Ipsychrights.org/.../090227JBiedermanDepoTranscript.pdf · Mr, Smith also has some questions, which means that jf Iget achance at all, jt will be very late in the day, if at all And

Joseph BiedermanFebruary 27, 2009

Il (Pages 319 to 322)


Page 319 Page 320

----------- .J. Edward varallo, RMR, CRR ------~--

Registered Professional ReporterSTRATOS [,EGAl SERVICES LP ~ HOUSTON. TEXAS

713 481..2180

Video Deposition of Jo~eph Blede~man. M 0f~ldl.ly, February 27, 2009Owye~ & collora, l..LP

fede~al Reserve Pla:a - 12th floor600 Atlantic Avenue

Boston. Massachusetts 02210

Alma Avila, as next friend ofAmber N Avila, <:In individual case

In ret Rlsperdal/Seroquel/ZypreX<l~i~i?i)~i~n Case Code 274

Tommy Fibich, E$q.Fibidl Hnmptonl.=hron & Gnnh, LLP

140J McKinney SUcci" Stlile 1800HOUlton, Texal 7101071315l.0025 ~ Fax 713 751 Q030tr,bith@fhlg"law.com

Kel1lle~1 W. Smith" ElqSheller. P,C

1528 WAlnut Stn:d·, lrd Floo!Philndelphia. PeIl1l5yl"nllia 19102215 790.1300 ~ fax 21 S546 09H!;smith!ii':ohelle!com

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lelT~' APed;, Es,!D<:ildn: R. Kille, EsqDtinket Biddle & Realh, t lP500 Camplll DliI'eFlorhMl Pnll;, New kw;y 07932973.360. f 100 ~ Fnx 973 3609831jclTr1:}'.pcd@dbr,comdeirdrdolq.dbr ,com

WHiinm V Essig. Esq.Drinker Biddle & Renth, ttl'

191 North Wocker Drhe" Suilc 3700Chicngo, lfIinob 60f,0631U69.1000 _ Fn 312 %9 3000\\'ilIiam_cI5i!t'!J;dbr com

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Clv!.l ActionDocket tlumber1-6661~06

PAGES 319 - 613

SUPERIOR COUR' Of NEW JERSEYLAW DIVISION - HIDDl,ESEX COUNTY

VOLUME; 2

Johnson ~ Johnson Company, JanssenPhllJ;miJ,ceutica Products. t· P a/k/ilJanssen. I·P" et al

Stratos Legal Services800-971-1127




Page 321 Page 322

BIEDERlvIAN EXHIBITS FOR IDENTIFICATION

loseph Biederman. M 0by Mr Fibich 327

17 CD labeled 02126/09 Production 330Responsive 10 Avila Subpoena of 12/16/08


PAGE

PAGE

19 Dr. Biederman's response to 8116/08 394Libby Seaman e·maH (Bates 8-E0002277 - 279)20 Newspaper reprint from The Washington 384Post ofTuesdny. February 15. 2005. titledGoing to Extremes, Expens Question Rise inPediatric Diagnosis of Bipolar Illness, II

Serious Mood Disorder (8 pages)21 Anicleelllitied Risperidone for the 398Treatmellf of Affective Symptoms in Childrenwith Disruptive Behavior Disorder: APost Hoc Analysis of Dnla from II 6-Week.Multicenter_ Randomized, Double-Blind,Parallel-Ann Study.loseph Biederman. MD.published in Clinical Therapemics. Volume28. November 5. 2006 (7 pages)

18 Prinlout Wednesday. February 25. 2009, 345from The Stanley Medical Research Institutewebsite homepage (2 pages)

DEPONENT

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Videographer:Shawn Budd, CLVS, VideogrnpherStralos legal Services toP

1001 West Loop SOUlil - Suilc 809Houston. Texas 77027

Also Present:George DObrcntcy, Videogrnpheron behnlfofHogan & Hartson

Counsel for the deponent. Dr Biedennan:Peter S. Spivack, EsqKeith BWTley, EsqHogan & Hartson, l L PColwnbin Square555 Thirteenth Street, N.WWashington. D C. 20004202637.5600 - Fa'( 202 637 5910psspivack@hhlaw com


Counsel for DefcndllIlt AstrnZcnccn:Donald C, LeGower. EsqDechert LLPCira Centre2929 Arch StreetPhiladelphia, Pennsylvania 191042159944000 - Fa'( 215 994 2222donald legower@dechert,com5

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Joseph Biedermanfebruary 27, 2009

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2 (Pages 323 to 326)


Page 324

BIEDERMAN EXHIBITS FOR IDENTIFICATION OIEDERMAN EXHIDITS FOR lDENTWICATION

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)7 A"icle cnlirletJ Cochrane Review. 546Comp,lred Wil], Indllsuy.Supportcd MCla·An~IY5el ~nd Olher MCl,l,Allalyses oflne SameDrug.: SYSlcl11:;llc Rcview published6 Oelohcr 2006 (5 p'lges)JS

BIEDERMAN EXHIlJITS FOR If)ENTlF1CATlON1234

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FOR IOENTIFICATION

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)9 Ncwsp~pcr reprinl headed \V:;U Sireel 551Journ,,1 luly I I, 2006. Financi~1 Tics 10Induslry Cloud M,l)nr Depreslinn Siudy: '\1lssuc: Whelher II's Safe for Pregn~nt Women10 Sl,ly on Medic.:uion~JAMA Asks Authors 10E.~plaio by David Arm~llOng (6 pa!Je.s)

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48 Spreadsheet untitled, with six columns: 596Pltasl Name; Fund; l.;lSl Mo Exp: CashBalance; Sponsor Name; Title (5 pages)49 Cover feuer dated February 25, 2009. 599from Hog'ln & Hanson to Leslie l.a1vlacchia,re: Subpoena issued to Dr Joseph Biedennandated December 16. 200ft with attachedprivilege log50 Document headed Editorial, Connict of 611Interest, American Journal of Psychiatry.April 2006. pages 57l lhrough 573

(ORIGINAl EXHIBITS SENT fa ATTORNEY l<>MACCHIA)



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3 (Pages 327 to 330)


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MORNiNG SESSION9:03 am

(Biederman Deposition Exhibit 17 markedfor identification.)

THE VIDEOGRAPHER: We are back on therecord. This is day 2 in the videotaped depositionof Dr Joseph Biederman, Today's date is February27,2009, and the time is four minutes after 9:00You may continue,

JOSEPH BIEDERMAN, M,D,having been previously sworn on oath, wasexamined and testified further as follows:

EXAMINATIONBY MR, FIBICH:

Q, Good morning, Dr. Biederman,MR PECK: Mr Fibich, before you begin

I wouldjust like to place my objection on therecord to your interrogation of Dr. Biederman today

Mr.. Trammell was admitted in the Avilacase and he spent all ofyesterday deposingDr. Biederman, With regard to the Adams case, hewas also admitted and the order of admissionindicates that he had the consent of his adversary,



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which was me, and I did in fact consent toMr, Trammell's admission in the Adams case Andthat was for the purpose of deposing Janssencorporate reps whose depositions have been ongoingfor the past several months

Iobject to both you and Mr Trammellexamining Dr. Biederman You are both sponsored bythe same law finn, you are one party, and that isthe party for Avila. One attorney should be doingthe questioning and one attorney should be doing theobjecting, not two attorneys

In addition, I have the right to cross~

examine Dr Biederman And the fact that twocounsel from the same sponsor, essentially for thesame client, are taking up time that would impede mycross~examjnation. I object I understand thatMr, Smith also has some questions, which means thatjf Iget a chance at all, jt will be very late inthe day, if at all And for these reasons Iobject

MR SMITH: Ihis is Ken Smith As I said,I told you I might have some questions. Ididn!tsay I would have some questions

MR FIBICH: Mr Peck, how long do youfeel you'd need to have for your cross ofDr Biederman?



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MR. PECK: I would suspect that I need at Ileast two hours, 2BY MR. FIBICH: 3

Q. DL Biederman, we have not formally been 4introduced, have we? 5

A. No. 6Q" Once again, my name is I ommy Fibich and 7

I'm here on behalf ofpeople that have brought a 8lawsuit against Janssen Pharmaceuticals. Do you 9understand that? 10

A I understand that 11Q, Do you understand the nature of the 12

lawsuit that we have brought against Janssen? 13A. No 14Q. You don't understand what the allegations ,15

are? 16A, I do not know anything about a lawsuit 17Q, You have been subpoenaed here today. Is 18

that correct? 19A Yes, 20Q, And in response to the subpoena to come 21

here today, you produced certain documents to your 122lawyers and they have turned those over to us in 123

h b h '104response to t at su poena. Is t at your runderstanding? 125

Stratos Legal Services I800-971-1127

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A That's correctMR FIBICH: Mr Spivack, we have labeled

as Biederman Exhibit Number I7 the production thatwe had, what you have represented to be responsiveto that subpoena. We have some questions about it,so Iwant to make this part of the record. That'sthe disc that was produced to us

MK SPIVACK: Sorry. My eyes are going,so"

MR, FIBICH: I understandMR SPIVACK: All right Thank you, sir,

BY MR, FIBICH:Q. You understand you're under oath?A YesQ. Do you understand the obligations that

that oath imposes upon you?A, Yes, I understandQ. And what are those, sir?A That I have to say the truth and

everything but the truth.Q. That's right, everything that there is

with respect to the truth, You can't hold anythingback, You understand that, do you not?

A. Yes, I do,Q, And you understand that there could be


IPage 331

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penalties applied against you should there be aviolation of that oath?

Ae I understandeQe You understand thaL Conect?A, CorrectQ Dr" Biedennan. have you ever given a

deposition before we started yesterday?A, YeseQ. And on how many occasions have you been

deposed?A To my knowledge, onceQ, And would you tell me the nature o!that

deposition? What type matter was that involved?A It was a patent litigation between Lilly

and some genetic companiesQ And did I understand you to say patent?A, (Witness nodded,)Q, You've got to say "yes" You can't shake

your head,Ae Patent, yes, patentQe And for which party did you testifY?A, [don't know which partye There was no

party; they were just lawyers questioning, Therewas a challenge to the patent and I was asked to bedeposed


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Qe And were you seeking to help protect thatpatent or were you seeking to try to have thatpatent voided?

A I was not seeking anythinge [n fact,I did not want to be deposed at all, bUL'e

Q. Was your testimony in support of thepatent or against the patent?

A NeitherQ Who asked you to testify?A, The genetic companies that were

challenging Lilly for the patent on StratteraQ, And when was this?A It was about two months ago.Qe And where did this take place?Ae In BostonQ And do you recall the names ofthe lawyers

that were involved in that?Ae I only -- NOe [on[y recall the lawyer

from Mass General that went with mc, His name is,hmmm -- I don't remember -- Paul Cushing

Qe And did that litigation involve apharmaceutical product?

Ae YesQe And what was the product?A The product was Strattera,



Page 334

Harvard Medical School you basically do for free?A Everything that [ do for Harvard Medical

School is for me because they don't pay me a centfor anything, I am employed by Mass, Genera[ and Iteach residents, That's who I teach,

Q, At Mass, -- Excuse me I didn't mean tocut you off- You teach residents, Is that correct?

A Yes,Q, And Mass, Genera[ Hospital, that is the

teaching hospital for Harvard Medical School?A, Yes, It's one of a dozen hospitals that

are affiliated with HarvardeQ, Is it the most prominent hospital that is

affiliated with Harvard?A, I don't know, I think that it's one of

the most prominentQ What is the reputation of Massachusetts

General Hospital?A It's a very reputable institution.Q. And is that the only hospital where you

treat patients? -----+--A YesQ,. And do you receive a salary from

Massachusetts General Hospita[?k That's correct


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Q" Can you spell that for our court reporter?A. Yes, S-t-r-a-t-t-e-r-a..Q, Now, I apologize for going over some

things we talked about yesterday but I'm somewhatunclear and it's probably my fault But as Iunderstand things, you are a member of HarvardMedica[ School?

A, CorrectQ, And at Harvard Medical School, you hold a

position of full professorship, [s that conect?A. That's correctQ, And as a result of being a professor at

Harvard Medical School, do you draw a salary fromHarvard?

A. No,Q, Do you derive any income whatsoever as a

result ofyour association with Harvard MedicalSchool?

A, None, Harvard does not pay me a centQ, Do you receive a stipend? Do you

receive -A. NOeQ Do you receive an office there?A, No; nothing,Q, SO what do you do -- What you do at


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see in your private practice, what is the bill -who is the bill from?

A The bill is from meQ< "Me, II do you mean some entity or-A. NoQ -- do you mean yourself?A MyselfQ Now, what is YOUT' relationship or

association with the Yawkey Clinic for OutpatientCare?

A The Yawkey Clinic is one of the buildingsof Mass General funded by the Yawkey family whereoutpatient clinics are located; and on the sixthfloor, suite A is child psychiatry

Q< Are you associated with that clinic?A, I am associated with Mass, General. The

physical place that I work is at the Yawkey Center.Q. Do you derive any income or moneys

whatsoever from the Yawkey Clinic?A, No, The salary is from Mass. General.Q. Now, yesterday we talked about the Johnson

& Johnson Center for Pediatric Psychotherapy. Doyou recall that?

A. Psychopathology.Q Psychopathology, excuse me. And that is


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Q. And what is your salary that you receivefrom Massachusetts General Hospital?

A. Could you repeat the question?Q What is your salary that you draw from

Massachusetts General Hospital?A. It's about 260,000, fifty -- sixty

thousand dollarsQ.. And in addition to that salary, do you

also receive income from patients that you treat atMassachusetts General Hospital?

A. No. The patients that I -- I have a smallprivate practice that I have after hours, but thepatients that I see through the clinics atMass. General, they pay the hospital, not me

Q And the small practice that you have afterhours, do you derive income from that practice?

A Yes,IdoQ. And what is the income that you derive

from that practice?A. Modest It's about, I would say, between

80 and a hundred thousand dollars a year.Q. And what is the name of the practice? Is

it Joe Biedennan, psychiatrist?A. No, it's -- YesQ. When you send a bill to a patient that you


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Page 337

just a name, is it? There isn't a building or awing?

A No.Q. Is that cDrrect?A, That's correctQ, Now, you are a director of that center,

Correct?A. I wasQ. You were. You are no longer?A. The center ceased to exist in 20050Q. And as a director for that center, you

received what you indicated yesterday was arelatively small amount of money?

A. Thaes correct.Q. Did you derive any other income from this

center during its existence?A. NoQ. Now, I also saw some terms, a Center for

Child and Adolescent Psychiatric Research, Is thatanother center there at Massachusetts General?

A. I am not sure, what are you referring to?Q I'm sorry?A. Where did you get that?Q, That wasjust in some papers, Do you know

what that means, where it comes from?Stratos Legal Services

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A I don't know, You have to be morespecific,

Q.. Well, I'm just asking you, is there aCenter for Child and Adolescent Psychiatric Researchat Massachusetts General, to your knowledge?

A NoQ. Is there a Massachusetts General Hospital

Center for Pediatric Mania?A We have a clinic for pediatric mania,

program for pediatric mania. It's not a center,Q. Well, I'm seeing the term Center for

Pediatric Mania. Is there a center?A. No We call it clinical and research

program in pediatric bipolar illness,Q, Do you derive any income from any of these

entities that we've been discussing other than theincome from Johnson & Johnson?

A. The salary at Mass. General is composed ofcomponents, clinical care, research, foundations,It is a composite of different sources ofactivities.

Q.. Now, when you go out and publish papers,you list your affiliation with Harvard MedicalSchool, do you not?

A YesStratos Legal Services

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Q, And you list your affiliation with 1Massachusetts General. Is that correct? 2

A 1hat1s correct 3Q, And why do you do that, sir? 4A. Because those are my affiliations, 5Q And what's the purpose of listing those? 6A. Because this is my affiliations, Like 7

Jput my last name and my first name and my degree, 8Q, Well, you put those on there, quite 9

frankly, because it gives credence to you, does it 10not? 11

A, No This is the truth and this is my 12affiliation, I work at Mass, General and I hold an 13appointment The standard in academia and 14scientific intercourse, the people that publish and 15present list their affiliation, It's nothing unique 16to me, 17

Q" And I understand, Pm not saying ies 18unique to you. Pm asking you, do you believe that 19your association with Harvard and your association 20with Mass, General give you additional credibility 21as a spokesman for whatever views you may hold? 22

A, I don't think so, I think that they 123derive credibility because of my scientific 1'24activities, not the other way around. There are 25



Page 340

many people, Mass General employs 10,000 peoplethat are not prestigious. 1am prestigious becauseofthe quality of my work, not because I work there.

Q, Well, we're going to get to your prestigein a little while. But as a practical matter, whenyou're here today, you're not speaking the views ofHarvard Medical School, are you?

A NoQ, You're not speaking the views of

Mass, General Hospital, are you?A NoQ. The views that you're expressing here

today are the views ofJoseph Biederman. Correct?A That's correct,Q. And the views that you express in your

scientific papers likewise are not the views ofHarvard, Correct?

A, That's correctQ And the views that you express in your

scientific papers and presentations and lectures,those are not the views of Harvard or ofMass. General but rather the views of .Joe Biederman,Correct?

A, Let me clarify, My papers are scientificpapers, I describe data I conduct statistical



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analysis, So it's not -- I don't proselytize orevangelize; I state the facts, This is science, notadvertising or proselytical type of activities, SoI express -- The results of a study are mine, butthe views as you describe it may be perceived assome kind of philosophical views on a subject.

Q. Doctor, I must not have asked my questionvery well because I don't think you were responsive,and I object.

A. MaybeQ. The views that you express in lectures,

seminars, scientific papers or in the newspaper,whatever views of yours that are out there, thoseare your views? You're not speaking on behalfofMass.. General and you're not speaking on behalf ofHarvard, are you?

A, That's correctQ Now, yesterday when we were talking about

the Center for Child and Adolescent PediatricPsychopathology, you indicated that it wasstructured along NIH cores, Is that correct?

A, That's correctQ, And NIH stands for National Institutes of

Health, Correct?A, That's conect.


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Q, But the National Institutes of Health hasnothing to do with this particular center, does it?

A NoQ, You were just using that to describe the

manner in which this center was structured.Correct?

A, That's correctQ, Now, what is the Stanley Medical Research

Institute?A. The Stanley family has a foundation that

is called now the Stanley Medical Institute thatfunded us for a few years to conduct thepsychopharmacological research on pediatric bipolarillness,

Q, The Stanley Medicai Research Institute yousaid was created by one family, the Stanley family?

A, To my understanding, yes,Q. Do you know the Stanley family?A No,Q, Who is the director olthe Stanley Medical

Research Institute?Ao I don't remember.Q Do you know any of the people that are

associated with that particular institute?A. I knew them, I just don't remembertheir


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names,Q Where is the Stanley Medical Research

Institute located?A. I do not knowQ, Have you ever been to that particular

institute?A. No.Q What have you had to do with the Stanley

Medical Research Institute?A, We put an application for conducting this

type of research that I described and they fundedus

And what is the Treatment Advocacy Center?Treatment Advocacy Center? I have no

Q, You've never seen that term used withrespect to the Stanley Medical Research Institute?

A. No.Q. How many studies has the Stanley Medical

Research Institute funded of yours?A. They funded a center, so there was a group

of studies, studies that involved neumleptics andstudies that followed up, but mostly a study thatinvolved treatment,

Q. What center did they fund?Stratos Legal Services

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research?A. Not at aiL They funded a huge number of

centers ofdifferent types, in adult and pediatricpsychiatry.

Q. Why does the Stanley family have aninterest in bipolar mania and schizophrenia, ifYOllknow?

A I do not know. Usually this interest canderive from personal issues, so I do not know.

MR. FIBICH: Let's mark this as the nextexhibit

(Biederman Deposition Exhibit 18 markedfor identification.)BY MR.. FIBICH:

Q. Doctor, this is an exhibit that's beenmarked as Exhibit 18

A. Mm-hmmQ. It was taken off the Web page for the

Stanley MedieaI Research Institute Do you seethat?

A. Mm-hmm.Q. And then on the next page, if you'd go to

the seeond page, it lists some studies that theyfunded. Do you see those?

A, Mm-hmm.Stratos Legal Services

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A They funded the center for the treatmentof pediatric mania, so we conducted studiesexamining Zyprexa, Seroquel, risperidone, We did astudy of preschoolers, these type of things.

Q. SO the Center for Pediatric Mania has beenfunded exclusively by the Stanley Medical ResearchInstitute?

A Yes, It's the center for the treatment ofpediatric mania. That's probably correct

Q Okay And what is your relationship tothat center?

A, I was the director of the center,Q You said you were, Are you currently?A No The center ceased to exist in the

early 2000Q Why did it cease to exist?A, Because they run out of funds Many of

these activities are time-limited; they are notlifetime

Q. Was the Stanley Medieal Research Instituteset up to your knowledge for the purposes of fundingyour research?

A. I am not understanding your question.Q. Was the Stanley Medical Research Institute

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MR. SPIVACK: Me. Fibich,just if! couldask, on the first page there is some type at thebottom that says "List of funded studies, seeBiederman1s name,1I

MR FIBICH: Right.MR SPIVACK: Is that on the original Web

page?MR. FIBICH: I do not know the answer to

that. I did not pull this oflmyself and I will notmake the representation that it is,

MR SPIVACK: Okay.MR. FIBICH: It may be that someone typed

that on there to call it to my attention; it may beon there, I don't know.

fYfR SPIVACK: OkayMR.. FlBICH: It looks unusual to be on a

website, let me sayMR. SPIVACK: Right. That's why I asked.

OkayBY MR. FIBICH:

Q. Dr. Biederman, if you would go to the topof page 2 of this particular exhibit, you see thatthere are four studies that are funded?

A.. Yes.Q. And you were the principal investigator on



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all four. Is that correct?A. That's correctQ, They were all four studies with respect to

bipolar disorder?A, Yes, pediatric bipolar disorder, yes.Q, And the first one was discontinued. Do

you see that?A Mm-hmm.Q. You've got to say "yes," You eanlt_~

A Yes. Sorry I apologize.Q. Okay. Why was this study discontinued?A. Because patients were improved enough when

we treated them. The study was sequenced to treatthe mania first Bipolar illness has two phases,mania and depression. And the issue whetherantidepressants can be deployed in the treatment ofthe manic phase is an area of great clinicalinterest, so the patients that were supposed to bein the paroxetine arm were offeredo

So what was happening, we had two options,to use bupropion, or Wellbutrin, or paroxetine, orPaxil, and patients were not sufficiently severelydepressed to enter the depressed part. So theyimproved enough with the anti-manic treatments thatwe did not recruit for the depressive part


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Q Did you publish the results of that?A Were too small number of patients to

publish. It was five or sixQ. SO the answer is no?A NoQ. SO you had a small number of patients to

begin with Is that correct?A. No. The patients were large Small

number of patients that were severely affected withdepression to be in the other anns,

Q. Well, I thought I understood you to saythat this particular drug worked so well that youdidn't have enough severely depressed people to goforward with the study Is that correct?

A. The treatment with the atypicalantipsychotic provided sufficient relief ofdepressive symptoms that many children were nolonger severely depressed after we treated them.

Q So you got a good result with respect tothe treatment that was afforded the people in thisstudy. Correct?

A. That's correct.Q. And you did not publish that Correct?A No, I published the results of the

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study was we publish the impact on bipolar symptoms 1and depressive symptoms 1

12Q. Then you had another bipolar study using 3risperidone and it says olanzapine" Was that a 4comparative study, the second one that's referenced 5there? 6

A. The second study was a study in 7preschoolersc 8

Q. And did that result in publication? 9A. Yes. 10Q. And what's the name of that paper? 11A. Risperidone and Olanzapinc in the 12

Treatment of Bipolar Illness in Preschoolers.. 13Q.. And when was that published? 14A. I don't remember, but you can find it in 15

PubMed. It's one olthe papers listed in my C.V 16Q. And then there was another one, 17

risperidone and olanzapine, quetiapine, that was '18completed. Do you see that? 19

A. Yes. 20Q. And was that published? E1A. We submit to be published We have it in C22

last stages of the review process 123Q. When you say "we," who is we? \2 4A. Myself; and I don't work alone Myself 125

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and my colleagues,Q And who are the colleagues that are

working on that with you?A. The statisticians, other colleagues that

work in the assessment of the subjects and so on andso forth

Q. Do they have names?A. Dr Wozniak, Dr Mick.Q. And who is the principal author on that

paper?A. I think that may be me I don't remember.Q. You may be the principal author but you

don't know?A I am not sure. I think that I am the CD,

the lead author of this paper, yesQ. Who is doing the first draft of that

paper?A. MeQ. Do you have a draft of that paper?A, The paper is in review in a scientific

journaLQ. Which scientific journal has it been

submitted to?A I think it's called Bipolar Disorders I

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A In the early 2000Q Why was it discontinued?A For the same reasons. The children that

were treated with atypical neuroleptics hadindicated enough improvement in their ADHD symptomsthat the parents were not interested to addConcerta

Q And did you publish the results ofyourfindings with respect to that study?

A No, Those findings, we reported that inthe study of risperidone and olanzapine and otherstudies that we did what is the improvement on ADHDsymptoms But this study had minimal amount ofpatients to be a valuable study, so that's thereason that we discontinued it

Q And a limited number of patientsoftentimes will mean that you cannot draw generalconclusions from the findings orthat studyCorrect?

A That's correctQ Now, I want to make sure I understood what

you told me, Did you tell me that the study thatwas discontinued that was a study of pediatricbipolar disorder in relationship to Concerta use andAteral use, that the findings were contained in


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for you if you wantQ, I'm asking you what the name of the

publication is that the paper has been submitted to,Can you tell me?

A, I cannot remember-. I can find oul ifyQUare curious to know, But it's a scientific journalthat the paper is being currently considered forpublication,

Q, I'm not asking you what type ofjournalI presume it's a scientific journal. Okay?

A 1dontt remember the journal, How manytimes you want me to tell you? [don't remember thejournal. I will be able to find out ifyou want toknow, I don't have it in my active memory.

Q. Is your active memory good today?A, It's very good, What about yours?Q, We'll find out,A, Okay,Q Actually, it's a little slow todayA Good,Q, Then the Concerta-AtemI study that

Stanley Center for Psychiatric Research funded, thatwas discontinued, Correct?

A. That's correctQ When was that discontinued?


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Research still exist today, to your knowledge?A, The Stanley Foundation exists. Our center

does not.Q, Does the Stanley center currently sponsor

any programs for the psychiatric department atMass, General, as far as you know?

A. I have no idea.Q You have no idea?A No. They may, The department is a very

large department and some investigators may receivefunding from the Stanley Foundation

Q, I'm asking you as to your knowledge, sir,A, To my knowledge, the Stanley family funds

the broad institute that is affiliated withMass, General, a very large effort at improving thegenetics of bipolar illness, I'm not sure if iesthe Stanley Medical Institute I believe it's theStanley family itself

Q. Doctor, as a member of either HarvardMedical School or Massachusetts General Hospital,were you required to disclose to either of thoseinstitutions outside income derived frompharmaceutical companies?

