Furious Seasons

August 19, 2008

New Details Of How Lilly Sold Zyprexa To PCPs

Several of the recently-released Zyprexa documents from the Alaska lawsuit against Eli Lilly, the drug's maker, are accounts of sales calls (or detailing, as it's known in the pharma biz) on PCPs in the state and what things sales reps aid to docs about the drug. These sales calls took place in the spring and summer of 2002 and the details offer further evidence of the lengths Lilly was going to in order to market its drug for use in "complex mood cases" which the company was out to convince doctors were in fact cases of bipolar disorder requiring the use of the diabetes-causing antipsychotic. In some instances, the documents further establish that Lilly reps were openly lying to doctors about the drug's safety profile.

Even more egregious in my opinion: Lilly was using cases of patients--apparently with bipolar disorder, likely type 2--who ran into problems on SSRIs such as agitation to create a scenario for selling doctors on using Zyprexa in these patients.

A bit of context, first. As I reported last year, in April 2002 Japanese regulators ordered Lilly to put warnings on Zyprexa in Japan.

"The label, according to a Lilly document, would instruct doctors not to use Zyprexa in patients with diabetes or in patients with a history of diabetes. The warning would also indicate that there was an increase in blood glucose for patients taking the drug. 'Strongly disagrees' is what Lilly's assessment was of the Japanese decision.
"'This does not change the status of Zyprexa as a safe, effective and cost effective agent in the US market,' the internal document also states."

It would be almost another two years before the FDA would order Lilly and other atypical antipsychotic makers in the US to slap black box warnings on these drugs. That left Lilly with an open door to market the heck out of its drug in the US while claiming it was safe and effective, despite the fact that the company acknowledged internally (and had also been informed by docs) since the late-1990s that the drug was causing explosive weight gain in some patients, diabetes and hyperglycemia.

That out of the way, on May 17, 2002, a Lilly rep named Margaret Williams visited a doctor named Kathyrn Flores in Soldotna, Alaska. This call is documented on page AK6930 of the new documents. (I have corrected typos and abbreviations in the document. The sales calls document can be found here. It is 15 MB in size, so please only download if you really, really need to read it or you'll kill my bandwidth.)

"[R]eminded doc that Zyprexa is a great mood stabilizer, especially for patients whose symptoms were aggravated by an SSRI...Dr. Anderson just stabilized a bipolar patient earlier this week on 15 mg."

Fifteen milligrams of Zyprexa would likely stabilize a horse much less anyone with a bad reaction to an SSRI such as Lilly's all-star agitator Prozac.

Williams visited another doc in town that same day and stressed the SSRI-agitation theme again:

"Really work Zyprexa via patient whose symptoms are aggravated by an SSRI, emphasize Zyprexa as a mood stabilizer."

Williams hit the same theme with a doctor in Palmer, Alaska a few weeks later.

In late June a Lilly rep named Kristen Clouthier visited a doctor in Anchorage and handled the weight gain issue (AK6931):

"Pam Engle [a doctor?] was concerned about weight gain for those Zyprexa patients but we discussed proper diet and the fact that if patients are feeling better perhaps they will be able to actually exercise. Also discussed the mechanism of Zyprexa and that the drug does not cause weight gain but it does increase patient's appetite."

As has been established since, the weight gain issue had nothing to do with patients feeling better and everything to do with the drug itself.

Soon after, this same rep and other Lilly reps were discussing patient types with doctors and had stepped up to recommend using the drug in elderly patients as well as in non-manic bipolar patients.

"[D]iscussed Zyprexa patient type--elderly and SSRI patient also angered or can't keep a job, marriage....He said he has seen many people come through the door like that."

Throughout sales call details in these Alaska documents, Lilly reps continue to dance around weight gain issues and press for the drug to be used in agitated patients as well as the elderly. These are all things we've known about previously, since details from the initial Zyprexa documents were reported by the New York Times and myself over 18 months ago, especially the company's "Martha" campaign for the elderly and its "Donna" campaign for the agitated and depressed (see here under Donna). But these new docs show that Lilly's campaign of deception had reached into deepest Alaska.

For example, this (AK6933) from another 2002 sales call:

"[S]cheulles [presumably a doctor] asked about Zyprexa and diabetes--was able to respond according and discus moa [method of action?] of Zyprexa--Increase in appetite which may lead to obesity but no causal relationship established between Zyprexa and diabetes. Also compared to other agents [other atypicals] there is no increased incidence with Zyprexa--high risk rate in this population any way."

That's Lilly: always blaming the patient. Cute.

Especially cute in this document (AK6937) is when in April 2002 sales rep Williams went to a hectic clinic:

"Took in Reese's Peanut Butter Cups so I got back OK [presumably back in to the inner office]. Gave Dr. Child a cupcake sized peanut butter cup. He was kind of tickled."

OK, so you are hocking a drug that causes weight gain and blood sugar problems and you are giving doctors Reese's? That's ballsy.

But then Lilly knew its audience. I continue to be amazed that doctors are stupid enough to fall for free food and Lilly's lying sales tactics as regards Zyprexa in 2002.

