February 09, 2007

The Zyprexa Chronicles: Operation Restore Confidence And NAMI

On July 7, 2003, Alan Breier, the Zyprexa Product Team and other Eli Lilly officials issued a "Diabetes Update" memo to the company's policy committee, according to Lilly documents I have reviewed. Breier, a psychiatrist by training, was named Lilly's chief medical officer and vice president for medical the next month. That summer was apparently a nerve-wracking time for the company. According to the memo, company officials anticipated that the FDA would issue a black box warning relative to Zyprexa, the company's star drug, and other atypical antipsychotics and the potential for patients taking the drug to develop diabetes. The company was also concerned about an expected consensus statement from the American Diabetes Association concerning the use of atypicals and the potential for diabetes.

In the memo, officials outline several methods to blunt "negative messages around Zyprexa" in the media and the psych meds marketplace. "We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase), solely on the basis of personal fear (of being sued)," officials state in the memo. So grave were the company's concerns that Breier, the memo states, would head an effort that summer and fall called "Operation Restore Confidence." The effort was apparently aimed at doctors, referred to in the memo as "customers."

One piece of Lilly's proposed strategy "to mobilize our allies" outlined in the memo was to provide "NAMI a multimillion dollar grant to stage a national screening" to "help educate physicians and patients on the inherent risks of diabetes--regardless of the antipsychotic." It is not clear what screening effort NAMI, formally known as the National Alliance on Mental Illness, later undertook or how much money the group received. NAMI, as I reported here last week, recently received an unspecified amount of money from AstraZeneca, maker of Seroquel, to conduct patient support groups around the nation.

NAMI did not immediately return a request for comment. Eli Lilly did not immediately return a request for comment.

NAMI has long received contributions from Lilly, totaling millions of dollars over the last decade. In addition, Gerald Radke, a Lilly marketing manager, served as NAMI's interim executive director from 1999 to 2001. A search of NAMI's website contains no information about Radke or his time with the group.

Another tack outlined in the memo was to legally indemnify doctors prescribing Zyprexa. "Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," officials state in the memo. "Our experience with Prozac confirms the impact and goodwill of such an initiative. We are investigating the viability of this action, and are preparing a business case analysis for senior management's consideration--ASAP."

It is not clear if the company later indemnified doctors. In the memo, company officials note that the year before the American Medical Association had made it clear that it considered indemnification an "inappropriate incentive" to doctors.

The memo also singled out Michael Fumento, a columnist, with authoring a "positive message." Fumento's column is dated June 26, 2003 and ran on the Scripps Howard News Service. In the column, Fumento assailed trial lawyers for circling Eli Lilly. "Frivolous lawsuits have sullied the reputation of many a safe and critical drug. This time, schizophrenics and others with severe mental illness could suffer horribly when frightened away from their medication."

Fumento cited "two studies from the University of Buffalo presented at medical conferences in May led the researchers to conclude that atypicals 'may actually have a protective effect' against diabetes." He went on to state: "It's widely accepted--including by the Pharmacology researchers--that many people found to have diabetes soon after starting an atypical medicine already had the disease, but their schizophrenia had prevented them from being diagnosed."

Zyprexa sales in 2003 totaled almost $4.3 billion and have largely stayed at the same level since then. Sales in 2005 were $4.363 billion. In 2005, Lilly settled a class action lawsuit, brought by patients who'd taken Zyprexa, for about $700 million. A copy of the settlement which Lilly filed with the Securities and Exchange Commission is on file here (scroll down about halfway through the document for the relevant text). Last month, Lilly settled a separate class action lawsuit for about $500 million.

NOTE: The memo referred to in this post may be viewed by accessing document number ZY100026321 on this blog's Zyprexa documents page.

Posted by Philip Dawdy at February 9, 2007 01:00 PM
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Comments

I don't understand Mr. Fumento's statement: "... many people found to have diabetes soon after starting an atypical medicine already had the disease, but their schizophrenia had prevented them from being diagnosed."

What is there in the collection of symptoms called "schizophrenia" that could possibly hide the presence of diabetes? And yet he says "it's widely accepted" that this is so. That doesn't make any sense. What drug has he been taking?

Posted by: Kent at February 9, 2007 04:19 PM

Scripps Howard News Service announced Jan. 13 that it's severing its business relationship with columnist Michael Fumento, who's also a senior fellow at the conservative Hudson Institute. The move comes after inquiries from BusinessWeek Online about payments Fumento received from agribusiness giant Monsanto (MON ) -- a frequent subject of praise in Fumento's opinion columns and a book.

http://www.businessweek.com/bwdaily/dnflash/jan2006/nf20060113_2851_db035.htm

Posted by: irrelevant at February 10, 2007 02:40 AM

Interesting that Fumento is part of the Hudson Institute.

Former Lilly CEO (and OBM head for GW Bush) Mitch Daniels, once ran the Hudson Institute. Hudson's ties with Lilly go way back.

Posted by: zipzip at February 11, 2007 05:03 PM

Interesting that the Hudson Institute used to have its headquarters in Indianapolis...

Posted by: irrelevant at February 12, 2007 09:05 AM

Fumento also had an article on ADHD in The New Reupblic in 2003. After it came out that Fumento had accepted money from Monsanto I emailed the New Republic editors and asked if they were concerned that he might have been paid by a pharmaceutical company for his ADHD article. In fact I have written them several times and have never gotten a reply.

