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735 at' Street,
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735 Bth Street,
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735 Et" Street,
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735 ath Street,
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MILLER REPORTING COMPANY, INC.
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DR. NERENSTONE :

3

DR. KENNEALEY:

Thank

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Gerry

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MILLER REPORTING COMPANY, INC.
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MILLER REPORTING COMPANY, INC.
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MILLER REPORTING COMPANY, INC.
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MILLER REPORTING COMPANY, INC.
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MI LLER REPORTING COMPANY, INC.
735 8th Street,
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calls
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S.E.

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MILLER REPORTING COMPANY, INC.
Washington,

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MILLER REPORTING COMPANY, INC.
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MILLER REPORTING COMPANY, INC.
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[Slide.]
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REPORTING COMPANY, INC.
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Washington,
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546-6666

for

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735 .flthStreet, S.E.
Washington, D.C. 20003
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735 Bth Street,
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Washington,
D.C. 20003
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MILLER REPORTING COMPANY, INC
735 Bth Street,
S.E.
Washington,
D.C. 20003
(202) 546-6666

risk
patient,

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254
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My name is Donna
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[Slide.]

7

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REPORTING COMPANY, INC.
735 Bth Street,
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Washington,
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20003
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546-6666

foundation
job

today
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on behalf

of

255

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unapproved

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MILLER REPORTING COMPANY, INC.
735 ath Street,
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Washington,

considering

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MILLER REPORTING COMPANY, INC.
735 8th Street,
S.E.
Washington,
D.C. 20003
(202) 546-6666

bit

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MILLER REPORTING COMPANY, INC.
735 8th Street,
S.E.
Washington,
D.C. 20003
(202) 546-6666

is

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DR. NERENSTONE:
this

afternoon

is

Miss

the

National

over

Breast

500 member

opportunity

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NBCC's

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beginning

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hope

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medicine

speaker

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for

from

on behalf

thank

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and

of

you

for

our
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to

years

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what

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breast

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breast

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MS. PLATNER:

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MILLER REPORTING COMPANY, INC.
735 ath Street,
S.E.
Washington,
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(202) 546-6666

is

unproven.
science
through

well-

ajh

259
There

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MILLER REPORTING COMPANY, INC.
735 ath Street,
S.E.
Washington,
D.C. 20003
(202) 546-6666

be

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MILLER REPORTING COMPANY, INC.
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Washington,
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the
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13

during

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II

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Phase

III

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safety

III

16

of

fairness

17

to

them

18

physicians

19

them

20

the

21

devoted

22

based

23

availability

24

and

25

thought

or,

usually

the

case

for
to

trials

it

is
of

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was certainly

the

case

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issue

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women with
breast

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up.

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and

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15

the

issues

trials,
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benefit

process,

even

does

10

known

investigational

and

it

have

saved

gruelling

Certainly

8

before

and we could

We could

7

available

frankly,

when

was with

Herceptin

no way
really

MILLER REPORTING COMPANY, INC.
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fairly

--

drug

we have

make the

262

ajh
single-patient

IND process
We recognize

We all

want

4

the

right

5

must

6

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7

Americans.

8

patient

to

include

this

save

public

policy

clinical

10

this

afternoon.

11

in

12

time

13

do want

14

committee

15

their

sort

of

to

to

outlining

all

more

and better

to

all,

problems.
the

discussion

it

time

for

the

ask

the

speakers

start

it

healthcare

for

all

done

all

you.

the

speakers

a tremendous

not

of

that

singleThank

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into

and

research,

thank

have

develop

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efforts.

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issue.

to

supporting

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you,

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to

get

open
to

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DR. NERENSTONE:

9

together

and access
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different

work

toward

We believe

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trials

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is

lives.

movement

INDs

fair.

going

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time

remaining

questions

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job

to

have

problems.
for

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clarification

of

presentations.

16

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representatives

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think

19

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That

21

of

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patients,

23

benefit

24

start

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to

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the

at

patient
least

research

no matter
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least

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treatment.

who really
our

this

discussion

get

investigational

should

by
agents?
and

status

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protocols

performance
give

the

community,

centers,

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suggests

especially

advocacy

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by saying
at

the

who we know

is,
our

of

by asking

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discussion?

MILLER REPORTING COMPANY, INC.
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171131 E(Llc;-C&KC

a lot

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263

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MR. ERWIN:
,.:
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been

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longer-term

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DR. PAZDUR:
patient

representatives

22

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concept

23

developed?

24

come out

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early

findings

say

Other

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hype

we have

of

really
familiar

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in
that

in

general

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making
is
are

you

clear
a
extremely

will

probably

limitations.

and
to

seen
interim

of

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perhaps

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on this,

and now is

a lot

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also

speak

drugs

ASCO with
data

the

questions?

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early

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that

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at

out

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DR. NERENSTONE:

21

turns

access
expanded

people

I think

interested

essentially

if

late

media-

know

harmed.

and

to

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is

basis

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as I know

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publicized,

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point

about.

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I don't

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patients

as far

I don't

19

this

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community

important

curious

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proposal

are.

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during

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interesting

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benefiting

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fact,

cases.

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10

is

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for

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publications

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MILLER REPORTING COMPANY, INC.
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and

data,
Gerry,

that
of
how

I

264

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hope

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filter

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results

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meetings

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DR. KENNEALEY:

23

noted

you

we have

ongoing,

especially

exist.

just

a single

is
really

long-run

does

I will

this.

it

reported,

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is

activity

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trial

head.

companies

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pick

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nail

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a sense,

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DR. PAZDUR:

11

less

Merck's,

public

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hit

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viewed

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is

a drug,

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hand,

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DR. KENNEALEY:

5
6

view

of

have
reasonable

MILLER REPORTING COMPANY, INC.
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the

people

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to

who

better
bring

into

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1

the

public

domain

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You

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I think

all

on Phase

III

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clear

evidence

or

that

the

differences

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that

a body

a recommendation

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reached

makes

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differences.

information

until
been

Phase

cancer.

keep

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really

a number

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information

are

4

10

days

early

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is

that

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be stopped.

11

DR. NERENSTONE:

12

DR. WILLIAMS:

13

terminology

or

14

beneficence

and

15

some conflict

there,

16

patients

were

suggesting

17

business

of

begin

to

19

feels

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oecoming

21

naybe

not.

autonomy,

they
involved

there

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this

are

.totally
in

the

safety

DR. SUGARMAN:

22
23

where

one of

24

this

25

autonomy

the

situation,
and

conflicts
a conflict

to

and

do good

if

were

it

I used

talking

seemed

some of

that

into

know

you

maybe

with

Williams?

I don't

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deal

Dr.

the

autonomy

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safety

me I was hear ing

advocates

and

really

be in

business.

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informed

right

about

to

FDA should

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and

analysis

the

How does

the

patient

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FDA perhaps

and

saying

one

who

that

concern?
I think
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of

you
and
those

are

right

there
principles

by patients.

MILLER REPORTING COMPANY, INC.
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to

certainly
to

point
is,
respect

out
in

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ia

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they

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greater

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bit,

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it

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work;

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are

wouldn't

to

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throughout

and what

what

the

know
risks

these

risk

informed

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consent

MILLER REPORTING COMPANY, INC.
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by

the
as an

risks

goes ? Some people

more

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do you
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know

assessment
are

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person

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be autonomy

about

counseling

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enhancing

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information

provide

risk

obligation

of

about

as a clinician,

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pieces

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different.

solutions

as a sponsor
to

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as we say.

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16

claim

piece

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like

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might
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4

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7

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Dr.

Pellegrino

to

hurt

someone
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results

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That

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nyself,

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25

patient

wants

fail

to

is

one
health

to
to

your

to

the
say,

clinical
well,

and particularly

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demand
if

is

it

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of

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an IND

an impact

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failure
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person

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autonomous

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know

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in

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probable

professional

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are

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grave,

limited

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it

on as well.

to

wh i ch the

if

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limitations.

you

do it

support
in.

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who
desire

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MILLER REPORTING COMPANY, INC.
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if

they

wouldn't

to

realize

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DR. PELLEGRINO:

11

to

are

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cancer,

there

wants

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seeking

if

clinicians

something

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make sense,

10

benefit,

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would
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268

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and,

acts

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as a

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clinical

a right

to

micromanagement
damage

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as Jeremy

on me --

again

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started

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17

to

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to

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are

saying

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privilege

23

but

don't

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is

that

I think

between

They

it.

patient

of

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balance

the

the

member

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wants

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more

demand

make this

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recent

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abandon

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question

carefully.

decision
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they

studies

are

by myself;
to

have

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saying

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I want

me;

I need

help.

