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I
Putting the LTC Puzzle Together
In~Servi cENeeds
i
Key Providers (Pl~ysici.nns) * Scsii fhem Wbb are they What nre they using Why are they using it * How many Best tl~nes sac office / NH to Nurse P~.nctitioner PA Cke~.inlric psych they work with Dirocfor of Nupiing Sell iBom In service needs
* Sell than1
a
: i i : ~ i ~ ~ f i : !1!:~ ;p!2cc? :s
* MIQ
Ps.ychotroplcDUR
a
* In service needs
Pull lhvu oppol [unities
I
* 15-20 $old Fr~qpclicy routlng scl~cduleo drive 68 sallrldny l . * Whales 2x9, rnonth/evcryonq else lx monlh Measngc physician kndwlcdgt Lodrivc pre-cnll plan
I
.
I
-
Nagotinfc for new business
ARP nata on evcry call Resourca Ulilitatioa Pcer-16-Pcet * Build orourrd whale6
-
-
.
I
11
-.,.,.- r...-..,l~.
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EXHIBIT B
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This nsidwt is t:eceivirg Zypre;m 2.5 n,lg daily at -aidpin Curtent g&c studies demothat Zypr.&a provides .mrpeti~r k y and safety when compared to e placebo and significantlyr e d d cmegivgr butden rit a dose of 5mg daily1. Zyprexq has also demonstrated superior efficaq in tr active, passive, and verbal aggression, as well as hallucinations and delmsoxd. Please msfaef upgrading this resident's treatment t 5mg daily a 5 p.m. t optimize their therapy, o t o
S m JS, C h k WS, Garmcg IS, a el 2000. Olmapme treatment of psychotic and behaviaPal symptom n patienrswtth Ahfieinler's disease inomsing care facilities: a double-blid, randmnized, ~lac&o-cmtroIledtriaL Arcb Gen 57:%&!376. EdeU et a1
'
'DearDoctor,
This resident is receiving Zyp-mg ( W ,BID) at &pm and either has d B * swallowing or fbas a G-robe. Zyprexa Zydis is a new formulation of ~ * x a that is an oraUy d~~ tablet that mn be placed on the resident's t o m o dissohal in wakr t be beadnrinistered via I;-mbe, Please consider upgrading this r o resident's therapy to Zyprexa Zydismg -(QD, BID} at am/pm to reduce the nursing time and effort required t admhher this tesident's medication thetapy. a
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EXHIBIT C
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To Lilly Human Resources 1)epartment: Listed below is documntation regarding my manager, Dan Tubridy. As you will see, Dan's behavior during his tenure as Sacramento District Long Term Care District Manager since early 2001 has been somewhat unprofessional. He has displayed favoritism toward the men o f t he team and made the women feel unappreciated, undervalued, and uncomfortable. At this point, I have no respect for this manager and feel quite uncomfortable and demotivared reporting to him. His values clearly do nor reflect those of Eli Lilly: particularly integrity and Respect for People. As a resuh, I have decided to share this infomtion with the company's Human Resources Department.
June 19.2001 Sales meeting in Las Vegas, NV Most members of our team (Beth Merino, Holly Burkhart, Tanya Calandra, Tremell Turner, and Bryan Zappulla) went out for reeeshments at Caesar's Palace after dinner. We stayed and enjoyed each other's company fbr a couple of hours. The women ofthe team noticed that Dan had taken his wedding ring off sometime during the evening and left our table to attempt to create conversation with some women who were seated near us. While Dan's choice ofwhat to do with his personal time is his own, he was cotnpletely unaware of the image he was creating for himself by exhibiting this behavior in the presence of his new subordinates. Around midnight Dan asked Tremell and Bryan to break off with him to go someplace else without the mamen of the team. As we were all new to the team and wanted to make a good impression with our new manager, Tremell and Bryan agreed to go w t Dan. Dm kept them out until 5:30 a.m.the next morning. Dan called me early ih the next morning and asked me to contact the rest of the team to announce that our meeting would be starting an hour later than scheduled. When the meeting finally did begin, the three were terribly exhausted and unable to concentrate. I was scheduled to give my first team presentation that morning,although 1 had to cut it short since we were now short on time. I gave my presentation, although many were not able to concentrate. One person actually fell asleep while I was presenting. We later learned that Dan had taken the three of them to a "gentlemen's club" where they passed the night away. This set the tone in o w minds (the women ofthe team) as to the level of respect that D n has a for women in general. We have felt quite uncomfortable around bim ever since that evening. We also felt that this behavior was extremely unprofessional for a manager as it clearly interfered with the progress of our meeting and our (the women of the team) level of respect for him as a manager.
Week of January 7.2002 Territory Overviews with Dm Those of us who live near the Sacramento district office (Beth Merino, Maggie Bolton, Tanya Calandra and myself) were all scheduled to drive to the office for a territory overview with Dan. For Tanya, this was actually a three-hour drive, Akhough Bryan Zappulla livedonly a 4.5-minute drive away from the Sacramento office at the time, Dan had Bryan fly all the way to Las Vegas for his territory review. Dan also flew Holly Burkhart fiom Sah Lake City into Las Vegas for her review. Holly asked if Dan would
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pay for her to spend the night in Vegas since a round trip fromSalt Lake City to Las Vegas all in one day was a bit exhausting. Dan told Holly that he wouId not be able to justify having the company pay for her room and that if she wanted to stay, she would have t pick up the cost on her own. Holly chose to f y back that same day. Dan told o l Bryan, however, that he would be happy to pay for his hotel room for the evening (despite the fact that it is less .than a 2-hourflight from Vegas to No. CA) and that he wanted to go 'out on the town" with Bryan and Tremell that evening. Having wives at home, neither of them reaIly wanted to do this, despite the kct that Dan put tremendous pressure on them to do so. In flying Bryan all the way to Las Vegas for hs review and i paying for his room, not only did Dan waste Lilly dollars, he once again displayed tremendous discrimination and Fdvoritisrn for the men of the team.