A. YesQ And to whom were you required to make


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another paper?A The study had two stages. Children were

treated with risperidone, olanzapine andneuroleptics first for their manic symptoms and theywere only eligible to enter the stimulant part ~~

Eighty percent ofchildren with pediatric mania haveADHD comorbidly So an issue is, can you treat theADHD in the context of bipolar illness? So this isthe question that we are addressing

The results after treatment withrisperidone, quetiapine, whatever we treated, thesymptoms of ADHD were reduced enough that childrenin general were not so severely affected with ADHDto qualifY for a trial of a stimulant but thesechildren were first treated with an atypicalneuroleptic,

MR" FIBICH: Object as nonresponsiveBY MR FIBICH:

Q, My question is, the Concerta-Aterolpediatric bipolar disorder trial, were the resultsofthat published in some paper?

A No We did not ~~ We discontinued thestudy, We did not have enough patientsparticipating in it.

Q. Does the Stanley Center for PsychiatricStratos Legal Services

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those disclosures?A, To both Harvard and Mass, GeneralQ And on what basis were you supposed to

make those insofar as time? Is that an annualrequirement, reporting requirement? Is it arequirement as you receive money from thosepharmaceutical companies? Or how or on what timebasis is it supposed to be reported?

A It was very unclear up till recentlyHarvard had cycles that they decided periodicallythat it's a new cycle and required reportingMass General had the chairman designated individualresearchers to report

Q Let's take Harvard How long have youbeen a member at Harvard Medical School?

A. I started as a resident in 1977Q And at what point in time did Harvard

impose upon you an obligation to report outsideincome from pharmaceutical companies?

A I believe in the late '80sQ And that would be the '88-89 time period,

approximately?A I don't rememberQ Okay. Your memory is not that good today

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A. That's correcLQ. And when is the last time that you

received a request from Harvard to disclose youroutside income from phannaceutical companies?

A. J believe that was the end of 2007, Ibelieve.

Q. And from whom does this request come?A, From the universityQ. And who at the university?A. I don't know It's a request Probably

from tHe dean.Q. You're guessing?A, I'm guessingQ. Who did you tum the requested information

in to?A, It was electronic, so it was a website

that I turned the information in.Q. SO you would receive an e-mail. Is that

correct?A. Yes.Q. Saying let us know how much income you

had?A. Complete the form for conflict of interest

and the instructions are here; complete it andsubmit it·


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A Nat very good.Q So from whatever time it was first imposed

upon you through 2006, did you fulfill thoserequirements accurately and completely?

A To the best of my ahilities.Q How often would you make annual reportings

to Harvard with respect to outside income frompharmaceutical companies?

A. They had cycles, usually occurred everythree years or more The last cycle was in 2007 to'8. So 200l? Yes

Q 200l?A Yes, the last --let me just think for a

moment It was two thousand ~-? Yes, it was 2007,Q And before that was it a three~year cycle'?A Before that was three years prior,. I

don't remember, It was a little bit even at random,so it's not that it had a precise cadence..

Q Were you supposed to make thesedisclosures to this institution at the end of theyear or at what particular time during the year?

A When the cycle request cameQ So it would be a written request from

Harvard and then you would have to fulfill that Isthat correct?



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Q. And you did that sometime in 200l?A Yes, toward the end of 2007 To best of

my recollection.Q. Now, did you have the same reporting

requirements with respect to Massachusetts General?A Massachusetts General has a different

system, In 2007 and '8 they developed an electronicWeb-based reporting system.

Q. And before that -- Excuse me. Were youfinished?

A Yes.Q.. Before that, what type of system did they

have?A Before that, the requirements were

nomination by the chairman to report to individualfaculty So the chairman requested from individualfaculty to report their activities outside theinstitution

Q. And who is the chainnan?A The chairman of psychiatry is Dr Jerry

Rosenbaum.Q. And how long has he been the chairman?A About five years.Q. SO from 2002 to 2007 that's who you would

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A, The reporting -- The request came from thechairman and the information went to the presidentof the institution ..

Q, The president of the institution would bethe president of Mass. General?

A, YesQ. And who is that?A. Now it's Peter Slavin.Q, And before Mr. Slavin, who was it?A. I don't remember what was the name of ••Q. When did Mr Slavin become the president

of that institution?A, rm going to say about five or six years

ago.Q So you would receive a request to report

to the president of the institution?A, I would receive a request from the

chairman to report to the institution. I usuallyreturned the response to the chairman and thechairman submitted it to whatever the agency or thedepartment in the institution was recipient of thatinformation,

Q And for how long were you requested by thechairman to submit this information to the presidentof the institution?


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A How long? I think I was requested a fewtimes. Every time that the request came, Icompleted the request

Q, I want to know, is this something that youdid yearly?

A The yearly is only recently. It has beenimplemented by Mass. General, yearly reporting, butbefore that, was not yearly

Q And typically how would the reporting goprior to it becoming a policy of doing it yearly?

A It was random and sporadicQc So it just varied, Correct?A. YesQ. And on each occasion that you were

requested by Mass General to report to them youroutside income, did you do so accurately andcompletely?

A. I did accurately and completely to thebest of my abilities,

Q. When you say to the best ofyourabilities, does that mean that there were onoccasion mistakes made?

Ao On occasions mistake could have been made,Q I'm not asking whether could have been.

We can all make mistakes. Correct?Stratos Legal Services

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A CorrectQ, Anybody can make a mistake Right?A CorrectQ, I'm asking you as you sit here today,

Doctor, under oath, at the time that you fulfilledyour responsibilities to submit to MassachusettsGeneral your outside income from pharmaceuticalcompanies as requested by your chairman, weremistakes made?

A. At the time that I completed the forms Ibelieved that I did them completely accurately.

Q. And did you later determine that a mistakehad been made?

A. Later others determined that some smallmistakes were made,

Q, Who were the others that determined that?A. There was a committee at Harvard

University that was set up after Senator Grassley'scomplaint that investigated all outside activitiesfor last ten years.

Q. And when was this committee set up?A, How?Q. When was the committee set up?A The committee was set up I believe in two

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Q And did the committee come about in youropinion as a result of Senator Grassley'sinvestigation into pharmaceutical income to clinicaltrial investigators?

MR. SPIVACK: Objection, calls forspeculation, no foundation

k Harvard has a standing committee and I donot know whether the committee was active beforethis or not. But it is a standing committee

Q Why did they investigate you?MR SPIVACK: Objection, calls for

speculationA Senator Grassley sent a complaint to the

university about me, and so they investigated me.Q, And who was the committee? Who was on the

committee?A They are sitting professors I cannot

remember their names, but you can probably find themin the Harvard website.

Q What would be the name of that committee?A The Committee on Outside -~ Committee on

Contlict ofInterest and Conflict of CommitmentQ Conflict of interest and ~-

A And conflict of commitmentQ Conflict of commitment. And you cannot


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remember any of the members ofthis committee?A.. I don't But they are public, in public

domain, so itls not a problem, Ifmy memory fails,you can find the names on the website,

Q. Did you appear before this committee?A, I did.Q And when did you appear before the

committee?A. In July of last yearQ Were you represented by counsel at that

meeting?A. I wasQ You were?A. I was.Q, Who repr esented you?A Mr. SpivackQ" And was testimony taken at that committee?A. Yes,Q Were you under oath?A. No,Q, Now, you indicated -- And how long a

hearing was this that they investigated you?A How long was the hearing?Q, YesA It was three hours,



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A- The preliminary findings as I understoodthem were small amounts over the last nine years,eight years, they identified, None of them were theproblems that Senator Grassley put in theCongressional Record,

Q. My question probably wasn't clear to youLet me rephrase it. Was there a written report asto the findings which you have characterized assomewhat small mistakes?

MR SPIVACK: Let me just interpose anobjection to the extent it calls for attomey~client

infonnation. Joe, to the extent it involvescommunications between you and me, don't answer, Ifyou can answer the question without that, please do

A Well, report is in process and theinformation that I have is infonnation that wasdiscussed with Mr Spivack So the report is notfinal, so --

Q. SO all you know is what you've learnedfrom your lawyer?

A YesQ There's been no written documentation of

their findings insofar as you know?A. The report, there was a draft report A

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Q And was a determination made that you hadmade mistakes in your reporting to MassachusettsGeneral?

A There was a detennination that came laterthat they found some relatively small mistakes,None of them are mistakes that Senator Grassleyaccused me of making,

Q, Was there an investigation into yourdisclosures to Harvard Medical School?

A That was the investigation,Q, It was the same investigation?A Yes.Q, And were determinations made that you had

made enms with respect to your filings withHarvard Medical School?

MR. SPIVACK: Objection, asked andanswered

A, The investigators alleged that there weresome small discrepancies that they identified intheir report. Their report has not been issued, soI don't think that there is a final report on that

Q Do you expect a report to be issued?A YesQ Were there preliminary findings with

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Q And have you seen the draft report?A I have seen the draft reportQ Do you have the draft report with you?A No.Q Do you know where I can get a copy of the

draft report?A You need to ask the medical schooLQ Now, as I understand it, you were

investigated by the medical schooL Correct?A, I was investigated following Senator ~~

not spontaneously because they had concernS aboutme, but because of due diligence secondary toSenator Grassley's complaint to the medical schooL

Q My question was, you were investigated bythe medical school. Correct?

A And my response is to explain to you thecontext of that investigation Itls not that theysuddenly out of the clear blue became concernedabout my activities., They could have investigatedthe other ten thousand faculties equally,

Q. Well, that's a good point How manyothers did they investigate for this allegedpotential conflict of interest and conflict ofcommitment?

A Only those that the senator brought to theStratos Legal Services

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fore, 1Q, And who is that? 2A, They also lodged complaints against two of 3

my colleagues, Dr- Timothy Wilens and Dr, Tom 4Spencer- 5

Q, Mett, did you say? I ;6A No; Dr Tom Spencer and Dr Timothy

WilensQ, And are these doctors that are i 9

psychiatrists? 110A, They are psychiatrists IIIQ And these are doctors that had ties to 12

drug companies? 13A. That what? 14Q, Had ties to drug companies. 15A, Yes, 16Q Was the committee hearing with respect to 17

you separate from the committee hearings with 18respect to the others? 19

A, They interviewed me separately than the 20interviews that they conducted with them, But the 21report I believe is going to be a report on all 22three of us, 23

Q Do you know ilthe medical school did any 24inquiry into the phannaceutical companies as to the 25


Page 368

amounts of money that had been paid to you?A rdo not know what they inquiredQ Were you required to produce any

documentation to this committee relative to theincome you had earned from pharmaceutical companies?

A I provided them with extensive financialinformation of my entire earned income over lasteight years

Q Were there any rights or privileges ofyours suspended pending this investigation?

A Not rights or privileges, I agreed not todo any work with pharmaceutical companies until theinvestigation is complete

Q That was an agreement by you Is thatcorrect?

A That's correctQ Was that a negotiated agreement?A Yes I think that the request, we decided

while the investigation is completed that I willwithdraw from activities with pharmaceuticalcompanies, speaking, doing research, or anyactivities of that type

Q, Have you appeared before SenatorGrassley's committee?

A NoStratos Legal Services

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A, $20,000 a year per companyQ Is that total? In other words, if Lilly

gives you 5,000 and AstraZeneca gives you-A. It's per company.Q. It's per company?A. (Witness nodded)Q. SO if I understand what you're telling me,

and !just need you to clarify it for me, if youreceive in a calendar year more than $20,000 fromone drug company, you are prohibited as a matter ofpolicy by Massachusetts General from doing anyclinical trials or work for that company?

A I have to disclose and the institutionneeds to decide if the research can be carried onThat's the way that is handled. They need to knowabout that and they need to decide if the researchor new investigator has to be put on that study,

Q You have to disclose it to theinstitution. Correct?

A To the institution, yes,Q, And then the institution can determine

whether or not that creates an issue of your goingforward with any clinical research you may want todo for that company. [s that correct?

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Q Have you had any contact whatsoever withSenator Grassley's committee investigators or thepeople that are assisting him?

A NoQ Have you provided any information to

Senator Grassley's committee relative to theaccusations that have been made against you?

A The information ~~ Senator Grassley senthis inquiries to Mass. General and Harvard, soHarvard asked me; I provided them~ they provided thesenator with the information

Q And why is it, ifyou know, that theinformation relative to your relationship withpharmaceutical companies is important?

k I am not sure if I understand yourquestion

Q, Why does Massachusetts General, why dothey care what income you get from pharmaceuticalcompanies? If you know

A Well, the major issue is that there areguidelines. When a researcher is doinginvestigation for a particular company, you cannotmake more than an allowed maximum, So those are thethings that they have to --

Q What is the allowed maximum?Stratos Legal Services

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1 Q, Did the committee that investigated you 12 determine that you had earned more than those 23 minimums and failed to reveal that to the 34 institution? 45 A, There were a few instances. The committee 56 determined that I was probably 99 percent compliant. 67 There were a few instances of small nonMdeliberate "78 violations, small violations, 89 MR. FIBICH: Objection, nonresponsive 9

10 BY MR FIBICH: 1011 Q My question to you is, sir, did the 1112 committee in their preliminary findings or tell you 1213 orally that you had violated that policy by not 1314 disclosing to them that you had earned more than 1415 $20,000 in a period and were doing work for a 1516 pharmaceutical company that had paid you that? 1617 MR SPIVACK: Objection, asked and 1718 answered 1819 A, There were small non-deliberate mistakes 1920 that they uncovered. 20n Q. That's not my question, sir. 12122 A, Well, this is my response. 2223 Q. Sir? What did you say? 2324 A, This is what I can tell you. 24~ 5 Q. Okay, let me ask it this way. Did the 25

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committee say that you had acted deliberately?A NoQ Did the committee say that you had acted

with reckless disregard?A The committee is not going to say thatQ Who is Libby Seaman?A Ubby Seaman is a counsel for Harvard

MR FIBICI-I: You want to take a break?I've got only one copy of something I want to askhim about

MR SPIVACK: OkayTHE VlDEOGRAPHER: The time is 9:5 I. We

are off the record(Short recesS taken,)THE VIDEOGRAPHER: We are back on the

record The time is one minute after 10:00BY MR FIBICI-I:

Q Doctor, are you ready to proceed?A YesQ Doctor, we were talking about your

disclosures to Massachusetts General and to HarvardAnd you understand the purpose of that disclosurerequirement, do you not?

A I understandQ Tell the jury the reason that Harvard and



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Massachusetts General requires that you disclose tothem your outside income from pharmaceuticalcompanies.

MR. SPIVACK: Objection, asked andanswered.

A. The policy is that if I conduct researchwith a pharmaceutical company, I cannot do outsideactivity exceeding the minimums.

Q. Why do they have that requirement? Whatdifference does it make what amount of money youmake from the pharmaceutical company?

A, The money is arbitrary, The idea is tominimize potential bias.

Q Do you believe that money that is used tofund studies creates bias?

A. Moneys that are given to support studiesare funding the study; they are not biased.Research is expensive and require funding, Itcannot be done without funding.

Q. Do you believe that pharmaceuticalcompanies that fund studies create bias by the factthat they are funding studies on theit product?

A. I don't I think that they contract withinvestigators to conduct studies that are expensiveto execute; and without funding, research cannot be


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conducted,Q. Not asking you whether you need funding

for research, Doctor. That wasn't my question,Okay? My question is a very simple one. Do youbelieve that when a pharmaceutical company funds astudy of one of its products, that that can createbias?


A. I don't think so.Q. Now, you consider yourself·· Do you

consider yoursel f primarily a clinician or anacademician?

A, I am a clinician researcherQ. SO you consider yourself both?A YesQ And as a researcher, you consider yourself

a scientist?A Yes.Q. Science is a discipline of very certain

exactitude. Correct?A, Science has a process,Q. And it's called the scientific process.

Right?A Yes..


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trying to understand the diseases that the childrenthat are under my care are afflicted and how tobetter approach them therapeutically, with medicinesand with psychosocial treatments.

Q. Now, you've already told us that youconsider yourself a world-renowned scientist,Correct?

A, It is not what I consider myself. It iswhat others consider myselL

Q So you're familiar with your reputationacross the world, Correct?

A I am familiar with my reputationQ. And your reputation is that you are a

specialist in the field of bipolar disease inchildren?

A Iam a specialist in pediatricpsychopharmacology

Q, Which includes bipolar mania?A It is one of many conditions that afflict

childrenQ. Well, I thought you indicated to me

yesterday -- and correct me if I'm wrong -- thatyour two subspecialties within the field ofpsychopathology are bipolar mania and ADHD.

A I indicated that that's the predominanceStratos Legal Services

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A. No, could be somebody related to thiscase.

Q.. Well, who?A I don't know It's not _. I have no

access to that information,Q. Well, the purpose for this is that in this

document, and I only have one copy but I willrepresent to you that I'm going to read itaccurately, it says "Dr. Joseph Biederman, aworld-renowned child psychiatrist" And that's howpeople see you, do they not?

A Yes.Q. Would you consider yourself the leading

psychiatrist in the world for the treatment ofbipolar mania or bipolar disease in children?

A. One of the leaders.Q One ofthe leaders?A. (Witness nodded.)Q. Are you a football fan?A Fair-weather.Q. Fair-weather We had a football coach in

Texas named Bum Phillips, You ever hear of BumPhillips?

A No.Q. His son Wade Phillips is actually the



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Q. And the purpose of the scientific processis what?

A, You are in a study, you are testing, youare addressing a question, you are testing ahypothesis. You subject the data to statisticalanalysis to examine whether the findings arc chanceor not likely to be chance, and you draw conclusionsbased on your findings

Q. It is a search for the greatest tr uth thatcan be obtained. Correct?

A, It is a method to investigateQ. And the method to investigate that you use

requires that you be very precise. Correct?A. As precise as the field allows.Q. And you arc a very precise individual, are

you not?A lamQ, You are a very deliberate individual, arc

you not?A, I am not sure what you mean by thatQ. Well, what you do is a result of your

intentional conduct?A. Well, what I do is I ask questions that I

have about how to improve the life of the peopleunder my care. So all my research is based on


of my scientific work, not the only work that Idoor the only type of research that [ do

Q" When the Grassley committee hearing or theGrassley investigation was initiated, you were thesubject of newspaper comments, were you not?

A. I was.Q. And I have today a copy of a page from The

New York Times, November 25, 2008 Was thatapproximately when this issue came to the public'seye? Approximately.

A. November 2008, I think The New York Timespublished e-mails that you released to the pressfrom some attempt to quash the subpoena This iswhat I think happened in the paper in 2008.. Therewas an article, there are articles before that, butthe 2008 I believe is related to e-mails that youreleased to the press"

Q. You think I released something to thepress?

A. Dbviously somebody releasedQ Well, you said "you" and you looked at me.

Do you think I released it?A I am using the "you" generically.Q. Okay. So the "you" could be anybody in

the world. Right?Stratos Legal Services

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coach of the Cowboys now. You know them, don't you?A I know the Cowboys, yesQ Bum Phillips had a running back one time

and he was asked if he's the best running back everand Bum Phillips said HI can't tell you he's thebest running back, but he's in a class where itdoesn't take long to call the roll," And myquestion to you is, are you in a class where itdoesn't take long to call the roll with respect toexperts in the treatment and diagnosis of bipolarmania in children?

A I would say that there arc probably fouror five people at my level

Q And who are they?A Dr. Janet Wozniak, Dr Barbara Geller,

Dr. Gabrielle Carlson, Robert Findling, people likethat that have done a substantial amount of work onthe subject.

Q So in the entire world as we know itsitting here today, it is those individuals andyourself that are the leading experts in the fieldof bipolar disease in children?

A I would say there are probably about onehundred people that in one way or another doresearch in child psychiatry, but these are the most



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prominent investigatorsQ I understand there's a lot of people that

do research in child psychiatry" As a matter 01fact, there's people --

A" In pediatric bipolar illness"Q As a matter of fact, there are people that

disagree with you as to whether --A" SureQ -- this disease even exists Isn't that

correct?A Absolutely"Q, As a matter of fact, you have compared

yourself, because this disease as you see it hascome under criticism, and you've compared yourselfto Galilee, haven't you?

A I have not compared myselfto Galileo"I only said that Earth was once nat

Q Okay" Well, are you familiar with aBoston Globe article where you indicated thatalthough you were under criticism for sayingpediatric bipolar exists, that you felt like Galileowho said the world was not flat?

A I only said that in science there is anevolution. The first response to new ideas is todemonize them, So the first answer, the people that



Page 381

1 described the HIV virus that won last year Nobel 12 Prize in medicine were ridiculed for a decade until 23 the reality hit that they may have been right 34 Bruce Jenner, when they discovered the smallpox 45 vaccine, had to inoculate his children to make the 56 point that a vaccine is a good idea. 67 So I think that the fact that new ideas ' 78 are met with skepticism occurs in all fields of 89 knowledge that 1 am aware of This is part of the 9o scientific discourse.. 10

11 Q" And part olthe scientific discourse with 11112 respect to your suggestion that bipolar disorder 12

3 occurs pediatrically is that others disagree with 1314 you" Correct? 14

5 A" I'm not sure if 1 understand what you are 1516 saying" Could you repeat it? 11617 Q" Yes You've indicated that new scientific 17

8 studies are often or new scientific discoveries are 189 often met with skepticism. Correct? 19o A Yes, in all fields of knowledge, yes. 201 Q" And the world being nat was one of them. ,,1

? 2 Correct? f,' 223 A" The world being nat is one of them 3? 4 Q" The vaccine, smallpox vaccine that you f4? 5 just referred to? 25

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A (Witness nodded.)Q And you have compared your determination

that bipolar mania or bipolar disease exists inpediatric populations has been met with the sameskepticism, has it not?

A I alluded to the fact that there is ahistory in the evolution of science that new ideasare met with skepticism,

Q" Sir, I'm not talking about the history 01science or anything else, I'm talking specificallyabout your position as a spokesman for theproposition that pediatric bipolar disease existscAnd that has been met by some with skepticism?

A" VesQ" And challenge?A" SkepticismQ" And challenge?A The people that--Q Do you disagree with "challenge"?A Ves. The people that express skepticism

are people that did not conduct research to supporttheir skepticism. And I used the Galileo experiencebecause one thing is to say "I don't like any ofthat" and other thing is to say that "I conductedsimilar research and I was able to show the


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opposite," That research is not forthcoming.So the people, the mostly vocal critics

are people that have not done any critical body ofresearch disputing the findingso They're onlysaying I donlt like it. which in science is not thesame You're not having the same interlocutors bysaying 1 don't like that You can say it about ahamburger or a hotdog but not in science Inscience in order for you to say that this is nottrue, you need to show equal amount of work thatshows the opposite result, and that's the disputeToday pediatric bipolar illness is accepted by thepracticing community

MK FIBICH: Object to that as beingnonresponsive,BY MK FIBICH:

Qo Do you disagree with this statement: Thediagnosis of pediatric bipolar disease iscontroversial?

A I disagree, The controversy is about howto best define, what are the best ingredients,That's the controversy, not that a group of childrenthat are very sick with high levels of morbidity anddisability exist That controversy is ovec Thecontroversy today is about how to best define it



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Qo Did you talk to The Washington Post?A. I don't remember who I talked to, but

apparently I talked to this person.Q. The comments that are contained in the

first two paragraphS are comments of yours and youwere quoted accurately. Correct?

Ao This is not a quote, this is aninterpretation of what I said,

Q. Is it a correct interpretation of what yousaid?

Ao I said the same as I said to you. I didnot eompare myself to Galileoo I said that Earthwas once flat. The reporter is not quoting me hereIt is her interpretation, She could have said thatI am comparing myself to Godo This is herinterpretation of what I said, I said that Earthwas once flat This is what I saido

Q. Well, why didn't you compare yourself toGod?

Ao Because I am not God. I am saying thatthe interpretation of my statement is herinterpretation.

Q, Is her interpretation of your' statement anaccurate statement?

Ao I said that Earth was once flat I didStratos Legal Services

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That's the controversy.MRo FIBICH: Mark this as the next

exhibito And we're skipping one but I'll come backto it

MR BURNEY: So I'm SOiryo The number onthis is 19 or 20? You said the next exhibit butwe're skipping one,

MR FIBICH: Hold onoTHE WITNESS: This is ISoMRo FIBICH: This is going to be 200MR BURNEY: This is going to be 20?

Okay.(Biederman Deposition Exhibit 20 marked

for identification)BY MRo FIBICH:

Q Let me show you what I've marked asExhibit 20, Dr Biedermano

Ao Mm-hmmQ And this is an article out ofThe

Washington Post, February 2005 Do you see that?Ao MOl-hOlmQ And iIyou would turn to page 3 and under

the heading Very Disturbed Children, read thecomments that are attributed to you, sir

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not compare myself to Galileo,Q. Sir, I'm asking you, what she says is

"Joseph Biederman, a professor of psychiatry atHarvard and one of the most forceful advocates ofthe aggressive treatment of preschoolers, thinksbipolar disorder has been severely underdiagnosed inchildren," Is that a correct statement?

A That is correct. That's a quoteQo Okay, that's a quoteo And the next

statement is "He likens the criticism he hasencountered to the outrage that greeted Galileo'schallenge to the notion that the Earth was flat"Is her interpretation of what you said accurate?Yes or no<

A, Yes, it was accurateQo And do you agree that you are one 01 the

most forceful advocates of the aggressive treatmentof preschoolers?

A It is her statement about meQ.. I didn't ask you ifit was her statement

about YOUo I'm asking you ifyou agree that you areone of the most forceful advocates of the aggressivetreatment of preschoolers

AlamoQ. Doctor, what is the purpose ofpublishing



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scientific papers?A To advance knowledge,Q, And the way yOll advance knowledge is that

you corne to scientific conclusions that have met,and I'm talking about you yourself, some level ofscientific rigor that you publish in papers forothers to read, Correct?

A Papers are published disseminatinginformation for others to read

Q, And you believe that the conclusions thatarC contained in the scientific papers that you havepublished with respect to bipolar disease and inparticular Risperdal have met your standards ofscientific rigor?

A All papers that I publish are data-drivenPapers that have insufficient amount of informationto draw more definitive conclusions, that level ofuncertainty is highlighted in the paper.

Q Dr Biederman, I'm only asking you aboutthe bipolar papers with respect to the use ofJanssen products with respect to this question. Doyou believe that those papers that you've publishedhave met your definition and your standards ofscientific rigor?

A, My papers described the facts that IStratos Legal Services

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noticed and whatever limitations the paper had, theywere appropriately noted. Ipublished a paper onthe treatment of ch i1dren with bipolar illness withrisperidone, I recognized it was an open study. Mypaper, my results were fully replicated ten yearslater in a controlled clinical trial that is themost rigorous type of evidence that you can providethe field.

MR FIBICH: I object to that as beingnonresponsive,BY MR FlBICH:

Q The papers that you publish havedisclosures as to any things that may influencetheir conclusions, such as whether it's open labelor randomized, Correct?