24

DR. NERENSTONE:

Mr.

25

MR. DIXON:

I want

Yes,

a last

really

word
show

information.
to

know

on it,
that

saying

me alone.

go back

MILLER REPORTING COMPANY, INC.
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when
I want

What
I want

what

to

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Dixon?
to

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ajh

269
1

information

2

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4

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5

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6

companies,

7

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very

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they

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government

to

requirements

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SEC to

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result

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reporting

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11

[Laughter]

12

DR. NERENSTONE:

13

DR. LIPPMAN:

14

iollowing

15

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16

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17

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18

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information

20

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22

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and what-not,

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yeally

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as though

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I think
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to

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positive

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MILLER REPORTING COMPANY, INC.
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a

research.

profile

still

is

congressional

sound,
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early,
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trials

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getting

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24

exemption

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25

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you

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versus

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MILLER REPORTING COMPANY, INC.
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Washington,
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(202) 546-6666

chance

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as a patient,

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MILLER REPORTING COMPANY, INC.
735 Bth Street,
S.E.

Washington,

D.C. 20003

(202) 546-6666

of

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groups
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DR. LINDEN:
controlled

drug.

on that.

DR. NERENSTONE:

5

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arm,
study

-arms

you
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I

272

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trial

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2

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versus

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sense

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endpoints.

13

control.

14

this

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Tetting

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we have

day

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hope

The only

16
17

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priority

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eligible,

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21

patient

advocate.&

22

50-50

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of

or
gett

DR.

NERENSTONE:

24

MR.

ERWIN:

25

Eylill

skip

that,

randomized

where

everyone
would

I bring

and

Mr.

the

of

the

knew

in

placebo
today,

what

this

up is

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seems

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is

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then

people,
I am not

see

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about
trials

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early

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trial.

even
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of

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just

patients

23

is

even

go on that

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industry,
is

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thing

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people

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ability

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risk.

it

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number
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Mr.

Dixon
second

Erwin?

made my first
point

about

MILLER REPORTING COMPANY, INC.
735 Bth Street,
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(202) 546-6666

at

one

sure

way if

on,

point
cross-over,

so I
I

a

273

ajh
1

think

that

2

addressed

3

pointed

4

will

5

standard

6

scientific

7

as to

this
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parallel

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DR. PELUSI:

11

to

12

hearing

13

that

14

--

15

Phase

II

16

great

effective,

17

the

18

information.

19

well

20

compassionate

21

these

22

be there

as well,

23

everything

should

24

that

25

studies,

quality

care,
over

we think
and at

other

review

is

So,
if

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good

becomes

use,
studies,

very

who really

Dr.

Pelusi?
the

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is

we want

access

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this

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past

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MILLER REPORTING COMPANY, INC.
735 8th Street,
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(202) 546-6666

is

drugs

we saw
a

some
when
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DR. NERENSTONE:

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ajh

274
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information

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12

must

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today
that

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15

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16

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17

Deing

18

ninority

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really

20

2egin

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hope
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Thank

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Cross-over

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MILLER REPORTING COMPANY, INC.
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(2021 54fi-6666

it

own arenas.

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therapy.

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DR. CARPENTER:

25

to

trials,

as this
this

to

is

information
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only

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cross-over

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populations.

is

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minority

23
of

at

show

we heard

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DR. NERENSTONE:

point

patients

has

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of

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me, what

22

24

is

clinical

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physicians

together

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information.

care

trials,
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cross-over
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ajh

275

1

early

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DR. NERENSTONE:

17

DR. SUGARMAN:

18

about

designs.

19

of

20

understanding

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21

unfortunately,

it

22

than

23

values

24

placebo

25

well

learning

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research

to

as alternative

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properly

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with

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ethics

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16

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be resolved

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because

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The world

MILLER REPORTING COMPANY, INC.
735 8th Street,
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Washington,
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(202) 546-6666

point

is

p

as

276

ajh
1

currently

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MILLER REPORTING COMPANY, INC.
735 8th Street,
S.E.
Washington,
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(202) 546-6666

to

need

One of

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there

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of
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277

ajh
1

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DR. NERENSTONE:

17

MR. DIXON:

18

[Laughter]

19

DR. NERENSTONE:

20

DR. LIPPMAN:
that

last

22

you

want

23

showed

24

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25

felt

point
to

pick

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uncertain,

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off

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potential

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and end-all.

Mr.

Mr.

Erwin

Yes,

a couple

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example

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of
of

Lippman?
I would

that

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made my point.

Dr.

and hope

examples

Dixon?

that

just
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examples

different
where

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uncontrolled

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like

be used.
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things

546-6666

I mean,

and

data

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know,
but

MILLER REPORTING COMPANY, INC.
735 8th Street,
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(202)

to

the
the

would
people

278

a jh
1

randomized

study

fulfilling

prophecy

when

we abandon
they

know,
example

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and

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bring

it

turn

out.

8

of

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DR. LINDEN:

14

point

15

progress.

16

advancement.

is

an area

that

DR. TAYLOR:

20

since

21

vulnerable

22

equipoise

23

your

24

position

25

we are

third

I think

it

dealing

a life

It

what

was the

there
and

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you

a good

if

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things

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to

get

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is

grave

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make sense

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with

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of

is

muddle,

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population
is

--

right,

markers

18

and

Sugarman's

things,

DR. NERENSTONE:

equipoise

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And Helsinki.

17

19

of

drugs

this

and how impoverished

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It

we develop

I think

Dr.

Yes,

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Linden?

and

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of

Dr.

randomized

DR. SUGARMAN:

13

So,

Into

10

that

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have

up as we move forward.

DR. LINDEN:

variable

we would

way that

DR. NERENSTONE:

12

done

is

normal

may not

to

been

are

he said
most

was about

different

things

population,
well,

medical

impossible

when

and get

that

and understanding

in

situation.

and

So,
the

MILLER REPORTING COMPANY, INC.
735 eth Street,
S.E.
Washington, D.C. 20003
(202) 546-6666

school

I

you

in

are

think

appropriate

in
it

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279

h
informed
it

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16

then,

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17

CHOP is

18

good

19

got

than

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I think
why people

willing
best

to

care

comments?

the

--

original

given

CHOP --

are

and

Dr.

we all

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So,

where,

when

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if

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follow

age

first

things

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think

to

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they

years

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example

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written

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coming

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You know,

definitive

standard.

are

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editorials

generation
the

ideas

where

work.

second

examples

other

examples

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course,

great

lymphoma

have

be inferior.

the

and not

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Any

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of

be the

of

another

drug

care

but

days,

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would

is

do it,

comment?

two

better

it

of

DR. LIPPMAN:

8

way to

brand-new

standard

may not

right

I think

DR. NERENSTONE:

6
7

It

consent.

and

shows

a lot
this

that

of

very

path,

we

burned.
I would

DR. NERENSTONE:

20
21

participants

22

this

23
24

everybody

25

and mark

committee,

DR. TEMPLETON-SOMERS:

I would

else

with

your

coming

in

March.

for

being

calendars

and

to

the

up again

for

like

patient
for

the

March

thank

all

the

and we will

like

our

thank

ambitious

meeting,

MILLER REPORTING COMPANY, INC.
735 Eth Street,
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Washington,
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(202) 546-6666

to

take

which

agenda,
is

on

280

ajh
1

t :he

13th

14th,

exactly

[Whereupon,

2
3

and

at

three
5:05

months

p.m.,

the

away.
proceedings

adjourned.]

4

MILLER REPORTING COMPANY, INC.
735 8th Street,
S.E.
Washington,
D.C. 20003
(202) 546-6666

were

281

CERTIFICATE

I, ALICE TOIGO, the Official Court Reporter

for Miller

Inc., hereby certify that I recorded the foregoing proceedings;
proceedings have been reduced to typewriting
that the foregoing transcript

Reporting Company,
that the

by me, or under my direction and

is a correct and accurate record of the proceedings

to the best of my knowledge, ability and belief.