03.2001
In the Long Term Care Division, responsibility for accounts is often a gray area. Some accounts are shared depending on what percentage of their business lies where, while others are not. During tny first year in the field, I worked very closely with my pharmacy directorsto determine exactly where tbeir business comes fiom m order to best identifj. how responsibility for these accounts should be shared, if at all. Sometime during 2001, Dan Tubridy had a conversation, without my knowledge, with Robert Eloneaga of Southern California to detennine how an account out of San Diego, Resource Pl~amaceuticals,should be shared with Northern California. Since Resource provides all the refills to the Sunscript Pharmacy accounts in Northern California, Robert felt strongly that at least one Northern California LTC rep should share responsibility for this account Since the Northern California Sunscript pharmacy physicaUy sits in my geography, D n and Robert made the decision, without my knowledge or input, to add a this account to my accountability profile. Dan never had the comesy or professional respect to infonn me of this decision. 1 only found out because the a~xount mysteriously appeared in my TUR reports the next time data was sent out to the LTC reps. I c d e d Dan immediately to ask why this account had been posted to my accountabilityprofile. Dan explained that he and Robert made the decision based on the hct that the Northern California Sunscript account sits i my u geography. I explained to Dan, (not for the first time), that although this pharmacy physically sits in my geography, only about 5% of their business actually takes place in my geography. The other 95% is completely out of my control. Which meant that of the business that Resource Pharmaceuticals handled out of San Diego, only about 2% at best actually came fiom my geography. Dan agreed that perhaps this account shouldn't be shared with me but that it needed to be shared with SOMEONE, k d since the northern California facility lied in my tcnitory, I was probably the best choice. After some discussion and argument, Dan finally agreed to have this account removed ftom my accountability profile. However, this did not occur until the beginning of Q4. Since Resource Pharmaceuticals perlbrmed poorly in Q3, it caused my performance for Zyprexa sales to come up short for 43, dramatically impacting my profissional ranking
and Premier Rewards. Rather than do the birthing which would have been to remove
this account retroactively and pay me the rewards 1should have been due based on the performance in my territory, the decision was made to leave the data as-is for 43 and
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basically allow me to "eat the loss." I can't stress enough how demotivated 1 felt after that incident. January 23.200: Sales meeting in San Francisco, CA The ladies of the team (Beth Merino, Holly Burkhart, Charmayne Rauch, and myself), Dan Tubridy, and Scott Reese went our to a nightclub called The Starlight Room. For this particular evening out, Bryan and Tremell told Dan they did not want to go. Since they were both manied, and D n always insisted on dragging them to places a their wives didn't appreciate them frequenting, they decided to avoid the situation altogether by staying at the hotel. Afier a couple of hours (a about 1 1:15 p.m.), we were all ready to leave except for Dan. Our group (minus Dan who stayed behind because he was having a conversation with a strange woman at the bar) walked the two blocks back to our hotel and retired for the: evening. I was rooming with Beth Merino that night. At midnight our phone rang. It was Dan asking us to come to the lobby bar to have more d r i i with him. We told him we were already asleep and would not be joining him. I actually told him that he should go to bed since we had a meeting the next day. He said, "We do?' I replied, "Yes, we do." I said Goodnight and hung up the phone. our Immediately after this, Dan u~lled administrative assistant, Charmayne Rauch, up in her room and asked her to corne down to the lobby bar to have drinks with him. Chammyne asked who eke was going to be down there. He lied to Charmayne, telling her that Beth and Jaye would be coming down as well (after we told him NO). Charmayne joined him and w;is surprised and unhappy to find out that she was alone with him. Once there, she felt obligated to entertain him and stayed for a while although she really did not desire to do so. In his dnmken state, D n confessed to Charmayne that he a was unhappy in his marriage. Charrnayne klt extremely uncomfortable and confessed what happened to me in confidence later in the week. Again, Dan exhibited very unprofessional behavior.
Januraq 24.2002 Sales meeting in San Francisco, CA Our team was scheduled to go out to dinner together. We had reservations at a restaurant for 7:00 p.m. and were to meet in the lobby at 6:30 p.m. At 6:30 p.m. D n a arrives in the lobby and announces to us ladies of the team that he, Bryan, and Tremell will be going out on their own and will see us the next day. D n had asked Bryan and a Trernel l to go out with him that evening to strip clubs. Dan made the women of the team feel as though they weren't important. It was becoming more and more obvious to us that Dan fivored the men of the team and that the only women he was interested in spending time with were those whose talents lied in swinging around poles on stages.
F e w 19.2002 Telephone conversation between Jaye Ramirez and Dan Tubridy I confirm with Dan that he received my e-mail suggestion for a new Long Term Care slogan for the national meeting. When he said that'he did, 1 asked him "What did you think? W s it good?" D n replied, "Yes Jaye, it was good. In fact, it was SO ~ o o d , a a I have to ask you whether it is an original idea?" I klt completely insulted. I replied to
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Dan, "How can you even ask lne that? I felt again as though he did not trust in me or believe me capable of being intelligent andlor creative enough to come up with an original idea.
April I. 2002 In a telephone conversation with teammate, Bryan Zappulla, 1 learned that Dan, in response to a request from Bryan, is having Lilly pay to send Bryan t o an upcoming American Society of Consultant Pharmacists conference in Las Vegas solely fbr the purpose of taking one of Bryan's customers who will be in attendance t o a show. Dan is also planning on attending this show. Bryan was not one of the reps on our team chosen to w n a ''perk" trip this year, however Dan once again shows favoritism to the men of i our team by sending Bryan on a company sponsored hip to help him build his relationship with his customer. The week prior I had acruaIly asked Dan whether I could attend this conference since the President of the ASCP, Mark Sey, is actually one of my cusromers and beginning to speak for Lilly thanks to my intervention. The answer 1 received in response to my request to go to Vegas however was NO. As it turns out, this trip ended up being a nightmare for Bryan, since this is the very trip where his wife, Angel Zappul la, died suddenly of an acute asthma attack. Bryan will tell you that upon return &om that trip, Dan's unprofessionalism and complete lack of compassion was evident. Rather than being concerned about Bryan's mental health after this horrific tragedy, Dan was m s w n c e m d about how long Bryan was going to ot be out of the field and when he was coming back. In fact, the Monday after Bryan's wife died, Dan asked me by telephone whether I had talked to Bryan and if I knew when he was planning to return to the field. I found this to be appalling. Se~tember 2002 I was given a specific dollar budget by Dan Tubn'dy of how much money I had to spend for expenses during Q3 of 2002. I stayed within that given budget, to the exact dollar. Just after the quarter ended, I was informed by Dan that because my expenses were not submitted and actually processed by EERS before the end of Q3,I had lost the money that was allotted to me and would have to use my allotted 4 4 budget to pay for money I had spent in Q3. Beceuse of Dan's mismanagement of our budget, 1 have been without any money to spend on customers during Q4. Perhaps had Dan not squandered Lilly monies earlier in the year flying reps on unnecessary trips and paying to take them to Gentleman's Clubs, we would have a little more money to spend on customers during
Q4.