A CorrectQ, But other than the limitations that you

yourself put in your papers, do you believe thatthey have met your standards of scientific rigor?

A They met my standards of what I was ableto do at that point in time, yes

Q. And as one olthe leading proponents inthe world of the disease ofpediatric bipolardisease, do you feel that you have an input withrespect to the people that read your studies?



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MR. SPIVACK: Objection, vague, calls for 1speculationo 2

A. Could you .-? I'm not sure what are you 3asking me? Can you reframe the question? 4

Q, Thank you,. Doctor, if I ask you any other 5questions that you don't understand, please feel 6free to ask me to rephrase it so that there's no 7miscommunication between the information that Pm Bseeking and the answer that you're giving, Okay? 9

A Sure, 10Q, My question to you is: Do you believe III

that scientific papers, not just yours but all 112scientific papers, influence doctors in how they use 13that information insofar as their prescriptive 14behaviors? 15

A Knowledge is not necessarily influence. 16The papers are given for people to evaluate. So if 17I have a piece of information on any subject and 11 Bpeople read that infonnation, it is something that 19they can keep in mind in their body of knowledge 20Every day medicine has advances in ideas and not all 21ofthem are great, so doctors and clinicians are ·22exposed to new ideas, and it is for them to evaluate 23ifthe information is useful for their practice. 24

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nonresponsive,BY MR FIBICH:

Q Do you read the American Journal ofPsychiatry?

A. I doQ, Is this a prominent journal in the field

of psychiatry?A. It isQ, Are you familiar with the editorial of

Dr. Kevin Hill regarding conflict of interest?A. Idon't rememberQ Iam going to mark this later but let me

just read you one sentence from it. It says"Surveys of physicians," and this is from theAmerican Journal of Psychiatry, April 2006, "Surveysof physicians find that over 90 percent of us lookto original articles in medical journals as our mostpreferred source of new information for help intreating patients."

Assume I read that correctly" Do youagree with that statement?

A If he says it, it sounds correctQ So 90 percent of the doctors get their

information for help in treating patients frommedical journals?


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MR. SPIVACK: Objection, calls forspeculation, misstates the document.

A. Medical journals provide a very largeamount ofinfonnation" The doctors read theinformation and evaluate the quality of the report,the usefulness, and make decisions accordingly..

Q. And if they evaluate your reports onpediatric bipolar, they ought to be able to drawfirm conclusions Correct?

MR. SPIVACK: Objection, calls forspeculation

A When they read my papers, I provide data;I discuss limitations h's descriptive; it's notideologic..

MR. FIBICH: Object, nonresponsiveBY MR. FIBICH:

Q, L.et's go back to your investigation atHarvard. You were not precise and exact in theinfonnation that you provided Massachusetts Generalabout the income you received from pharmaceuticalcompanies, were you?

A, At the time that I provided information,I believed that I was precise and correct

Q, SO you just made a mistake,A I made a mistake on a few occasions,


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Q. Was there a transcript or a draft reportthat you've seen? I think you said there was,

A YesQ Were there findings in that draft report?A There were findings in that reportQ. Were the findings against you termed

deliberate and reckless disregard for the policiesof Massachusetts General?

A In the first draft those words wereincluded ! disputed those, and in the next draftthey were eliminated,

Q, SO how many drafts have there been?A Two.Q And then welre still looking at a final

draft Right?A That's correctQ Well, what happened between the first

draft and the second draft to cause the committee totake out that terminology that you just testifiedwas taken out?

A. I disputed that I did not do anythingdeliberate or reckless, and they agreed with me

Q, Was there a transcript oftheseproceedings?

MR.. SPIVACK: Objection, vague.Stratos Legal Services

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BY MR FIBICH:Q. Was there a court reporter or a tape

recording of these proceedings where we could lookto see what was exactly said and the questions thatwere asked, to your knowledge?

MR SPIVACK: Objection, vague as to timeA This was a non·court proceeding

environment.Q, I understand it was non-court, Let me

rephrase my question. How many times have youappeared before the committee?

A Once.Q. When was the first time? Or what time was

that?A. The single time was in July of 2008.Q. And at the time that you appeared before

the committee, was there any means to your knowledgethat recorded in any form the testimony that wasgiven to the committee?

A I think that people took notesQ. Other than taking notes, was there a tape

recorder or any recording device or court reporteror any other means other than taking notes of thetestimony that was given?

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1 Q. Let me show you what we've marked as2 Biederman 19, If you would, sir, turn to the second

I 3 page. This appears to be an e-mail from you to Mike4 and Jeny.. Is that correct?5 A Mm-hmm6 Q Does that mean "yesU ?7 A Could you repeat the question? Sony.a I cannot read and listen to you, Could you repeat9 your question?

10 Q I'm sony. Who is Mike and Jeny?11 A. Mike is the president of Newton-Wellesley12 Hospital and Mike Jellinek is the chiefaf child13 psychiatry at Mass. General114 Q Tell me who Mike is again .. I'm not _.15 A. Mike Jellinek, J-e-I-I-i·n-e-k16 Q. And he is what?17 A. He is the president of Newton-Wellesley18 Hospital and the chief of child psychiatry at19 Mass General And Jeny is Jeny Rosenbaum, thei20 chairman of psychiatry121 Q It says on the -- Go ahead and read it122 A (Pause) Yesb3 Q In this, you reference that there were124 five issues that they had identified. What were125 those five issues?i Stratos Legal ServicesI 800-971-1127 I:

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A There was a __ This is one ofthem, t::

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$7,000 exceedance because ofsome misunderstanding ! 2about the presence or absence of a conflict There 3was a thousand dollars in one year from Lilly in 4exceedancc.. There was another thousand dollars in 52006 for an exceedance which are considered 6technical violations and there were a few others, 7two others of a few thousand dollars, The total Bamount of those five instances with five different 9phannaceutical companies, only one from Janssen, did 10not exceed 26, 26 or 27 thousand dollars over eight 11years 12

Q And based upon what occurred at that 13hearing, they called your violations deliberate and 14reckless disregard? 15

MR SPIVACK: Objection, misstates the 16testimony, 17

A They -- 118Q Initially I~ 09A Initially I argued that none of them ~

were deliberate or reckless disregard, and in the 121new draft those epithets were eliminated I~; 2

Q, Why are they considering the Stanley 23Foundation contributions to go against the limit 24that was imposed upon you since Stanley Foundation 125

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is not a pharmaceutical company?A Well, that was my understanding, Because

the study included risperidone and risperidone ismade by Janssen That kind of leap was not clear tome at the time, I would never have exceeded theminimums if! were to have suspected, But becausethe grant was tram the Stanley Foundation and notfrom Janssen, but I was testing risperidone, Zyprexaand Seroquel, so they thought that that should havebeen a violation

Q This one says uThis situation occurTed in200 I when the Cal environment," COl, is thatconflict of interest?

A, Conflict ofinteresLQ. uWas very different and rules of

engagement for contlict of commitment were hardlyclear U

A This is conflict of interest.MR. SPIVACK: Objection Objection,

misstates the record You might want to read thatagain.

MR. FIBICH: Okay.BY MR. FIBICH:

Q. 'This situation occurred in 2001 when theCOl" ~- conflict~of-interest -- "environment was



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very different and the rules of engagement reconflict of interest were hardly clear. n Correct?

A. Correct.Q, "At best this is a legitimate mistake but

not a deliberate act, as they conclude!' Correct?A That!s correct,Q, And why are you sending your side of

things to Mike and Jerry?A. Because they are my superiorsQ.. And then subsequent to this e-mail you

went before the committee and persuaded them thatyour actions were not deliberate or recklessdisregard. Correct?

A. I sent a letter disputing the argument ofreckless disregard and deliberate,

Q. And you say there has been now asubsequent draft that takes that terminology out?

A. Yes.Q, And we're now awaiting a final draft?A, Yes.Q So we don't know as we sit here today what

the final conclusions of the committee are going tobe. Correct?

A. We do not knowMR. FlBICH: Let's mark this.Stratos Legal Services

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(Biederman Deposition Exhibit 2 I markedfor identification,)BY MR FlBICH:

Q, Dr, Biederman, let me show you what we'vemarked as Biederman 2I. Can you identify this?

A, YesQ, What is it?A It's an analysis that we conducted,

Excuse me, Let me just read the paper before I tellyou,

Q. We've only got a few minutes left on thetape, so why don't you read it; we'll just go aheadand take a break,

A I'm ready,Yes, this is an analysis that we conducted

on Dr, Aman's study in the American Journal ofPsychiatry and that examined the effects ofrisperidone in children with conduct disorder andmental retardation

Q, And you were the lead author on thisstudy?

A YesQ Were you the lead investigator?A. Yes,Q. And the other individuals that arc listed


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with you, Mr, Mick. Mr Faraone, Ms Wozniak, 1Me Spencer -- 2

A Dr Spencer They are all doctors 3Q. Dr, Spencer. Excuse me, all doctors 4

They're all Mass General doctors? 5A With the exception of Steve Faraone, who 6

works, used to be at Mass General, now he's in 7Stony Brook -- Where is he? He's in Albany, State 8University of New York at Albany; and Gahan Pandina I 9is from Janssen 110

Q That's G-a-h-a-n P-a-n-d-i-n-a He is a 11Ph.D, not a medical doctor Correct? i12

A He's a Ph D psychologist, yes 13Q And he was one of the authors on this 14

study? 15A Yes 16Q And he's from Janssen? 17

A He is from Janssen 118Q And Faraone is also not a medical doctor 19

Correct? l2 01A He is a Ph D psychologist. !2Q And at the time he was with Mass General? ~ 2A Yes 123Q, Now, when you listed earlier the leading ~ 4

experts in the world, the short list of which you f 5Stratos Legal Services I

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consider yourself one, you listed Dr, Wozniak andDr, Spencer

A No, I did not list -- Dr Spencer is inpediatric bipolar illness. I listed Dr GabrielleCarlson, I listed Dr Barbara Geller, RobertFindling, myself as the lead, and Dr Wozniak

Q. And the ones that you listed as being inthis small group of leading experts, how many ofthose are at Mass. General?

A. Dr Wozniak and myselfQ. And the other doctors are where? Geller

is where?A Geller is in St l·ouis at Wash.U.

Gabrielle Carison is at Stony Brook RobertFindling I believe is in Cincinnati, Differentcenters

MR FIBICH: We've got the tape runningout Let's take a break

MR SPIVACK: Okay.THE VIDEOGRAPHER: The time is 10:35.

Welre off the record,(Short recess taken.)THE VIDEOGRAPHER: We're back on the

record. This is tape number 2. The time is tenminutes to I 1:00



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BY MR. FIBICH:Q. Dr Biedennan, you have an association

with virtually every pharmaceutical company doingbusiness in the United States today, do you not?

MR SPIVACK: Objection, argumentativek I have an association with phllnnaceutical

companies doing work on ADHD molecules or drugs andpediatric bipolar medicines.

Q, SO is the answer to my question yes?A, I have an association with many but not

allQ. Let's go to puge 798 ofyour -A 798? YesQ. Your publication in Clinical Therapeutics

and it lists on the back certain acknowledgments.And why do you list these acknowledgments, sir?

A It is actually disclosures, notacknowledgment Differentjoumals use differentwords for that

Q This one uses "acknowledgment ll Right?A. I understand But I usually submit when

I submit a paper, I send all my associations withpharmaceutical companies as disclosures,

Q So at least with respect to 2006 thesewere the pharmaceutical companies that you


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acknowledged having some relationship with, Right?A. YesQ Ifyou would, sir, follow along with me

and make sure that I'm accurateA Mm-hmm.Q You received research support from

Supernus Pharmaceuticals. Did I say that correctly?A. YesQ You received, and that was formerly Shire

Laboratories. You received support [i'om Eli Lillyand Company. Correct?

A Yes.Q, Pfizer, Incorporated, Correct?A" CorrectQ. McNeil Consumer & Specialty

Pharmaceuticals. Correct?A Correct.Q. Is that now a part of Johnson & Johnson?A. Yes.,Q. Abbott Laboratories. Correct?A CorrectQ. Bristol-Myers Squibb. Correct?A, CorrectQ. New River Pharmaceuticals Correct?A" Correct



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Q. Cephalon, Incorporated, Correct? 1 Company, Shire Laboratories, McNeil Consumer &A Correct 2 Specialty Pharmaceuticals, Janssen PhannaceuticalQ Janssen Pharmaceutical Products Correct? 3 Products, Novartis Pharmaceuticals. and Cephalon,A Correct 4 Inc, Correct?Q NeuroSearch AlS Correct? 5 A. Yes.A Correct 6 Q" Now, as a result of those associations,Q Stanley Medical Research Institute, 7 you make a lot of money, do you not?

Thaes not a pharmaceutical company. Correct? 8 A I make money, yes, and ~~

A. No I 9 Q, As a result of your associations with theQ, Novartis Pharmaceuticals? 110 pharmaceutical companies that you have listed inA. Correct ,.11121 this particular paper?Q The Lilly Foundation Correct? I k My activities with pharmaceuticalA Correct 113 companies as an expert consultant or speaker areQ The Prechter Foundation, as well as the 114 professional activities and I make money, as you

National Institute of Mental Health 115 make money doing what you are doing today with me,A. Yes 1116 Q. I don't make money for pharmaceuticalQ And the National Institute of Child Health 17 companies; I try to take their money.

and I-Iuman Development? 118 A Correct, I understand But it will comeA Correct 1'19 to you.Q And the National Institute of Drug Abuse ,20 Q. The what?

And then you were on the following speakers' 121 A No, nothing Yes, what is your question?bureaus: Shire Laboratories, Eli Lilly and Company, 122 Q. My question is, you make a lot of moneyMcNeil Consumer & Specialty Pharmaceuticals, UCB 23 working for pharmaceutical companies?Pharrna, Novartis Pharmaceuticals, and you're a 124 A, I make money. "A lot" is-~

member of the advisory board of Eli Lilly and b5 Q A relative term?Stratos Legal Services i Stratos Legal Services

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Joseph Biederman I Joseph BiedermanFebruary 27, 2009 February 27, 2009

What are you paid for that work, sir?Depending on my time, I charge by time,And you charge by the hour?By the hourAnd I saw where several years ago in someStratos Legal Services

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A, Yes,Q. As a matter of fact, you make more than

your salary working for these pharmaceuticalcompanies do you not?

A, NoQ.. You make as much working for

pharmaceutical companies as you do your salary atMass, GeneraL Right?

A, No, not corTece I think that my incomefrom pharmaceuticals is not larger than my salary.My outside activities is about the size of mysalary, but not only from pharmaceuticals. Myoutside income comes from pharmaceutical and non~

pharmaceutical sources,Q, What other sources do you have income from

that's not nonpharmaceutical? And I'm not talkingabout investments, I'm talking about --

A No, I don't have any investments in stockof any phannaceuticaL Things like consultationwith lawyers, consultation with investment bankers,consultation or CME activities, congresses, if Ispeak in a congress, I get an honorarium, Things ofthat type,

Q, SO you're an expert witness for lawyers?A I am not an expert witness, purely


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consultant on legal matters sometimes pertaining tocases of my practice. I don't do any forensic work

Q And when you're dealing with investmentbankers, are you dealing with pharmaceuticalproducts?

A, The investment bankers are interested toknow about the diseases that I treat and if there ispotential for a particular compound or how themarket is shaping up, But the consultation is toinvestment bankers.

Q, And you're paid for those consultations?A I am paid for those consultations.Q What investment bankers have you consulted

with and what products?A, There is not a specific product I

consulted to agencies like Deutsche Bank, things ofthat type, and there are other kind of investmentorganizations that do this type of analysis of whatthe market is and where it's going and so on and soforth

Q.AQAQ

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papers you were charging $550 an hour?A That sounds correctQ, What are you charging today?A Pretty much the sameQ< Does that mean the same?A, The same

MR, SPIVACK: Objection, vague, I think,when you say what are you charging todayBY MR FlBICH:

Q, Currently for consulting work, ifsomeonewanted to ~~

A Yes, $550Q And you understand that your ability to

earn these moneys from these pharmaceuticalcompanies is dependent upon you being favorable totheir products?

A Being what?Q< Favorable to their productsA Not necessarilyQ You don't think so?A No, I don't think so,Q. Now, J also noticed in the reference part

of this paper ~N And what are references in apharmaceutical paper?

A This is a scientific paper, not aStratos Legal Services

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pharmaceutical paperQ This is a scientific paper regarding a

pharmaceutical product Right?A, This is a -- Yes, regarding a condition

for which the pharmaceutical product was used Buta major purpose of this paper is to point out thatchildren with a conduct disorder have a lot ofaffective symptoms that benefited from the sametreatment that was shown to benefit the conditionthat the investigators initially studied

Q, The references in the back are used forwhat purpose?

A, The references is to support an assertion,So if I say depression affects 10 percent of thepopulation, I need to put a source of where I gotthat information

Q And [ noticed that in the referencesection that there are nineteen references, Do yousee that?

A L.et me see, Where are the references?Q Should be page 800A Yes, I see itQ There's nineteen references?A Nineteen referencesQ And eight ofthose references are to you,



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are they not?A, Yes,Q, Number 1, 7, 8,14,15, 17,18 and 19A, Mm-hmm,Q, Does that mean lfyesft?A, Yes,Q. SO you reference yourself a lot in an

effort to give this paper credibility, Correct?!vIR SPfVACK: Objection, argumentative

A I reference myself because I did the lineof work that the papers that I am referencingalludes to. In other words, in science it's anincremental process, It's like a big puzzle. So Idid the work up to that point and the references ofthe work indicate that this type of activity waspreceded by other activities.

Q Let's go to page 798, if you would, sirA. Yes,Q. And the paragraph following this chart,

the first full paragraph that begins "Whether" Doyou see that, sir?

A. Mm-hmm,Q. It says "Whether risperidone is effective

in treating affective symptoms outside the contextof comorbid DBD," and tell the jury what DBD is.


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A It's disruptive behavior disorders.Q. That!s not bipolar disease Correct?A NoQ. "Whether risperidone is effective in

treating affective symptoms outside the context ofcomorbid deceptive behavior!! _M

A. Disruptive behavior disorders,Q. M_ "disruptive behavior disorders awaits

confirmation in future randomized clinical trials, n

Do you see that?A Mm-hmm,Q And by randomized clinical trial, you mean

a double-blind compared to placebo randomizedprospective clinical trial Correct?

A Correct Our study was a post hocanalysis of a randomized clinical trial, but thatwas not the purpose of the original study,.

Q. But you!re saying for a detennination tobe made as to whether risperidone is effective withrespect to this particular population, you need agold standard clinical triaL Correct?

A, That's correct That was done,Q, You didn't -- Excuse me. Go ahead,A. The randomized clinical trial that I

advocated to be done in bipolar illness was done,Stratos Legal Services

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Q, You didn't do it, did you?k No, but it was done,Q.. I'm not asking you whether it was done

I'm asking you, you didn't do it, did you?k I didn't do itQ, Why is it that when pharmaceutical

companies want the gold standard, they go tosomebody else as opposed to you?

MR SPIVACK: Objection, argumentativeA, They come to many. The request from the

Food and Drug Administration is to have a smallnumber of subjects from many, many sites

Q. Do you lack credibility with the Food andDrug Administration?

A Well, I could not participate fortechnical reasons. I was not available at thattime, I dontt have the resources to participate inthis study, I would have been very happy toparticipate if I could

Q, You weren't asked to participate, wereyou?

A I was asked to participate. I couldn't.Q, Tell me why you couldn't.k. I was very busy with other studies, I did

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Harvard?k NoQ, You did not?A. No.Q, And you're telling me the institutional

review board at Harvard did not deny that, a requestfor Harvard or Mass. General or somebody atMass. General to do this study?

k I can only do studies if I receivefunding I did not receive funding to do a doubleblind study so I did not submit, to the best of myknowledge, I did not submit any application to theIRS. IRS approves studies all the time

Q Well, Doctor, he.e's what my problem is,Maybe you can help me out and help our jUly ouLYou have told me what an authority you are in thefield of these behaviors. Right?

A Mm-hmm..Q. World-renowned. Right?A, Mm-hmm,Q, L.eading authority in the wotld, one ofthe

leading authorities in the world, Right?A YesQ. There may be others that are equal to you

but there's nobody that knows more about this fieldStratos Legal Services

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Q Sir, are you telling me that you turned itdown because you didn't have time, or was it turneddown because the institutional review board atHarvard would not let you do it?

A No. I don't recall exactly the details ofwhat was the particular issue, but I did not submitThe institutional review board gets involved onlyafter I submit the application, not before So Ibelieve I did not participate in this study

These studies sometimes require recruitingat high velocity and Iam not always able toprovide. It's a lot of work for me to participatein these multi-site studies lhey usually have anarrow window, so it's a huge amount of work, and myjudgment may have been that I would not be able torecruit at the time that the study was interested inrecruiting, so they have to use other sites thathave more availability to recruit at the speed thatthey wanted, That's my recol1ection to the best ofmy recollection

MR FIBICH: Objection, nonresponsiveBY MR. FIBICH:

Q I'm asking you a very specific question,Did you make application to do a double-blindclinical trial as suggested in this paper to



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than you do?A. I do not know that that is true But in

any event,Q, Okay, But, in any event, you do studies

in this area that are all open label, CorTect?A, I do some double-blind studies tooQ, The studies that you have done with

respect to _.A, My studies, they were open label, yes.Q And that creates a potential bias in these

studies, does it not?A The results of my studies have been fully

replicated in independent large-scale double-blindrandomized trials, In fact, the study of Zyprexareplicated my open label study completely; the studyofrisperidone replicated my initial open labelstudies completely; and the study olAbiliIY, to thebest of my knowledge, fully replicated what Ireported in open label studies

MR. FIBICH: Objection, nonresponsive.BY MR. FIBICH:

Q. The studies you did with respect topediatric bipolar disease and risperidone were allopen label, Correct?

A, Yes.Stratos Legal Services

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Q But what Idon't understand and Iwant tobe clear on, and this is the last time I'm going toask it, you didn't do it because you didn't haveenough time. Correct?

A. I did not do it to the best ofmyrecollection because the window that they wanted torecruit was too tight for me and Icould not stopdoing other activities and just do this

Q, Why do you keep telling me to the best ofyour recollection? Isn't everything you're tellingme today to the best of your recollection?

A YesMR SPIVACK: Objection, argumentative

A I do many studies I run a very largelaboratory. The majority of my studies have nothingto do with pharmaceuticals and I cannot recall everysingle detail of every study It's impossible forme to keep it in my active memory

Q What is Dove Publishing Company?A Say again?Q Dove PublishingA I have no ideaQ Do you not have a company called Dove

Publishing?A I don't have any companies.


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Qo And that has a potential for bias, does itnot?

Ae That has a limitation.Q, And there were additional limitations in

all the studies you did with respect to risperidoneand bipolar mania in children, that being smallsample size as welL Correct?

A Small sample size were pilot studies, werenot definitive studies, were proof-of~concept

studies where there is a reason to pursue a largerandomized clinical trial Ifan open study showsabsence ofactivily, there is no point in doing adouble-blind study.

Q. My question to you, sir, is if you havethe knowledge base that you claim to have and you'vedone these studies that have limitations, why don'tyou do one that you can call the gold standard?

MR SPIVACK: Objection, misstates thetestimony, calls for speculation, argumentative,

A The studies that will be definitive, thereare registration studies that have to be done by thepharmaceutical company, I encouraged Janssen topursue and run a large~scale multi~site randomizedclinical trial. Those are the gold standard of thefield, so"


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Qc On a paper entitled Risperidone Treatmentfor ADHD in Children and Adolescents With BipolarDisorder. This is your paper, is it not?

k Mm-hmm, yes,Q, Down here it says 2008, Biederman et aI.,

publisher and licensee, Dove Medical Press, Ltd, Isthat not your company?

A, No, I don't have any companies<Q. Do you know what Dove Medical Press, ltd

is?A, I have no clue,Q. Do you know who Excerpta Medica is?A. I believe it's a CME providerQ. Do you know what else they do?A. No.Q, What did they have to do with the paper

that we've been talking about, that is, your reporton risperidone for the treatment of affectivesymptoms in children with disruptive belmviordisorder?

MR. SPIVACK: Objection, calls torspeculation.

Ao Ido not knowQ, Do you know that they are listed in this

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A If they are, they are listedQ Well, I'm asking you if you knowA I do not knowQ, Okay, look at Conclusions You see at the

bottom?A, YesQ. It says nAccepted for publication,

copyright Excerpta Medica" ~-

A, Wait. Where are you reading? SorwQ. At the bottom of the Conclusions

paragraphA. After the acknowledgment, the conclusion

says "The results of this post hoc analysis ofaffective symptoms using data from a previouslypublished" --

Q. The bottom of that, sirA Says "suggest that risperldone was

effective in treating the factors of explosiveirritability; agitated, expansive, grandiose; anddepression."

Q. Is that the bottom of the paragraph?A Ofthe Conclusions? YesQ So the sentence that fbi lows that isn't at

the bottom of the paragraph, to your knowledge?A As I see it here. Are you reading


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MR. SPIVACK: Objection, argumentative.A I don't know. I do not know.Q. You don't know?A. NoQ Well, why did you say it?

MR SPIVACK: Objection, asked andanswered, argumentativeBY MR. FIBICH:

Q, Are you just pulling your answers out ofthe air today?

MR. SPIVACK: Objection, argumentative.A No.Q What is Excerpta Medica?


A, I believe it's a medical educationcompany

Q That's all you know about it?A Yeah,Q. You don't know that they're a company that

ghostwrites papers?MR SPIVACK: Objection, calls lor

speculation, argumentative, misstates the testimony.A. No

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somewhere else?Q. L.et me see it My fault The other

Conclusions, on the first page .. It says "copyright2006 Excerpta Medica, IncorporatedI' Do you seethat?

A. YesQ. And then it goes down and says "copyright

Excerpta Medica, Incorporated:'A Mm·hmmQ. What did Excerpta Medica have to do with

this paper, to your knowledge?A We submitted the paper to Clinical

Therapeutics, not Excerpta Medica. I think thatClinical Therapeutics belongs to Excerpta Medica, Iguess, But our transactions ~-

MR. SPIVACK: Don't speculateTHE WITNESS: Okay

BY MR. FIBICH:Q CI inical Therapeutics belongs to Excerpta

Medica Is that what you said?A I do not know<Q. Why do you say that?A I guessed.Q. Youjust pulled that out of the air?A. Well, it's listed here


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BY MR. FIBICH:Q. Do you know what the responsibilities and

duties are ofa company by the name of ExcerptaMedica?

A. NoQ" Have you ever had communications from the

company Excerpta Medica?A. I don't recall.Q So you might have, you just dontt know?A. I don't recalLQ. SO you might have, you just don't know?A. I don't recall.