ALICE

?cLuQO

Food and Drug Administration
Oncologic Drugs Advisory Committee

107:18

O-2 39:13;88:4,5,5;89.4
o-~~24:1;37:19;39:8,11,
19
0.5 19:13;68:1
002 47:17
00367:25
005 19:18;20:3,14;
21:18;22:4;26:23;27:13;
31:4;36:4;48:9;51:21;
56: 11; 58: 11; 62:2,9;
72:22;74:25;76:7,14,23;
77:3,9;80:13;81:23;86:5,
13,15,22;92:5;96:20
009 19:18;20:6,14;
21:19;22:4;26:24;27:13;
36:4;58:11;59:10,12;
72:22;74:20;76:7;77:9;
86:4,13,18,21

-

1 17:6; 19:14;29:14,17;
44:10;78:14;80:2;82:21;
84:21;86:25;91:20;
97:lO; 107:18
l-10 1 10:2
1-32 91:2,3
l-4087:19
1-5 138:G

I
II

I

150191:25
150031:10
15722.25:6
16 27:6,20;30:9;40:15;
11:13;42:23;83:15,16;
:54:21
16th82:9
17 28:15,16
17/9388:17
175 19:14
175069:21
17th 82:9
18 7:3;73:21;88:17;89:6;
135:22;203:24
I&year
203:23,25
18.1 32:lO
i80 32:9;81:15,16

1.5 14:14;26:21
1.6 79:9;97:20,21
10 24:10;25:2;26:15;
27:16;28:21,25;
30:6;
41:14;49:20;59:12,17;
75:24;76:1;82:12;88:8;
94:12
10,000239:17
lo-15 44:16;98:1,20;
101:5
10.1 32:2

18th 191:15
1949:16,23;90:18
1962 192:ll
1963 250:25
:970’s 14:4;71:17;
83:25
974 199:7,8
978 12:10
980 153:9
980’s 15:17
983 153:9
I 1987184:2
199 174:4;175:13
-1990 12: 15; 200:8

10/149 37:17
100 57:12;74:11;209:13,
25
100,000 3 1:ll
1000 53:11
101 190:20
10:15 70:7
11 29:9,9;31:9;137:23
11.8 27:8;30:10

1990's

11583:12
12 18:7;41:15;48:8;
49:8;
62:9;72:19;74:11;78:21;
79:22;81:3;83:17;84:20;
90:4;91:13,24;235:11
12,000 245:25
12.5 39:11
12.6 17:16;22:9
12:10 132:22
12A-307:7;136:1
13 39:20;49:8,21;59:12;

1G 71:18

207:lO

1992 19:10;59.9
1993 20:16;74:21

-

1994 208:8;209:3
1995 20:16;74:21;
209:ll
1996 21:3;24:7;79:12
1997 12:18; 20:16;72:19;
74:23;160:5;163:14;
169:19,23
1998 12.21;19:23;73:5;
74:16;208:16;234:17
_~_______

27.5 22:4;27:20
28 42:3,25;81:14;88:25;
125:l
28,200 160:23
28,300 160:22
28-4292:24

2

-I 28.1

2-16189.1

21:19

2t5 79:16
2/649:24
20 17:5;24:9;26:16;30:8;
44: 1 I; 45:20; 78124;
80:22; 108:22;110:3;
138:22;139:1;175:13;
2464
20,000 89: 12
200 57:12;91:11,12,14,
20,23,24;230:12,12;
242~22
200,000

245:24

200Imicroliter
93:13
2000 53:11;73:13,21;
74:17, 18;80:1;138:6,25;
148.10;160:22;173:8;
175:12; 176:11;177:5;
204.10;234:17
208(b)(3 7:3;135:22
21 89:14;92:20
211 52:15;59:10,13;
66:6;73:5,17;74:15;75:8,
11, 18,20;76:19,25;
77:l 1,23; 79:21; 80:23;
84:21;87:13;90:8,19;
92:12;93:5,10
22 18:4;41:11, 13;82:4;
85:2;99:18
23 79:7,23;89:24
23f31 29:15
23/5591:21
23rd73:12,13
2474:22;108:4
240 19:13;76:9
25 56:18;60:10;62:13;
68: 15; 92:20; 93:7; 209: 13
25,000 40:13
25-30 68:18
25.9 22:3
250 ‘40:12
25th 73:6
26 31:9;74:17;79:20;
176:ll
2781:15;84:10;91:24;
93:12; 94:24

-.

Min-U-Script@

40-4479:x9

29 84:10,13;98:15

2CDA

2-165 89:14
2-6 38:10;69:12
P-month 89:21
2.5 51:21;67:23

4.740:16;80:4
40 128:12;148:20

28/9399:13
29,000
29/l%

19,21,23,25,25;
40:24;
41:12;47:16;48:16,21;
56:21;74:9;76:19;78:21,
22;80:3;82:
12;87:13, 16,
19,21,23; 88:10, 11; 89:4;
91:23; 93:7,13; 95:3,7,7;
97:ll;
108:5; 262:21
4-12 25:5

28.2 33:24
28.962:5

2 25:2; 29:5,10, 10; 35:12 I;
36:20;37:7;39:3;59:16;
76:21,23;77:2;78:8,13;
79:5;80:12;86:24;87:1;
90:4;91:21;92:11;93:7

149 20:11;30:17;31:20;
92:9
14th 2,43:21;280:1
15 29:7,9;31:20;45:19;
74:18;85:1;92:17;99:9,
21;108:22;162:4;204:11
15-20 t8:5
15-30 123:19
15.4 21:25;34:6
is.9 8O:ll
-

1

1999 12:21;73:6,12;
160:13; 163:9; 174:19;
175:23
19th 191:1,15
1:10 132:23

; 90:2;91:25;92:17;108:3;
109:6
: 13.435:7
133 16:23;41:11;98:14
13th 28O:l
14 51:24;81:18;107:18;
114:8; 121:14; 138:15;
139:6,8,16
1400 17:l
147 17:25

0
0 18:4;29:15,17;

Hearing Volume 2
December 142000

40066:12;74:12

163:9
99:18

400-900

86:13

4000197:14

57:9

41 85:8
4291:22

3
3 14:14;17:7;19:14,17,
19,24;22:20;25:1,3,3;
30:20;31:24,24;33:5,25;
35:13;37:21;48:10;
59:16;67:17,24;68:7,8;
74:3;75:22;76:13,20;
78:11,13,24;81:7;82:18,
20;86:8,19,21;87:13,16;
38:9,11; 89:4; 91:2,3,21;
?3:5,19;95:9,15;97:2,
10;101:7;105:6;
llO:l;
!62:21
S-4 51:4;80:15;108:3
).433:18;89:7
b.8 21:23
1.9 21:23
b/4 39:7;40:6; 54:17;
15:6;87:18, 18,22;88:15,
7,19,19,21,25;89:9,9,
3;95:6
IO 19:17,19,24;22:20;
!5:3;30:20;31:21;32:3,9;
'0:23;48:10;54:18;
19:17;66:19;67:17;68:6;
‘4:4;76:1,4,
13;81:1;
;3:15;84:25;85:2;91:18;
'3:19;95:11;97:2;99:13,
8;137:23;222:7
10-100 182:l
1310.2 9716
100 235:23;240:22
si 28:14,18;79:6,20;
'9:25;90:7
82 20:5;80:4;86:14
3329:9;42:20,25;62:13;
79:6;92:10;99:8
33.3 21:20;26:13;30:5
3481:2

45 32:18
46 31:13;39:11
47 84:13;87:17;108:3
4989122
49/93 88:5
4:05 243:5
4th 190:25

5
5 19:14; 28:20;32:17;
35:11;48:19;50:16;
68:11, 12;80:13,13;
87:14;88:7,10;93:6;
94:12;95:14;
139:17
5-10 94:12
5-FU 161:8
50 15:13;17:6;21:9,14;
28:21,24;75:5;84:25;
92:25;93:3;138:23;148:8
50's 145.11
50-50 144:24;270:21;
272:22
500 31:14;36:25;52:6;
57:ll; 94:25; 258:15
5000247:12
52 89:7
5681:5
58 13:10;31:9
58.762:12
l,.,
59 41:12;78:18;
137:18
5:05 280:2

6

36 69:21
37.56217
38 26:2;85:8;90:3,7;
93:7

4
4 31:24,25;33:5,25;
I i36:21;37:7;39:9,16,

43 79:7;85:17;
138:15;
139:2
4487:16,24;88:10

17,

6 23:15;36:21;37:8;
48:19;49:22;61:15;
74:21;78:13,25;80:13;
81:11;82.17;86:3,3;
90:24;91:24;97:23;
139:13
S-month 35:17;37:8,
57:lO
;.4 29:10

11;