February 2003 Area meeting in Sconsdkle, AZ. We aU dressed up for the 70's themed reception our first night in town. O r team wore Afio wigs. Tremell Turner, who is Afiican u on American, was sitting across the table c r me at dinner. While Ttemell in real life has no hair, this evening he was wearing an Afro wig like the rest of us. Dan was seated next to me. Halfway through dinner, Dan leaned over and said to me "I'll bet that's what Tremell looked like when he ha.d hair.. . good thing he shaves his head!" 1 found this comment to be inappropriate, prejudiced, and rude. I did not reply to Dan's comment.
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March 2003
This month Dan delivered a homemade presentation to the consultant pharmacists of my biggest customer, Neighborcare. The presentation was so biased, that I actually received an e-mail fiom Stephanie Ponedal, the lead consultant for Neighborcare, complaining about it. Stephanie said:
" J a y e , F i r s t , I need t o let you know t h a t t h e c o n s u l t a n t s were very unhappy w i t h the p r e s e n t a t L o n on Wednesday. M c o n s u l t i n g group y is very p r o f e s s i o n a l and e t h i c a l . They f e l t the presentation was extremely biased and dial not take into account t h e v a r i o u s issues we need to d e a l with i n our p o p u l a t i o n . "
D n actually handed out a homemade upgrade recommendation letter (created by a Jerry Windle of our Oakland territory) to the pharmacists. I took Stephanie out to lunch a couple of weeks later to apologize. She explained tbat the only reason she let us give a resenta at ion that day was because of her respect %r me and the knowledge that I \vould never deliver such a biased presentat ion. She said she was extremely disappointed with the unprofessionalism of the I.illy management team.
June 2003 I haven't documented anything in a while, but not because things do not continue to happen. I am simply tired. I have been cxtremely~dernotivated since the SPP process of last year during which I was made by Dan to be the scapegoat fbr this team's lack of motivation. I was accussed of "leading" the team's bad attitude toward him. It is unfortunate that he cannot see he has accomplished this all on his own.
We just returned fiom a quota nip during which we all feh compelled to lie to Dan's wife, Meta, who asked several of us one-on-one about why she cannot reach Dan by telephone whenever h' out of town. She asked why we drag her husband out until 4 es a.m We tried to tell her that we do not go out with him and we do not know why she cannot reach him at all hours c)f the night when he is out of town. She replied by stating that either we are lying or he is. We all felt extremely uncomfortable. What kind of manager would put their empl~yees this position? in
Overall, my two-year.tenwe with Lilly under the leadership of Dan Tubridy has been disappointing, at best. He is, in the entire length of my adult career, the most .unprofessional, hsensitive, demotivating manager 1 have ever worked with He is an extremely poor communicator and does not like having "difficult" conversations with his subordinates. He seeks the negative in everyone and everything. He does not possess the values that Lilly proclaims to hold in utmost importance. While Dan has excellem analytical skills, he does not have the people skills required to lead a team J fact, in my n opinion, he is a "lawsuit waiting to happen."
This team is cunently at high risk of losing many of its employees within the near future, primarily due to extremely poor leadership. I regret not having come forward earlier with this information, however fear of retribution has kept me silent. I am so completely demotivated and disappointed by my experience here at Lilly over the past 2.5 years, I no longer care.
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"Pomdal, Stephanie"
0310712003 11:42 AM
To: "[email protected]
Jaye, First, I need to let you-knowthat the consultants were very unhappy with the presentation on Wednesday. My consulting group is very professional and ethical. They felt the presentation was extremely biase,d.and did not take into account the various issues we need to deal with in our population.
Back t Dr. Verma, I discussed with the consultants and they thought a dinner in the Concord/Walnut Creek area would be a good idea and we could invite
physicians and psychiatrists. Two or three of the consultants who live in the area could attend. It is really difficult to get all the consultants together outside of the consultant meeting. Most will not travel unless they absolutely have to since they are generally on the road all day for work. I don't know what else you have for Dr. Verma, but if this sounds like something you want to pursue, we can talk. Thanks, Stephanie Ponedal >From: RAMIREZ-JBYE-J@LIUY . COM >To: Stephanie Ponedal
I
-
>will need to knou right away, however, if you would like to work with us. ,>to.set something up. Lilly will pay for a meal for the consultants and >for ~ r . Venna's expenses, of.course. We just need t lock in an o >approximate time ... either lunchtime or dinnertime. Please let me:know
if
>we can work something out ISSAP. Thanks! >Jaye R d r e z
>.
>
........................................................