MR. SPIVACK: Objection, asked andanswered,BY MR. FIBICH:

Q. Do you know that Excerpta Medica ownsjoumals that are thought to be scientific joumals?

MR. SPIVACK: Objection-A. I have no idea

MR. SPIVACK: -- lacks foundationA. I do not know who they are.Q. Have you ever dealt with Excerpta Medica?A. I don't remember.Q. You dontt remember?A (Witness nodded.)


Q Is that your testimony?A Yes

MR. SPIVACK: Objection, asked andansweredBY MR FIBICH:

Q, Has Excerpta Medica ever written papersfor you?

A NoQ. Have they ever modified papers for you?A All my papers were written by me.Q. It's not my question, sir My question

was, has anybody at Excerpta Medica modified anypaper that youtve written?

MR. SPIVACK: Objection, asked andanswered.

A Not that I know.MR. SPIVACK: Excuse me Let me

interject, please.THE WITNESS: Okay, sorry.

BY MR FIBICH:Q You say you have a good memoryc Correct?

MR.. SPIVACK: Objection, asked andanswered.BY MR FIBICH:

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A I have decent memory 1Q Decent? I thought it was great this 2

morning. Has it diminished as we've been sitting 3 Q Do you do a cover letter? What is thehere? i 4 process by which ies submitted?

MR SPIVACK: Objection, argumentative i 5 A Every journal has a procedure forA I think SQ, I'm tired 6 submission of papers and we follow those procedures,Q Are you too tired to go on? 7 Q Okay. The papers that you have writtenA No 8 with respect to risperidone or bipolar disease, wereQ, Well, ifyou're too tired to answer my 9 those all submitted directly to scientificjoumals

questions because your memory has diminished, let me 110 or were they submitted to some third party thatknow, because I want your best answers ill would then try to get them published in scientific

A I will let you know 112 journals?Q You understand today is an important 13 A We submit the papers directly to the

proceeding, do you not? 14 journaLA I do 15 Q So you've never submitted a paper to aQ, Even though we're here in the informality 16 different party that would then try to get them

of Mr Spivack's office and wc're doing this with 17 published in a scientific journal?professional courtesies to each other, today is very 118 MR., SPIVACK: Objection, asked andimportant You understand that? 119 answered

A I understand it 20 MR. FIBICH: No, it's a differentQ, Who did you submit the paper to at 21 question.

Clinical Therapeutics? Or, strike that Let me ask 122 MR SPIVACK: Same objectionanother question When you prepare a paper and it 123 A I submit the papers directly to theis submitted to a scientific journal such as 24 journalClinical Therapeutics, do you personally direct that t5 Q You have ncver submitted a paper for

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1 publication to any third party for submission to a2 journal?3 MR SPIVACK: Objection, asked and4 answcred.5 BY MR FlBICH:6 Q Is that your testimony? I want to make7 sure--8 A My testimony is that to the best ofmy9 recollection my papers are submitted directly to the

10 journal11 (Biederman Deposition Exhibit 22 marked12 for identification,)13 BY MR FIBICH:14 Q. Dr- Biederman, if you would review a15 series ofe-mails that we've marked as 22 (Pause)16171819202122232425


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that was published in Clinical Therapeutics thatwe've been talking about. Correct?

MR SPIVACK: Objection, calls forspeculation, asked and answered.BY MR. FlBICH:

Q. tet me ask you this: Can you determinewhether this poster presentation applies to thereport that you had published in ClinicalTherapeutics? Read it and tell me whether you cando that

A (Pause) It appears to be the samedataset

Q It's the same dataset And will you agreewith me that this is a poster presentation arisingfrom the dataset that was the basis of your paperpublished in the Clinical Therapeutics journal?

A It seems to be


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things that afC later disseminated in some form tophysicians, Correct?

MR SPIVACK: Objection, vague, misstatesthe testimony,

A This is a poster based on analysis of datathat we conducted The data that we conducted weresubmitted for peer-review evaluation to a scientificjournal that's called Clinical Therapeutics Inaddition to having the paper in a journal, thisinformation was sent as a scientific poster that isalso peer-reviewed to the American Academy of Childand Adolescent Psychiatry

During that process Excerpta Medicaappears from these e-mails to have been involved inthe production of the poster, not in our analysisThe analysis was conducted, the data are factual, sothe poster is just a production that requires someartistic abilities, takes time, you need to have theright colors to be presentable, et cetera,et cetera So they were helping in the technicalaspects of preparing a poster for a scientificmeeting,

Q So when you testified you didn't rememberExcerpta Medica preparing any drafts of scientificmatters for you, that was inaccurate?


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MR SPIVACK: Objection, calls forspeculation

A Posters requires a production So youhave a limited amount ofspace in a poster for ascientific meeting to put your tables, your figuresYou have much less space than 10 or 15 written pagesin ajournal, so the production of the posterrequires an investment of time on how to arrangeSo Excerpta Medica may have been asked to put ittogether as a poster and they had some qualitycontrol issues that the numbers did not match orsomething like that

Q So Excerpta Medica is preparing drafts ofStratos Legal Services

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MR. SPIVACK: Objection, misstates thetestimonyBY MR FIBICH:

Q, Correct?A I testified that I did not rememberQ. And now you remember. Correct?A It's written in this e-mail, because you

showed me the e~maiL It's not that it comes flyingfrom my head

Q. And now you remember -- Excuse me, Andnow you remember that Excerpta Medica prepared aposter that contained your name on it forpresentation at a medical seminar. Correct?

MR. SPIVACK: Objection, misstates thetestimony, misstates the document

A. I do not know what exactly Excerpta Medicadid, I interact with many pharmaceutical companies,with many different organizations. I cannotremember who did what ten years ago,

Q But, sir, you said you wrote every word ofyour scientific papers,

A, The papers that I wrote, I wrote everyword< The production of the poster requires somebullet points and it's a different technique than apaper, so you have much less space, And in a



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1 limited space you have to present materia! that2 needs to be condensed,345 MR SPIVACK: Objection, misstates the6 testimony, misstates the document789

1011 A, Making edits to make sure that the poster12 is written under the limitations of the space that13 you have in a poster' in a way that is clear and with14 acceptable syntax. So maybe the sentence was a15 r'Un~on sentence or something like that16 Q Tell me what revisions he made, sir,17 specifically.18 A I don't remember.19 Q, You're just making that up out of whole20 cloth, aren't you?21 MR. SPIVACK: Objection, argumentative.22 MR. PECK: Objection, argumentative.23 BY MR. FIBICH:24 Q. You're just making it up? You're25 speculating what you think Mr, Pandina did.



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1 MR SPIVACK: Objection, argumentive.2 BY MR. FIBICH:3 Q Aren't you?4 A. The process --5 Q Let me ask my question All right? You6 do not know what revisions Mr Pandina made to the7 draft poster presentation that Excerpta Medica8 prepared, do you?9 A I don't remember the specific ones

10 Q. Was it customary for Exeerpta Medica to do11 all of your poster presentations or some ofyour12 poster presentations?113 MR SPIVACK: Objection, calls for114 speculation, misstates the--15 A, I do not remember16 Q, I'm sorry, I didn't mean to interrupt you17 Do you --18 A I do not remember19 MR. SPIVACK: let Mr. Fibich ask the120 question!21 A, I'm sorry I was responding to a previousb2 question123 Q. Now that you have seen the exhibit that we24 have marked as 22, has that refreshed your25 recollection about the role of Excerpta Medica in



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any other poster presentations? 1A Refresh my memory about this poster 2Q No others? 3A I submit many posters, many meetings, and 4

I interact with many educational organizations that 5from time to time help in the preparation of those 6posters Not in the content but in the display 7

Q You're a very busy man, aren't you? 8A. lam 9Q. Probably get up early? 10A Yes 11Q Work late? 12A Yes 13Q. It's what you have to do to be world- 14

renowned. Right? 15MR. SPIVACK: Objection, argumentative 16

A I am world-renowned because the quality of 17my work. I could work 24 hours a day and not be 118world-renowned Okay? Like I am not world-renowned 19in playing baseball or being a chess champion 20Certain things I do well and it is the quality of 21what I do, not the hours I spend, that make it 122possible 123

MR. FIBICH: Mark this, please. r4(Biederman Deposition Exhibit 23 marked 25Stratos Legal Services

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for identification,,)BY MR FIBICH:

Q, Let me ask you to describe for our jury,what is the difference between an abstract and aposter presentation?

k I'm not sure if I understand correctlyAn abstract, every paper has an abstract- When wesubmit to a scientific meeting a poster, comes inthe form of an abstract. If the poster is accepted,a poster has to be produced to be presented at ameeting

Q. When you say if a poster is accepted, doesit undergo some sort of review process that would beequal to the peer-review process?

A It's a peer-review process Posterssubmitted to scientific organizations undergo apeer-review process.,

Q. And can an abstract be presented at amedical seminar in some fonn other than a posterpresentation?

A, The scientific meetings have differentvenues of presenting infonnation. Some are posters,some are oral presentations.

Q. Some are written? Can you just hand outan abstract?

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Q, Are you familiar with il?A, Iam reading it.Q OkayA. (Pausc) What is your quesrion?Q You just told me that you always prepared

your abstract. Do you want to stand by thattestimony or do you want to change it, having readthis document?


scientific rigor that you so champion in yourtestimony here today?

MR. SPIVACK: Objection, argumentative.A Abstracts submitted to scientific meetings

are proposals to present information at the meeting,By design. they contain a very small amount ofinformation to elicit the fiJll evaluation of theinformation contained

Q. Well, let me ask you this way. When youprepare or desire to present an abstract at ameeting, do you prepare the abstract or does someonedraft the abstract for you?

A My work, I prepare rhe abstract0, Let me show you Exhibit 2]

Page


A.Q.

A NoQ, SO it's an oral presentation or a poster

presentation. Is that right?A. That's correct.Q. Are abstracts important, the information

contained therein?A. Abstracts are a mechanism for submitting

material to a scientific meeting, The abstracts forthe meeting are published for people to know whatmaterial the meeting contained. So the abstractcontains, as its name indicate, a very smallabridged amount of information that is notsufficient to know exactly what the information isunless you find the poster or get the paper and getadditional details

Q. Well, my question is: Are abstractsimportant, the information contained therein, thatare accepted for publication at a medical seminar?

MR. SPIVACK: Objection, asked andansweredBY MR FIBICH:

Q Are they important?MR. SPIVACK: Same objection

I don't know what you mean by importantShould they meet the standards of

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Q. SO you're asking a Janssen employee to 10draft an abstract for you. Correct? 11

A I asked him to help me in putting an ,12abstract for this particular meeting in a very rapid 113turnaround time on material that we already 14developed. I did not ask him to create anything. 15

Q. You asked him to draft the abstract. 16Correct? 17

A I asked him to draft an abstract, to help 118me with the draft of the abstract from material that 119

weQalreaHdY develokPed . I h h d d ~12 ~o. e was ta 109 matena t at you a an

putting it in abstract form, Correct?A. Correct. It was a rapid turnaround that ~ 3

this required, and I was not able to put it together E4at the time frame that this required, so I asked him Q 5


to help me out because hets a co-author of thepaper, as you saw.

Q. SO when I asked you earlicr do you alwaysdraft your abstracts, what you should have said wasI always draft them unless Idonlt have enough timeThat would have been an accurate statementCorrect?

MR PECK: ObjectionA. The abstract for the paper was drafted by

me. I asked --Q. Then why are you asking him to draft it?A. I asked him to complete the material

necessary for the submission for this journal, forthis meeting, at the rapid turnaround this requiredtrum the material that we already have" Being aco-author of the paper, a co~author has access tothe information; it was not a secret activity. Heis a co~author of the paper that you saw when youshowed me one of the previous exhibits



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Q I want to go back to your study that wascopyrighted by Excerpta Medica Do you know whythey copyrighted the study?

A. 1think all scientific journals copyrightthe papers.

Q. Well, they're not a scientific journal,are they?

MR. SPIVACK: Objection, calls forspeculation.BY MR. FlBICH:

Q Do you know if Excerpta Medica is ascientific journal?

A Clinical Therapeutics isQ Well, Clinical Therapeutics didn't

copyright it, Excerpta Medica copyrighted it, andI'm asking you ifyou know why

A, I have no idea,Q. Now, ifyou would, sir, pull your paper

outMR. BURNEY: Which exhibit?MR FIBICH: Excuse me 21.

BY MR FIBICH:Q. Sir, this is one ofyour papers that you


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say you drafted Correct?A YesQ. And this is one of those papers that you

say meets your high standards of scientific sanctityand rigOL Correct?

MR. SPIVACK: Objection, argumentative.BY MR, FIBICH:

Q. Con'ect?MR. SPIVACK: Objection.

A I don't think that Usanctity" is a wordthat applies to science

Q. Okay Is this paper that we haveidentified as Biederman 21 representative ofthetype of scientific work that you customarily do?

A Yes.Q Now, I want to make sure that our jury

understands what was done here, Okay?A. Mm-hmm.Q. Because I doubt that any of the members

will have the background that you have in this areaOkay?

A YesQ. SO what I understand that you did was you

had 110 patients and you had 49 that you gaveRisperdal to and 61 that got a placebo. Is that


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correct?A. I would like to clarify that this is not a

study that I conducted; this is a study thatDr. Aman conducted. What 1did is 1conducted apost hoc analysis from the published data thatDr" Aman conducted,

Q. Okay, 1 understand that. You took a studythat someone else did and evaluated that study for acertain purpose, Correct?

A. That's correctQ. And the purpose for which you looked at

that data was to determine whether risperidone wasbeneficial for the treatment of affective symptomsin children with disruptive behavior disorder,Correct?

A CorrectQ. SO you took somebody else's data and

analyzed it for this purpose. Correct?A That's correctQ, And you came to certain conclusions.

Right?A CorrectQ. Now, in evaluating this dataset you looked

at certain types of behavior that we call affectivesymptoms. Correct?


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A CorrecLQ, And affective symptoms are serious

symptomatology associated with disruptive behaviordisorder. Correct?

A Correct The symptoms, the analysis thatwe did used information from the rating scale thatthis study relied upon that is called the Nisongerrating scale. So we did a statistical techniquethat is called factor analysis in which weaggregated mathematically and empirically certainsymptoms from the 100 items or so that the scale hadthat alluded to agitation, euphoria and depression,

MR FIBICH: I object to that as beingnonresponsive,BY MR, FIBICH:

Q. My question is, you were looking ataffective symptoms. Correct?

A Yes.Q. And you used a rating scale to do thaL

Correct?A No. I used data from a rating scale that

Dr Aman used in his study, double-blind study ofrisperidone showing that children with conductdisorder or disruptive behavior disorder, mentalretardation, had a very striking benefit under


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double~blindconditions to risperidoneMR FIBICH: I object as being

nonresponsiveBY MR FIBICH:

Q Dr, Amao had information about how thesechildren reacted when they were on risperidoneCorrect?

A That's correctQ. And you took the description that he made

of these children and applied that to the Nisongerrating scale, Correct?

A I took the Nisonger rating scale andsubjected that to a technique that is called factoranalysis that examined a natural aggregation ofcertain symptoms under certain categories So theway that the symptoms were aggregated were symptomsthat we called agitation, euphoria, and depressionThose arc symptoms that are known as affectivesymptoms, and we reanalyzed the data that Dr Amanproduced in light of those symptoms

Q Well, you also looked at one nonnflectiveoutcome variable. Correct?

A Yes,Q And a nonafTective outcome variable, what

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A, It means other symptoms that were not inthe category of depression, agitation or euphoria,

Q These would be symptoms that are not asextreme as affective symptoms?

A No, they are different symptoms Theseare symptoms that are more in the disruptivebehavior category more strictly speaking. So Iextracted from the disruptive behavior disorders thekind of symptoms that could be construed asaffective.

Q Now, let me make sure that I understandand hopefully our jury will understand. You lookedat affective symptoms, and these are grandiose,depression, great irritability?

A. YesQ. Those are affective symptoms And then

you looked at nonaffective symptoms, andnonaffective symptoms are symptoms that are justkind of ordinary misbehavior?

A. Not misbehavior These are symptoms ofchildren with disruptive behavior, lying, bullying,these type of things.

Q. Lying and what?A. Bullying.Q Bullying?


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disorder standing alone?A The symptoms in the scale are not a

diagnosis of anything, Children were entered intothe study; they had to qualify for a diagnosis ofconduct disorder' based on the DSM.

Q. Okay, let me tI)' it one more time Tellthe jury the difference between affective symptomsand nonaffective symptoms in lay language, ifyoucan

A Affective symptoms refer to problems withmood regulation and include things as agitation,aggression, depression, these type of examples,Nonaffective symptoms could be distractibility,inattention, oppositional, things that are more inthe behavior category The symptoms by themselvesare not diagnosticc The rating scale is not adiagnosis A rating scale is a measurement ofseverity.

Q. Okay. Now, let's look at your results, ifyou would, sir Go down to the sentence starting"The treatment" ~-

A Where are you reading?MR. SPIVACK: Do we have a page number?MR. FIBICH: The first page

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A. Yes, as examples, So then the rating 1scale has more than one hundred items, so some items 2were not in this mathematical analysis that we 3concluded were not part of the affective symptoms. 4We called them nonaffective or disruptive symptoms, 5

Q. And I'm trying to make sure that our' jury 6understands that, and so I'm going to try to put it 7in words that hopefully you'll agree with. 8Nonaffective behaviors are kind of like being a 9brat, lying and bullying. Would you agree with 10that? 11

A I don't think so, that being a brat is the 112right tenninology. These are kind of behaviors 113that, remember, these children were ofsubnormal 114intelligence so some of the behavior'S were aberrant !15I don't remember exactly the items, but we deemed 16them nonaffective. But IIbrat" I don't think applies 17to·· 18

Q. Well, let me see if) can try another way. 19Nonaffective symptoms are not as serious as 120affective symptoms? 21

A. No, I don't say that They are difterent ~ 2Q. Okay. Nonaffective symptoms alone would 123

not be -- Nonaffective symptoms alone would not b4constitute a diagnosis of disruptive behavior li25

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Q, It says "The treatment effect analysisfound that the mean scores of all three independentdimensions were significantly reduced withrispeddone compared with placebo at weeks two, fourand six. II I read that correctly, right?

A YesQo So what you did was you measured these

children or assessed these children based upon theearlier data at weeks two, fouf and six, Correct?

A. I did not assess the children; Ijust usedthe data from Dr. Aman So it's not that I examinedthese children,

Q. I understand that. And thank you forclarifying that. The data that Dr Aman had thatyou looked at had validity at two, foUT' and sixweeks. Correct?

A. Yes.Q. And when you say "all three independent

dimensions," what arc you talking about?A We mathematically extracted the three

areas, euphoria, aggression, I believe, anddepression, Those are the domains; and wereanalyzed the data. In other words, children thathad those domains, we were able to examine how theyresponded to risperidone in this study..



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A What do you mean by false?Q. I mean it's wrong. Well, let's look back,

if you would, sir, and tum to Table 4 on page 799.A Mm-hmmQ, Now, the .95 effect size applies to

nonaffective conduct Correct?A, Yes,Q. But in this Results section you say .95

applies to affective behaviors. And that's notright, is it?

A. Just let me read it Okay? (Pause)There appears to be a mistake here,

Q The way this is written is misleading, isit not?

MR SPIVACK: Objection, argumentative.A. It has an error that you pointed out to me

that I did not pick up before.Q, It is misleading, is it not?

MR, SPIVACK: Objection,A It has an error..Q. It attributes an effect size that is

larger than the effect size that is attributabie tothe factors you looked at Correct?

A. It is an error.Q. You took the largest effect size you could


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Q These were all three affective variablesthat you looked at Right?

A That1s correctQ And so you say" The effect sizes of

improvement," and effect size would be a method ofdetennining how much improvement there was?

A, It is a statistical method that is used toexamine the magnitude of improvement So the effectsizes arc divided into small, I, ,2; medium,.4 to,6; and large, above 7

Q So it goes on and it says "The effectsizes of improvement in these factors," and thesefactors refer to the three independent dimensionswhich you've identified as affective behaviorsRight?

A YesQ "Range from 44 to 0.95 at endpoint"

Correct?A To .95; ciose to IQ And that is a false statement, is it not?A Say again?

MR. SPIVACK: Objection, argumentativeBY MR FIBICH:

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find and applied it to nonaffective behavior.Correct?

A There was an error in that report,Q You took the largest effect number you

could find and attributed it to other behaviors, didyou not?

MR SPIVACK: Objection, asked andanswered, argumentative.

A, There was an error, We made an errorQ. You wanted this paper to come out to show

that Risperdal helped these children more than itdid, didn't you?

MR SPIVACK: Objection, argumentative,misstates the testimony,

A I am not If you iook at --MR SPIVACK: I'm sorry, Doctor, If you

would just let me finish. Thank youBY MR. FlBICH:

Q. Did Excerpta Medica write this paper?MR. SPIVACK: Objection, asked and

answeredA. No,Q How did it pass the rigor of science that

you have so diligently tried to apply to this paper?A. I think that there is a mistake here.


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1 Q, But it wasn't reckless disregard for the2 truth, was it?3 A Absolutely not4 Q, It wasn't a disregard of the scientific5 method, was it?6 A Not at all, If you look at the previous7 number in the agitated depression, the effect size8 of ,74 is a very large effect size. The effect ,699 in the explosive behavior is a large effect size,

10 Q. You're saying ,74? Well, let me ask it11 this way. Are you saying effect size has

2 definitions for small, medium, and large?13 A. Yes14 Q, And it is your testimony under oath here15 today as a scientist that those effect sizes, those16 numbers represent a large effect?17 A. Effect size above 7 are considered18 large--19 Q, You consider Is that--~ 0 A No, no, that's the conventionb1 Q, Refer me to a text on that, please,? 2 A. It's Cohen The person that described23 that, his last name is Cohen, I can give you the? 4 reference.25 Q I'm waiting


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A, I don't have it in front of my memoryQ, And in this study that we've been talking

about, these were retarded children, were they not?A Yes,Q, Severely retarded, were they not?A No, They were mildly retarded.Q Minor retarded?A Mildly, mildlyQ Mild?A Yes

(Biederman Deposition Exhibit 24 markedfor identi fication.)BY MR FIBICH:

Q. Doctor, let me show you Exhibit 24, Thisis an article that appeared in The Boston Globe

A Mm-hmmQ. Now, you told us yesterday you didn't read

the paper Did you read this article by chance orwas it called to your attention?

A It was called to my altention I did notread it,

Q, This again goes down to, refers to SenatorGrassley, It says that Senator Grassley has accusedyou offailing to tell Harvard until last Marchabout most of the more than 15 million the



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pharmaceutical industly had paid him in consultingfees from 2000 to 2007, Has the pharmaceuticalindustry paid you an amount, approximately thatamount from 2000 to 200n

A This is the total earned income frommultiple pharmaceutical and nonpharmaceuticalsources.

Q, It goes on in the next paragraph where ittalks about the doctor's critics say these paymentsare troubling because you have been the leadingproponent ofthe idea that bipolar disorder canaffect young children. Do you consider yourself theleading proponent of the idea that bipolar disordercan affect young children?

A, i am one of the leading proponents, notthe only one,

Q.. And earlier I referred to a New York Timesarticle, which I'm going to also mark as 25, And inthis article it says lIOr, Biederman's work helped tofuel a fortyfold increase from 1994 to 2003 in thediagnosis of pediatric bipolar disorder ,Il Do youbelieve your work helped -- helped -- to fuel afortyfold increase from '94 to 2003 in the diagnosisof pediatric bipolar disorder?

MR, SPIVACK: Objection, calls forStratos Legal Services

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speculation.A, I think is the reporter giving you a

reference to suggest, to support that assertion?The difference from scientificjoumals, in thepaper you can say whatever you want; it's a freecountryo This is the writer's opinion, and opinionsare not the equal of data So this is what theauthor of the article thinks about the subjectmatter, without any data to support it.

MR, FIBICH: Objection, nonresponsiveBY MR FIBICI-I:

Q. Do you feel you have helped create afortyfold increase in the diagnosis of bipolar maniain children?

MR SPIVACK: Objection, no foundation,calls for speculation,

A, My work helped increase the awareness thatbipolar illness exists in children,

Q Your work has helped increase theawareness of bipolar disorder in children" Is thatcorrect?

A That's correct.Q So you've had an effect, you just don't

know what effect, is what I understand you to betelling me?


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1 A My work has had an effect of making 1 Q And during the 30-year period that you2 clinicians aware that bipolar illness exists in 2 have been a clinician at that hospital, how many3 children. 3 patients have you treated that you believe had4 Q. But you don't have an idea ofthe 4 pediatric bipolar disease that were under the age of5 magnitude as we sit here today, do you? 5 six? Approximately6 A- I don't. And I am not the only one that 6 A It's hard for me to know. I would say two7 helped in this awareness As I said to you before, 7 dozens.8 there are about one hundred laboratories and 8 Q. And from six to age twelve, how many?9 researchers in the country and in the world that are 9 A. A few hundred.

1'- 0 interested in the subject. Each one of these people 10 Q Two hundred?11 has contributed their part in making this diagnosis 111 A. A few hundred.12 more visible in the practicing community 112 Q, Three hundred?1'- 3 Q. Do you feel that you are the creator of 13 A- I cannot tell you exactly.14 the diagnosis of pediatric bipolar -- 14 Q And then what about 12 to 18?15 A. Absolutely not 15 A Less than that.16 Q _. disorder? 16 Q So it's a very rare disease?17 A_ Absolutely not. The famous psychiatrist, 17 A No, it's not rare. We calculate it to18 Kroeplin, that described manic-depressive illness, 18 affect somewhere between 16 and 20 percent afour19 I mean, his textbook he already described that can 19 referral pool.bo exist in children, so I did not invent anything 20 Q 16 to 20 percent of what?li1 Q. When did you first start seeing children 21 A Of our referral pool, the peopie that come~ 2 at Mass_ General Hospital, what year? 22 to our program.~3 A In '79 123 Q. But still over a 3D-year period you haveb4 Q. SO that was 30 years ago, approximately? 124 only seen .-li5 A Yes.. 125 A Well,l am one of the clinicians. I think

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that my program has many clinicians, so Iam in 1charge. 2

Q, You are aware that a lot ofphysicians do 3not believe that the disease exists? 4

A, Some believe, some don't believe, 5Q, And those that discount it are those that 6

don't have your knowledge about it. Correct? 7A, Those that discount call these children 8

something different and treat them the same way. So 9don't think for a moment that the fact that they 10don't ascribe a diagnosis means anything different 11These children, as I told you a few times before, 112are very disturbed, they will come to clinical 113attention. So a clinician may call them something 14different That does not mean that the child does 15not exist or has no problems or has a minor 16headachc_ That clinician may call that patient with 17other epithets,. They may call them disruptive 18behave disorder, they may call it oppositional- 119defiant, they may call it conduct disorder. 20

So my argument was that if you ask for the 21symptoms of bipolar illness, if the child has the 22symptoms required for the diagnosis, this is 123probably the more appropriate diagnosis than calling 24them with some vague term and then treating them 25



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with the same tools orthe trade They will get thesame treatment

MR. FlBICH: Objection, nonresponsiveBY MR FIBICH:

Q Doctor, are you familiar with thecontents, generally familiar with the contents ofthe label with respect to Risperdal?

