Did Lilly’s New CEO Urge Off-Label Promotion?
John Lechleiter, who is about to be elevated to ceo, wrote e-mail in March 2003 to other Lilly execs that appears to have encouraged the drugmaker to promote its antipsychotic for an unapproved use, The New York Times reports. His remarks were sent after he traveled to Cincinnati to watch Lilly sales reps talk to doctors.
The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa, which drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes, the paper notes.
In the message, Lechleiter, who was then executive vp for pharmaceutical products, noted to other Lilly execs that sales reps were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The reps, he wrote, could also discuss Zyprexa with such doctors. However, Zyprexa was not approved for children.
“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” he wrote, while encouraging Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase sales. UPDATE: To see a lengthy response from Lilly that was issued at about 9:30 pm EST, keep reading….
Lechleiter’s e-mail message has not previously been discussed publicly. In the Alaska trial, after plaintiff lawyers presented it without the jury present, Judge Mark Rindner, said it could not be admitted into evidence in the trial because off-label use was not at issue in the case.
The Times continues by noting that the disclosure comes at a sensitive moment for Lilly, which is also under federal criminal investigation for its Zyprexa promotion and efforts to play down risks to doctors. Between 2000 and 2002, internal Lilly documents show the drugmaker aggressively tried to expand Zyprexa’s sales into markets for which the drug was never approved, including elderly patients with dementia, the paper writes.
To settle that investigation, and related investigations by several states, Lilly is negotiating with federal prosecutors in Pennsylvania on a deal that could result in paying $1 billion to $2 billion in fines and restitution, the Times writes.
The Lilly response: “The Times article not only mischaracterized Dr. Lechleiter’s email, which the court deemed inadmissible, but significantly minimized Lilly’s perspective on this topic, resulting in a very skewed and inaccurate article. Dr. Lechleiter’s email was nothing more than a call to action to ensure Lilly’s development organization placed a high priority on conducting clinical trials to address these important medical questions. His specific reference to “the opportunity to expand our work with Zyprexa” referred directly to clinical development already underway, not promotional activity.
“This email indicates his support for continued company investment and focus in gathering this critical information (such as data on safety, efficacy and dosing in these special populations) to ensure it was not only submitted to regulatory bodies, but also accessible so that doctors and caregivers could make informed treatment decisions.”
Lisa Van S
These Individuals are clearly “DEMENTED”!!
Laurie
““The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” he wrote, while encouragig Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase sales.”
I believe the above statement answers the question. Yes, they promoted offlabel, and not only with Zyprexa.
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STRATTERA. A failed SNRI antidepressant so, having failed, its now promoted to make a profit from children as a drug for ADHD - of course minus ethics or scientific integrity.
See how they run! They all ran after the Pharma’s wife who cut off their brains with a carving knife. Did you ever see such a thing in your life as …
CHILDREN’S LIVES BEING USED TO MAKE A PROFIT FROM A FAILED ANTIDPRESSANT?
TRY HERE!
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E-LIE LILLY. LIES ABOUT ZYPREXA.
E-LIE LILLY. LIES ABOUIT FAILED ANTIDEPRESSANT STRATTERA… let just promote this failed SNRI as a drug for ADHD and kill kids with its side effects. - at least we can make a profit then.
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ELI LILLY..
are just LIARS.
Atlex
Based on the information I have read thus far, I don’t know one way or the other regarding the intent of this email. However, to me, it depends more on who the target of the email was. If the recipients were research scientists, the implication is (as Lilly suggests) a call to action for additional research in the area. If it was directed at sales and marketing professionals, there would be a more suspicious implication. Ed, are you aware of who were the recipients of this email?
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“…in order to increase sales…”
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WHAT have you all done to inflict this on the children of our generation, our species, spread from AMERICA across the globe in our lifetime to OUR CHILDREN?
WHAT HAVE YOU DONE TO OUR CHILDREN?
http://www.youtube.com/watch?v=0-zDH_ekIUg
Ed Silverman
Hi Atlex,
No, I’m not aware. As I stated, this dispatch is courtesy of the NY Times, to which a link is provided. That’s because the NY Times sent a reporter to the Anchorage courtroom and I’m not there. Hence, I’ve not seen the e-mail. As an aside, Lilly issued a statement Friday night that I’ve included, in part, as an update, along with a link to the complete statement.
Regards
ed
Lisa Van S
Why doesnt Eli Lilly place the e-mail on its website, and allow the public to determine their intent.
As Senator Grassley would say,.. “Sunshine is the best disinfectant”.
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Because its not in their ‘corporate nature’ to be honest, let alone transparent.
Justice in Michigan
My question has long been - Why is Zyprexa making several $billion per year?
Clearly, there are not that many psychotic people….
So the broad options are that either docs are more or less spontaneously discovering all kinds of exciting off-label uses for the the drug……
Or they are being “cued” (to put it most neutrally) in that direction.
The criminal indictments and what has emerged from those don’t suggest a lot of doubt about this.
As I’ve noted in an earlier post, a student of mine (salt of the earth) who had a job with Lilly was afraid of reading the Zyprexa stuff when it first came out. She had a pretty good idea what it would look like.
Doc
How much smoke does the public, judges, congress, regulators, et al need to see before they realize there is a forest fire of unethical behavior in these big pharma companies. They have many good people trying to do the right thing, but they also have many aggressive sales and marketing reps, managers and VPs that are only about a buck - no matter how it is received. Without STRICT govenrment oversight these companies will spin out of control even more.