> >Sumer Venna, M.D. >Psychiatrist in Charge, Special Care Dementia Unit, McLean >Hospital, B e h n t , MA >Lecturer on Psychiatry, Harvard Medical School >Associate Professor, Department of Psychiatry, Boston University School
of
>Medicine > > >
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> > >Stephanie Ponedal
>
> >
>
>
To :
CC :
RAMIREZ-.IAYE
-JeLILLY .COM
'
Subject:
Re: Visit from Dr.Sumer Verma, May 2003
>
> > >Hi Jaye, >Is this st111 something you want to set up? >Let me know. >My Neighborcare e-mail is [email protected] >Stephanie > > > >
>
> >To: Stephanie Ponedal
> >CC: COOLEY [email protected], [email protected] > >Subject: ~ T s i tfrom Dr.Surner Verma, May 2003 > >Date: Wed, 23 Oct 2002 13:56:46 -0500 > > > >Stephanie, > > > >Per our phone conversati~nthis morning, Dr. Swner V e m a (credentials > >listed below) will be in the Northern California Bay Area May 14-16,
> >From: [email protected]
> > ? > > >
>2003. > >
> > >
>Hospital, Belmont, NA > Lecturer on Psychiatry, Harvard Medical School > Associate Professor, Department of Psychiatry, Boston
Sumer Verma, M . D . Psychiatrist in Charge, Special Care Dementia Unit, McLean
University > >School of Medicine
> > > >We at Lilly would very much like to work with you and Neighborcare to > >arrange a presentation to the consultants and pharmacists of
Neighborcare > >during that time frame. Breakfast or lunch on Thursday, May 15th or > >Friday, May 16th would be ideal. > > > >Please call or write me to discuss. > > > >Thanks! > > > >Jaye Rarnirez > >Neuroscience Specialist > > L i l l y Long Term Care > >stockton, CA > ,209-604-2649 >
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EXHIBIT D
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Predictable symptom control of both psychosis and elevated mood helps YOU restore calm.
!/
Dependable maintenance of treatment response in schizophrenia helps you bring comfort..
Flexible dosing helps you
F
customize care.
ZYPREXA is indicated for the treatment of schizophrenia and acute bipolar mania.
Cautlon should be used in dosing to the elderly, especially if there are other factors that might additively influence drug metabolism and/or pharmacodynarnic sensitivity.
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Significantly more patients achieved higher levels of
improvement in psychosis compared to risperidonel
In a schizophrenia study,:.a significantly grater percentage dpltienrr -red
with
ZYPREXA achieved an improvement of 24096 in PANSSTod S C O ~compmd ~
with riqmidonc-t&ated paticnk?he percentage of patients achieving a 20%. impmnmurt in PANSS Total Scorr was comparabk b c m n treatment group'
<
1 tz.w.aa J C ~ W
igs.1~407-4ia
WL-~s ~ u h ~ n e W m o r 3 0 e
See~89e6lamoarJmreWh
Efficacy in treating symptoms of elevated mood112
Symptoms
include: IRRITABILITY DISRUPTIVE/
AGGRESSIVE BEHAVIOR
SLEEP DISTURBANCE
In this bipolar mania study, for those witb psychotic symptoms, p p s mated with
ZYPREXA and divalproot showed comparable improvement i Y-MRS Total Scorc n (ZYPREXA 42%, divalproa 43%; P N S ) .
ZYPREXA is Indicated for the treatment of schizophrenia and acute bipolar mania.
prem
%
Dlanzapln e
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Efficacy in total symptom improvement1
*
hr~mr*
Symptoms
include:
nor&
I -with risperidone-tread patients.
DELUSIONS
m L
EXClTEMENT HALLUCINATORY BEHAVIOR
In this schimphrcnil srudy, a signhcantly g e t percentage of patients neared with r au ZYPREXA achiwcd an improvement of 24096 in PAi'riSS Tocal Scorc as compared
ZYPREXA is indicated for the treatment of schizophrenia and acute bipolar mania.
I TrmRletY.Jffi ~ o r ~ ~ ~ m d o ~ a i m p a r ~ r ~ ~ ~ ~ 9 e e p s p e ~ l ~ l ? ~ d h f l ~ e -1Sm.17r t o r p ~ s c
~ a o . r e ~ ~ i a i 9 1 n t ~ ~ m h d y ~ n i ~ & r r i . F O T ~ i n f t m p d a n m . c i j p e r i d a a w4a. ~ m . ~ ~ s
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Superior maintenance of treatment response'w2
_ . . . . _
.
. . -
.
.
-- -
In this schizdphrcnia study, s i g d a n t l y kwcr patients who rached more robust
lcvdr of i m p m c n t (&totaking ZYPRE)W ocpericnccd relapses at 28 wvccks, cornparcd to patients taking rispcridone. Significantly more ptiemts taking ZYPREXA who had
impmcment in
PANSS Totd Score at week 8 maintained their clinical response through wck 28 (ZYPREXA 8 . 9 .n=105;risperidone 67.796. 796 n=94; F-.001).','
Patients should be pcriodidy rrv~ssed determine the need for mainrcnancc to
n a n e n t with appropriate dose.
N R X I indicated for the treatment of schizophre.nia and acute bipolar mania. PEA s
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ZYPREXA tablets
Oncedmly dosing without regard to meals:
Starting dose of 5 mg recommended in patients 265 years of age.
--------
ZY PR EXAQ Zyd is"
(Olanzapiine)orally ~isintbgrating b ~ c t s P
Quickly dissolves orally in-as little as 5 seconds.
When symptoms potentially lead to noncompliance (chceken, spitten). When residents axe having difficulty swallowing medications.
Caution should be -usedin dosing to the elderly, apccially if then: are
other factors that might additivcly influence drug metabolism and/or pharmacod~marnic sensitivity.
ZYPREXA is indicated for the treatment of schizophrenia and acute bipolar mania.
Fu~salerypor4andmner~~~.ge~Ib17dhSReSaDnpIsc~
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Favorable safety profile
Low pot,ential for harmful druginteractions if conconlitant useis necessary
LinL potential shown in uh to i n b i t P450 cyw&mws
C c e d m i t i i i c i a ~ fo&
o ethanol Hi& ZYPREXA rcny b t c a t i r t c onhonadc r
bnmenh~. Lnvaduscj dZY!?REXA chould be wnriderrd in pltici~a receiving rancanitant m a t m a t with ikmmmbc.
Low potential for cerebrovascular accidents
Low potential for anticholinergic-like side effects
Iro'darr of common mtrcbolinagic-lik N c n r r nor r r ? . t i n i d y &
Anticholincrgic sidc cffms s and i& hcan n r c .
t y indude:
i
t from plocba'
dry mouth. blumdvkion,&pation.
urinary remytion.