A. I do not memorize them but I am familiarwith.

MR, FIBICH: Ijust heard somebody'sstomach growl. Did you hear it? Maybe we ought totake a break for lunch

THE WITNESS: It's about the right timeTHE VIDEOGRAPHER: The time is 11:58

We're otT the record..(Cuncheon recess at 11:57 am)

AFTERNOON SESSION1:07 p.m,

THE VIDEOGRAPHER: Okay, we're baek on therecord. This is tape number 3 The time is sevenminutes after 1:00BY MR. FIBICH:

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that you do not consider the research you do to bewhat is termed clinical research?

A, No, it is clinical research.Q. You what?A, It is clinical research,Q. Okay. There seemed to be some

misunderstanding about thaLNow, before we go any further, I'd asked

you if you generally understood what was in thelabel for RisperdaL

A. YesQ, And are you aware that the labe! contains

a statement that the mechanism of action torRisperdal is unknown?

A CorTect.Q. And what does that mean?A It means that the exact way that the

risperidone and other medications work in the brainis not fully elucidated

Q. Well, I'm not interested in othermedications, I'mjusl interested in Risperdal withrespect to that question Okay?

A Yes, yes,Q. What it means is we don't know really how

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A Fully.. We have some ideas, For example,the prolactin problem that we talked yesterday isdue to the effect of risperidone on a particulartype of receptors in the dopamine system that arecalled dopamine 2 receptors, So other' mechanismsare not fully known.

Q. Well, basically we know that Risperdalaffects the chemistry in the brain, Correct?

A The hypothesis, the reason thatrisperidone, Clozaril and others are called atypicalneuroleptics is because they exert influences atleast in two brain systems. One is dopamine and theother one is serotonin<

Q And do children's brains develop overtime?

A Children's brain and adultsl brain developover time,

Q And are there any studies on the longwtermeffect ofgiving children Risperdal for any periodof time, the safety of that?

A There ale studies today ofa few years,not more than a few years' follow-up When a drugis, say, brought to market there is a requirementthat there is at least one or two years offollow~up, so I believe that risperidone has some



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type of follow-up data. 1Q. You believe so? You don't know so? 2A. I do not know for sure. As 1told you, 1 3

did not participate in the study so I do not know 4But that's a standard requirement ofthe FDA I 5

Q. And of course if the drug is being used I 6off-label, then the FDA would not have required that I 7type 01 study. Correct? 18

A Physicians use all the time medicines 9available to them to help their patients off-label. 10It's a legal activity; it's done all the time; and IIImany of the discoveries in medicine, in psychiatry 112and other fields occurred through using medications 13off-label. So off-label is not a bad practice 14necessarily. Only means that the pharmaceutical 15company has not yet conducted the clinical study. 16In the case of risperidone, as you know, the pivotal 17studies were conducted" 18

MR FIBICH: Object to that as being 19nonresponsive. 20BY MR FIBICH: 121

Q. What I was asking you was, were there any '22long-term studies of the effect of Risperdal on 123children? And you said -- 24

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followed the children that responded to risperidone,our small sample, for a year So we had some smalldata on long-term effects

Q You have anecdotal evidence from yoU!practice. Correct?

A No, itls w_ Yes, Ihave anecdotalevidence, but we followed in the studies ofrisperidone that we conducted, we followed thosechildren that responded and were willing to befoHowed, we foilowed them for a year and wecollected data

Q And my question is the long-term effect.Are you aware of any published data that establishedthe safety of Risperdal on children for a longperiod of time?

A The risperidone -- [ am not aware, butthere is no data on adults either, on long-termeffects

Q. I didn't understand what you said.A There is not only absence of longwterm

data in pediatrics, but there is neither long-tenndata in adults.

Q So this is a drug that we don't know howit works and you propose giving it to certainchildren under the age of six, Correct?



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know what it is, can you?A The risks require long-term follow-up and

longMtcrrn follow-ups arc not easy to do,particularly if people arc asked to come back forfollow-ups for a very long period of time. It's avery difficult practical thing to do

Q, And when doctors use Rispcrdal for anolf-Iabel purpose, they don't know what the risk 01that drug is on that particular population, do they?

MR PECK: Object to formA They know some of the risks. Some of the

risks arc monitorable For example, theneuroleptics can produce abnormal movements, sothose are monitored clinically. The neurolcpticscan produce metabolic changes that can be monitoredSo when doctors prescribe these type of medications,they monitor their patients for safety for whateveris known

Q So that's what ought to happen when adoctor uses a drug for a purpose other than itsapproved use There ought to be certain monitoringto ensure that there's not adverse effectsCorrect?

A That's correctQ Now, although you have testified you are


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A. I propose to use it in children. Thepediatric age group, as we discussed, is a longperiod of time,

Q, And you don't know the long-term effect onthe developing brains of children of that age ifRisperdal is given to them for a long period oftime, do you?

k I do know the long-term effect of nottreating, so in this case --

Q. That's not what I asked you,A So in medicine doctors are trained to

weigh benefits and risks, So on the one hand I havechildren that have in frunt of them a very rockyclinical course with the possibilities ofnot beingable to remain at horne, of being hospitalized. Andon the other hand I have tools to help some of themSo even if! do not know fully the long-termeffects, I know what happens if I don't treal Thatwill be very catastrophic outcome, including deathfrom suicide or possibilities of homicide with thelevel of violence,

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unaware of the long-term effects of Risperdal, thereare some effects that have adverse effects that youare aware of. Correct?

MR. SPIVACK: Objection, misstates thetestimony

A Yes, there are adverse effects, They arelisted in the package insert and also known toclinicians that these drugs can produce,

Q. And you have observed -- You're aware thatnot only are some of those adverse effects listed inthe Physicians' Desk Reference Or the label, but youhave also observed those in your practice. Correct?

A. Sometimes. I think that in general myexperience with this line of treatments has beenpositive and not negative,

Q,. I'm not asking you whether you think it'spositive or negative. I'm only asking you ~-

A. No, I'm saying--Q, Excuse me Adverse effects that you may

have observed in the population that you prescribethis medication for. Okay? And what is the numberone adverse effect that you've observed in thepopulation that you treated with Risperdal?

A The most common adverse effect is weight

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Q And that weight gain can be relativelysignificant, can it not?

A. Sometimes,Q, And as a clinician and as a physician, you

are aware, are you not, that weight gain canoftentimes lead to metabolic syndrome?

A I am aware ofthat and I monitor for thatin my practice,

Q, And that's how you guard against it, youmonitor for it. Correct?

A Yes,Q. And have you also seen -- You indicated

some movement disorders .. Are you referring totardive dyskinesia?

A. Tardive dyskinesia refers to long-termeffects, There are other problems that are caIledextrapyramidal reactions that can include tremor,rigidity, things of that type that occur, that canoccur more acutely or more proximately to the onsetof treatment.

Q Have you seen in your population thatyou've treated with Risperdal extrapyramidaleffects?

A, Sometimes, ICs quite uncommon.,Q. And have you also in the population that



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1 you've treated discovered cases of tardive 1 A I apologize2 dyskinesia? 2 Q I'm as anxious to get through as you are,3 A I have seen children that developed 3 A I apologize4 movements, extremely rarely. And in those cases I 4 Q. That's okay It's probably my fault5 discontinue the treatment 5 In the geriatric population, you're aware6 Q, Right But you're aware, are you not, 6 that Risperdal can cause strokes?7 based upon your clinical practice, your education, 7 A Yeso It's a very rare event, but it can8 your background, your training and your studying of 8 happen9 this drug, that Risperdal can cause weight gain and 9 Q That's your opinion Right?

10 subsequent glucose dysregulation? 110 A No, the statistics on stroke in the11 A I am aware of that 11 elderly are larger than placebo but they are small12 Q, And it can also cause tardive dyskinesia? 12 in size. It is not a frequent occurrence13 A Very rarely, I am aware of that too 13 Q, You are aware, are you not, that there's a14 Q And also extrapyramidal side effects? 14 black box warning in the label for the use of15 A. Yes 11156 Risperdal with dementia?16 Q. And in the adult population, you're aware A. I am aware17 that it is often associated with strokes? 17 Q. And the adverse effect that is warned18 A In the geriatric population, 18 against is strokes. Correct?19 Q. The geriatric population 19 A. Correct. I am only--I?O A I would not say often. It's a risk ~O Q Go ahead121 Q. You're aware that Risperdal can cause F1 A I am only saying that the risk is small,~2 strokes in the -- ~1223 but there I am only qualifYing that this is not a23 A. It's a small -- b one-to-one correspondence that all geriatric124 Q. Let me finish. He can't take us both p4 patients that take risperidone will have stroke~5 down. 125 What I'm saying is that the risk is there, but it's

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uncommon. Still a risk.Q. It is a significant-enough risk that the

FDA has required that Janssen put in its label abalded black box around that particular riskCorrect?

A. It's statistically significant but small.MR FIBICH: Object as being

nonresponsive,(Biederman Deposition Exhibit 26 marked

for identification.)BY MR FIBICH:

Q. Doctor, let me show you what the courtreporter has been kind enough to mark as Exhibit 26(Pause)

This document contain~ a couple of e~mails

that reference a protocol, a draft version of aprotocol. Right?

A. Yes.MR. SPIVACK: Objection, foundation.

BY MR. FIBICI-I:Q. Are you familiar with what the e-mails

reference?A I vaguely recall that there was some kind

of interchange about this protocol.Q. And this appears to be, it says marked


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confidential.. Do you sec that?A Where?Q On the protocol outline itselfA YesQ And this is a protocol outline that was

furnished to you, was it not?A I do not remember exactly, but I got it.

It was furnished to meQ Go back to the first page, if you wouldA YesQ There's nn e~mail from Gahan PandinaA Mm~hmm

Q Importance high, and he is e~mailing

somebody named Magali Do you see that?A YesQ Do you know Ms Magali?A, I don't remember who she isQ, It says uHi, Magali, Here are a number of

e~mail with helpful documents, including the noteson meetings with Gaye Carlson and Joe Biederman."Do you remember having meetings with Gahan Pandina?

A I had meetings with Gahan Pandina, Idon't remember the specific meeting about this

Q In any event, ifyou would, go back to theprotocol outline; and it appears to be uprotocol


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outline for a study to be entitled The Efficacy andSafety of Flexible Dose Ranges of Risperidone versusPlacebo in the Treatment of Manic or Mixed EpisodesAssociated with Bipolar I Disorder in Adolescents

A, Mm-hmmQ Did you ever do this study?A No,Q, Do you know why not?A I don't recalLQ. Have you ever started a study with the use

of Risperdal for any purpose and not concluded thatstudy?

A Not that I recalLQ. It goes down on that first page, sir,

under the headline Rationale for Study, ifYOll wouldgo down to the third paragraph, starts with "We,"

A Mm-hmmQ, And if you would then go down to the

middle of the fourth line where it says IIInaddition,,"

A Sorry. You are talking about asubparagraph still?

Q. Third paragraph where it says M_

A, Yes, "In addition,n I have it.0, It says "In addition, even though it is



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widely known that the typical age of onset ofbipolar disorder is in the second and third decadesof life," that would be in someone's twenties orthirties Conect?

A Yes,Q, "It is extremely rare to find bipolar

disorder with onset in childhood" Do you see that?A Yes,Q. Do you disagree with that statement?A That was the wisdom of the day.Q And that was the wisdom in 2002, Correct?A That's correct.Q It goes on to say "[n a retrospective

study performed by Loranger in adults with bipolardisorder, less than 5 percent reported that onset ofthis disease began before the age ten. H Are youfamiliar with the study ofl.-oranger?

A I am vaguely familiar, but I would like toremind you that the more recent studies done by theSTEP program in close to 5,000 adults with bipolarillness, a study funded by the NIH, finds that 70,close to 70 percent of adults have onset inchildhood and less than 30 percent start before ageof twelve

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nonresponsive. 1BY MR. FIBICH: 2

Q, Let's go back to the body, and ifyou 3would turn to Bates number -- 4

MR, SPIVACK: I'm sorry, Mr, Fibich, I 5just wanted to ask for clarification .. Did you read 6this document to say that the typical age of onset 7of bipolar disorder is in the second and third 8decades oflife and you interpreted that as the 9twenties and thirties? Wouldn't that be the teens 10and twenties? 11

MR FIBICH: I suppose it could be, Good 12point Surprised a scientist didn't catch thal 13

MR. SPIVACK: But the lawyer did.. That's 14what's more surprising, 115BY MR FlBICH: 16

Q, Let's go back to Bates number 3927579, 17A. What's the last digits? 118Q, 7579, 119A, 79, yes, 20Q, This appears to be commentary on proposed 121

risperidone in adolescents mania study" See that at 122the top? 123

A Could you point out where you are 124referring to? 125

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Q, Yes L,et me find it for you (Pause)Right there at the top it says Commentary, and itsays "Commentary on the protocol of this proposedrispeddone study in adolescent population,"Correct?

MR SPIVACK: Objection, foundationA Could you ask me the question again?Q, Read the top sentence on this pageA. "There is no expert consensus that JB's

view is a valid one"Q. Well, that one wasn't the one I wanted you

to read, but let's go to that one: "There is noexpert consensus that .JB's view is a valid one ll

And .IB is Joe Biederman. Correct?A. CorrectQ And then under Expert View that they're

referring to, it says "JB felt strongly that mostbipolars manifest first in this age group, that thisgroup is easily characterized and available for anoutpatient study. GC felt that this group wasimportant to study as it formed a significant partof a child psychiatrist's practice in the US" Andthen the commentary, whoever's making thiscommentary, says they disagree with you, Correct?

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page of yours under the 12 to 17 age group..A, Mm-hmm,Q. Says "JB did not think that doing a study

of acute classical mania in this group was feasiblebecause he thought these kids would be too ill anddisturbed to participate in a study on a voluntarybasis, and that this type of mania was rare, sorecruitment would be difficult ifnot impossible"Was that your view back in 200 I?

A Idonot ..Q Excuse me '3A. I do not know what this alludes toQ Well, the e-mails were in 2003, They

refer to this protocol outline and it says that yourview, and let's assume for the purposes of myquestion it was 2003, that you do not think or thatyou --

MR PECK: Counsel, let me just point outthe bottom of the page says February 2002

MR. FIBICH: Okay, thank youBY MR FIBICH:

Q February 13, 2002, it says that youthought the type of mania that is sought to bestudied here is farc and recruitment would bedifficult if not impossible. Was that your view in


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BY MR. FIBICH:Q There's a comment that there is no expert

consensus that your view is a valid one Correct?MR SPIVACK: Objection, foundation

A This is what the writer of this note saysQ And ifyou would, go on down to like the

middle paragraph, it says -- Let me mark it for youso you don't have to look I've drawn a line whererwant to call your attention It says "We will behard-pressed to convince a significant group ofpsychiatrists to come up with clear diagnosticcriteria, let alone convincing the FDA of how thisgroup comes under the umbrella of DSM-IV ascurrently written"

And then it goes down, the last sentenceis llA study of this sort may well be feasible andappropriate for Dr, Mahmoud's group rather than fora regulatory focus study" What does that mean,that this study may be more appropriate for Mahmoud?

MR. SPIVACK: Objection, foundation, callsfor speculation

A I have no ideaQ You have no idea?A NoQ Go down to the expert view on this same


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of'mixed symptoms of mania and depression, This iswhat we were seeing more commonly,

MR.. FIBICH: Objection, nonresponsive,BY MR. FIBICH:

Q Pediatric bipolar disorder, what age groupdoes that apply ro? When we say pediatric bipolardisorder, what age group?

A It's up to 18. And parenthetically thecontroversy is not in adolescent mania.. That wasnever controversial. The controversy has been inyounger children,

MR FIBICH: Objection, nonresponsiveBY MR FIBICH:

Q, Does pediatric bipolar disorder as youunderstand it involve both manic and depressivestates?

A, The most common fonn is mixed, that bothare occurring togethec Some children only havemanic symptoms and some children have manic anddepressive symptoms, the same as adults.

(Biedennan Deposition Exhibit 27 markedfor identification,)BY MR FIBICH:

Q, Doctor, would you review briefly thedocument that I've marked as Biederman 27.


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2003?A. I do not know what was my view; and I also

do not know, this is a narrative of somebodyinterpreting something that I may have said.. 1don't know what they are alluding to,

Q. My question to you is, forget what's infront or you, Did you have a view in 2003 thatacute classical mania was rare in the 12 to 17 agegroup? Was that your view?

A. The thing that I do not know is, what isthis type of mania?

Q It says acute classical mania"A Okay,. So I assume .. The problem is it

has to be defined, what is the definition of acuteclassical mania So this could have many differentinterpretations of what it means,

Q Let me see the document, please,In 2003 did you believe that acute

classical mania was rare in the 12 to 17 age group?A, I believe then and today that most

children present with a mixed, what's called a mixedpresentation, a very chronic state and a kind ofwhat has been described by Kroeplin at the beginningof the century as uncommon; and the most commonpresentation is one of an agitated state with a lot


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A Mm-hmm.Q And this appears to be a planned letter to

the editor of The New York Times?A Appears to be.Q, And Jellinek evidently you had review this

letter Correct?A, He appears to have done itQ, And then sent it to you. Correct?A I sent it to him to look at the letter, he

reviewed it and sent it backQ And what changes did he make?A, I don't know because it does not have the

highlights, so I don't know what he editedQ, But, in any event, he made some changes to

your letter thinking it would enhance the purposefor the letter. Right?

MR, SPIVACK: Objection, calls forspeculation,

A., He probably made cosmetic changes for --English is not my primary language.

Q. But you understand English, do you not?A. Pretty wellQ. Did you send this letter to The New York

Times?A I did.


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Q Is the letter that you sent to The NewYork Times the one that is contained here on Exhibit277

A I do not know if I sent the letter withDr. JeJlinek's edits or not

Q Well, in any event, as of the date of thisdocument, which appears to be December of'08, whichwas a few months ago ~~

A Mm~hmm

Q ~~ this is what you were proposing to sendto The New York Times?

A I did send a letter to The New York TimesWhat I cannot remember if whether I incorporatedDr. Jellinek's edits or not

Q In any event, this letter says to theeditor "Your reporting on my relationships withpharmaceutical manufacturers is inaccurate First,my and my colleagues' work on pediatric bipolardisorder focuses on this illness, its symptoms,impainnenls, and neurobiology, not on medicationsOur work helps understand this devastating disorderand treatment options- Second, the J&J Center in2002 to 2005 performed research on ADHD and bipolardisorder The center performed no clinical trialson 1&J products It was called 1&1 Center to be



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1 transparent about its funding n 12 It then goes on down to the fifth point, 23 says HI have not engaged in ghostwriting. The lead 34 author, a J&J researcher and expert scientist, wrote 45 the abstract II What abstract are they referring to 56 there? Arc you referring to 67 A There was an abstract in the Academy of 78 Child Psychiatry. I'm not totally sure which one, 89 but was an abstract that Dr Pandina authored 9

10 Q Was that the abstract that we earlier went 111110111 through with respect to your study of the mildly12 retarded children? 1213 A I am not sure which abstract, but I know 11314 it was an abstract that Dr. Pandina authored, There '1415 were no details in The New York Times which exactly, 1516 what abstract that I could review 1617 Q Then it goes on that J&J did not pay you 1718 58,159 in 2001, that 50,000 was an educational grant 1819 to Massachusetts General Hospital. What was that 1920 educational grant for? !2 021 A For a conference on pediatric bipolar 12122 illness Q223 Q. And Massachusetts General would get the 12324 money, and then what would they do with that money? 12425 How was that money used? 25


A, The money was used to fund a conferencethat brought 100 researchers from all over thecountry to discuss issues pertaining to pediatricbipolar illness,

Q Well, was it used to pay travel expensesDr' to rent a room, or what was the money actuallyspent on?

A For all of the above, It was to pay lortravel expenses, rent a room, and have a daylongconference,

Q. And what was the conference on?A Pediatric bipolar illnessQ, And was there a transcript made of this

particular presentation?A. There was no transcript but there were a

series of papers that were published in thescientific literature

Q. Well, whether or not this is the actualletter that was sent to The New York Times, are thestatements that are contained in this ~~ and let'scall it a draft letter or planned letter -- are thestatements that are contained in here true andcorrect?

A Yes.(Biederman Deposition Exhibit 28 markedStratos Legal Services

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for identification,)BY MR. FIBICIi:

Q Doctor, if you would, look at Exhibit 28A Mm-hmmQ, And do you know what this is?A. It's a presentation that we gave about the

J&J CenterQ_ And when did you give this presentation?A I do not know., Whenever the date. There

is no date hereQ. Would it have been about the time that the

center was getting started?MR SPIVACK: Objection, calls for

speculation,A I do not know. We met with Janssen twice

a year, as I mentioned earlier.Q, What was the purpose of the center? What

was the center's purpose?MR SPIVACK: Objection, asked and

answered,A. The purpose focused on understanding the

illnesses that Jansscn and McNeii had products Thecenter focused on the diseases of pediatric bipolarillness and ADIiD

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products in connection with that goal?A Because Janssen had products that could

potentially treat those diseases, so there was in myview a potential intersect between a commercialentity like Janssen and McNeil and our interest toadvance science. And the premise was that if theillnesses that we are studying are serious anddevastating, as we believed that they are, and ifthe medicines that they have could provide relief tothose problems if proven effective and safe, thenthat is the synergy between academia and acommercial entity.

Q Well, Doctor, there were other drugs thatwould also potentially assist in the treatment ofthe diseases you were going to study, were therenot?

A But I was speaking to Janssen; I wasspeaking to McNeiL So I wanted to engage -- Theintersect was with the medicines that they have,I would not propose to study medicines of anothercompany to Janssen, They have risperidone andMcNeil has Concerla, and there were other medicinesthat other companies have, like olanzapine forexample, or Topamax that we're also interested inpsychiatry



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1 Q. Well, was there a limitation put on what 12 you could study by Janssen? 23 A ~ 34 Q. Only their products? 45 A. No. I did not just study their products 56 I wanted to engage their interest in supporting 67 science and I believed that this was a win-win 78 opportunity for scientists like myself and a 89 commercial entity. The idea was that they have 9

10 potential medicines to treat disorders We need to 1011 understand the disorders that they have medicines III12 that could help And my proposal was to advance 11213 knowledge on the disorders, not on the treatment of 11314 the disorders 1415 MR FIBICIi: Objection, nonresponsive 1516 BY MR FIBICIi: ,1617 Q My question to you is, did Janssen limit l718 your ability to use other products in whatever you 1819 were going to study? 1920 A I did not study in the center other 12021 products or any products, I studied the diseases b122 As I have mentioned several times, the center had 12223 five cores, none of them therapeutics< The cores 12 324 were on neuroimaging. on genetics, on paradigm ~ 425 development, on assessment and analysis. Those were 25


the cores, There was no treatment in the centerMR. FIBICIi: Objection, nonresponsive,

BY MR FIBICIi:Q, My question is: In the cores that you set

up for your center for pediatric psychopathologyresearch, did Janssen limit YOUT' use in your studiesto their products? Did they limit you?

A No This--Q The limitation was one that you imposed on

yourself: Correct?A. I proposed a center, that we focus on ADIiD

and bipolar illness in the sense that Iwasinterested in researching

Q Let me ask you another way because I don'tthink I'm communicating very well with you

A, Okay, please doQ. When you went to them and said ttl need two

million dollars to do this study," this center, didyou say "I will only use Johnson & Johnsonproducts"?

A The center did not use any medicines,I proposed to them a center. A center was budgetedfor a year for $500,000, I never knew if the centerwill be refunded.

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A, SureQ. Was part of the plan for this center to do

clinical trials?A The center did not have any clinical trial

activity< The center could support clinical trialactivity but not do ic

Q. Okay, let's talk about that The centercould support clinical trial activity, How wouldthey do that?

A. Well, the center had personnel that hadexpertise in assessments. A clinical trial requiresassessment. The center has expertise in dataanalysis, A clinical trial requires analysis Sowe have inMhouse the expertise that could allow torise to the occasion if we have additional fundingto do a clinical trial, so a clinical trial that weconducted with Johnson was separate from the centerand was a clinical trial on risperidone,

Q.. The clinical trials were separate from thecenter?

A. Yes.Q, But the center supported those trials?A The center did not support the trials

The center funded personnel that had the expertiseSo if I have a person that knows how to do



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structured interviews, that person can help me trainother people that they hire for the clinical trialto conduct structured interviews,

Q. Okay, give me an example of what you'retalking about You said the center fundedindividuals that had expertise. What do you o.

A. Well, we had from the center funding for acore of psychometricians that are trained to dostructured interviews and cognitive assessmentsTakes us about a year to train a person like thatSo having a core of people that are trained if weneed to hire additional people and train them, wehave people with expertise that can help trainadditional personnel to conduct another study

Q And that's what some of the money thatJanssen gave you was used fof'- Correct?

A Some of the money was to maintain a coreof psychometricians in our lab, yes.,

Q And the psychometricians would then helpwith the clinical trials?

A Would help train additional personnel thatare required for a clinical trial.

Q. This is a PowerPoint presentation that youprepared, is it not?

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BY MR FIBICH:Q. Were clinical trials done with respect to

the use of Risperdal?A. We conducted a clinical trial of

risperidone in children, not as part of the centerbut as a separate contract,

Q. And who did that clinical trial?A. I did that clinical triaLQ. And under what auspices did you do that

clinical trial?A, The clinical trial was done in my program

and it was a separate contract with ¥¥

Q What program?A This is a clinical and research program in

pediatric psychopharmacology.Q. Say that again, please.A. Clinical and research program in pediatric

psychophannacology.Q Is that a center?A No. It's a program.Q. A program?A (Witness nodded.)Q. SO you did a Risperdal clinicai trial in

the clinical and research program in pediatricpsyehophannacology?


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Q And the page that I've referred you to isentitled Johnson & Johnson Center for PediatricPsychopathology Research, Mass General Hospital,Clinical Trials Program Correct?

A Yes The clinical trial program was notpart of the center What I meant, that the centercould have infrastructure that could allow us toconduct clinical trials The clinical trials thatwe conducted with risperidone and Reminyl were donewith separate funding, not with the center fundingThey were a separate contract for those trials

Q So in addition to the two million dollarsto set up this center, you got additional funding todo the Risperdal and the Reminyl clinical trialsCorrect?