Posted by: Jonathan Leo at February 13, 2007 07:35 AM

I never took a dime from Lilly. They are one of the largest pharmaceuticals in the world and in approximately 130 columns written for Scripps it was rather inevitable that I would write on some of their products. That was also the case with the seed and biotech company Monsanto. Specifically, as BusinessWeek actually points out in its article, Hudson received a BOOK grant from the agri-business giant in 1999 that was properly put into my account. It was spent during the course of that year and the book appeared in 2003. My column with Scripps began in 2004. Even though biotech was my specialty then, I only wrote two columns on Monsanto. (A third mentioned them in one sentence.) Not much of a pay-off case there, is it. Scripps dropped me without even consulting me, on nothing but a whiff of scandal. (BusinessWeek called them and said they were doing a hit piece on me.) Insofar as they are the same people who fired me in 1991 the very day I published a controversial book on AIDS, cowardice seems to be intrinsic to their business plan.

Hudson actually moved from New York to Indy because it was so heavily underwritten by Lilly's PHILANTHROPY. I think one of their scholars also got money directly from Lilly Corp. But the very reason I'm no longer with Hudson is that we're only paid out of our own accounts. No Lilly philanthropy or corporate money ever went into mine. Indeed, the last corporate donation I got was Monsanto's in 1999. Hence, in 2007 Hudson cut me free because I couldn't cover my expenses. I am now NOT making a living off my freelance fees. Corporation donors want somebody they can rely on; they cannot rely on me.

Posted by: Michael Fumento at March 4, 2007 07:17 AM

Thanks you for your candor. I am curious if you feel led astray by Lily as virtually nothing in your article, mentioned above, has turned out to be accurate.

Posted by: Jonathan Leo at March 5, 2007 05:29 AM

Mr. Fumento:

Someone is showing worrying signs of disorganized thought patterns. Compare what you wrote with BusinessWeek's reporting:

You write: "Even though biotech was my specialty then, I only wrote two columns on Monsanto. (A third mentioned them in one sentence.)"

They write: Fumento didn't disclose the payment from Monsanto either in the book or in at least eight columns he has written mentioning Monsanto since 1999. http://tinyurl.com/cntpq

In your June 26, 2003 article you wrote: "The newest class of anti-psychotic drugs causes diabetes. We know this because trawling lawyers tell us so. Fortunately, almost nobody in the media is buying it – yet. But frivolous lawsuits have sullied the reputation of many a safe and critical drug. This time, schizophrenics and others with severe mental illness could suffer horribly when frightened away from their medication." ..."Lawyers? That's impressive! But what do medical researchers believe and why is Zyprexa being singled out?" ..."To some lawyers these represent dollar signs. But to those suffering the demons of madness, they're miracle drugs."..."Based on all this, two studies from the University of Buffalo presented at medical conferences in May led the researchers to conclude that atypicals "may actually have a protective effect" against diabetes." http://tinyurl.com/2jpp2r

But an article in the Baltimore Sun published March 19, 2003, three months before your article, which even a perfunctory Lexis-Nexus search would have found, you can read the following:

"It's clear this is not rare," says Dr. E. Fuller Torrey, director of the Stanley Medical Research Institute in Bethesda, which studies the causes and cures of schizophrenia. "How common it is is not clear yet, but it's very serious. Torrey contends that the Food and Drug Administration, which regulates the safety of medications, should require a "black-box" warning - with the text in bold type - on Zyprexa's label about the risks of hyperglycemia and diabetes. "There's almost no one who's aware of it out there," he said. "You may be getting deaths of individuals, but no one is putting it together."

"Japan's Health Ministry, concerned by reports of two deaths and seven comas, barred doctors last year from prescribing Zyprexa for any new patients with diabetes, and warned them to monitor closely those already on the drug by regularly measuring blood-sugar levels. British drug regulators issued a warning in April." http://tinyurl.com/2lhafn

In other words, it wasn't just "trawling lawyers" but lawyers, a medical researcher and patients' advocate, and even regulatory authorities. Did you, or did you not, run a Lexus-Nexis search before you wrote your article?

You write: "Hudson actually moved from New York to Indy because it was so heavily underwritten by Lilly's PHILANTHROPY. I think one of their scholars also got money directly from Lilly Corp," which serves to underscore the distinction between Eli Lilly & Co and the Lilly Endowment.

This page pointed out that their fortunes are not quite that separate: The Endowment's assets, $15.4 billion, consist primarily of Eli Lilly and Company stock. Therefore, the performance of the stock market affects ...the amount of future year grants ... If Eli Lilly and Company stock decreases in value, as it did in the 1970s, the size and/or number of grants will also decrease. http://tinyurl.com/2loxxl

In other words, you wrote an article that was strongly supportive of a product whose sales partially funded an employer of yours, and conveniently neglected to disclose these financial entanglements.

Can you understand why I think your credibility is irretrievably shot? What would you tell a Zyprexa consumer who made treatment choices based on your slipshod column and went on to develop diabetes while on Zyprexa?

Posted by: curious at March 23, 2007 04:29 PM

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