Grieving
Well, there’s another name of a Lilly exec (soon to be head of the company)who needs to be tried in a criminal case and sent to prison. Or do we want to quit pretending that over 1000 innocent young people died from Zyprexa, leaving massive devastation in their families. The word “death” has pretty much been dropped from news stories and labels, as if it really hasn’t happened.
Justice in Michigan
Strongly concur with both Dod and Grieving. Re: Doc’s comment, I believe the key will be to find ways to enforce accountability externally (through criminal investigation, civil liability, transparency requirements) _and_ to support the many industry insiders who are committed to doing the right thing. There are no shortage of these people, and, as I’ve said before, we (and they) are toast if we have _only_ external means of accountability.
Even “deaths” is probably the wrong word under these circumstances. It implies a “natural” process.
Former pharma Marketing Exec
JIM:
I haven’t forgotten what your question is, but I am spending a great deal of time thinking about it. How do we protect the people who want to do the right thing. The WB rule, doesn’t work as we can see that every time someone tries to bring a really big ethical question up to upper management the person usually gets tossed, then they have to go through the Qui Tam (Qui tam pro domino rege quam pro se ipso in hoc parte sequitur) process, which takes a lot of money and time and takes a serious human toll on the person who launches it.
Maybe the government should make it mandatory that there be a human rights/ethics audit of companies. Pharma first. They must report yearly an overview of their actions and be subject to unannounced inspections of personnel. Any fines or wrong doing recorded for any give company puts them on a list that is more closely monitored. Sales and marketing activities are more closely scrutinized. R&D and regulatory as well.
The point being, if you have nothing to hide, then implementing this process isn’t difficult at all. It gets really easy when you just do the right thing. Anything that you have to think about and reconstruct and repackage is probably something that you shouldn’t be doing.
I guarantee you that if you start calling prescribing physicians to the witness stand and asking them to specifically provide details of the product educational information such as time, place, date and contents and what honorarium or payments of any kind they might have received will be quite effective. If doctors realize that they will be brought in and held just as accountable, much of this activity will stop. Ask the doctors to provide exactly the information they received that assured them that prescribing the drug for this particular use was the right thing to do.
Anytime any drug is promoted with un-published material or for indications other than what it has been originally prescribed should be questioned thoroughly.
There are instances (although not in this case) when off label use is justified, but as long as the doctors know that at some point they may need to provide more details and information this will certainly make many physicians think twice about what they are doing.
I have said it before and I say it again - nothing less than full disclosure. Patients should be able to look up a website of the product, find the disclosures and find any warnings from the FDA and all studies should be there. If you put something up with sales and marketing initiatives, maybe then the patient will have half a chance to really have informed consent.
Just my thoughts for a Saturday…
Justice in Michigan
FME - Much thanks for taking your time on this, and for your thoughtful reflections. As noted, as an outsider, it is particuarly difficult to understand how “things go down” in the relevant range of circumstances.
I know a few WBs who have gone through the hell to which you refer - not only in the context of pharma. Only a few, and the very lucky ones who get a good deal support, luck, and related, would do it again. Vindication alone is rarely reward enough.
That’s why I stay focused on how to support those people as well as things like external modes of accountability.
Your thoughts about docs right to the point. I hear their war stories too…
Again thanks.
Melody
Ed’s March 3 article, “Nursing Homes And Chemical Straightjackets” shows another side of the story. The story states: “Connecticut has consistently ranked in the top four states in the prevalence of antipsychotic drugs dispensed to nursing home residents who have no psychotic or related conditions.” Obviously there is NO market these pharmaceuticals are unwilling to exploit.
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“Even “deaths” is probably the wrong word under these circumstances. It implies a “natural” process.”
So, lets call a spade a spade. It is death of children due to corruption, lies, hidden data by a company that knew what would happen.
Its name is MURDER. In any other walk of life, that is MURDER. There is absolutely no reason to let drug makers be the only people on this planet who can GET AWAY with doing what anyone else ends up in prison for.
IT IS MURDER.
THE MURDER OF CHILDREN.
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Perhaps, when citizens recognise and call a deed done knowingly by the name it is given when anyone else does that - MURDER - perhaps then, when the ‘drug company’ influence is lost, the people will do what should have done decades ago.
DEMAND A STOP TO MURDERING OUR CHILDREN.
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THERE IS NO EXCUSE. Drug fronts can argue and spin - WHY ARE WE LISTENING. THEY HAVE KNOWINGLY KILLED OUR CHILDREN.
They continue to do so.
STOP MURDERING OUR CHILDREN, OUR FUTURE. OUR SPECIES. IN OUR LIFETIME DRUG COMPANIES HAVE KNOWINGLY KILLED CHILDREN, PARENTS, GRANDPARENTS, AUNTS, UNCLES.
Why are stupid enough to let them continue by giving them time to continue while we discuss why, how, whether?
IT IS MURDER.
Grieving
Interesting you would pick up on, and negate, the word I used about my son “death” from profound hyperglycemia from Zyprexa. As time has gone on, and as I have learned more about the industry, doctors, and the government, I usually use the word “killed” or “murdered”. My son was murdered, no question about it, and his murderers belong where all murderers belong. That it is prison. Not a white collar, country club prison. A REAL prison.
I compare this crime with Enron sometimes. Large corporation; executives went to prison over matters having to do only with money. While Lilly’s crime has to do with the killing of innocent, sweet, loving, family members who with their families were taken by surprise. Stealth murders.