A rhe center had support for these coresthat supported neuroimaging, genetics, statisticaland paradigm development The budget for the centerwas haifa million per year, roughly distributedbetween the five cores of the hundred thousanddollars. Remember that the 500,000 has a tax,institutional tax of 25 percent, so the net paymentis 25 percent less than that The center did nothave money to conduct a clinical trial

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A Yes 1Q. And did you do a clinical trial with 2

respect to Reminyl in that same program? 3A. Yes, 4Q. And did YOtr do a clinical trial with 5

respect to Concerta in that same program? 6A. Yes, 7

Q And did YOtr do a clinical trial with 8respect to Topamax in that same program? 9

A Yes 10Q, And were those clinical trials assisted in ;11

some way by people that were hired by the Johnson & 112Johnson Center for Pediatric Psychopathology 113Research? ,14

k Toaverysmallextent 115Q, That means yes? 16A. No, that means to a small extent 17Q, That means yes, Correct? 18A Let me recap, The neuroimaging core paid 19

for neuroimagers to do neuroanatomical software 120development. The paradigm development core paid 121M,LT. to develop a driving simulation, paid a Ph.D, 22psychologist to develop work simulation paradigms; 23provided a salary, part-time salal)' for a 24statistician to conduct analysis from data that we 25



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collected from other grantsSo we have a small component that had this

assessment expertise that we were able to trainpeople for a clinical trial more rapidly, but to doso with personnel on the salaries and expenses thatthe center had,

MR. FIBICH: Object to that asnonresponsiveBY MR FIBICH:

Q Sir, you represented in a planned Jetterto The New York Times lo the editor that the centerperfonned no clinical trials on J&J products

A The center did not perform clinicaltrials

Q But you yourself through another programdid do clinical trials on fbur J&J productsCorrect?

A Outside the cenler. lhe center did not doclinical trials

Q Would you llgree with me that this issomewhat misleading to The New Yark Times about yourinvolvement with J,lOssen-sponsored clinical trials?

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A, NoQ, Were most of the clinical trials in which

Risperdal was used sponsored by Janssen?A. No Some were sponsored by the Stanley

Foundation.Q. My question was, were most of them

sponsored by Janssen?MR. SPIVACK: Objection, vagtre

BY MR. FlBICH:Q. Or was a majority of them sponsored by

Janssen?A- Yes.Q. As a matter of fact, all btrt one of them

was sponsored by Janssen Correct?A. Well, yes. There is a study of

risperidone in children six to 18. Our principalsttrdy was ftrnded by the Stanley Fotrndation and wehad a sttrdy of spectroscopy ftrnded by Janssen. Sothere were two studies funded by Johnson and onesttrdy ftrnded by the Stanley Fotrndation

Q. Well, there's more than that, isn't there,sir?

A, lell me moreQ Well, your open label eight-week trial of

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preschool age children, that was a Janssen-fundedsttrdy?

A No, that was based on the StanleyFoundation

Q Your open label trial ofrisperidone inchildren and adolescents with bipolar disorder, thatwas Janssen, Correct?

A, That was Janssen, yesQ. The risperidone for treatment of affective

symptoms in children with disruptive behaviordisorder, that was Janssen, Correct?

A That was a data analysis; it was not aclinical triaL

Q. That wasn't sponsored by Janssen?A, The data analysis was done as part of our

data analytic efforts at the centeLQ The Aman sttrdy was sponsored by Janssen.

YOtr know that, do YOtr not?A, The Aman sttrdy I believe was sponsored -

And I am not totally Strre about that either. Ibelieve the Aman study was part of the research unitin pediatric psychopharmacology ftrnded by the NIHI am not sure that they were funded by Janssencompletely.

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respect to Toparnax and the other drugs that werelisted in your PowerPoint, the clinical trials youdid on those were sponsored by Janssen?

A No. The Topamax study was sponsored bynon~Janssen I don't remember- May have been theStanley Foundation. We added Topamax to Zyprexa andexamined the weight gain in people that took Zyprexawith and without Topamax, and Topamax reduced theweight lability of Zyprexa in half. The study ofReminyl was funded by Ortho-McNeil, not Junssen

Q Funded by whom?A Ortho-McNeil That was a separate company

from Janssen, And the Reminyl study, by the way,was solidly negative

MR. PECK: I'm sorry, Could I have thatread back?

(The reporter read the answer ,)MR FlBICH: Let's mark that(Biedennan Deposition Exhibit 29 marked

for identification.)BY MR FlBICH:

Q Sir, we have handed you Exhibit Number 29Let me find the page for you that I want to ask youabout. It's this page here And I apologize;that's been copied poorly


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A Mm-hmmQ But it's supposed to read Johnson &

Johnson Center for Pediatric PsychopathologyResearch, You see that?

A YesQ It says "Supports research on the

disorders that J&J products treat" and lists thefour products that we've been talking aboutCorrect?

A Supports research on ADHD and pediatricbipolar illness that these compounds potentially cantreat

Q That's right Do yOLl want to turn back?Go forward

A Forward?Q One more page And here it talks about M_

MR PECK: Page, please?MR FIBICH: Johnson & Johnson Center for

Pediatric Psychopathology Research.BY MR FIBICH:

Q It says "Puts J&J at the forefront ofpediatric psychiatric research" Do you see that?

A YesQ "Provides ongoing consultation for

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for existing compound!' Do you see that? 1 that supporting research on ADHD and pediatricA Yes 2 bipolar illness is a good thing for a responsibleQ, And that was really the purpose of the 3 pharmaceutical company

center, was to create new markets for Johnson & 4 MR FIBICH: Object to that as beingJohnson products. Correct? 5 nonresponsive

MR, SPIVACK: Objection, argumentative 6 BY MR, FIBICH:MR, PECK: Objection, foundation 7 Q, Who did you show this PowerPoint

A I believe -- 8 presentation to?MR SPIVACK: Calls for speculation, 9 A We showed this PowerPoint presentation to

misstates the testimony 10 people in Janssen and McNeil that were involved withBY MR, FIBICH: 11 the center,

Q Isn't that true? 12 Q, Well, did you do this for the purposes ofMR. SPIVACK: Same objections :13 convincing them to make contributions to this center

A No, 114 or was this done after the center was agreed to beQ. Ifyou're doing strictly scientific :15 funded by Johnson & Johnson?

research, why are you concerned with what this does 116 A, This was an ongoing reporting that Ifor Johnson & Johnson? 17 impose upon myself to make sure that the people that

MR. SPIVACK: Objection, argumentative 18 fund us know what are we doing with their funds andA, I am concerned with Johnson & Johnson 19 ifit's scientifically sound fI'om their perspective,

because Johnson & Johnson, Janssen-McNeil have 20 and in the hope that they will be interested incommercial interests I need to find an intersect i21 continuing funding of the workAdvancing science for a pharmaceutical company or to !2 2 So it is responsible, The same I do withdo research that is removed from the most parochial 123 NIH grants, that I report periodically what I haveinterest that most pharmaceutical companies do is a 1124 done with the funding, that I am fulfilling myleap So what I was telling Janssen and McNeil, 25 obligations- So this is a reporting to say what

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have we done and what we would like to do in theyear to come,

MRo FIBICH: Object to that as beingnonresponsive,BY MR. FIBICH:

Q. At the time that Johnson & Johnson agreedto fund the Center for Pediatric PsychopathologyResearch, was it a tive~year commitment? Four~year

commitment, rather.A It was only one~year commitment,Q. SO they gave you $500,000 for one year and

then you would do a PowerPoint presentation toeducate them on what you were doing so that theywould continue to support you Is that correct?

A. I was describing reporting on what we havedone and what are the plans for the next year

Q, Because you wanted them to continue tosupport this center?

A Yes.Q, Were you disappointed after four years

that they decided not to support the center?A I consider that part of life I think

that funding is never forever, so we have done fouryears of activity and it was very productive. Wepublished dozens of papers.


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Q How many papers did you publish as aresult of this four~year tenure of this center thatwas sponsored by Janssen?

A Dozens of papers,Q When you say dozen, you mean twelve?A No, no, dozens. I am using the plural. I

don't know Forty. I don't know I didn't countthem

Q.AQA Yeah My program publishes seventy to

eighty papers a yearQ What program are you referring to now?A The program that I run as the clinical and

research program in pediatric psychopharmacology andaduitADHD

Q Did you seek other pharmaceuticalcompanies to sponsor a similar center after Johnson& Johnson decided not to fund anymore?

A We seek funding from all sources possible,pharmaceutical companies, private foundations andthe NIH Research is very expensive and requirefunding. Research cannot be conducted withoutfunding. We have been funded by each, with the




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for identification)BY MR FIBICH:

Q Let me show you Number 30, Dr BiedermanA Mm-hmm.Q And this was a presentation that was made

at the Four Seasons Hotel here in Boston, November10, 2003 Do you see that?

A YesQ_ Do you recall being at this presentation?A. YesQ And I see there's an example of imaging

core, George Bush, That isn't OUT president, is it?A It was not our President.Q That's too bad

It goes on and says that you do theopening and overview of the center at MassachusettsGeneral, Do you see that?

A Yes.Qo And did you make that presentation?A Yes.Q. Is the attachment to this the PowerPoint

presentation that you had?A, Seems to beQ. And was this at the very beginning of the

center? Was this kind ofthe opening ofthe center?Stratos Legal Services

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exception ofSeroquel that did not fund in aclinical trial, we had funding for Abili!)', forGeodon and for Zyprexa from the phannaceuticals,just to conduct the clinical trial, not to fundresearch

Q, SO have the other makers of secondgeneration antipsychotics also funded clinicaltrials through your center?

A Just oneQ And who is that?A. Lilly for Zyprexa We did a clinical

trial with them, a very similar clinical trial thatwe did. Our clinical trial was eight weeks openlabel, small studies. We had funding from LillyWe have funding from Pfizer for Geodon and we havefunding from Bristol-Myers to conduct the trial ofAbilify. We also had done a similar clinical trialwith Abbott with Depakote We did two studies withDepakote, in fact, one on the immediate~release andone with the extended~release, that showed very poorresults, And we also did a study with Shire fortheir anti~manic carbamazepine Equetro

MR FIBICH: Object to that as beingnonresponsive

(Biedenman Deposition Exhibit 30 markedStratos Legal Services

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A No, This was at the end of the first year 1 central to the short and long~term goals andof the center- 2 interests of J&J" Is that correct?

Q. Okay. 3 A. CorrectAnd if you would, go to page 222, the 4 Q. And this was something that you felt was

Bates number, 5 sufficiently important that you wanted to prescntA, Yes, 6 this to the people at this meeting, Correct?Q And do you see the block in the left-hand 7 MR SPIVACK: Objection, foundation

corner, says "Supports research on the disorders 8 BY MR FIBICH:that J&J products treat, Concerta, Risperdal, 9 Q, Well, you prepared this slide, did youReminyl and I opamax." Do you see that? 1 0 not?

A Yes. 11 A. I prepared these slides, yes.Q, Did you prepare this PowerPoint 112 Q And you thought this was important that

presentation? 113 you project this to them, Correct?A I did 14 A I thought that there is an intersect, aQ, And the attendees at this particular 15 win~win situation between our interest to advance

conference were whom? 16 science and the commercial interest of Janssen andA Were scientists that participated in the 17 McNeil.

center and teams from McNeil and Janssen, 18 Q It was a win-win prospect because you wereQ, And then if you would, go to page 224, in 119 going to advance science and they were going to have

the middle left-hand side there is "Added value of 2 a an opportunity to expand the market for their drugsthe center." Do you see that? Entitled Added Value 21 Correct?of The Center 22 MR. SPIVACK: Objection, misstates the

A. Mm-hmm 23 testimonyQ, Ihe third bullet point says "Ihis fosters 124 BY MR, FIBICH:

a collaborative effort that prioritizes projects 25 Q Is that what you mean?Stratos Legal Services L1 Stratos Legal Services

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A. ~. 1Q Okay I ell me why my statement is 2

inaccurate, 3A We thought about the center as advancing 4

science, so we need to study the diseases for which 5they have compounds that can help the diseases_ We 6wanted to document if the diseases are morbid enough 7that required treatment and if the treatment is 8shown safe and efficacious, then the treatment can 9be deployed and then the pharmaceutical company that 10makes those treatments, if they are effective and 11safe, can benefit 112

But it is a sequential process; it is not 113a one-to-one correspondence. The pharmaceutical 114companies usually support direct things that are of 15benefit to them, clinical trials, For them to 116support something that is quasi-esoteric science, 1;17knowledge, is several steps removed from their 18commercial agenda and is predicated on several steps 19that have to occur for them to be successful 0commercially with their product. The products have 121to be tested; the diseases have to be tested as Q2serious enough to warrant treatment So that's the !23way that you predicate the -- !24

Q Well, Doctor, I object as being i25Stratos Legal Services 1,1

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nonresponsive These products had already beentested; they had already gotten approval from theFDA Correct?

A Not for the conditions that we arc testingthat we are interested. Adult ADHD was not tested,the pediatric bipolar illness was not tested,

Q. Was it a win-win for both parties?A I believed that supporting research on the

diseases that they could have successful compoundsis a very important part of their' mission. Doing agood thing, advancing research I believe iseventually or potentially profitable. The stepsthat are required have some risk. The diseases thatyou are studying may not be warranting of treatment.The treatments may not work. So those are things,the steps that they take by advancing science,

But it is certainly several steps removedfrom all the other pharmaceutical companies thatjust want to do a clinical trial, the FDA kind ofclinical triaL So doing non~clinical trialactivities is a very different approach that thepharmaceutical company took.

MR. FIBICH: Objection, nonresponsive.BY MR F1BICH:

Q Was it a win-win result for the center andStratos Legal Services

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1 Janssen, in your opinion? 12 MR. SPIVACK: Objection, asked and 23 answered. 34 A. I believed that has the promise of a 45 winMwin situation, 56 Q. Okay, you believed it had the promise at 67 the time you started, correct, that it could be a 78 winMwin? I 89 A Could be a win-win if all the forces 9

10 align, we can do the research that will lead to the 1011 decision to do clinical trials and that in tum if 1112 successful and safe and effective can lead to 1213 their -- that will be the alignment with the 1314 commercial interest, not before, 1415 Qo And now we're seven years out from the 1516 time this started, we can look back. In your 1617 opinion was it a win for the Johnson & Johnson l718 Center for Psychopathology Research? Was it a win 1819 for your center? 19~ 0 A I believe that the center advanced 20>1 science. We did what we are paid to cloo 12122 Q. SO the answer is yes, it was a win? 12223 A We did what we are paid todo. The 12324 company, Janssen, did a registration type study that 12425 showed, replicated our initial findings and showed !25



48 (Pages 507 to 510)


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that it's safe and effective for children andadolescents,

MR. FIBICH: Objection, nonresponsiveBY MR FIBICH:

Q Was it a win for Janssen to contributethis money to your center?

A I believe it was the right thing to doQ That's not my questionc I object to that

as being nonresponsive. I'm not asking you whetherit was right, I'm not asking you whether it wasintended, I'm asking you, do you believe it was awin for Janssen?

MR SPIVACK: Objection, vague,argumentative

A I do not know. I think that yes, theyinvested in a good cause and at the end they hadapproval of risperidone for pediatric bipolmillness They have shown it is safe and effective,did not only rely on open or off-label use and openlabel data. They did the right thing But it was avery lengthy process from the time that we startedinvestigating till the time that the approvaloccuned

MR FIBICH: Objection, nonresponsive.BY MR. FIBICH:



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Q. If you would, go to page 225, the topblock, J&J Center Data Management and BiostatisticsCore, Do you see that?

A. Yes.Qc It goes down to the last bullet point,

"These studies demonstrate the unique value of ourcollaboration," And collaboration, that means yourcenter is working with Janssen, Correct?

A Janssen is funding the center-Q. Well, actuallY there was an individual

over there that helped you do some of your analysis,a Dr. Wu.

A. I don't know who Dr.. Wu is. I believethat you are referring to the analysis of Dr, Amandata.. Since Dr- Aman data was not our data, we hadto ask the help of Janssen statistician for ouranalysis,

Q. You asked the help of Janssen'sstatisticians for your analysis for what?

A, For the secondary analysis of the Amanstudy that we talked before.

Q That's the one that had the mistake in itRight?

A No, had only the mistake in reporting theone number. That was not picked up by us, it was


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not picked up by the reviewer, and it was not pickedup by the publishing company. It was a mistake.

Q. Excerpta Medica didn't pick it up, didthey?

A It was not picked up by us, it was notpicked up by the reviewers, and it was not picked upby the publisher, Clinical Therapeutics

Q. Or the copyright holder, Excerpta MedicaRight? They didn't pick it up either?

A. They did not pick it up.Q It says "The findings are critical steps

in meeting J&1's goals vis-a~vis productdevelopment." Do you see that?

A Say again where?Q The last bullet point in the block at the

top right~hand side: "The findings are criticalsteps in meeting J&J's goals vis~a~vis productdevelopment." I read that cOIT'ectly, didn't I?

A. Yes.Q And that's really what you were trying to

do in your research, was help J&J meet its productdevelopment goals.. Correct?

MR. SPIVACK: Objection, argumentative,misstates the testimony,

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1 diseases Ihat they have potential drugs wilL could 12 may be profitable for them if they do the right 23 clinical trinls rhc entire idea of doing a 3<1 clinical trial in pediatric bipolar illness was ·15 dependent on developing enough daw to understand .s6 the illness in itself That is a necessary lirst 67 step 78 MR FII3ICI-I: Objection. nonresponsive 89 Let's take a short break 9

10 fHE VIDEOGRAPHER: fhe lime is ten minutes 1011 aOcr2:00 WCllreolTthcrccord 1112 (Short recess taken) 1213 (Biederman Deposition Exhibit.3 J marked 1314 lor idcntil1cation ) 1415 IHE YIDEOGRAPHER: We arc back on the ,1516 record This is lape number 4 The time is 2:29 i1617 BY MR FIHICH: ,1718 Q Dr Biederman. tcllme again when the 1819 lohnson & Johnson Center for Pcdlauic 11920 Psychopathology began? 2021 A In 2002 2122 Q Do you remember the month? ;2223 A No 2324 Q Was it late in 2002" 2425 A! don't remember :25


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Q You don't know whether it was the firstpart, the middle, or latter part of the year?

A I don't rememberQ Youjust remember it was 2002?A YesQ Show you a document we1ve marked as 31

Q

What ccnter is hereferring to, ifyou know'?

A The J&J CcnlcrQ The J&J Center, that's the Johnson &

Johnson Center for Pediatric PsychopathologyResearch?

A YesQ Can we just call that" J&J Ccnter" and use

that telm?A YesQ Okay


Joseph BiE!derlnanF'obruary 27 I ?009

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:10jll11213'1415161718 Q And that was one of the things that the19 J&.I Center was to do. Right?20 A The center, I think there is a little bit21 of a misnomer here This core, we call it22 assessment cOle becausc, as you see in the23 activities, those are personncl that we reserve that24 had expertise in asscssment, psychological testing25 and things like that that are necessary for clinical


50 (Pages 515 to 518)



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Qc And who made the determination of theallocation of J&J funds?

A I didStratos Legal Services

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to start allover again,So it's a body of competent, trained

individuals that can train other people if we haveadditional funding.

Q, And who would make the determination as tothe percent of the funding that would go to theserespective cores?

A. Me.Q, SO the budgeted amount over there was

something that you came up with Correct?A Yes_ I distributed the total funds

available in the different activities depending onwhat resources those activities required,

Page 515

trials. So this program did not conduct clinicaltrials but supported infrastructure of personnelthat could train people for clinical trials if weget a contract for a clinical trial

Q_ Well, in any event, does it not appear toyou that Janssen viewed the center, the J&J Center,as doing clinical trials?

MR_ SPIVACK: Objection, calls forspeculation, no foundation,

A I don't think so- As you see, the budgetwas modest for that activity Clinical trialscannot be sustained with that budget

Q_ So technically the J&J Center didn't doclinical trials, it trained and supervised clinicaltrials staff Conect?

A The center supported a few personnel withexpertise in assessment. That expertise inassessment can be used in clinical trials and oonclinical trial activities. So, for example, if wedo a genetic family study of pediatric bipolarillness, we need people that have expertise inassessment to be able to do that. We can also trainpeople ifwe have a contract for clinical trial muchmore rapidly than starting at point zero that I need


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Q. And these were things that the J&J centerdid" Correct?

A_ The J&J center supported infrastructure,so this is infrastructure quality assurance..Reliability efforts arc infrastructure activities.

Q_, And then I don't understand_ We've got aJ&J funds and a core allocation_ What does thatmean?

A_ That we are allocating these funds listedhere and the core allocation means we representedwhat proportion of the core are for these expenses

Q_ Do I understand you to be saying that theJ&J funds that are listed here are being allocatedfor the clinical trials core?

A_ Yes _ These are the funds in dollars inpercentage of the core that were allocated to these


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activitiesQ_ And then in addition to the J&J funds that

go to the respective cores, we have a centerallocation< Correct?

A YesQ_ And where does the center allocation money

come from?A_ The center had the total budget that was

500,000 minus 25 percent, :

Q And what is the center contribution? Whatis that?

A, I cannot tell you how we calculated thatBut it's all -- The dollar amounts are here probablyare the most straightforward_ It's what percentage-- Some of these calculations represent whatpercentage of the total budget of the 500,000 minus25 percent were allocated to these individualactivities

Q Let me ask you this_ If I took all of theJ&.J funding that's listed in these respective coresand added that up, would it or should it have comeup to $500,OOO?

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takes in overhead,Q And for the record, the attachments that

we have been looking at, these documents here thatarc attached, are actually J&J Center documents,Correct?

A. I don't know who they areQ. Well, you made the allocations and it

appears that they're assigned according to coreYou can't tell me that those are J&J documents?

MR. SPIVACK: Objection, asked andanswered,

A I do not know,Q. You don't know?A, No

(Biederman Deposition Exhibit 32 markedfor identification)BY MR FIBICH:

Q, Of', Biederman, does it benefit you whenyou do clinical trial research?

A Could you define benefit?Q. Is there some benefit to you? Does it

enhance your standing in the scientific community?Does it enhance your standing with respect to youruniversity? You know, is there some benefit to youin doing clinical research?



Page 521

that advancing knowledge is good for humanity. Allof us benefit from advancements in medicine that wecan have better treatments, save lives and so on andso forth. That is very costly and cannot be donewithout money.

Q, Now, Dr. Biederman, I didn't mean tosuggest that there's anything wrong in beingbenefited by your science. And I object to yourlast statement as being nonresponsive. I'm notsuggesting that there's something wrong with it Mypoint is that ifyou go and do these things and youpublish, doesn't that benefit your standing in therelevant scientific community that you practice in?

A I do not do it to advance my standing. Ido it to advance knowledge.

Q. Then why do you make a big list ofeverything and make your resume or C V. a hundredand some pages long?

A. These are factuaL These are facts on theground.

Q. The exhibit that I've given you, ExhibitNumber 32 -- is it?

A. Yes

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A Research is expensive and requirescontinuous support

Q But as I understand you, you do clinicalresearch because of your background and knowledgeand you want to benefit mankind, Correct?

A I do research to advance knowledge, yes,Q.. And in addition to that, is there a

benefit to you in doing this research?A, You need to define what benefit means,Q. Well, do you understand what the word

benefit means?A I know what benefit meansQ Something of value to you.A The value is advancing of science,Q Thal's the only value you get? You don't

get -- It doesn't help your prestige, it doesn'thelp you with regard to your recognition by yourpeers? It doesn't help you in any other way?

A Not necessarily, To do research is toadvance science and knowledge and I'm very proud tobe able to advance science and knowledge. You areusing the word "benefit" as I understand by thepassage as a commercial benefit. Idon't sellT-shirts, I don't have any benefit of that kind.Advancing knowledge is an abstraction and Ibelieve



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A May I read it?Q SureA Tell me, which part are you --? There

are several studies here Which one are youreading?

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1 Q And can lead 10 diabetes?2 A Yes3 (Biederman Deposition Exhibit 11 marked4 for idcnti llcatiol1.)5 BY MR FIBICH:6 Q Doclor, let me show you \vhal I believe is7 B I want to ask you what this is89

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1 Q And when you would do clinicnl trials, you2 would get a principal investigator rcc RighI?3 A Sometimes I collected vcry lillie solely4 ll'O!l1 clinical Ida Is I'm nOI sun; in this study 15 collected anything6789

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',10ill12'1314151617181920'21 A I know Dr Ghmabawi. Dr Mahmoud, and22 Dr Pandina23 Q How aboul MI Kent Boekes?'24 A. I don't remembel who he was25 Q He's a marketing guy, Did you knO\v that?



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A I have no ideaMR. SPIVACK: Objection, asked and

answered,BY MR FIBICH:

Q. I'm sorry?MR. SPIVACK: Same objection

A, I don't know who he was,MR. FIBICH: Okay, you don't know who he

is, right(Biederman Deposition Exhibil34 marked

for identification.)BY MR. FIBICH:

Q. What is the Center for Child andAdolescent Psychiatric Research?

A, 1have no ideaI think that this is the J&J Center; this

meant the J&J Center Maybe at that time I didnot -- I wanted to make sure that the center'sfunding are clear, so I renamed it the J&J Centerfor the Study of Pediatric Psychopathology



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Q.. Then you are also in a foundation as a 1director that is involved with research into issues 2dealing with pediatric bipolar, are you not? 3

A. We had the funding from the Prechter 4Foundation -- 5

Q. From which foundation? 6A, Prechter. Prechter, it's the name of an 7

individual who has bipolar illness, he committed 8suicide, and his family formed a foundation and the 9money we got, I believe haifa million dollars, to 10study the genetics of bipolar illness 11

Q. What is the name of that foundation? i12A. Prechter, P-r-e-c-h-t-e-L It's Michigan- 113

based; I think it's a Detroit-based foundation. 114Q, Are you on the board of this foundation? '15A. No, 16Q. What do you have to do with the 17

foundation? 18A. We applied for funds. ,19Q. And do you receive funds from it? EOA. Yes. fZ1Q. Is this foundation funded by [22

pharmaceutical companies in addition to -- ~ 3A No, t24Q. Let me finish my question, please, -- in ~ 5

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addition to the Prechter family?A Not that [ know..Q Not that you know. Are there any other

foundations that you have relationships with? Andin particular I'm concerned about directorships,

A. I am not in any directorship of anyfoundation,

Q. Have you ever been a director of anyfoundation?

A. No.Q. No? Is that right?A. That's rightQ. Sir, has the issue of who funds a study

been studied by scientists to determine whether ornot that in and of itself may potentially create abias in the study?

A. Not that I know ofQ. Are you familiar with a psychiatrist by

the name of John Davis?A I believe that John Davis is the president

of Mount Sinai Medical SchooLQ And he is a psychiatrist?A YesQ Do you know Mr. Davis? Dr. Davis.A I do not know personally. I know his


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nameQ And do you know his reputation in the

psychiatric community?A. J know that he is an expert in

schizophrenia(Biederman Deposition Exhibit 35 marked

for identification.)BY MRo FIBICH:

Q Why is it that you think he is an expertin schizophrenia?

A Because he writes papers on schizophrenia,Q, And do you find him to be authoritative

with respect to the papers that he has done withrespect to schizophrenia?