No baseline ECG required
No routine liver or kidney function tests required
1:DaraonHe.lity~
No adjustment of dosage required based upon degree of renal impairment
t
h a e rp S m*n 2s01das~Mupm6~
d ~ ~ m 2 5 1 0 '75 mahtar b=248lor md3
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Incidence of EPS comparable to placebo
----.
..-.
In p ~ b o r o n t r o U c d schizophrenia trials, the incidence of &anent-emergent extrapyramidal symptoms (EPS) associated w t ZYPREXA w ~ s ih comparable to phcbo,' as asxssed by the Simpson-Angus Scale for Rrki~~~nisrn.'
f n only onc +sis
of a pIaccbo-oontrollcd study, only onc specific form of EPS,
m p d with placebo.
aluchiiia, xv3s reponed sigrificantly more often with ZYPREXA at any specific dose
(10.w.5 or 15.Od.S mglday) m
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Efficacy in improvi~ig depressive symptoms1 '
Symptoms
include:
SADNESS HOPELESSNESS
In this xhizDphrenia study, ZYPREXA bvas ;ignificantly more effectivethan risperidone in improving depmsiw symptoms.
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Additional prescribing considerations
me most common treatment-emergent adverse went assodated w t T/PRMAvs phmbo in Week-la ih
~ormoren~ep6okv~15%).~~soobservedmv~ptacebo)wete.
Whypo$nsion(5%vs%) persarahtr-18%=4%)
hsls was
aka(hlaa(6%vsl%)
dlzmess(ll%vs4%)
-(9%vsm weiamrn6%~1%)
The most mmmotl treatment-emergent adverse event ( r e p k l hr 210%d pabenPsf wth ZYPRMA n nsperidone m a sYu~@~enia bial
wassaMdencep~us24%).Also~ved(zvPRMAvSnspendone)were:
aralefl(l9% 17%) vs insomnfa (1 1% vs 14%) nausea (4% vs 10%)
The most mmmon tmatment-emergent adverse event ?ssa%ledwithZYPEM vs phc&c~ b, m-lenn,
~ m J n i a ~ a s ~ ~ r ; ( 5 % v s t3%3%)./UsoobservedpyPRExAvs~)wsre:
dryrouthtP2%~796) Qniness' (18% vs 696)
headache (15%s 11%) hinitis (9%vs 14%)
bials m
~ w ~ - P 6 % = 3 % ) B e r n (6%vs 3%)
~ p a t l o fli%vs 5%) n
dyspepsia(Il%a5%)
a.dImb1(l5%
us 6 ) %
events h a 3-week bipohr mania bk4 of ZYPEW vs dnatproa:were ~ncreased appelne ( 2 0 6vs 2.4%) 1.9 my moutr, (33.6%vs 6 3%)
Common and signifimdy different admnmobm (392%vs 2 . % 06)
natsea (10.4% 6 28 6%)
I
I
OWf beatmenr-emergentadvem eenl~ ~Zporld 5-10% ol p a l m and signiRcantfy k t e r for NPRD(A n r!mpoec induded lremar n (9.6%~~32%),nedc~ty(7.2%vs 16%),speechdrSorder(80%us0.896). and~sieepder(56%vs0.8%)
Orthostatic hypotension
1
h pwr\arketingm
a Ws, some pabents taking PIPRDC4 scpenenced orthosramhypotefision associated wth dnzines9: tachycard&;
and, hsome case$syncope (1 WW. 0.6%)
Case 3:07-cv-04911-CRB
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Page 29 of 50
kansient, asymptomatic elevationsof hepaUc bansaminase
B
c b u d y signiRcantA C l o elevations (23 times the upper lima of the mmai range)were ~ t I a pu observedh2%(sn43)ofpaMexpDsedtoZVPRMAcomparedtomW151oftheptacebopatikms. W d 1 h e s e ~ e w i m m - J ~ . ~ a s s e s s r r e n t o f m a m i M s e s s ~ i n ~ m V I s r g n m c a n t ~ M : ~
Asniihall~medcaliws.Mef~gconsiderations~b~hED~whenprescnbingPIPRMA.
Tardive dyskinesia (TDt-prescritungshould be consfstentwllh Lhe need 10 minimize U?e risk of TD.If Hs signs and sFptoms w, discontinuationshouM be Consdered
Sei2utesdmared inhqwtly in pemkliy c
W trials d MPRD(li Q212500.0.9%). CoFdoundrngfadas may have unbbuted b many oftheseaxx~rences~shaddbeused~inpatieots\~ilhahblwydse~wwiQlmliassthalbvrertheseiMe
Use in special populatioosin a d W slu6j m W n g home palknts having variwrr psychilric in h l wUh AWeimer's dsease. scamlem.abnmral gait. W,dehydratifxl, badc pain were obsaved mcue olten vn7h NPRMA U wah ptacebo. and m Orthe2500patientsinpre~~stlalles~ZYPRMqIlok~~weffiyearsofage~clver.AswN,dher~-activemugs. ZYPRMA shouW be used wilh &in ekMy pfknts with dememia. Fa patients d any age requbing special cMsjdemtiM eg, paW% Nho are MfiaIed, who are p r e d i lo hypotensi .mctim, who'have a mbbatia,of factas that may result in sknw metab3ism d
NPREXA.or~may~more~m~~sensitivebP(PREXA,as~arting~ol5mgMay&recommended.When~.dose es&tionshwMbeperlormedWrlhcautanfnU~~ts.