Posted by Philip Dawdy at August 19, 2008 12:03 AM

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Comments

Whatever happened to doing a proper workup before prescribing all these pills? Oh, that's right - Pharma donates money to universities and so can dictate what students learn.

Posted by: Lilly NC at August 19, 2008 02:43 AM

And see, the doctor gave all those yummy Reese's to the patients, and THAT'S why they gained weight, not the drug ....

Philip, I know the Pulitzers still are too troglodyte for your stuff, but I think you can self-nominate to the IRE Awards from the University of Missouri, which cover online work. G-d knows you deserve it.

As an aside, my own Zyprexa story -- gained 30 pounds in three months several years ago that I only lost in the last year. (With no particular improvement in mood, either.)

Yeah, that was three months too long given that I have a family history of diabetes, but at least I wasn't stuck like a guy I know on one of my online support groups. He's in the public health system, has gained 70 pounds in six months (not a typo) -- but can't get another drug because Zyprexa is the formulary in his area for schizoaffective disorder. And the poor guy honestly thinks its his fault for overeating ....

PLEASE keep fighting the good fight, Philip.

Posted by: Larry at August 19, 2008 05:30 AM

This just all strikes me as the lowest of the low. To treat agitation from SSRIs by giving Zyprexa has just got to be one of the biggest jokes around, only it's far from funny. (How about lowering the dose of SSRI or better yet, getting off it altogether -- not adding Zyprexa?!!) And to claim that being on a cocktail of psych drugs might make you feel "well enough to exercise" -- that is a howler. Finally giving Reese's peanut butter cups to sell an antipsychotic -- what are we coming to here? Do you notice the incredibly short term focus of all these individuals? Just like the shareholder interests they are really serving, not the patients. This just demonstrates that doctors are little puppets in the hands of big pharma and drug reps. And darn naive puppets too. This is playing with lives -- it is truly disgusting and has nothing at all to do with healing people and making them better. The less one has to do with the medical profession as far as I'm concerned the better. It is a disgrace what has happened to what was once an honorable career. Because this kind of thing is not limited to psychiatry even if they are the worst abusers.

Posted by: Sara at August 19, 2008 07:46 AM

Does not cause weight gain??? DOES NOT CAUSE WEIGHT GAIN?!?!?

Sort of like what my psy.d. said when he put me on it - "it might make you eat a little bit." uh...ONLY LIKE A PREGNANT WOMAN IN THE THIRD TRIMESTER! and my metabolism hasn't been the same since. i was only on it 6 months and gained 60 pounds.

i believe that the atypical antipsychotics are this generation's answer to tricyclic / MAOI antidepressants. this generation are the guinea pigs for antipsychotic drugs - i can only hope somebody, somewhere has learned something from all this.

Posted by: anon for this one at August 19, 2008 09:18 AM

It is a shame that Lilly downplayed the side effects of Zyprexa out of paranoia (maybe the execs need to be taking it) about how well it would compete with other atypicals. Obviously it should have been forthcoming about the metabolic side effects and recommending an appropriate diet for those who found everything else to be ineffective (like me). It is not as if dietary restrictions with psychiatric medicines are anything new (re: the highly effective MAOi's). My doctor was upfront with me about Zyprexa. Through careful diet, I have not gained weight (and have lost some), and my blood sugar has been kept in check. Maybe I am the exception.

Does Zyprexa have it's problems: hell yes. But for some like me, it is the only thing that has stopped the madness. Take the bad with the good.

Phil, thanks for bringing to light what Lilly has tried to hide.

Posted by: Tony at August 19, 2008 09:41 AM

This is sick. My 11 yr old in 1999 was given 15mg of Zyprexa while on 150mg of Zoloft; she never changed her eating habits, and gained 100 lbs in one year. The pdoc told her to "take a walk and stop drinking soda". She didn't drink soda! and she DID walk.

She is the victim of a crime that's all I can put this into in my mind now.

Posted by: Stephany at August 19, 2008 09:42 AM

Here's another thing that can happen as a result of taking Zyprexa Metabolic Syndrome.

Posted by: Stephany at August 19, 2008 09:45 AM

"Really work Zyprexa via patient whose symptoms are aggravated by an SSRI, emphasize Zyprexa as a mood stabilizer."

So Lilly is admitting there are problems with thier SSRIs?... but saying "please docs, trust us this time, we promise we aren't hiding anything from you like we did with our marketing of the very ssris that are now causing patients to become so aggravated that you're diagnosising them Bipolar."
WTF? and docs fall for it again!

See, THAT is why I have little faith left in doctors, especialy psych docs, and haven't bothered seeing a psych specialist in quite some time. And to boot I am hooked on Seroquel and can't find anyone who knows how to help me get off the stuff (at least the wieght gain has FINALY stopped after gaining 75pounds!)... so I am stuck with just seeing my GP and having him give me what I ask for, which includes continueing the Seroquel since I can't function without it. AT least my GP doesn't think he knows EVERYTHING in the universe like psych docs do and will listen to me when I tell him that a certain drug has a certain unmentioned by the sales reps side effect. He thinks I have a brain amazingly! Feels nice to be able to share what you know with your doctor, such as: "champix has been making people suicidal and nuttso doc so I really don't think it's a good med for me to try, especially since it seems to have THAT in common with SSRI which we both know are my worst enemy."... and have the doctor respond "Oh, I didn't know that, I will have to look into it". Instead of "You're just being a paraniod crazy person to second guess my suggestions for you".