A I don't have an opinion Schizophrenia isnot my area of expertise, I know that he writes onschizophrenia,

Q, tel me show you an article that hasappeared in The Washington Post You probablyhaven't read this since you don't read newspapers

Sir,just on the first page, this articlewhich was written in 2006 says "Pharmaceutical giantEli Lilly & Co recently funded live studies thatcompared its antipsychotic drug Zyprexa withRisperdal, a competing drug made by Janssen All


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five showed Zyprexa was superior in treatingschizophrenia. But when Janssen sponsored its ownstudies comparing the two drugs, Risperdal came outahead in three out of four In fact, whenpsychiatrist John Davis analyzed every publiclyavailable trial funded by the pharmaceuticalindustry pitting five new antipsychotic drugsagainst one another, nine in ten showed that thebest drug was the one made by the company fundingthe study, 'On the basis of these contrastingfindings in head-to~head trials, it appears thatwhichever company sponsors the trial produces thebetter antipsychotic drug,' Davis and others wrotein the American Journal of Psychiatry"

Did you read the article that he preparedfor the American Journal of Psychiatry on thissubject?

A NoQ Assume with me that this study contains

the conclusion that is set forth in this article.Does it surprise you that the pharmaceutical companythat sponsors the trial is the one that comes outahead?

MRo SPIVACK: Objection. argumentative.specylation l no foundation.




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approved indications by the FDA for schizophreniaIn the decision about which drug to use,

doctors not only take data from these head-to-headcomparisons that are very difficult to execute,because when you have an effective treatment, it'svery difficult to show superiority against anothertreatment So the weighing orthe evidence is, isthe drug effective in the condition that I want touse it? What are the side effects of one or theother? And those are the decisions that cliniciansuse in selecting a drug,

MR. FIBICH: Objection, nonresponsive.BY MR FIBICH:

Q, This article goes on to say "Such studiesmake up the bulk of the evidence that Americandoctors rely on to prescribe $10 billion worth ofantipsychotic medications each year," Were youaware of this figure as a proposed figure for thecost of antipsychotic medications each year?

MR SPIVACK: Objection, no foundation 0

Ao I do not know how much money is spent onantipsychotic medications

Q. Do you currently use Risperdal at yourclinics?

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I have no idea I need to read theAarticle,

Q, What article?A, The article that Dr Davis published in

American Journal of Psychiatry,Q And if you read that and his conclusions

were that the company that sponsored the trial wasthe one that came out ahead, would that make youthink that there is a potential money bias in whofunds studies?

MR. SPIVACK: Objection, multiple levelsof speculation, no foundation, argumentative,

A. A clinical trial is sensitive to theinstrumentation that you use, the type of patientsthat you recruit, the length of follow-up,et cetera, et cetera. Doctors in practice inweighing risk and benefit take into considerationeffective treatments..

All ofthese studies show individuallyefficacy against placebo, so these are approveddrugs. So the relative superiority of one overanother is a matter of debate like saying that onlyHonda produces better cars than Chevrolet, so theHonda advertising will favor one over the other.But each of these compounds showed efficacy in their


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A I see thatQ And that's what we've been talking about

Correct?A We have been talking about a lot of

thingsQ Well, the most recent thing we were

talking about is the relationship between outcomesof clinical trials and its relationship tophannaceutical funding Correct?

MR SPIVACK: Objection, misstates thetestimony

A As I told you a few times before, thestudies that compare two compounds are differentthan registration studies that establish safety andetncacy that compare against placebo. Some studiesmay examine the impact of medicines in severalaspects of the illness, such as quality of life Sothe basic studies that lead to registration andapproval ofa compound for the FDA meet a very highstandard ofquality that is acceptable to the moststringent reviewer on the Earth, that is the FDA

So what these studies, and I do not knowwhat are these studies, I suspect that they arestudies similar to what Dr Davis was talkingbefore, this kind ofhead~to~head comparison trying


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Joseph Biedermantebruary 27, 2009

at the department of psychiatry, Beth Israel MedicalCenter in New Yark City. Is that correct?

MR. SPIVACK: Objection, no foundation,calls for speculationBY MR FIBICH:

Q Does the article suggest to you that thisis sponsored in part by the people at the departmentof psychiatry, Beth Israel Medical Center?

MR SPIVACK: Objection, calls forspeculation, no foundation

A, The answer is yes.MR SPIVACK: Excuse me Calls for

speculation, no foundationBY MR. FIBICH:

Q. The answer is yes?A. There is a notice here, yes,Q. Okay

And the background is that pharmaceuticalindustry funding of psychiatric research hasincreased significantly in recent decades, raisingthe question of the relationship betweenpharmaceutical company funding of clinicalpsychiatric studies and the outcomes of thosestudies, and that this study examines thatrelationship. Do you see that?


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to see if there is some advantage to one compound ina class versus another compound in the class, Whichis a different agenda than establishing safety andefficacy of an individual compound.

MR. FIBICH: Objection, nonresponsive.BY MR FIBICH:

Q Sir, under Results, would you read thoseresults for our' jury as reflected in the abstract?

MR, SPIVACK: Objection, no foundationA. "The percentage of studies sponsored by

drug companies increased from 25 percent in 1992 to57 percent in 2002," You want me to continue?

Q. Please., Read the entire results section,MR. SPIVACK: Same objection, calls for

speculation, no foundationA. "Favorable outcomes were significantly

more common in studies sponsored by the drugmanufacturer, 78 percent, than in studies withoutindustry sponsorship, 48 percent, or sponsored by acompetitor, 28 percent, These relationshipsremained after controlling for the effects ofjournal, year, drug studies, studied ~- sony --time since FDA drug approval, diagnosis, samplesize, and selected study design variables. II

Q. And wouid you read the conclusion of theStratos Legal Services

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authors of this paper?MR. SPIVACK: Same objection, cails for

speculation. no foundation,A, HThese data indicate an association

between pharmaceutical industry funding of clinicalstudies and positive outcomes of those studies,"

Q. And you--A. Let me finish, "Further research is

needed to elucidate the mechanisms underlying thisrelationship. "

Q. And you had never read this study beforetoday. Is that correct?

A I did noL(Biederman Deposition Exhibit 37 marked

lor identification.)BY MR. FIBICH:

Q. Let me show you 37, ask you to review thatabstract for me. (Pause)

Have you had a chance to look over this,sir?

A The abstract, yes,Q, And this is Hum another medical journal?

MR. SPIVACK: Objection, no foundation.A It is another medical journal, yesQ. Sir?


55 (Pages 535 to 538)



Page 535 Page 536

1 Q. Do you currently use Invega in your 12 clinics? 23 A. Yes, I do. 34 Q Do you currently use generic Risperdal in 45 your clinics? 56 A Yes, [do. 67 Q. [s the generic Risperdal as effective as • 78 Rispeldal? ! 89 A. [did not study that [cannot tell you.. I 9

10 Patients frequently complain when they are switched 11011 to generic that the efficacy is lost 1112 Q But you have no basis to know whether 1213 that's true or not, do you? 1314 A. I have basis to know that patients 1415 complain to me when switched to generic that they 1516 are not doing as well as with the compound that I do 1617 before, 1718 Q. The next-to-Iast paragraph of this article 1819 says "Reliance on industry-sponsored studies is not 1920 limited to psychiatry, but experts say the problem 20?1 is exacerbated in areas of medicine where the goat

2 of trials is not to demonstrate cures but to measure? 3 symptomatic relief; which allows more latitude in24 how the results are interpreted and marketed," Do

5 you agree with that statement?Stratos Legal Services

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A. Ninety percent or more of medicine issymptomatic relief. Medicine can cure very littleconditions, With exception of infections, which arebacteria, we are very ineffective in curinganything What we can do in medicine, however, isto allow people to have a decent life despite havingthe disease

MR F[BICH: Objection, nonresponsive.BY MR FlBICH:

Q. Do you believe you get a less biasedresult from publicly funded studies than studiesthat are funded by pharmaceutical companies?

k No.Q If you would, turn to the second page,

down to the third paragraph starting with "Daviswarned, II Do you see that?

A. YesQ. And tell the jury who Davis is again.A Dr. Davis is I believe currently the

president of Mount Sinai School of MedicineQ And where is that?A [n New YorkQ [t says "Davis warned that the circular

results he found could undermine the confidence ofclinicians and patients and even cast doubt on


Page 538


entire paper from start to finish is anadvertisement It is a much more subtle and tellingad than anything they can publish as an ad." DidI read that correctly?

A. You read it very welLQ, And do you agree that when a company uses

you as an author, it gives credence to anadvertisement if the paper promotes their product asa safe and effective drug for the treatment of acondition that you studied?

MR. SPIVACK: Objection, argumentative,calls for speculation, no foundation

A A clinical trial is a scientific exercise,Patients are blindly assigned to drug or placeboPatients from very different parts of the country,different centers, parts of the world participate.The findings are collected exhaustively. They arejudged by the FDA -- [ am talking about registrationstudies -- to be adequate to establish safety andefficacy. I can hardly consider results ofaclinical trial as advertising,

MR FlBICH: Objection, nonresponsive.BY MR. FlB[CH:

Q, Dr, Davis thinks so, does he not?A. It's a free --


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Page 537 imedications that are genuinely superior He andRennie, U who is Drummond Rennie, the editor of theJournal of The American Medical Association. Do youknow Dr, Rennie?

k [do not know him personallyQ But you know he is the deputy editor of

theJAMA?k I actually do not know, and I'm glad that

you are pointing out to me,Q. He says uHe and Rennie also questioned

academic researchers' role in these studies It Andan academic researcher is someone such as yourselfCorrect?

A YesQ "Says Davis, who joked in an interview

that he no longer gelS to fly first class to Tokyoand Monte Carlo since he stopped accepting moneyfrom pharmaceutical companies, guessed that 90percent of industry·sponsored studies that boast aprominent academic as the lead author are conductedby a company that later enlists a universityresearcher as the authoL 'We know that happens allthe time,' Rennie said. 'The only reason that thecompany wants a non~company person as an author isto give credence to an advertisement. The whole


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noQ And if you were to see the studies, might

that help persuade you that who pays for a clinicaltrial may determine in some part its outcome?

MR SPIVACK: Objection, calls forspeculation, no foundation ..

MR FIBICH: Well, let's do it this wayLet's mark that.

(Biederman Deposition Exhibit 36 markedfor identification.)BY MR FIBICI-I:

Q, Doctor, have you had a chance to look overExhibit 36?


nonresponsive Listen to my question; I'm trying toget through

Have you seen any studies that studied therelationship between who funds a study and theoutcome of that study?

MR SPIVACK: Objection, asked andanswered

A, You mentioned this study here in thisarticle,

Q. But you1d never seen that study beforetoday, have you?

A, I have not seen this study specifically,

Page


MR. SPIVACK: Objection, calls forspeculation"

A, I said it's a free country, People canthink whatever they wanL

Q Well, ifthe position of Dr Davis isaccurately reflected in the article that we've beenreading, he certainly thinks that a scientific papersponsored by a pharmaceutical company with anacademic researcher and author is an advertisement,doesnlt he?

MR SPIVACK: Objection, argumentative,calls for speculation, no foundation<

A. Dr. Davis can think whatever he wants, Weare a free society and we encourage free thinking.If I agree to what he says or not is a differentquestion, and [ don't

Q. And you have never seen any studies thatstudied the relationship between an outcome ofaclinical trial and who pays for the clinical trialIs that correct?

MR. SPIVACK: Objection, asked andanswered,

A, I have seen clinical trials that werenegative funded by pharmaceutical companies, so,

Q That's not my question, sir' Objection,Stratos Legal Services

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MR, SPIVACK: II you're going to ask himabout this exhibit, I think he needs more than25 seconds to take a look at it

MR. FIBICH: Okay. Tell me when you'reready.

A. What would you like me to read, the entirepaper or parts of it?

Q, You can read as much of it or as little ofit as you want. And if you want to read more,I certainly don't want to deprive you of thatopportunity.. Okay?

A. The only thing I can read is the abstractIs that agreed upon?

Q. Okay. Well, the abstract is a summary.A. This paper has a few pages. I cannot read

in two minutesQ. No, no, my question to you, sir, is a

simple one. An abstract is a summary of the paperitself, is it not?

A. It is But does not have details of thepaper itself.

Q, Sure. Do you want me to ask you somequestions or do you want to study this?

A.. Let me read it first and then -Q. Please take your time.


A. Let me read it at least No?Q. Sure.A. (Pause) Okay,Q. All right First of all, this is a

peer-reviewed article that has been published in ascientific journal. Correct?

A That's correctQ And that scientific journal is the Journal

of Psychological Medicine Correct?A. It's called Psychological Medicine.Q Okay, Psychological Medicine And that is

a scientific journal that you recognize as beingauthoritative in the area in which it isdisseminated. Correct?

tvlR PECK: Objection, foundation.A It's a good journal.Q It's a good journal, okay, And this is a

scientific study, is it not?A. It appears to be.Q. And it is done by a number of individuals,

Do you know any of these people that are listed?A NoQ. None?A None..Q It appears that it was done by individuals


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A It is another medical journaLQ. This appears to be a medical journal from

Denmark Is that correct?MR SPIVACK: Objection, no foundation

A I think it's a British Medical JournalQ, Okay, BMJ would be an acronym for British

Medical Journal, Is that coneet?A YesQ And you understand British Medical Journal

to be a prestigious journal?A Yes,Q, And this abstract concludes like the

abstract we previously looked at, that being thatindustry-supported reviews of drugs should be readwith caution because they are less transparent andhave methodological limitations Correct?

MR, SPIVACK: Objection, calls forspeculation, no foundation.

A I think that this pertain to reviews, notnecessarily to the SOurce studies,

Q, What do you understand the conclusion ofthis research to be?

MR SPIVACK: Objection, calls forspeculation, no ~-

A I need to read the paper more carefully,Stratos Legal Services

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I have no idea what kind of analysis they are doing,what areas of medicine they're investigating and soon and so forth

Q So you can't tell me what the conclusionof this papel is from the abstract?

A I cannol(Biederman Deposition Exhibit 38 marked

for identification)BY MR FIBICH:

Q Doctor, I earlier understood yOll to saythat you were not associated with any foundationsIs that con'ect?

A You asked me if I am in the board ofdirectors of foundation I have been a scientificadviser for some foundations

Q What foundations are you a scientificadviser for?

A I've been in scientific board of the Childand Adolescent Bipolar Foundation and I have been inscientific advisory board of, I do not remember thename because it has changed, the Association ofBipolar -~ Depression and Bipolar ~- I'm sorry, Idon't remember the correct name, but it's anassociation that supports the patient in bipolarillness




Page 550

A, No,Q, Do you attend meetings of this

organization?A Not particularly. The organization has

meetings during the child psychiatry meetings thatif I attend the child psychiatry meeting, I attendtheir meeting. Otherwise r don't.

Q, How much have you contributed?A. A few hundred personally, Not for the

institution. r contribute a few hundred dollars ayear as a charitable contribution.

Q, Do you have a relationship with the SangFoundation?

A Yes, I have a relationship with the SangFoundation,

Q. What is the Sang Foundation?A The Sang Foundation is the Sang family had

the tragedy of losiag theil I believe 21-year-oldStratos Legal Services

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I am in the scientific advisory board

Let me show you 38

A

Q.

Ac Professional, okay, sorry. Professionaladvisory board,

Q And with respect to this foundation, doesthis foundation support research into bipolardisease?

A, Not at aiL The foundation supportsfamilies in despelate straits with their young ones,

Q, SO the answer is no?A The answer is no<Q, And in this foundation, the development

director is asking Mr. Bockes with Janssen for acontribution, Is that correct?

A It appears to be,Q.. And are you paid for your work on this

advisory board?A, No,Q. Do you leceive an honorarium?A. NoQ.. Do you receive travel expenses?


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young son from suicide secondary to bipolar illness, ! 1so they are very interested in supporting activities ! 2to educate the public on bipolar illness in the I 3young. So they have supported, agreed to support I 4the conference that I have been running for last six 5years funded by the NIMH when I run out of funds 6from NIMH They agreed to continue the funding so 7we can carryon the con ference, 8

Qo And what conference are you talking about? 9Ac The pediatric bipolar conference that we 10

have been running for last six, seven years, 11Q. And where is that bipolar conference held? 12A It has been held in different parts of the 13

country "'1154

Q. Name some of themA Boston, Miami, Washington, 116Q. And this is funded by the Sang Foundation 17

sometimes? 118A No. The foundation only funds, is going 19

to fund itthis year because the moneys that we got 120from the NIMH run out They did not renew. It was 21a five-year grant and we run it for six years with !22no cost extension and -- 123

Q I'm sorry. What is NAMH? iz4A. National Institute of Mental Health. 25



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Q Okay, I didn't understand you That'sfederal funding. Conect?

A Federal funding, yesQ And they no longer are going to fund it,

so the Sang Foundation is going to fund it thisyear Correct?

A. CorrectQ And where is the conference going to be

held this year?A In BostonQ And in what amount did they fund this

bipolar conference?A $50,000.Q And what does that $50,000 go to?A To travel stipends and renting a room at

the hotelQ And when is that conference?A. That conference should be held the last

Friday of MarchQ Do you need something to drink?A Maybe. You know what? Maybe you can give

me some water Thank you IapologizeQ Was Mr. Sang a patient of yours?A NoQ Was he a patient of Mass. General?



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A. No.Q. The pedialric bipolar conference that will

be held in Boston in March, where will it be held?A The Charles HoteL The Charles Hotel in

Cambridge.Q. And will you be a presenter at that

conference?A I am the chair olthe conference.Q Is there an agenda?A Yes, there is an agenda.Q. If I wanted to attend that conference

would I be allowed in?A You need to get an invitation and a reason

to attend. The conference is limited to people thatare working on pediatric bipolar illness,

Q, SO it's an invitation only?A. It's by invitation for people. It's not

very difficult to get an invitation, but have to bepeople -- It's not open to the public because wedon't have room for anybody that wants to walk in.

Q. Well, will you send me an invitation?A Why would I send you an invitation?Q. Because I'm interested in the subject

I've had the pleasure of meeting you here these lasttwo days and this issue of pediatric bipolar disease


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is something of interest to meMR. SPIVACK: Objection, argumentative.

BY MR FIBICH:Q, Will you give me an invitation?A Probably not

MR. SPIVACK: Same objection.A. Probably not I don't think that somebody

like yourself that has venomous views on thesubject, hasn't any good intentions for the field,should attend the conference. The idea is to try toadvance the field, not to bury it

Q. And is it your opinion I'm trying to hurtthat field?

A I think that you don't hold great views onthe subject, from what I heard in your questioning.

Q. Well, who do you invite to thisconference?

A. People that are working on pediatricbipolar illness

Q. And who determines that? I mean, do youhave somebody that goes out and searches theliterature or do you solicit people that may beinterested? How does it work?

A. I invite my colleagues, people thatpublish on the subject, and! encourage them to


60 (Pages 555 to 558)

March Have you gotten your invitation listprepared yet?

A. I think we sent -- The invitations havebeen sent long time ago, {am not sure, I cannottell you on top of my head if there is anybody frompharmaceutical. But if there is somebody frompharmaceutical, it's going to be isolated eventThe majority are scientists in the field inacademia,

Q.. Do you know what a key opinion leader is?A I don't know how it's defined.Q. Well, do you know whether or not you are

considered a key opinion leader by Janssen?A I believe I am.Q And what do you understand a key opinion

leader to be?A I do not know how Janssen thinks about key

opinion leaders, but I interpret as people that havedone good academic work

Q Someone that has a good reputation?A Someone that has good reputation.Q Someone that is a leader in fanning

opinions?A I do not know what that means, forming

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invite theirjunior faculty that are interested,residents and fellows that are interested on thesubject But all the people that attend are peoplethat published something or has done some scientificwork on the subject ofbipolal' illness.

Q. Now, I thought you indicated that there'dbeen one in Miami. There's one in Coral Gables Isthat what you're referring to?

A. Yes, that's what I refer toQ. Will there be any industry people at this

particular conference? And by that I meanpharmaceutical industry people

A Not that [ particularly know, In somepharmaceutical companies they have scientists thatare interested in pediatric bipolar and if so, theywill be invited

Q. SO there will be employees trampharmaceutical companies invited that have aparticular interest in the su~ject of pediatricbipolar disorder, Correct?

A. Sometimes they have been invited It isnot something that I particularly court, but in somepharmaceutical companies they are very involved inpediatric bipolar

Q. Well, you have one coming up at the end otStratos Legal Services

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(Biedennan Deposition Exhibit 39 marked 1for identification.) 2BY MR FIBICH: 3

Q. Doctor, the court reporter has marked as 4Exhibit 39 a Wall Street Journal article in July of 52006 entitled Financial Ties to Industry Cloud Major 6Depression Study; At Issue: Whether It's Safe for 7Pregnant Women to Stay on Medication; JAMA Asks 8Authors to Explain. That's the title of this 9article. Correct? 10

A. Correct 11Q, Now, this article cites psychiatrists at 12

Massachusetts General Hospital. You see that in the 13first sentence of the second paragraph? 14

A. Yes, mm-hmm 15MR. SPIVACK: Objeetion, foundation. 16

BY MR FlBICH: 17Q Are you aware of the controversy that is 18

referenced in this article? 119A Yes,Iam. ,20Q. You said "yes and no"? 121A. Yes, I am. 22Q. Okay Tell me what you understand the 23

controversy to be, .2 4A, Dr Cohen did a study funded by the 125

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National Institutes of Health examining whetherwomen that are pregnant with depression shouldcontinue on their antidepressants or not· The studyfound that women that continue on antidepressant hadbetter outcomes than those that did not

It was not a particular drug, was notfunded by any pharmaceuticals, The controversyarose that Dr. Cohen did not disclose his ties topharmaceuticals His understanding was that sincethis study was funded by the National Institutes ofHealth and not by a pharmaceutical company, he wasin no obligation to disclose,

So this is what actually happened. Thedemonization of the study and the conduct is in theeyes of the beholder.

Q. Well, are you saying that this statementin the middle of the third paragraph, "The leadauthor" -- You know Dr. Cohen, do you not?

A. I do know Dr Cohen, yesQ So the lead author, Lee S Cohen, a

Harvard Medical School professor like yourself.Correct?

A" Yes. Where are you reading?Q. Go down to the third paragraphA One, two, three,


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Q, The second sentence, starting with "Thelead author." You see that?

A Yes,Q, "Lee S, Cohen, a Harvard Medical School

professor and director of the perinatal andreproductive psychiatry research program atMass. General, is a longtime consultant to threeantidepressant makers," [s that true?

A I don't know Dr, Cohen's ties topharmaceuticalsc

Q, Says he's a paid speaker for seven ofthem, Is that true?

A I have no idea He does not share withme --

Q, His research work is funded by four drugmakers. Do you know if that's true?

A, I do not know, I do know that theresearch that was published in lAMA was funded bynone.

MR FIBICH: Object as nonresponsive,BY MR FIBICH:

Q That's not what I'm asking, sir. J'masking if this information that is contained in thissentence is inaccurate to your knowledge

A I have no ideaoStratos Legal Services

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Q, "None of his financial ties were reportedin the study. In total, the authors failed todisclose more than sixty different financialrelationships with drug companies" You don't knowwhat all his financial relationships with drugcompanies are, do you?

A I have no idea,Q Was Dr. Cohen one of the doctors that was

investigated by the committee at Mass, General?A No,Q, Do you know ifhe was investigated because

of his ties to drug companies as a result of thiscontroversy?

A To my knowledge, he was not investigated,Q. It says "Dr Cohen and some of his

co-authors subsequently hit the lecture circuit,telling physicians about their findings while alsospotlighting flaws in other recent studies that havefound increased risks to babies born to mothers whouse antidepressants, It And that's what you have doneon behalf of Janssen, you've gone on the lecturecircuit telling physicians about your findings withrespect to Risperdal and spotlighting flaws in othercompanies' drugs, Isn't that correct?

MR SPIVACK: Objection, to form, noStratos Legal Services

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1 foundation ~- 12 A Absolutely not 23 MR SPIVACK: Objection 34 THE WITNESS: I'm sorry 45 MR SPIVACK: Argumentative, misstates the 56 testimony 67 BY MR FIBICH: 78 Q, It goes on to say "The work of these 89 academic researchers highlights the role of opinion 9

10 or thought leaders coveted by drug companies because 1011 of their ability to influence not only the practice 1112 of doctors but popular opinion as welL" Do you see 1213 that, sir? 1314 A. Yes,lseethat 1415 Q. And that's what a key opinion leader does, 1516 right, tries to influence the practice of doctors 11617 and popular opinion? 11718 MR SPIVACK: Objection, argumentative, 11819 misstates the testimony 111920 A. No It's a free country and Mr Armstrong 2021 that also has similar views, toxic views about 2122 psychiatry, writes venom. That does not mean that i2223 it's true 2324 One more time, Dr Cohen treats women that 2425 have depression and bipolar illness and are 25


Page 562

pregnant It's a very difficult point in women'slife. Having an acute bout of depression or anacute psychotic episode secondary to mania is acatastrophic state of affairs for the womenaffected So I believe that Dr Cohen is doing anextraordinary job in consulting in one of thehighesH'isk populations that are women duringpregnancy, His work did not allude to a particulardrug, did not say that use Prozac because it'sdivine. His work compared women that continuedtreatment with an antidepressant and women that didnot, and the work fbund that women that continuedwith the antidepressant had better outcomes

In going back to weighing risks andbenefits that doctors like Dr Cohen and myself do,you have to weigh the consequences and the tragedyof a woman that wants to be a mother and may not beable to be a mother because of depression, Thoseare the women that he has to consult

So the idea that there is some riskpotentially to the babies is something that he hasnever said that it's absolutely free and it's avitamin. But the risk, the small risk that could beto the baby pales compared to the risk to the babyand the mother secondary to an acute bout of


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psychiatric illness This is the crossroad, this iswhere the rubber meets the road, and this is thesame dilemma that I have: I have to weigh a childthat may kill or may commit suicide and I need totreat This is what is the intersection with myclinical practice

MR. HBICH: Objection, nonresponsive.BY MR. FIBICH:

Q. My question to you, sir, iI you didn'tunderstand it, was that a key opinion leader's roleis to influence the practice of doctors and popularopinion as well?

MR, SPIVACK: Objection,BY MR. FIBICH:

Q Isn't that right?A. No,

MR. SPIVACK: Objection, asked andanswered, argumentativeBY MR. FIBICH:

Q. Now, the reason that Dr Cohen in hispublication didn't mention any particularantidepressant was because he's worked for all themanufacturers, Right?

MR. SPIVACK: Objection, calls forspeculation, no foundation.


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BY MR FIBICH:Q Do you know that?A No. He did not mention because the study

was funded by the National Institute of Health andhis understanding was that since the study was notfunded by pharmaceutical industry, the disclosuremay be irrelevant This is the reason that he didnot disclose Not to obscure critical information

Q So you think th'at ties to drug companiesis irrelevant information with respect to studiesthat are published by someone that has those ties?