Hearing Volume 2
December lb,2000

I
I

6.737:17
6.979:10
“s 142:17; 192:l;
&19

9
9 17:16;22:8;40:25;
44:24;49:20;56:12;
139:lO
9-12.6 27:3

6QO 36:25;57:11
61 26:2;31:10;85:14
62 84:15

90 15:5;60:8;108:2
900 74:12

63 59:23;78:19
65/9388:18

91st 138:6
9280:2

6630:23
66-8092:21

93 28:14;59:9;74:16;
78:9

67 108:6
6893:9

95 22:5;27:7,12,21;80:3
98 40:22;91:19;124:10

7

A

7 62:8;76:2,14;77:13;
78:7;80:23,25;
81:1,5;
92:12
7-53 81:4
7.1 21:24
7.5 47:15,22
7116 79117
7t31 79:23
7045:12;88:18
70's 192:l
700 208:23;210:4

1,000 46: 18
72 176:ll

abandon
268:23;278:3
ability 50:24;107:24;
167:19,192:4;194:12;
203:6; 261:18; 272:ll;
275:4
able 50:9; 755; 102:15;
122:19,137:23;
144:22;
156:11, 157:23; 165:17;
168:12;173:19;176:3;
1~6~9, 15;221:21;243:16;
246:14; 261:19
abnormal
38:25

47:6

7777:24
79 98:13

8
8 29:16;39:18;86:18;
87:10,20;88:20;93:4;
97:23
8.7 26:22
8118 79:18
8/20 29:14
S/30 91:23
8/9 56:13
80 58:16,17;67:24;
68:16;76:9;97:6
80's 200:6
81 153:9
82 77:11
8L?83:13
16 91:19
vu 31:1;78:6
87 84:ll
88 78:lO; 84:23
88/9388:4
89 40:23;84:23

(2)

! 24:8;26:17;44:19;45:1;
1 49:lO; 124:7,12; 128:l;
1 168:5;258:24;262:4
, achieved
2l:lO
acid 58:19
acknowledge
71:4;72:5
acknowledged
118: 13;
126:16; 127:9
acquiesced
210:13
acquired
103:14,16
ACR269:16
across 27:15,19;47:14,
22; 51:19;68:3;91:1;
176:6;249:14;252:3
Act 153:8,19; 154:11;
163:14; 197:25; 199:7,12;
251:l; 268:1
action 12:2; 70:24;
160:12; 161:25; 188:4,7,
18; 208:24; 255:20
activation
71:1
active 23:23;120:19;
125:2;126:7;127:2;
157:23;162:6;163:2;
174:8;176:24;186:18;
234:15;255:12;269:17;
270:6
actively
255:25
activism
200:19; 208:18
i iactivist
157:14; 207:16

!
i iactivists
I :208:8,9,

38:2,4
39:lo

; 254:11, 15;255:11,24;
I 257:5,7,12,21;258:21;
1
~ 259:11, 14,18,20,23;
260:2,2,5,17;261:16,17;
absent 71:14
262:6;263:4,6;271:18;
absolute
56: 14; 93: 17
273:10,12,19
absolutely
9:11,12;
accessed
214:23
51:3;64:25;239:3;279:13
accompanied
I 19:18
absolutized
267:11, 17
accomplish
179: 17;
absorbing
47: 12
203:7
abstention
107:17,18;
accomplished
212:11;
114:7,8
215:2
Abstentions
107:16;
accordance
7:3; 135:22
114:6; 121:12
according
21:3; 23:12;
abstract
264: 13; 269:22;
24:7;55:24;138:11;
27O:lO
203:21
abstracts
264: 11,24
account
1743
abuse 204:4
accountability
230: 15
academic
216:19
accountable
228:12
accede 146: 11
accrual
73117; 123:9,16;
accelerate
243:24
124:19; 168:24;231:1
accelerated
I 04:5;
accrue
130:24
113:20, 114:11,12, 14;
accrued
274:17
115:4,6;116:14,17;
accumulate
97:4
117:17,19,22;118:4,8,9,
accumulated
14:22;
25; 119:17; 120:8; 121:6,
17:ll
14, 17; 123:2,6; 126:3, 10,
accurate
100:2; 188:s;
12; 127:lO; 128:4; 130:5,
266:18
8,23,23
acetaminophen
25~10;
accept 123:5, 10; 198:ZO;
76:25;93:15
279:4
achieve
15:22; 23:14;
I acceptability
122:6

75 24:11;47:15,22;90:2

6.7 - advances

acceptable
23:3;108:14;
110:15; 113:8,10,25;
126:ll;
127:22; 129:ll;
145:19: 181:20;186:19;
248:6
acceptance
253:22
accepted
126: 18; 127:9;
131:24; 279:13
access
117:5,7; 143:3;
147:ll; 148:12,15; 153:7;
154:18,23; 155:1,12,16,
18; 156:8; 157:5,9;
158:24; 161:14; 162:9,21;
163:4,11,12,23;
164:15;
166:15; 167:7,11, 12, 14,
21,25; 168:6,7,11,18,
23;169:2, 12;178:3;
183.18,19,23,25;
1846,
10,14; 185:16; 195:24;
200:13,15,24;
204~22;
205:15,17,21;
206:2;
207:18,20; 208:1,5, II,
19,22; 209:9,11,20;
210:2,5,7,
14,17,19,22,
24; 21 1:lO; 212:16;
213:10, 18,23; 214:2;
216:17,21;217:12,
15,16,
’ 18; 219:22; 220:4; 222:24;
223:3, 15; 230:17; 231:11,
14;233:15,24;235:15,21,
~ 22;236:2,8,12;237:4,5,
6,8,19;238:21;
239:8,22;
/ 241:6;242:8,22;243:24;
I 244:23;245:19;246:22;

above 53: 11; 59:23;
210:3; 213:25
absence
65:24: 108:9

73-8892:23
750,000

&iCR234:24

abnormalities
abnormality

rt)00235:7

Food and Drug Administration
Oncologic Drugs Advisory Committee

Min-U-Script@

/

207:10,14;
17,19,21,25;
209:4, 10,19; 210:7, 18;
211:4;213:16
,activities 16:12; 162:22,
24;223:17;238:9
iactivity 12:7; 15:12; 44:6;
i2:18; 68:7; 110:5;
123:22;124:25;129:8;
138:18,19;1~49:5;182:9;
187:10,21;222:13;
234:18;235:1,25;264:13
acts 252113; 268: 14
actual 53:23; 121:5;
139:1;151:6
actually
12:13; 14:lO;
23:5;26:16;38:13;47:15,
16;50:20;58:20;63:7;
64: 10; 67: 18; 68: 15;
73:17;82:19;88:12;
94:19;97:8;98:9;103:16;
105:23;109:21,22;114:9;
116:23; 117:15; 120:9;
124:3;127:15;130:19;
138:21;150:20;180:20;
182:9;208:3;221:13;
228:18;237:20;257:4;
264:12;269:16;270:1,8,
IO;27612
ACTUP 200:16; 207:14;
208:24
acute 32:25; 33: 14;
41:23; 76:5; 1 lo:22
adage 195:20
ADCC 71:1
add 53:s; 64:20; 111:4;
12O:ll; 151:14;203:8;

221:9; 259122
added

223:25

adding
125:18
addition
19:2;20:25;
25:12,15,25;26:9;27:15,
25;29:13;30:10;31:7,11,
21;34:15,22;
50:21;
56:16; 106:23; 144:6;
169:7; 211:14
additional
20:17; 22: 1;
32:10;34:15;41:5;77:13;
113:23; 121:21; 122:2;
125:21; 139:15; 170:21;
212:19; 225:lO; 233:25;
255:14
Additionally
16:13;
213:15
address
7: 15,25; 43: 13;
59:8;123:1;137:1,150:3;
152:25;157:14;165:1;
166:19;171:13;206:8;
217:ll; 221:21; 222:23;
243:9,16;258:9
addressed
122: 1 I ;
140:2;254:5;273:2
addresses
6:20; 106:2;
126:3; 135:14; 169:lO
addressing
147:10;
178:12; 255:8
adds 104:3; 240: 11
adenosine
57:7
sdequacy
187:21
adequate
116: 19;
118:16,23; 125:lO;
126:18; 157:6; 168:19;
218:lO; 219:12; 229:12;
239:9
adherence
48:22
adjectives
205:5
adjourned
28013
administer
144: 15
administered
14:23;
?4:20;25:1,2,3;47:18;
57:24
administering
14/1:6;
155:lO; 168:22
administers
155:4;
180:21
administration
29: 12;
75:20;135:1;136:13;
144:19;163:13
administrative
72:7
admit 247:25
edmitted
140:20
sdopted
167:13; 184:2
adult 174:10
advance
148:6; 213:25;
250:17; 252:14
advanced
19:6; 21:l;
23:7;25:24;37:25;41:1;
13:6;45:13;101:9,18;
138:12; 139:12; 151:21;
207:19; 230:21; 242:lO
advancement
278:16
advances
16:s; 167~18;
269:17