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Methodology and study limitations
lkswas a double-blhd. mndomhed, tnMumler, h t e m a m tnal of 339 pabents W@I s c h w h m a , s c h a o a m dbcrder,rx sd&ph%m disorder. Patients here randanhed a1 a 1:l ratio l treatment wRh ZYFTEXA 10-20@day or risperidane 4-12 mgWay. o P a m eruuRed in the sMy had the oppomsPty to CCullpleE 28 weeks of treatment A total d 178 patients (52.5%)cmplekd Uh? sbdy n s%;rtspendone 47.3%: P-.E~)
m
f&msentwlm fa&rg, nsperidona-treiledpatients began litratmn at a .I mg h x daily cn day 1.2.mg twrce daify.mday 2. and3mg~dabj~nba)s3fta~7.'lhereaner.~tors~adjustdose~pward~d~by2wwevery7dayswi~ t e appmved range d 4-12 W a as dlnically *hc!icaW The mes, modal doSB for rlsperidonewas 72mqrday. h Uy
Treatment-emergent EPS v a s W& tad on the fobvhg Meria: Simpson-AngusScde Wd saxe 981any cat-kdmvisi fa ~wim~~a;BameSAkathisia~~tsmer2atanypmt-~visitfw.~with~~.
Pattents M were preuiws)y m p e d t nsperidone-werenot -from I O o MPRW\ m e .
Ws shrdy,whereas patients peviouslyexpmd ro
ZYPREXA vs divalproex in bipolar mania
mis was a doubkbbnd. rambmed,mle-phase,3-week sk@ amcbded in 44 US sites to unrpam the
and safety ol ZYPRf3A vs c%@oex251 patierrtswithaEM-N~ofbipdarId~.acperiencingaar$mixedamanicepisodes~meYoungManiaRating % [Y-MRQ TOMScore ;l20), vhth or vriatwut pqdnbc feahues,Kith a without rapid cychg murses were 'kduM. &
Dostng ranges were 5-20 mg 00 lor 2Wf43A and 500-2500 mg dnlded f dhmlpoat. with sbdmg daily doses at 15 mg fcr ZYPRMA and u 750qtordvalproexFaW3-weekMat.meanmodaldoseswem 17rngfwZYPAMAand1 4 0 O m g t a ~ ; m e a n e n d o l g d o s e s
were 17mgODforZYPfEXAand 1500mgdrvLdedlordnalpmexDaiiadjt&mentscadd bemadeaRer2daysandwerebasedonclinical response 4 pbmta lev&. Pksma lev* were performed t ensm t l h t p ~ x o hough W l s were mantabed w m n the targeted l k ~ e u i k it
range o 50-125 yglml Up to 4 blwd samp!es were obtarned f 79 4 Wrrk
panent (mean. 2 . 7
w):mean vabe d all levels ctmned was the
Case 3:07-cv-04911-CRB
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P A N S Total Score hdidual items indude: dellsions. comW ds m mk .halluchtw b e b h . esm tbrandimav. io a t n a e d n l
.I
and poshaing. depresson.mPtw fetafchlbt tmcooperahems, uramralMougN content,disacie.ntabTn, poor attention,
t% ol Iudgment and safght,(EsWmce of VOTin, p a r ltioknpk preocnpak~. sctive mial a m . The items are rated a contd, and on a 7poin scale kom 1 fabserdl b 7 () -. 1
Y-MRS Individual Items include: ekvated W,inaeased m o b adivityfq, smd Meres& s8eep. hilabifity, speed amourt), languagelmarght (6sMder, UKUCM thougMnt ntentWaggressrve aPPeam. and insW
m,
w and e
S i m m A n g u s Scale for Parkinsonism is used to meanne d n r g l m parkinsontsm lm h c M x o a t m dmgptnp.straulder t wrist leg pendubusnes$ head g&eW tap,tremw, and sabbm. Uems IT rated on a Spoint scale shalorrg. ekuu fmmO~absenceol~)to4@resmcedmnditbnin~~.
m.
-.
PANSS C0gn.m Score indudes c n e W dlsorganizatii. O mI in aLEtm3 Uiilonq, stereotyped Wnlong. tension. mannerisms and o cp R ly poshning,pmattention.andh&dIodgmenlanclinsigM
PANSS Depression Item mmres depressive qmptams'Mng sadns adn.
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Predictable symptom contiol :of both psyc hosjs and
Flexible dosing helps you
customize care.
Pre's'cribed for more than 10 million patients worldwide.
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- ,
EXHIBIT E
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ZYPREXALONG TERM CARE
GUIDE
DATA FOR 2001 SALES AID
For your information ONLY; not for use in detailing.
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0
TABLE
O F CONTE'NTS
Short Mcssag Sihtldons ...................11
........... -12 Data on Demand.. ........... .-.
Objection Handling ......................,... IS
.
m
Case 3:07-cv-04911-CRB
strategy is evo-
STRATEGY OWERUrIEW
Document 1-3 Filed 09/21/2007 Our Strategy
Page 40 of 50
The ZYPREXA Long Tam Can: rncbsagc
in rcsponx ro cunwncr fdbadr. However, stabilidng symptoms and behaviors, rnaintcnana of response, and d q continue r be the main drivers of thc businas in o this setting. Message d data indicates that wc havc bem & & in getting both the &cy and safety messages acm-is to our customus. Now is the time to diffcrentiatc 2WREXA u the product that ~&iliw symptoms and
Ourgoalistoenu~lragrdodorstotry ZYPREXA i patients similar t .thcone we n o p d c , Rose Jackson. In this way, doctors can see for themselves that ZYPREXA dillzes symptomsand bdmiors BaMy. Thcy win: be able t see for t h a i v c s that ZYF'REXA makcs o patients Wrt R s e h e r and keeps them bettu.
The a a h Z t ofmmparativt &a versus a vibiy major competitor and the decisjori of t h e m for maintenance therapyl in s c & q h m i a haor opened a window of o p p o d t y for us to c l i f f d a t e omdvts b c o the comvtors. L p g T m Can customers an imprmed with tht comparative data and thc fia
dmZWREXAistbehandor3yp$mmpic
to receive a indjcmion for maintenance therapyn Afta & c u s t o m arc not only intacstd 'in getting Rosc better, but i k q G i h a better." n
To c f f e d d y di&cotiatc from dbt cornpetion
in both d a y and saticy, we mvst conwmte on thc m ofar.biSzing symptoms and bchavim to our product in customus' minds. Rtmsnber, wc have the d& to hck &ex: efficacyand sdety claims, nnd these claims will business.