MR SPIVACK: Objection, misstates thetestimony, argumentativeBY MR. FIBICH:

Q Is that right?MR. SPIVACK: Same objection

A Dr. Cohen did not disclose not because ofany demonic anything Dr Cohen's understanding ofhis responsibilities of disclosing are limited tostudies that are funded by pharmaceutical companiesTo the best of my knowledge, Dr Cohen has disclosedextensively in his papers about his ties topharmaceutical companies. That's the reason thatthis writer knows about that

MR. FIBICH: Objection, nonresponsiveStratos Legal Services

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opinion leader, it is a designation that they useto describe me. I don't have any contractual orotherwise agreement to discharge my function of keyopinion leader.

Q, Earlier today you listed for us the peoplethat in your estimation form the group of mostrenowned psychiatrists in the field of pediatricbipolar disordeL Correct?

A, CorrecLQ, And that was yourself; Dr. Wozniak,

Barbara Geller, Gabrielle Carlson -A, Carlson, yes,Q. -- and Robert Findling. Right?A Yes.Q. And are you aware that Gabrielle Carison,

Robert Findling, Barbara Geller and Janet Wozniakare also key opinion leaders for Janssen?

A. I have no idea.Q. To your knowledge, does Dr Wozniak have

relationships with Janssen?A. I do not know, I have no idea what she

hasQ You don't know whether she consults with

them?A, No


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do you know about how much longer you have?MR, FIBICH: About an hour and twenty

minutes,MR SPIVACK: Then we should take a break

at this pointMR, FIBICH: Okay, I think so too, give

our court reporter a break,MR, SPIVACK: Yes.THE VIDEOGRAPHER: The time is 3:38

We're offthe record.(Short recess taken,)THE VIDEOGRAPHER: We're back on the

record. This is tape number 5 and the time is4:00 pm,BY MR FIBICH:

Q. Dr- Biederman, we were talking about keyopinion leaders and their purpose, and you'veindicated that you recognize that you're a keyopinion leader of Janssen Pharmaceuticals, Correct?

A, I believe soQ, And what do you believe your

responsibilities are as a key opinion leader forJanssen?

A. I don't have any responsibility us a keyStratos Legal Services

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Q.. You don't know whether she is an adviser 1to them? 2

A. I do not know 3(Biederman Deposition Exhibit 40 marked 4

for identification,) 5BY MR, FIBICH: 6

Q It is your interpretation that key opinion 7leaders is just a term that Janssen uses to describe 8you, that they're not looking for anything in 9particular when they want you as a key opinion 10leader, Is that correct? 11

Ao I have no idea what Janssen thinks about 12the meaning of key opinion leader.. You asked me a 13different question You asked me whether I think 14that I am a key opinion leader I think I am very 15prominent and probably would be considered a key 16opinion leader. My expertise is because of the 17science that I have, not because of self-declaratory 18anything And so my influence in the field is 19because of my scientific work 20

Q, Regardless of the reason for you being a 21key opinion leader, and let's ass~me it's because of 22your standing in the scientific community, your 23reputation, the body ofwork that you devoted your 24life to, let's assume it's all of those things, 25


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What do you think the purpose of being a key opinionleader is? To influence opinion?

A, I do not know,Q. Do you think that being a key opinion

leader is related in any way to your status as aprincipal investigator in scientific trials?

A" I don't think so. I think my status ofkey opinion leader is because of the quality of myresearch, I would say 80 to 90 percent of my workhas nothing to do with medications.. And Ipublished, as you know if you looked at my CV ,I have more than 600 papers

Q, Let me show you an exhibit that we'vemarked as 40, ifyou would. Right there. sir,


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(Biederman Deposition Exhibit 4 I markedfor identification .. )

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A, National Institute of Mental Health,

(Biederman Deposition Exhibit 42 markedfor identification,)


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Joseph Biederman Joseph Biedermanfebruary 27, 2009 February 27, 2009

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1 12 23 34 45 56 6 MR FIBICH: I tell you what, let's do it7 7 this way. We'll come back to that question.8 8 (Biederman Deposition Exhibit 43 marked9 9 for identification,)

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1 12 23 34 45 56 67 178 I 89 Q. You don't remembcL Are you getting

il~10 tired?1 A I am finco 11

12 Q Okay. If for some reason your level of 123 energy is such that you can't answer my questions, 134 please let me know ,14

"5 A. I am more than capable to answer your i156 questions '167 178 189 19

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Massachusetts General?A. Yes, she's an employee of my program at

Massaehusetts General HospitaLQ< Well, I donlt understand; there's so many

different terms. Are we talking about the I&JCenter she's an employee?

A No, she's an employee of Mass GeneraLQ Okay. But she works for you?A She works for meQ Reports to you?A. Yes.

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Q. Letls assume that Janssen made it. Thenby labeling this an NIMH conference and notreferring to lanssen, that is misleading to theparticipants, is it not?

MR. SPIVACK: Objection, calls forspeculation, no foundation, argumentative<BY MR. FIBICH:

Q. Can you answer my question?A I think that ifthe grant were to have

been granted, that should have been disclosed.Q. If the grant had been granted, that should

have been disclosed? That's your testimony?A. (Witness nodded.)Q. Tell the members of our jury why


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A, Because the audience need to know allsources of suppmt for a conference

Q., Did Janssen ever sponsor your pediatricbipolar conference?

A. I he tirst bipolar conference was funded byJanssen,

Q, How many have there been?A Only one funded by lanssen.Q, Well, no" How many conferences have there

been?A Six through NIMH and one by Janssen, so

seven"Q. And one potentially by Janssen that you

can't recall?A One potentially that may have had

additional supplemental funds, not funded, becausemost olthe funding came from the NIMH

MR FIBICH: Mark that, please.(Biederman Deposition Exhibit 44 marked

for identification.)BY MR. FIBICH:

Q. Doctor, Exhibit 44 are some documents-excuse me; I didn't mean to pull it back likethat -- that were produced to us in response to thesubpoena that was served on you


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MR SPIVACK: Do you have copies?MR. FIBICH: I do not

BY MR FIBICH:Q. Can you identify what that is?A I don't know what this isQ. Is it your handwriting?A No.Q. It's not your handwriting? (Pause) My

question to you is, do you know what that is?A. Looks like worksheets of different

amounts.. I'm not Sure what this refers toQ And neither am I because I didn't prepare

it. But it was produced by you and it appears to bea rather haphazard way of recording moneys that mayhave been paid to you. Would you look over that andsee if that is a fair characterization, or would youcharacterize it in SOme other way if it's not?

MR. SPIVACK: Objection, no foundation,calls for speculation, argumentative.

A, [don't remember what this is,Q, Let me make sure that I understand your

testimony. The handwriting on this document, is ityours?

A. No.Q. You're certain of that?


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A. YepQ. I'm sorry?A. Yeah, it's not my handwritingQ. Let me see the document, ifI may

Now, the last two pages appear to beinvoices wherein $2,000 was paid to you on twooccasions for a lecture on March 2nd of 200 I andMarch 14th of 200L Would you look over that andsee if you think my comment is correct?

A Seems to be correct.Q. SO the last three pages you recognize as

evidence of payment to you by Janssen?A. Yes.Q. But the first pages, you don't know what

that is?A. I don't remember what it is I think it

looks like some kind of draftQ. Well, whatever it is, it appears to be

moneys and some relationship to phannaceuticalcompanies, Would you agree with that?

MR. SPIVACK: Objection, no foundation,speculation.BY MR FIBICH:

Q Just read it and see ifyou would agreewith that characterization,



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MR SPIVACK: Objection, no foundation,calls for speculation,BY MR. FIBICH:

Q, Does that appear to be what it is?MR. SPIVACK: Objection, no foundation,

calls for speculation"A, I'm not sure what it isQ. Okay By what method did you keep up with

the money that was paid to you by pharmaceuticalcompanies?

A By 1099s that the pharmaceutical companiessend at the end of the yeaL

MR. FIBICH: Mark that as an exhibit,please.

(Biederman Deposition Exhibit 45 markedfor identification,)BY MR. FIBICH:


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Q. Doctor, do you know who Joyce Myers is?A No


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MR PECK: Do you have copies for counsel?MR FIBICH: No,

BY MR, FIBICH:

BY MR FIBICH:Q You looked at this document, did you not?A I have no idea what this document is

about.Q, Let me try this question Have you looked

at this document?A I looked at the documentQ, Does this document contain your name?


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MR, SPIVACK: Objection, no foundationA The document contains my name,

BY MR, FIBICH:Q, Does it contain a funding amount?

MR SPIVACK: Same objections,A I have no idea what this document is"Q, Does it contain a funding amount?A 1have no idea what the document is,Q. Does it contain a funding amount?

MR SPIVACK: Objection, calls forspeculation. no foundationBY MR FIBICH:

Q, Does it contain a funding amount?MR, SPIVACK: Same objections

A I have no idea what the document is,Q, Does it contain a funding amount?

MR SPIVACK: Same objections,BY MR. FIBICH:

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Q. Well, can you read it? It's right hereA, f can read it.. I don't know what that

amount represents Or what is it


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Q In your dealings with Janssen, have theyever said there's money on the table?

A, I have no idea what that means,Q. I'm not asking you whether you know what

it means, Pm asking you if that is a term thatJanssen has used with you, money on the table

A. No.(Pause)MR. PECK: We will have to make copies

because we're not given a courtesy copy.MR. FIBICH: What was that? What did you

say?MR. PECK: I said we will have to make

copies because wetre not given a courtesy copy(Biederman Deposition Exhibit 47 marked

for identification ,)BY MR. FIBICH:



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Meridia in conjunction with a regimen ofRisperdal? .23A, Because we documented that risperidone 124

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Q. And you never did a study long enough tosee what the long-term weight gain would beCorrect?

A. We followed some of the children in ourstudy of risperidone for up to one year,


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get them I don't understand what you're talkingabout

A Well, sometimes I have some sundry fundsthat allow for travel The NIH studies all havetravel in them, so for every one of the grants thatwe have for NIMH there is a set amount of funds totravel So those are funds that I have available totravel

MR. FIBICH: Lees take a fivewminutebreak Let me get a copy fbr y'all And this willbe the last thing I'll go over with the doctor

THE VIDEOGRAPHER: The time is 4:43 Weare off the record

(Shan recess taken)(Biederman Deposition Exhibit 48 marked

for identification)THE VIDEOGRAPHER: We are back on the

record The time is 4:51BY MR FIBICH:

Q Doctor, I want to show you what our courtreporter has marked as Biederman 48, and ask you tolook over this document (Pause) And while you'relooking over it, I will represent to you that thiswas a document that we obtained from the partiesthat were submitted to us in response to the



1 A Depends If the meeting has something to 12 do with a particular work that we did for a 23 phannaceutical company, the pharmaceutical company 34 will support it 45 Q. Well, what about ifit -- Well, let me ask 56 it this way. Were any of these trips to these 67 national and international meetings done, paid for '78 by the J&J Center? 89 A The J&J Center did not support travel 9

10 Q. Well, where would you get the money to go 1011 to these meetings if it were not given to you by 1112 pharmaceutical companies? 1213 A I attend these meetings with or without 1314 funding.. 1415 Q Well, are you trying to say that you pay 1516 it out yourself or arc you reimbursed by MGH or 1617 Harvard or any organization that you belong to? 1 '718 A If I have funds to reimburse for travel 1819 expenses, I will submit the bill If I don't have 1920 funds, I will pay myself 2021 Q Okay So is there a set amount that you 12122 receive each year for travel to professional 12223 meetings such as these? i2324 A Not really. 12425 Q Well, you said if you had funds you would 125

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subpoena that was issued to you My question would 1be: Are you familiar with this document? 2

A ~ 3Q. Have you seen this document before? 4A Not that I remember 5Q, Excuse me? 6A Not that I remember. 7Q Well, let me ask you a few questions, see 8

ifit can refresh your recollection The thing that 9triggered this is you said you had some sundry 10funds, and there is a cash balance on this sheet and 11the sponsor1s name is sundry. The first one is 12$21,834, sponsor is sundry, for a pediatric mania 1'13conference. Do you have any idea what that is? ,14

A The pediatric mania conference was not a 115sundry fund, it was a pediatric mania conference 116Maybe has been classified as a sundry, but was for a 1117pediatric mania conference 18

Q. Well, let's go down to like one, two, 119three, four, five, six, and the title is npediatric 20psychopharmacology project fund, operating expenses" 21and it's got $ I,006,509 and it's got "sundry" by '22sponsors name, Do you know what that is? 23

A, That is a conference that we have 24Q. Well, when you say you can go to sundry 25

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funds for travel expenses, could you go to this fortravel expenses?

A I could go to thisQ So any amounts that are on here as sundry

funds are funds that are available for you to travelto these institutes that we're talking about?

A This fund is primarily there for helpingmaintain operations during times that we cannotsecure funding

Q I understand that But my question to youis that for you to go to these national andinternational institutes for the purpose ofparticipating as an expert in the field of bipolardisorder, you can take sundry funds from thesebalances that are reflected on this sheet?

A I couldMR FIBICH: Well, I have a lot more

questions, but I think we1re at the end of the day,so I'm going to terminate my exam at this time dueto time. And I think we have a statement we need toput on the record as well about the production

MS LaMACCHIA: It was represented to meupon production by Dr Biederman in response to hissubpoena duces tecum which has now been marked asExhibit 17 to his deposition that there were


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approximately 30,000 pages of documents included onthat CD, when it has come to my attention that thereare approximately 17,400 documents on that CD Andalso the privilege log as it was produced, it wasrepresented to me by Mr Spivack that copies ofdocuments needed to be redacted because theycontained personal information and Social Securitynumbers and information such as on 10995, And afterviewing the documents, there was no such informationcontained within the documents that were produced toplaintiffs in this matter

In addition to that, some documents thatwere referenced on the privilege log which washanded to me with five -- pardon me ~~ seven pages,I, 2, 3, 4, 20, 21, 22 and 23, it appears that thereare pages missing, and they are Bates-numbereddocuments that arc represented within the privilegelog that were not turned over to me pursuant to thesubpoena duces tecum

And I would like to go ahead and mark thisas Exhibit 49, as it appears plaintiff has beenhanded an incomplete set of documents pursuant tothe subpoena duces tecum

(Biederman Deposition Exhibit 49 markedfor identification)



Page 601

anything that is inaccurate or is responsive andshould have been produced, we will undertake toproduce that

With regard to any personal financialinformation, that's another thing that we willcheck" We actually believe that there were 1099swhich contain home addresses and Social Securitynumbers. If there are such documents, as werequested at the outset, what we will do is provideyou with a replacement CD and ask that you use that

MS. LaMACCHIA: Okay, counsel,just so therecord is clear, upon my review of the entirety ofyour production, there were documents containedwithin the privilege log that were not in theproduction, And 1believe Mr, Burney made arepresentation to the court in New Jersey that therewas approximately 30,000 pages of documents on theCD.. In actuality there were 17,474 pages ofdocuments.

MR. BURNEY: For the record, I told theCourt that I wasn't sure and that I thought therewas 30,000 pages, This was not because I -~ I amnot giving you an empty CD, you know, or a CD thatonly has half the documents. I misspoke..

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(Pause)MS LaMACCHIA: Furthermore, plaintiff

wishes to reserve her right at this time to furtherexamine Dr. Biederman upon a complete and fullproduction of documents pursuant to the subpoenaduces tecum

MR SPIVACK: For the record,DI'< Biederman has been subjected to two full days ofexamination, We think that's more than enough forsomeone who is a third party and really has no otherparticipation in this litigation. So to the extentthere's any reservation of additional examination,we would object and will oppose attempts to examinein the future if that arises

As far as the production, we think thatthe production actually was of all documentsresponsive to the subpoena, I think it's actuallyan issue with splitting up documents for the numbersthat you see in terms of the numbers that appear onthe CD We actually think we produced everything.

Now, as far as the privilege log, we alsothink that was a complete privilege log fordocuments responsive or were potentially responsiveto this production. However, we will certainly goback and check both, well confirm, and if we find



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MS. LaMACCHIA: And with a completeprivilege log, I'm unsure as to why plaintiff wasonly provided with pages I, 2, 3, 4, and then 21,22,23

MR BURNEY: It's a printing error thatoccurs in Excel because those columns go beyondThat should have been shrunken down to beyond pagesI through 4 So there's no intennittent pages_ Theintermittent pages are blank. If you'd like, I canprint the entire document for you and you'll have 19blank pages and then the last four pages will havethose columns that you see before you

MR SPIVACK: So we'll stipulate that wedon't know how to use Excel

MS LaMACCHIA: I would also like you tostipulate that another production, a complete andfull set of documents will be produced to plaintiff

MR. SPIVACK: If we haven't producedanything, we will produce any responsive documentsif they exist

MS LaMACCHIA: Okay. Then I furtherreserve my right upon the production of additionaldocuments

MR SPIVACK: Right, and we have alreadymade our objection, so we can restate or not But r



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1 understand,2 MS LaMACCHIA: Thank you3 MR, SPIVACK: And we'll try to take a look4 at that and confirm.5 MS, LaMACCHIA: Thank you,6 MR, FIBICH: And will you check with your7 client about my invitation to the pediatric bipolar8 disease conference?9 MR, SPIVACK: I'll be happy to check with

10 him11 MR FIBICH: Thank you,12 MR, SPIVACK: Is there any furthel13 examination?14 MR, PECK: Yes, there is Actually,15 before I get started, I'll move over to MI. Fibich's16 seat, I would ask that he provide me with the17 American --18 MR FlBICH: Hold on a minute, I'm not19 through, I stopped because it was 5:00 o'clock20 MR, SPIVACK: You're not through?~ 1 MR, FIBICH: Through with my examination,22 MR, SPIVACK: So are you saying that you12 3 are intending to continue the deposition?24 MR FIBICH: Well, what I thought we were25 going to do was stop at 5:00 o'clock like we did



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yesterday. I've got more examination,MR, SPIVACK: Okay. That is between you

and Mr PeckMR, FIBICH: So you want the witness to

continue to be --? Well, let me ask it this wayIf Mr. Peck is going to cross~examine him, then Iwant cross~examination after Mr, Peck

MR SPIVACK: That's up to you and he todiscuss.

MR. FIBICH: Okay So my question to you,and I understand you're trying to stay out of this,but my question to you is: Are you going to tellthe witness to leave so that I'm deprived of myright of cross-examination of him after he examinesyour witness?

MR SPIVACK: Well, Dr Biederman hasstayed till 5:00 o'clock, which was the agreed-uponschedule

MR, FIBICH: Right.MR, SPIVACK: As a matter of courtesy, if

Mr Peck has questions, we are going to afford himthat right for another fifteen minutes. We don'tintend to stay here for the rest ofthe evening.

MR, FIBICH: Well, that was what myunderstanding was, I mean, I have more questions



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I stopped because I thought that as a matter ofprotocol we were stopping at 5:00 dclock

MR SPIVACK: Well, in that case, then youand Mr. Peck can work it out We'll be happy to gooffthe record while you and he discuss it.

MR, FIBICH: I don't want to discussanything off the record with him,

MR, SPIVACK: Okay, Well, discuss it onthe record. As you said, I'm going to stay out ofit.

MR, FIBICH: Well, here's the questionDo you have more than fifteen minutes?

MR PECK: I suspect I do,MR FIBICH: So what's your deal now? I

mean, we're at a dilemma, because I thought we weregoing to go to 5:00 o'clock every day,

MS, LaMACCHIA: ML Spivack, in yourcorrespondence with plaintiffs counsel it wasn't adeal, it was 9:00 to 5:00 for February 26th and 27thand then from day to day until completed,

MR. SPIVACK: We have a differentinterpretation of the order, so we think the ordergave you two days< We think that's more thanadequate. As I said five minutes ago, we're goingto raise an objection to any further examination of


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Dr, Biederman, So that's our position If theCourt decides di fferently --

MS. LaMACCHIA: The order says what itsays and it goes from day to day till completed.

MR, FIBICH: Well, heIe's where we areI'm not going to pass the witness unless I have alimitation on how many questions he's going to askIt's my right to continue my examination. I did notget through with my examination, I wiII representthat to you. I've got other questions that Iwantto ask, other documents I want to go oveL Quitefrankly, I've got quite a bit more to do, I made adecision since it was 5:00 o'clock that we should goahead and stop and go on about our business becausethat's how we do it.

If Mr Peek wants to ask questions, then Ithink I have the right of cross-examinationthereafter. He's now said that he is likely to takelonger than fifteen minutes, which means we're goingto go at least another thirty minutes or 10ngeLI'm willing to accommodate him. If it's fifteenminutes, then Iget fi fleen minutes for recross Ifthat's not the case, and ifhe's here to answerquestions, then I'll just keep going on myexamination"


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recall?MR PECK: American Journal of Psychiatry

It was produced and read by you _w

MR FlBICH: I tell you what's doMR PECK: -- Washington Post article,

which was Exhibit Number 20MR FIBICH: I'm sorry. Say that againMR. PECK: It was produeed and read by you

following Exhibit 20, whieh was The Washington Postarticle regarding a rise in pediatric bipolardiagnosis,

MR FIBICH: Okay, I tell you what's dol.et's terminate the deposition, let the doctor go,let me look through my things, see ifI can find youa copy of it; and we can either mark it as anexhibit _w

MR PECK: Let's mark it as an exhibitMR FIBICH: If I can't find it here

today, then I will get you a copy and send it to thecourt reporter

MR PECK: Fair enoughMR FIBICH: OkayMR PECK: We are going to make a copy of

Exhibit 46, which we didn't have.MR. FlBICH: I didn't have a eopyStratos Legal Services

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I am not trying to be difficult. But whatIdon't want is to give Mr. Peck the right to crossexamine or examine this client and me not have theright to cross~examination. This was neverdiscussed before the Court, despite numeroushearings that were held before the Court, thatJanssen would be asking questions and under whatconditions, for how long, and whether we split thetime up,

We have now utilized the entire time forthe examination of Dr Biederman, so Isuggest quitefrankly that we terminate the deposition today andif Me. Peck wants to take his deposition some othertime, then he can petition the Court.

He had the opportunity, I might add, to dothat before these hearings. He could have said ifthis is our two days of Dr.. Biederman, then Janssenreserves the right to do an examination for someperiod of time, and the Court could have allocatedwhat portion ofthe two days that he would beentitled to, But in the absence of that, I don'tthink we can go on like this

So do you want me to keep askingquestions? Not really?

MR SPIVACK: You know, it's up to you andStratos Legal Services

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reserve the right to continue the deposition and Iwill object to any dissemination of this depositionfor any reason to any person anywhere any timewithout my opportunity to examine Dr Biedennan onthe documents that you produced,

I will remind everybody oltheirobligations under the protective order in the NewJersey case, the Foti case and the otherlitigations, that anything produced by Janssen inthis discovery in the litigation remainsconfidential and is not to be disseminated.

Doctor, thank you for your time, and maybewe meet again,

MR. FIBICH: Thank you.MR PECK: One more thing One more thing

before we go off the record. Mr. Fibich quoted froman article this morning from the AmericanPsychiatric Journal to the effect that 90 percent ofdocuments get -- I'm sorry _M 90 percent ofphysicians get infonnation for treating patientsfrom medical journals" That article was not markedfor identification. It was read from; it wasreferred to. I'd appreciate that it be produced,marked for identification, not given to guesswork.

MR FlBICH: Where was it from? Do youStratos Legal Services

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1 Mr, Peck to work it out- We have tried to~-

2 MR FIBICH: Well, no, no, here's the3 problem, Peter You're saying he's going to stay4 here and answer questions, so ifhe's going to stay5 here and answer questions, then I'll ask my6 questions. because I'm not through, Ifyou tell me'7 that he's not going to stay here and answer8 questions. then I'll finish as a matter of courtesy,9 He's told me twice today he's tired. I'm tired,

ID we're all tired, it's Fridayill MR SPIVACK: The Celtics are playing

1

12 tonight13 MR. FIBICH: And the Celtics And the14 Roekets beat the Cavaliers last night15 MR SPIVACK: All right. Then in that16 case, as far as my client's interest, it is now five1'7 after 5:00 and --18 THE WITNESS: Ten after 5:0019 MR. SPIVACK: Ten after 5:00 by your watehi20 and we'll finish with the deposition then I mean,121 terminate it~2 MR FIBICH: All right.,122243 MR. PECK: For the record, Mr. Fibich, you

had fifteen hours, I can't agree to your offer of~ 5 fifteen minutes on cross~examination I willI Stratos Legal Services

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1 MR. PECK: And I think there were other 12 exhibits that we didn't have a copy of We're off 23 t~~~ 34 THE REPORTER: We have to let him go off 4

5 the record 15~6 MR PECK: Oh, I'm sorry7 THE VIDEOGRAPHER: The time is ten minutes8 after 5:00. We are oITthe record 89 (Discussion off the record) 9

10 MR FlBICH: Mr. Court Reporter, I have 1011 marked as Exhibit 50 an editorial that I read from 1112 this morning, and Mr. Peck has asked that it be made 1213 part of the record, So I tender to your possession 1314 Exhibit 50, entitled Conflict of Interest, an 1415 editorial that appeared in the American Journal of 1516 Psychiatry that I referred to this morning 1617 (Biedenman Deposition Exhibit 50 marked 1718 for identification) 1819 (Deposition concluded at 5: 15 pm) 1920 2021 2122 2223 2324 2425 25



74 (Pages 611 to 613)


Page 612

COURT REPORTER'S CERllFICATEI, J Edward Varallo, RMR, eRR, Registered

Professional Reporter and Notary Public in theCommonwealth of Massachusetts (my commission expires12/24/2015), hereby certify that the deposition ofJoseph Biedennan, M 0 taken on February 27, 2009,in the maHer of In re: Risperdal/SeroquellZyprexaLitigation, Case Code 274; Alma Avila, as nextfriend of Amber N Avila, an individual case vJohnson & Johnson Company, Janssen PhannaceuticalProducts, l-P, et al was recorded by mestenographically and transcribed; that thedeponent's oatil continued from the previous day

I certify that the deposition transcriptproduced by me is true and accurate to the best ofmy ability

I certify further that I am not counsel,attorney, or relative of any party litigant, andhave no interest, financial or otherwise, in theoutcome of this suit

DA TED: 3/9/2009 J Edward Varallo


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Page 613

WITNESS: Joseph Biederman, M 0 [Volume 2]

DATE: February 27, 2009

IN RE: Risperdal/SeroquellZyprexa Litigation,

Case Code 274; Alma Avila, as next friend IofAmber N Avila, an individual case v IJohnson & Johnson Company, Janssen

Phnrmaceutical Products, L P nIkIa

Janssen, LP , et al

DISTRIBUTION TO COUNSEL The original signature

pllge/errntn sheet was sent to Peter S SpiVllCk,

Esq , to obtain signature from the deponent When

signed. please send original to Leslie l-aMacchia,

Esq , who will supply a copy of the signed errata

sheet 10 other counsel present at the deposition

WITNESS INSTRUCTIONS After reading the transcript

ofyour deposition, please note any change or

correction and the reason for it on the errata

sheet DO NOr make any notations on the transcript

itself Use additional sheets if necessary

SIGN AND DATE THE ERRATA SHEET and return it, along

with the transcript, to your counsel