Food and Drug Administration
Oncologic Drugs Advisory Committee
advancing
advent
_

147:s; 198:21
200:6

adverse
14:lG; 31:19,22,
24; 32:16,25,25;
33:1,3,
15, 19; 37:15, 16,lB; 38:2;
41:23;45:14;46:7;47:1;
54:17; 59:l; 67:l; 75:2;
78:24; 79:2; 81:2, 10; 82:4,
19,25,25; 83:2,2, 10, 1 I,
13, 13,23,25;84:3,7;
92:20,22,22,23;
lOO:ll,
13,17; 107:22; 108:5,7;
219:17; 220:20; 227:11,
25; 248:22; 256:13
advertisement

46:4

against
11:24; 25:lG;
36:12;42:16;65:8;70:23;
115:20,21; 121:15;
130:22,23; 145:23;
17O:lB; 173:25; lW4,B;
209:16; 248:13,19; 275.;
age 13:10,13,15,17;
45:13; 59:3,21,25;77:19;
162:12; 176:ll
agency 6:24; 11:17; 13:5;
15:16; 23:8,72:20;73:1;
115:ll; 117:20; 118:s;
135:lB; 155:25; 156:24;
164:9, 17; 213:2; 247:21;
266~20; 269:2

advertising
188:5, 11,
16, 17; 199:21

agency’s
7:7; 136: 1;
154:22; 156:22

advice 164.18; 179:14;
18O:G; 187:23; 238:1
advised
73:s; 14l:lB;
157:20; 176:4; 247:17

agenda 6:23;7:10; 1l:l;
135:17; 136:20;214:1;
279~24
agendas
162:s

advisor

agent lS:lO, 15; 17:22;
23:12; 25:15; 26:5; 34:20,
23; 58:9; 98:2; 1lO:B;
117:12; 119:9; 120:17;
125:12,13; 148:24;
149:ll; 155:ll;
168:19,
Z2; 204:s; 2.46:3,6;
251:15;256:6,9

advisory
203:lS

207: 13
126:21; 197:ll;

advocacy
147124;
154:24; 160:13; 162~22;
165:lS; 167:6;233:19;
24O:lG; 242:14,23; 243:8,
17, 23; 245~3; 248:23;
258:19; 262:17; 263:14
advocate
5: 10; 11 I :9;
161:21; 162:16,25; 163:~
180:2; 255:15; 27418
advocates
161:20;
162:3; 167:6; 169:ll;
211:13;217:1;240:3;
245~21; 265:15; 272:21
aeruginosa
34:9
Aesculapius
191:s
Affairs
10:20; 135:s;
136:15;216:1;225:17
affected
98122; 169:9,12;
176:l
affects 98:23; 157’: 18
afford 144:7,11
afraid 176:21
afternoon
132:21; 133:1,
137:6; 147:s; 152:17;
160:4; 162:15; 165:3,5;
167:4; 172:24; 207:2/i;
208:3; 211122; 232:9;
2456; 258:12; 262:10
afternoon’s
161:24
Again 25:20; 26:25;
32:ll; 34:l; 55:12; 56:22;
76:15; 82: 13; 89:2,6;
105:17; 111:21,24;
114:ll; 119:12;124:9,25;
131:12,23; 144:8, 16;
159:14; 164:22; 172:21;
185:23; 202:3; 216:20;
219:3; 220:8, 12; 224:10,
18; 225:lB; 227:12;
229:24; 230:s; 238:15;
239110; 241:3,4, II, 14,
18; 242:19; 249:l; 268:lZ;
273:12; 274:16; 279~22

2agent’s 168:25
: ; agents 11:13; 12:6;
I15:19; 43:17; 44:17; 57:4;

‘2: 15; 102:8,9; 112:4;
,25:8,9, 10,15,16;
I 47:13; 148:9, 14,22,24;
I 49:4, 15, 17,19; 161:19;
166:22; 200:3; 206:3;
’ i !44: 17; 262: 19
alges 13:16; 195:19
2tgo 8:ll;

lO:lO, 11;

/ 104:17; 137:18,20,21;
1 57:19; 208:16; 215:23;
2‘16:12; 234:9, 17; 247:G;
1 2‘58: 17; 279: 12
I a‘gonizingly
259:G
la !gree 46:21; 63:25; 64:4,
7,13; 65.7; 91 12; 96:24;
I; iO2:lB; 106:9; 113:7;
118:20; 164:ll; 172:15;
!11:17; 224:21; 272:5, 17
1; igreed 22118; 24:G;
‘8: 16; 79:4; 140:23;
73:7; 203:20; 209:6,12,
2!l; 210:13; 218:lG:
2!J8:25

agreement
65:4; 96: 10;
!09:22; 211:20
lgreements
72:12
agrees 166: 11
thead 233:ll; 235:22;
:.i1:6; 271:3
lid 151:4
MrS 111: 1; 200:6,7,9;
07:16; 208:6, 19,21;
10:23; 226:22; 235:18;
71:13
ir 20614

--

Hearing Volume 2
December 14, 2000
al 18:3; 35:20; 79:12

altruism

Alabama
alarmed

always
16:3,5; 17:4;
59:11;64:5; 111:s;
177:lG; 186:s; 189:3,4;
218:16; 251:17; 268:l;
271:s; 279:3

alarming

5:14; 134:17
203: 18
264:22

ALBAIN
5:11,11;64:19;
65:9,10; 95:20,21; 97:16
112:12,13; 132:8,10;
134:18,18
Albain’s
96:s
alemtuzumab
alert

70:17

227:11,21

Alexander

192:lo

algorithm
alike

129:ll

211:16

alkylating
11:13; 15:19;
23: 12; 43:17; 44:17;
72: 15; 102:6,8,9; 112:4;
125:8,9, 10,12, 13,15,16
afkylator
75:14; 78:17;
84:7; 88:13; 89:3; 94:9;
127:20; 132:l
alkylators
59:20

83:21;88:1,7;

ALLCASE
242:24
allergic 77:8, 14
allocate
104:lG

192:8, 16; 196:i;

allocated
Iflocation

260:3; 261:21
166:14

/ LIllow 83:2; 129:22; 136:5;
’ 157 1; 158:17; 168:s;
171:25; 179:15; 181:12;
182.17; 184:7; 214:23;
; 232:23; 236:14, 15; 243:3
allowed
23:17; 52:15;
76:20; 209123; 228:9, 10;
239:7; 259:24; 260:2,5
allowing
10:23; 162:lB;
24814
dbws
153:11;237:5,9,
11,13
allusion
254:6
allusions
220: 12
almost 118:2; 170:4;
218: 16; 224:13; 272:s;
278:23
alone 15O:lS; 192:22;
I 194:1, 11; 268:20
/ along
llZ~lO.lAl;.lr
‘J.‘,,
A I”_&
3
I alpha 2t 16:6
i alphabe !tically 106: 1
; alternate
120:23
1 alternative
23: 1; 150~2;
163:21,24; 165:15;
204: 16; 275125
alternatives
l64:7;
205:3,5, 13; 216:18
although
35:10; 59:l;
60:9; 61:23; 6622; 95: 19;
106:3,23; 110:23; 114:22;
IIS:?; 119:17; 120:14,18;
121:1, 140:24; 142:24;
147:19; 167:14; 203:20;
216:5,218:16;
225:19;
252:25; 269:21

Min-U-Scrimti

252:14

Alzheimer

anecdotal

226:22

amazing

angered

138:lO

ambitious

50:6; 52:5;

ameliorated

53:G

amendment

79:13

iamendments

I 5~5

Angiogenesis
147:7,9,
25; 148:9; 149:15

279:24

ameliorate
36: I

46: 15; 263:3

anemia
14:ll; 16:15;
28:s; 29: 3; 57: 18,20;
86:17; 87:16,18,19;
88:2,
15; 95:6
angels
129: 18

animal

181:12

animals
152:2; 181:15;
222:l; 232:14
Ann 149:24; 152:lo;
193:l

197:25;