$~
W want our 1% term care customus to e r 2 main points: n
ZWREXA &m
-7behaviors
symptoms and
, ~ bctta c
ddy
7
m P R E X A gets patients like 1 and bxps h e m better
For your- 1nfonneb;on ON& not for use In detailing.
It contains comparative data vs rispaidone,
Case 3:07-cv-04911-CRBaafid and tested 1-3 Document This message has been d y
to ensure that it accomplishes the foIlowing go&.
and Bows differently from our pmrious picrrs.
Filed 09/21/2007
Page 41 of 50
PURPOSE OF THE. PIECE
To
& I
the LTC team with. a foarscd and messagc that d t s in action.
T inspire w~ salts rrprcxntatives to create o
a dialogue w i h the customq the healthcare profesional, and customize thc: message based on bidhcr knowledge arid questions.
T ensun that our custom& o
u d m d the
atcdlcnt produd prof& of ZYPNWL
To disseminateimpkmmtatibn bcst practices h m LTC PreminCound M &
In order to m e t & four& g 4 o smd your implunentadon bcst practices t your o P r & Coundl Member so we can shan tfic learning via future imphurntion guides. Your LTC Brand Team is committed to ensuring that you hrvr whn yra aecd to be d !
~~
THE DE7AIL PIECE IS NOT 10 BE LEFT 8EMIND OR GWEN TO CUSTOMERS!
*
For your Infamarion OHIIY; n d , f w u
n in detuUing.
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PATIENT PROHLE-ROSE
Idcntifj.patient, Rose, and highlight her currcnt sympromatology, clinical obscmations, and diagnosis.
& p & g on the sening, rliffirrnt symptoms may be highlighted-
Market Research
D o not make Rose sound like an emergency patient This will make the physidan think about immediate &racy and prescribe an IM such as Haldol or Advan.
Suggesfed Prolies
What are your goals o f thaxpy for a patient
--Theg$ i to stab& the patient's s symptoms a d behaviors by using a n medication thar is safe.
likc Rose?
Doam,what a you currently usiog with n your patients like Rose?
What kind ofruuia art you seeing?
Dco, o t r doer:it make sense to use ZYPREXA as a first choicc for a patient like Rose, sina ZYPREXA hdps to d y : s k b i l i z e symptoms and behaviori such as agitation, h s i i y delusions, and mistancc to care? otlt,
w,
Doctor, if I wzrc to show you some comparative data betyeen ;WREXA and another product that p are using, would you be more conhrtablc prescribing ZYPREXA for your patic'ntslilGC Rosd
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-----..---
, . I
Suggesfed Pmbe
Haw is this consistent with your cumnt
trcatmcnt regimen h r
Row?
r. . ; ..
PAGE 1
.. . .
. - .I
Market Research
Many of our customers arc not famifiarw t ih BPRS,so thcy apprcaate when wc use
descriptors such as 'agitation, hostility,
and anger."
TOP OF PAGE
Doctor, this data mmes fiom a head-to-head clinical study of 339 patients, which compared
- The ZWREXA and rispaidonc in found that but no diffucnce between
study
was
ZYPREXA VY rispcridone.
Physicians do not respond well to "bashing the cornpeti&n,' but they do appreciate when sales rcprescntativer show comparative data behjeen heir product and a competitor.
Some customers perceive rirperidone.tohave better &caq and 'fistern onset of astion than ZYPRIXA, which is not consistent with the head-to-head data.
6 i n g h s symptoms and behaviors. ce
(Point to symptoms.)
BO7TOM
OF PAGE
The goal of tbc first page is to level the
playing field and makc the physician ST, 'Wow, ZYPRFXA aabilizcs symptoms 2nd behaviors and has the same onset of action as rispcridone."
lo looking at both gmupsB improvement
scorn, the study atso found that both ZYPREXA and risperidont had a similar onset of action.Abuatl~ they saw ZYPREXA beginning to apuatt after &c sixth wtek Bottom linc, Doctor, it hs likt both drugs k had a compPabIe onsct of acdon, doesn't id
'Ittansitional Statement
I would like m show you how the data on ZYPREXA difhentiata from risperidone.
For your fnfennadion ONL): not far use in detaning.
Case 3:07-cv-04911-CRB
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PAGE 2
TOP OF PAGE
The study found a difference between
It.ansifiona1 Stafement
Doctor, wodd you agree that you arcnot only trying m get a padcnt Eloc Rose better, but a s kccp her better? lo
ZYpREXA and Aperidone with those patients who n s p o n d d This graph segments patients who bad a 20%,30%, 4096,and 5096 improvement.
When you look at those paldenti who had 3C%,40%, and 50% improvement, ZYPREXA stabilized symytoms and behaviors more often than ~ispnidone.
*
BO'J7OM OF PAGE
I the same head-to-headstudy, physicians n found that those patients who wae on mPREXA were able to maintain their rcsponsc to &c medication at a hi@u rate than those on risperidonc. Patients on ZYPREXA maintained their response at a rate of 8896 for up to 28 weeks. This was 2096 b e m r than risperidone. Doctor, does it make sense that treatment is not about j s gating ut &ern bemq but k + e n g them bettcr?
ZYPREXA began to xpamt'e at 30%, and at
40% and 50%it was statistidly signi6cantly better hrispaidone in ~ducing-symptoms such as anxiety, suspiriousness, and delusions.
Doctor, does this make you more comfortable in choosing ZYPREXA 61.patient like a Rose, s h e this data suggests that you may be able to stab* symptoms d behaviors such
as anxitty, aggression, and suspiaousness?
This dinical study s h d that ZYPREXA helps patients such as Rose get b c t t ~because ,
it stabilizes her symptoms and bchmion such as anxiety, aggrcssion and suspiciousness, and
What additional i n h a t i o n ' w w l d
demonstratt m p u h a t flIPREXA
mREXAkccpsRosebcttuovertilnc.Tbis is why the indication for ZWREXA has bccn expanded to indudc mainmane treatment.
stabiics symptoms and behaviors?
hnsitronal Stafement
Haw important is this type of data for you?