Personaly I think PCPs GPs etc are easier to work with as an educated patient than shrinks. But they are also probably easier to dupe when it comes to beng told what drugs to rx, just they aren't getting the kickbacks for psych meds in the same way so they are also easier to reason with if you have some good info.

Really I think with PCPs and GPs they CARE about they're patients more because they aren't operating from the assumption that you are a crazy person and that is all you are. I think GPs and PCPs probably catch on easier that thier patients are atually having bad reactions to certain drugs rather than to blame it on the patient and the illness to the extent that psych docs do.... least that's been my experience.
... I bet you though, if you checked the adverse events reporting site and the doctors who make these reports have to list what they practice, well I bet you will find more GPs report adverse events where most psychs just attribute these responses to the patients illness and don't generaly make reports.
I dunno, I'll have to go take a look at the site again and see what the trend is, if it's published.

Posted by: BipolarBunny at August 19, 2008 10:14 AM

Does not cause weight gain??? DOES NOT CAUSE WEIGHT GAIN?!?!?
Sort of like what my psy.d. said when he put me on it - "it might make you eat a little bit."
Posted by anon for this one at August 19, 2008 09:18 AM

The pdoc told her to "take a walk and stop drinking soda". She didn't drink soda! and she DID walk.
Posted by Stephany at August 19, 2008 09:42 AM

This is the main reason why I have trouble with psychiatrist or even GPs.
Till today they deny side effects. Even when it's even reported in the directions.
They remain silent.
I cannot take it.
Or they... lie.
"-No! Its not side effect!" "-No! My other patients don't have these side effects."

They say it for drugs that are around for more than a decade and that they have already have clinical evidences.
I don't understand.

Posted by: Ana at August 19, 2008 11:40 AM

re: my daughter's 100lb weight gain: she lost all of it w/out trying once the Zyprexa was gone.

Posted by: Stephany at August 19, 2008 01:36 PM

During my last mental health hospitalization, the pdoc I had at the time wanted to put me on Zyprexa, despite the fact that I have put that drug (and several others) in my advanced directive. I stated I would never ever take these drugs.

The pdoc in question, a kind man really in his 60s but a piss poor shrink, wanted to know why I refused to take this drug and placed it in my advanced directive.

I asked permission to go online, and showed them all the Zyprexa docs on this site.

The doc said he didn't have the time or the inclination to read the docs here. Then he made a disparaging comment that I haven't heard in psychiatry since Freud and his hysterical women.

And then had the chutzpah to tell my parents that I wasn't getting any better and he wanted me to go to a state hospital for a year to work things out with my meds.

I fired him on the spot. The thing is, most pdocs around here don't care about any drugs side effects other than rashes from lamictal.

But then, sigh, it's my fault I guess for living in part of the country where, according to one of NJ's papers, 18 out of the 24 USA headquarters are, and just think of all those "poor"" drug reps who would be out of work- not to mention all those donuts from Dunkin Donuts I have seen them bring in for the pdocs staff.....

Posted by: susan at August 19, 2008 10:38 PM

Love your blog,damn Zyprexa took it for PTSD 1996-2000 worthless for symptoms cost $250 month co-pay got diabetes.

Posted by: Daniel Haszard at August 21, 2008 12:01 PM

oh, and! the dr who took over my care from the other dr (original rx was from dr at a hospital) asked me at EVERY APPOINTMENT if i'd lost any weight. not only had i NOT lost any weight, i was GAINING, thanks to the zyprexa. and i was going to the gym daily, reating a restricted diet as part of my general treatment plan. didn't make a dent. didn't even slow it down. and this mofo is asking me every appointment in his accent, "hev you lozzt any vveiight?"

eventually i called his office one day and said that the side effects of this medication were outweighing (LITERALLY) their intended effects. he took me off the drug immediately. go fig.

but the weight question continued. i finally told him that i did not care to hear that question anymore, that i would discuss it with my GP if i felt the need, that i would let him know if i was looking for suggestions, and that it really made me feel as if he wasn't listening to me when he kept asking that question.

the very next appt. "hev you lozzt any vveiight?"

dropped him for a new (female) nurse practitioner. i think this one actually sees me as a human being. well, pretty sure.

Posted by: anon again at August 21, 2008 12:05 PM

Lilly hid the Zyprexa lethal side effects, plus the clinical trial deaths (see Bob Whitaker's book "Mad in America" - excellent - because they wanted to have a blockbuster come bursting forth from their pipeline. It is this conscious sin of omission that makes them eligible for a criminal trial. Please write your member(s) of Congress or state/federal AG and tell them to get on the stick. Second degree murder or manslaughter. There are plenty of families of those who died (unexpectedly; no warning) who will testify.

Posted by: Sorrowful at August 21, 2008 12:36 PM