150:25

Annie

1American

138:7; 1436;
1L60:20; 182:23; 183:l;
II93:24
IAmericans 160:22;
;!45:24,25; 248:25; 262:7

announced
204:7

zamong 24~4; 54:19; 62:9;
I 27122; 181:17; 195:25;
2!08:20
1\mongst 105:ll
almount 94:s; 119:13;

annual 138:6; 220119;
227:24; 228:2

1 20: 15; 200:4; 226:10;
2 29:7; 23O:ll; 238:ll;
2 40:14
a mounts

229120
a mphotericin
108:22
a mple 149:s
a mply 235:17
Ainaissie
35:20; 55:14
a nafgeSiCS 85: 14
a nalog 69:22;78:12
ai nalogs 57:13,16
al nalyses 62:22
A nalysis
6: 15; 24: 15;
2’ 7124; 28:2,13; 29:2,19,
2.1; 34:24; 36:18,19; 38:3;
413:14; 55:15; 59:21,25,
215; 60:7; 72:3; 74:3, 18;
7: >:25; 87:7; 88:21; 89:ll;
1OO:lB;
9,4:14;96:15,19;
2 49:17,25; 263:24;
2 65:20
a nalyStS 255:4
a nalyZe 83: 19; 85:20;
9 5:17
a nalyzed 45:6
a nalyzing
72:G
a naphylactic
60:24
a naphylactoid
Go:23
a naplasia

93:4

ai napfaStiC 230:24
A .NC 38:6,14,16;
40:4,5;
5 1:11;53:9,13;101:10
A NCs 31:10

d/or 24:4; 90:20;
;: 14:25
A nders 56: 17
A ndersen
53:15; 5513;
2( )4:6, 10
AI nderson
6:1 I

149:24; 1529
199:22;

announcement
6:19;
135:13
announces
197:4

,
i

answered
127:4; 161:24
anthracycline
14:s

snthracyclines
44:2,5,6
anti-cancer
166~22,
!I
!51:11
’ i Witi-CD20 129:5
ji mti-fungal
111:4;
I, 1I_
!22:12
i

i Inti-melanoma
ernti-neoplastic

138: 12
221: 14
mti-PCP 77: 12, 15
anti-rodent
71:21
lnti-tumor
187:20
lntiangiogenesis.
48:21

lntiangiogenic
147:11,
5,22; 148:9,14,24;
49:3,6,7, lo
ntibodies
12:11;70:14;
1:17, 18, 20, 24;74:13;
10:19; 214:ll; 229:4
mtibody
11:19,23; 1213,
6; 57:3; 63:4,18; 70:16,
7,19,21,22,23;71:16,
!1,22,24;81:12;
129:6;
30:20,22; 210:4
57:12; 25521
t ainticipate
250:17
alnticipation
85:lB
aintiemetics

aintigen 11:24; 65:12;
! 7‘0:24; 7l:G
amtigen-bearing
8i:4
aantihistamine
8;5:17

77:s;

antihistamines

85: 15;

; 3:16
152:7
a ntioxidants
a ntitUmOr 138:18, 18;
1 49:5
175:15
1 a nxious
a nymore 8:23,24; 228:s
- ai POfOgieS 190:21
-

t-2-l qA,,,-d:--

---I

-

Hearing Volume 2
December lb,2000
apoptosis
apparent
-tparently
,JpealS

12:4; 71: 1

24; 143116; 150:9, 17;
151:9; 171:4,10,12;
172:ll; 182:7; 184:9,12,
16; 185:25; 188:7; 211:19,
21; 212:lO; 216:22;
217:12; 2258; 2284;
23l:lO; 24217; 251:2;
270: 17
approvals
114:18,24;
238:lO
approve
111 9; 130:s;
154:15;253:7;254:14
approved
11:15; 15:10,
15,16,20; 16:23; 17: 14;
18:13; 19:2; 22:25; 31:5;
41:9;42.18;43:10;62:16;
102:24; 114:lS; 116:6;
129:7; 145:24; 148:2;
_
151:7; 161:6,7; 17312;
182:22; 184:ll; 208:15;
213:ll; 229:17; 234:2;
242:18; 246:2; 254:25
approving
130: 12;
151:20
approximately
17:5,6;
35:ll; 39:20; 44:22;
48:16, 19;57:11;82:12;
245:24
April 138:6,25
apropos
55:5
apt 252:23
arbitrary
211:22,23

58:3
48:5; 176:13

131:1

appear 49:6; 50: 19,23;
54:10,21; 57:13; 100:9;
106:ll; 141:24; 148:25;
203:19
appearance
6:22;
135:16;210:12
appeared
58: 14; 68: 16;
77:14;97:3; 141:20;
234125
appears
36:s; 50:7; 82:6;
85: 18; 86:23; 112:8;
141:22; 273:15
appendectomy
267:4
applaud
153:2; 154:24;
157:4
Appleseed
149:24;
152:lO
applicability
135:23
application
162:12;
180:11;211:15;244:20;
248:14
applications
71:19;
148:13; 149:15; 179:8;
181:1;213:1,3,4,5,6
applied
118: 11
apply 167:1/i; 22311
aopointment
174: 18
Treciate
152:25;
_ :8:23; 256:16; 258:9
appreciated
22019
appreciative
169:17
approach
17:24; 117:21;
119:23; 127:7,9; 13O:l;
180:7; 19O:ll; 193:3,15;
196:18, 18;205:12;
208:24;211:13
approached
9:16; 72:20;
239:18
approaches
18:14,17;
63:21; 193:/i, 19; 208:18;
212:12; 214:lO; 233:25;
276:13
approaching
.48:18;
190:4
appropriate
89: 10;
106:ll; 118:lO; 119:14;
121:3; 155:16; 168:6;
169:6; 172:5; 179: 15;
180:25; 183:6; 187:19;
205:18; 217:10,11,23;
226:13;232:10;
253:10,
18; 276125; 278~25
appropriately
114:16;
205:19
approval
11:17; 16:22;
~1:10;73:3,7,8;38:10;
‘:5; 113:19,20; 114:11,
13,14,15, 17; 115:5,
6,3, 10,16; 116:14, 17;
117:17,20,22;
118:4,8,9;
119:l. 17; 121:7, 14, 17;
123:&b; 126:4, 10,12;
127:lO; 128:4; 130:5,23,

apoptosis

- bash

Food and Drug Administration
Oncologic Drugs Advisory Committee

area 119:24; 142:M;
146:25, 154:lO; 165:ll;
204:24,219:14;
278:15
areas 21:9; 117:21;
1186; 190:9,9, 13
arena 207:9; 221:13;
271:13
arenas 274: 12
argue 120:12; 194:15;
260:9
argued
193:2
argument
16:4; 200.13;
21816; 252:19; 260:12;
266:11, 12
arm 92:2; 99:7; 102: 16,
17,19; 107:20; 112:2;
117:lO; 119:2,123:11;
246:lS; 256:5; 271:14, 16,
20,21,22,23
armamentarium
106:23;
111:12; 119:lO
arms 117:13; 208:5;
26518; 271125
around
22:6; 2712;
44:16,2$48:19;87:20;
133:6; 147:2; 191:21;
192:6,9, 13; 195:19;
215:22; 230:18; 24O:lO;
256:21,21; 271:7
arrive 225:15
arrived
68:13
223:19
/ arrows
1 arthritis
103:19,22
1 article 79:12; 139:5;
I 150:22

(4)

articles
artifact
asbestos

13:23; 138:5
151:17

attention
18:19; 43:19;
94:2; 105:21; 142:24;
1528; 160:17; 168:4;
197:lS; 206:9
attitude
159:1, I

174:6,10

ASCO 234:23; 263:24;
264:lS; 269:10, 14,16;
270: 1
aside 197: 10
asparaginase
aspect
272:lO
aspects

attorneys
163:6
attractive
127:15; 231:5
271:lO; 272:3, 10

23318

attractiveness
attributable

33:20; 187:4;

attribute
attributed

222:25; 238:19

222:13
I aspergillosis
Aspergillus
34:12;
I 35: 14; 54:2
; iassess 20:19; 31:12;
52:18;63:10; 107:24;
164:7; 25219; 272:9
assessed
21: 17; 26:6;
’ (52:11; 68:.4,9; 78:22;
‘ >7:24; 223: 11
i tSSeSSing
2492
i assessment
21:2; 26:ll
36:16; 60:5; 83:3; 97:23;
148: 18; 266:23
aSSign 277: 13
assigned
99:3
assist 163:lo
assistance
72:5; 248:l
Assistant
174:23
assisted
207: 15
assisting
152:21
associate
216:12
associated
19:3; 21:21;
24:1,23;29:5;30:10,
11;
34:21; 37:13;42:22;43:2;
58:2;68:15, 17;76:10;
82:15;85:22;
171:8;
207: 14
Association
5:8; 46:13;
100:5; 1356; 136112:
1 138:7; 157:22; 245:9; 16,
/ 20; 247:7; 249: 1
I assume 4710; 54:3;
105:7; 279: 10
assumes
180:14
assurance
250:22
assure 161:20
assuring
180:15
AstraZeneca
135:11;
136:17; 233:4; 236:7;
239:17
AstraZeneca’s
155:10
aStrOCytOma
230:24
attached
i39:5
Attaches
138:4
attack 147:16
attacking
50:20
attempt 83.1; 139:25
attempted
104:13;
208:25
attempting
140:6
attempts
505
attend 151:lG
I attended
I 5 1: 1

