diabetes is listed as a potential side effect of Zyprexa, so when you start taking the drug it is surely a risk you are accepting.

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19. Dan on June 16, 2009 3:38 PM writes...

Cherry picking by the lilly spokesman was a weak attempt to pacify the public.

Documentary evidence is demonstrative evidence. As such, in this particular case, there is a preponderance of evidence considering the weight of the evidence.

Such evidence cannot be debated and is not subject to opposing paradigms. Eli Lilly is guilty. Plain and simple.

Anything in writing is golden in a courtroom.

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