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*
MARKET RESEARCH
Some ctlstomas do not understand the
c t S m n c c be
PANSS and BPRS.BPRS
focuses ID&+ on positive symptoms, whcrcas PANSS I& at broader symptom m g e (ie, positive, negative, depressive, and
cog;&
5ympro~).
Many of our customen ut not 6am3iar w& i PANSS, so they appraiatt when we use the drsaipton snch as "anxiety, suspiciousness, and delusions."
The impad of20%, 30%,4Q96, and 50%
imprcrvcmcnt m b e aplainedto physioans in ferms ofwfut this bprovcntcnt means to
rht patimt
Ifpositioned coucdy, in t a m s ofwhat it
means m Rox, physkians respond artrcmdy wtll tothcseZgraphs,espcd&yibepph containing the maintenance data.
T h e god of the second page is not to %ashD
our competitors, but to diffmr~tiate ZYPRMA f h m rispaidonc.
For your lnlonnaUon O
w n d for use In detaBIng.
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PAGE 3
Doctor, now that pw have seen that ZYPRFXA can stabiizc Rose's symptoms and behaviors, Itt's look at the safely
Suggested Pmbe
DOC&,
wo&t pou agrce that ZYPREXA offers you true dosing Uaribiity? Do p havc this option with products you arc
currently using?
of ZYPRFXA.
Possibly the biggcst snf* cbnatn i s EF'STD. Doaor, whetha yow patient nceds r higher or lo& dwe of ZYPREXA, the risk for EPS is low. Unlikc some of the products on the.&.today, ZYPREXA docs not
appar to have dostdependent EPS-
Market Research.
Many of our customen we& not a &at ZYPREXA had "efficacy unmmpromiscdby
excessive dose-&tcd
side effects."
- Dosags 15-rng
and
The oncedaily dosing allows staff to administer ZWREXA without regard to meals. Wouldn't your staff appreciate the easc ofwc Z Y P W & < ?
a~aiIab1c 25-, 5-, are
EPS is one of b e major.safktyconcerns that our c u s t o m a s have.
7 5 , lo-,
tablets. Now you zko havc ZYPREXA Zydis' M y Disintegrating Tablets fbr those patientswho havc ~robkrns swatlowing pills, and those who cheek and spit their rncdicarion.
Bottom he: ZYPREXA has dosing flucibity because you do not have to worry about
dose-dependent EPS.
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PAGE 4
k r patients h . b s cwho &ght be on d h p k medications, dq$ntcractioris :can be a big conccm..Addingsome medications mightfurther complicate their medical state. Howeva, the phamamkbcxks of ZYPREXA
show VQY little potential for P450 inhibition, meaning &at inrrraction risk is vcry low.
C r i c advcnc map are ato a major ada w n c h . . W i & ZYPREX.A, there w no
evidence of c l i n i d y significant QTc piolongptionor other ECG.changsin dinicalniak
Another rmson why ZYPREXA is'easyto use is that no additional blood monitoring is nquirtd. The package insat fir ZYPREXA states d ~ no dose adjustment f r r e d l y impaired r o paticnts is required. So, ifyou have patients with this typc of medical situation, ZYPREXA may have some advantages
under thac circumstances.
Bottom linc ZYPREXA scabidins symptoms
So, for ywr patients who are taking other
medications, you can safdy add ZYPREXk
ZYPREXA has a low potential for anticholinergic side cfFecrs. For uclmple, physicianshund that the rate for constipation among patients treated w t ZYPREXA was ih not statistically diE&cot from pkccbo-aeatcd patients. Consequently, because of the Enrorablc wcnll side &ct profile. ZYPFEXA may be a good alternative for paticnts at risk for these side &ects.
and behaviors s f y ad.
For yaur Informatien O W ; not h r use in d6teilbg.
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Suggested P o b e
Doctor, what additional data. wwlld yw
need to see i or& to d c m o ~ t that n t ZYPREXA symptoms and
* ,
- -What
b$lavimslfi!y?
has b u n your arpcriaxc with the safq pro% ofother products in
these patients?
Mark@ Research t
Safety or -doing no harm" is a critical reason why customas choow: a prodoDrug interactions arc'thcnumber one &ty concun our customers hsvc.
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PAGE 5
C-s
Exampk Doaor, you a p d that maintaining rcsponsc L, a patient Iikc Row is important. I was ahlc to show you data f h m a hcad-tohud**danonslrattdht ZYpRFXA ompchrmcd rispnidone in
* S$urnmarv .(Whatwill m do? What u wilI the Iblb do?m a t is the h e frame to ~ tittdone?) Doctor, I would also like to make you stwarc
of the hct that ZYPREXA is cIassificd by the FDA as a psychotropic, &use ZYPREXA is
d=F= A Tk action statement ae
more than just an atypid vltipsychotic
Example Based on the information I have shown you,docs this data makc a case for yw
to use ZYPREXA instead of'rispuidone in a patient like Fbsd
Though OBRA ~uidelins have not yet been and imp& by this change yet, f3mSc.s tell us that rhe psychotropic classifisadon has less stigma than an
antipsychotic does.
Eramplc Doctor, bow
for yoti>
can I .&
this easier
Case 3:07-cv-04911-CRB
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Page 50 of 50
t B
SHORT MESSAGIE
SITUATIONS
W r ee &
p& i responses from our customas who partidpad in .?&kt Research for & ncw &tail piccc. This clcmonstratcs the advantage ofddking a focusrxl message that helps customcn see that ZYPREXA stabilizes
symptorm and behaviors safely. Higbcr mesage impact, h h r e d ofspec& points (ie, i a g maintenance, ctrug/drug interactions) and wcrall message racatl abserPed with this message.
Front axm
Probe for an area of concern andlor follow up on thc customer's previous commitment
Respond to arras of wwrrrb
Close using the CAPS P r o c q give customer
a ZYPREXA dming card -(0L17251)
For yaur infamstkn ONLK n d FOI use in detalIlng.
United States Free Forms
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