Min-U-Scrip68

16:9
58: I

audience
215:13
audit 73: 15; 75:4
1audited 74:25
1hgust
IO:1 1;73:21;
‘!09:11; 241:9
: author 122:16
i authority
115: I 1
; ruthorizing
1839
i ruto 193:22
rutoimmune
57:18,20;
1;6:5,14, 19; 86:8,9,14,
17; 93:5
alutofogous
276:9
a lUtOt?IatiCally

a lutonomous
2 68:6,8

120:25
267:21;

a UtOnOmy
193:20,22;
1 94:lO; 196:4; 197:21;
1 99:24; 214:19; 265:14,
1 7,25; 266:9,16,17;
2167:10,12,13,22;
268:4,
9.,16,19
atvail 176:6
1 8’ vailability
116:22;
1t53124; 164:7; 192:3;
200:2; 246:lO; 261:23
available
17:18; 42:19;
I :51:22; 52:16;69:23;
,91:22; 116:20,22; 117:3;
I 119:13; 123:8,14; 144:15;
148:2,8; 153:15; 155:3;
159:17; 165:20,23; 166:2,
10; 167:23; 169:6; 170:15,
/ ,
24; 171:l; 172:15; 177:21;
L82:23; 183:3,6; 187:11,
22; 205:6; 209117; 211:13;
!17:23; 231:20; 233:9;
!34:2; 244:18,22,25;
!47:9,16,24;
2489;
!54:13; 255:17;258:24;
j;$
10,19; 261:1,22;
.
\ventis
155:9
rverage 14:13; 18:4;
39:s
rverse 266:24
rvoid 205:14; 232~22;
!73:7
Iware 711; 65:19; 129:5;
36:22; 166:13; 186:7;
89:l; 190:24; 203:18,22;
28:20

160.16;

away 9:s; 175:23; 176:ll;
228:lO; 237:16; 280:1
awful

123:9

awkward

212:i

B

219:13
29: 11

atypical
78:8; 217:4
AUC 47:23
ii

awareness
242:6

B 11:25; 276:24
B-cells

36:13; 71:8

B-symptoms
18; 28:6,16;

IB.c
Ibaby

16:9; 24:4,
80:18

190:25
193:1

I Isack 18:20; 39:15; 51:10;
j3:ll; 65:lO; 69:7; 70:7;
71:17;72:11;76:4;82:24;
%7:12,14;91:16;94:20;
104:25; 124:25; 127:12,
1.4; 132:20; 142.17,20;
1.43:24; 144:lS; 145:2,5;
1.46:5; 156:25; 210:20;
2!24:18; 225:9; 228:5,13;
2!40:19; 241:18; 243:4;
2!58:3; 265:3; 268:25
104:1,3;
brackground
142:17; 143:22; 178:25;
2 16:l I; 238:4
backing
236:17
backward
119:3
bacteremia
34:4
bacterial
34:3,8
bad 10:7; 146:8; 169:16;
195:2,4; 269:6
bag 175121
balance
156:18; 164:19;
196:12; 204:21; 268:6
balanced
275:lO
Balderdash
248: 14
Baltimore
6:3
IBarbara 5:s; 7:4; 69:17
Ibarred 246:16
Ibarriers
25o:l
I3ase 167:20; 259:22
I I3ased 6:22; 12:2; 19: 16,
1 :~0;22:10;41:10;66:20;
(;7:11;68:7;72:21;74:1;
78:20;80:1;83:1
1;98:11;
---1109:19; 114:17,18;
1 1115:16; 116:1,5; 119:15;
’ 1124:23; 130:7; 135:16;
1:41:4; 167:25; 172:5;
1.93:24; 201:15; 204:lO;
2!07:14, 15; 253:12;
!58:2.3; 261122
raseline
20:20; 21: 15;
!5:19; 28:16;31:7; 36:16,
!O, 21,21; 37:9, 10, 23;
18:14,16,22; 39:13,18;
‘0:l; 53:10, 11; 86:25;
;7:22; 89:22,24,25;
90:1,
#,4, 5;31:11 14.94:25.
15:1;97:10 ’


rash 224:12

Food and Drug Administration
Oncologic Drugs Advisory Committee
--

_
.

basic 67:21; 163:17;
l99:9
Basically
14:5; 6320,
130:7; 185:19; 187:20;
199:23; 200:7
basis 16:23; 18: 15;
23:22;50:19;67:19;
73:23;118:9;142:21;
143:13;144:21;166:4;
210:12;227:18,23;260:7;
263:16;275:2,5,6
battled 160:7
Baylor

6:6; 133:22

BCLL

78:7,9

be-all

277: 1

BEAM

69125

bear

193:4,20;

bears

250:21

259:s

beating
l/i2:25; 146:15
became 12:18;20.17;
158:25;159:5
become
l4:17; 15:17;
16:19; 61:2; 110:21;
159:4; 170:15;211:7;
214:24; 236:23; 267:ll
becomes
182:22;
199:lO; 231:15; 264:14;
273:24;276:8

/ below 28:20,25;40:12,
1 13; 59:23;89:11;91:14
I beneficence
191: 12;
! 193:21; 194:15; 196:5;
199:24; 204:20; 205:7;
214:19; 265:14; 266:ll
benefit

16:21; 24:15;

: 27:25;28:1,3, 13;29:2-1;
i 62:19;73:10;80:16,
19;
i 89:23;92:16;106:5;
107:3,7,10,
12;108:15;
; 111:21; 114:l. 19.21;
117:24;119:9,12il:15;
123:7;131:5;147:22;
148:1,16;149:3;150:19;
151:1,8;164:16;169:1;
182:10;183:2;201:22;
205:14;221:2;237:10;
242:17;251:11,13,20;
252:6, 10, 11, 1.3, 17, 22,
24;253:9,13;254:10;
256:5;261:3;262:23;
263:10,11, 17;266:13;
267:l

: 1benefit/risk
Ibenefited
Ibenefiting

198; 43:4
29:24
263:4

Ibenefits
14:l; 16:7; 19:3;
24:19;29:6,20,25;30:12;
13:2;110:6;149:10,12,
20; 15O:lO; 151:lO; 152:1,
-~
221:2;
‘ 2; 173:22;205:9;
!52:22;269:21
Ienign 14:7

Hearing Volume 2
December l&2000

BIO 216:s
biochemical
bioethicist
bioethics

59:18
207: 11
207:13

biologic
110:19; 166:7;
179~1; 203:5; 254:24
biological
l49:17; 179:3
208:12;221:14;246:3,6
biologicals

214:3,11

Biologics
133: 15,17;
153:20;165:23;178:16;
179:5,8;202:6,18
Ibiology 65:ll; 136:s
IBiomedical
l99:14
I3iopsies

67: 11

1aiotech 226:l
/ Iaiotechnology
136:9;
142:13; 143:2; 214:6,8
Birmingham
134:17

5:14;

birthday
243:21
bit 20:2; 50:4; 65:ll;
68:22;70:4;72:17;73:24;
75:6,17;76:24;79:14;
80.22;83:7;84:22;97:21;
100:7;101:2;103:3;
11 1:21; 122:14; 125:21;
12717; 147:2; 208:4;
215:6; 227:14; 233:12,22;
236:20,22;256:25;
266: 12

becoming
177:16; 264 9;
265:20
BED 44:3, 11; 177:10
bite 203:2
bedside
268: 13
BLA 10:23; 11:5; 12:21;
began 19:ll; 39:23; 994;
3ennet 11:s
26:9;27:25;71:2,5,10
137:22;139:25;141:14;
Bennett 26:7
17O:l; 196:24; 200:5;
black 145:10,23; 159:9
208:8;211:4;216:12;
Berman 5:4,6,6; 57:1,2,
bladder
153:24; 154:2,2,
234:16
1?;58:4,8;59:3,9;60:2;
4,5
68:20,22;105:24;
106:1,
begin 5:3,5; 17: 18;
blame 141:2; 155:25;
2;109:24,25;122:8,9;
38:ll; 51:5; 72:4; 75:22;
156.24; 257:23,25
124:1,2;125:5;127:13;
133:s; 137:4; 173:8,9, 12;
blatantly
274:13
128:s
180:9; 191:25; 207:25;
BLAYNEY
6:8,8; 7:4;
besides
193:3
208:25;213:11,24;216:4;
45:23,24;47:9;48:3,20,
218:24;224:9;247:16;
best 9:5; 119:8,9; 130:21;
25; i9:13; 5O:l; 106:17,
265:18;274:20
148:l; 151:19; 162:lo;
18; 110:16, 17; 112:23;
beginning
8:15; 160:21,
170:5;172:16;
173:7,25;
133 20.20
1 177:21;182:25;183:3;
161:17;166:23;192:25;
blessed
13:20; 160:9
254:20;258:17
~ 190:5;192:16;
195:17;
blessing
273:25
223:14;237:4,5,8,11,13;
begins 170:13; 223:2;
blind
146:18
258:23,24;259:5;261:22:
257:15
268:2;279:4,5
’ blindly
2603
begun 104:24
beta-2
45:14

blood
10:2;
49:3,5;
behalf 10:21; 162:17;
58:10;61:1,6;65:24;74:6;
better 9:20; 16:5;.24:10;
165:5; 178:lO; 233:21;
79: 12; 87: 15; 90: 18;
26:16;60:13,21;61:13,
258:14
147 17,18; 221:23; 222:2,
16;128:19;129:3,19;
behave 201:17
4,8;232:15,16
149:19; 151:4,10;152:3;
behavior
178:20
159:25;194:19,21;
i BLS 72:20
Behavioral
199:14
197:24;229:20;233:16;
blue 36:4
behind 145:21; 19O:lO;
255:23;256:1;257:3;
i board 156:15; 165:4;
215:25; 236:22
262:5;264:24;279:11
I 205:10;242:1
BEHMAN
188:15
beyond
143:5; 184:3;
body 70:3;265:8
235:ll
beings 152:4
/ bold 112:15
bias 256125
belief 201:5
bolstered
2003
biases
277:9
beliefs 176:20
bone 12:l; 14:24;31:15;
big 54.22;195:3;275:22
believes
99:22; 147:25;
37:24;49:3;124:11;
164:17; 245:20; 259:16
bigger 162:7
j 137:21;222:6;260:25;
. . ..
Belmont
199:18,18, 19
binding
196:9
I 27619
-___-_

Min-U-Scripts

Bonnie
37:11, 14
book 62:25
books 257:2
borders
206:3
born 196:20
both 13:ll; 14:6; 20:4;
26:13; 30:5;47:3; 51:18;
77:12; 103:20; 110:22;
138:12; 1587; 1608;
161:9; 174:21; 177:13;
179:3,8; 184:6; 201:2,20;
207:15;246:20;247:20;
248:11;249:15;251:4;
254:10;255:10;257:4;
266:9;271:24,25
bother 24:17
bothersome
28:5
bottles 226:6
bottom 26: 12; 69: 11;
162:s
bottoming
37:4
Ibought 204:9
Ibound 26:15; 27:7,16;
30:6,9
Iboundaries
198:19
Ibowels 177:13
’ I30x231:12
I3oy 143:5
t>oys203:25
Ixain 137:22,22; 158:6;
1!30:21,24;231:6,18;
!43:20
3rainerd
137:13; 147:4,
1;
i,6
Brains 206: 15
brand-new
128:25;
!79:3
Srandt l97:4
break 68:21;70:6,8;
32:9,19;215:9;240:4;
:43:3
breakdown
77:18; 94:21;
141:ll
breakthrough
250:s
breakthroughs
250:12;
257:14; 259:3
Breast 135:l; 136:14;
150:13; 153:22; 162:17;
165:12; 207:9,19; 208:13;
258:14,20,20,21;
260:24;
261:20,21; 276:lO
breath 9:25
BRETTMAN
10:19,20;
18:20,22;45:25;46:12;
47:13;48:8,23;49:1,16;
50:12,15;51:17;52:12,
20;53:8;54:6,15;56:8;
57:10,23;58:6,11;59:5,
20;60:4,17,24;61:8,18;
62:1;63:7;65:14;66:10;
67:7,18;69:2;72:11;
75:21;96:14,14;97:8
brief 10:25; 11:2; 18:23;
70:8;126:14;182:13;
189:6;206:16;207:25;
1 243:3,6,18;244:1;274:3

briefing
32:18; 47:9;
217:25
briefly 21:6;67:20;
178:24; 181:9; 183:23
bring 128~22; 142:23;
160:17; 206:lS; 221:19;
241:11;264:25;272:16;
278:5
bringing
brings

205: 12
125:5

broad 22:6; 25212;
253:22;263:18

!I

broader

254:10,17

broadly

148:7

aroken

151:12

xonchospasm
3RORSON

82: 12
70:13,14

wrought 177:11; 191~4;
193:19; 196:25; 199:13;
!08:20

I3ruce 6:12; 133:18
E3tpOn 167:3,4,4;210:9
tBuild 221:16
E3uilding 78; 136:2;
1 55:1;237:20;257:5,8
bluitt 131:15, 18
bWkt
112:7
bburden 15:24,25; 21:14,
1 5;48:1,74:5,6,8;95:24;
9 16:23; 113:4; 218:20;
2 51:5
b ureaucratic
205:18
, b urned 279:19
IE lurroughs
12:15; 19:lo;
'7 4:21;76:8; 77:4; 103:13,
14
business
143:14;
144:10;192:20;229:18;
265:17,17
businessman
142:14
busy 223:13,20
buy 198:4
buying
199:21; 221:5
Byrd 11:s; 53:1, I
~-~

C
c 184:2,7; 185:16; 233~6
hnaX47:23
calculate91:25
calculated
Cahhting

cafcutation

89: 12; 90:23
88:23
24:ll; 74:9

calculi
190: 15
calendars
279:25
California
6:9; 133:21
Caligaris-Cappio
26:s
Call 5:2; 114: 17; 158: 15;
176:2; 197:24; 202:5;
208:17; 222122; 223:7, 14,
17;224:24;230:16;
231:15;238:17;246:16
called

(5)

11:25;

basic

14:18;67:3;

- called

Food and Drug Administration
Oncologic Drugs Advisory Committee

Hearing Volume 2
December 14, 2000

callers

240:3

calling

247:14

calls 143:lO; 1569, 19;
163:9,223:20;
224:18,20;
235:8, 12, 12; 237:23;
238:lG. 19
CAM211 19:22; 20:1,8;
22:lZ; 24:24; 26:4; 27:13,
17;28:14;31:11;36:2,G,
10,15; 40:9; 43:5; 49:20;
51:20,24; 57:23; 58:ll;
60:5,10,18,25;
66:s
Cambridge
12:12, 14
came 73~5; 88:3,4,21;
145:2; 191:17; 193:4;
200:7; 202:19; 208:9;
2359.12; 238:22; 270:13
campaign
209: 10
Campath
8:4, (1; 9:4;
10:2/t; 11:2,7,11,11,
17,
19, 24; 12:2,5, 10,13;
18:25, 19:6,8,9,24;
24:8,
20,25; 25:3, 11, 15; 26:5,
17; 28:3; 30:2,3, 15,20;
31:17; 32:4,9,20; 33:21;
34:23; 36: 12; 37: 13;
38:18,20; 40:11,14,20;
1, 17;42:12, 17, 17;
11, 16; 47:2, 18; 48:2,
l&22; 49:8, 15,18,22;
50:8, 17,22, 23; 51:9;
53:4,6; 55:8; 56:10, 19;
57:lG, 21; 5&l, 18; 59:lO;
61:17;65:16;66:6,13,
18;
67:13, 22;68:24;69:14;
70:16;71:2;72:13;73:1;
76: 15; 77:s; 82:2,7, 13;
86:10,16;90:17;91:17;
93:25; 1OO:ll; 101:25;
102:1,1; lOS:lO, 14;
113:8,25; 114:lO; 121:6,
16.21,24; 122:1, 12;
125:ll. 17; 127:20; 128:4,
6,23; 129:10, 19; 132:l
Campath-l
H 70:16
Campath-1M
71:18
Campath-related
campus
209:5

92:17

can 11:20; 13:9; 16:22;
18:8, 14; 25:21; 2G:7; 27:7,
11, 1,3,6,23;
13; 32:15; 37:4,7;
33:2; 35:15;
36:
40:14; 42:s; 44:1;45:2;
47:12,21;48:14,
17;43:8;
50:4; 51:1,14; 52:5; 54:19;
55:23; 56: 15,25; 57:4,20;
60:4, 14, 17; 65~7; G7:5;
23; 69:9; 7O:lO; 75:15,
25; 77:20; 86:12; 88:6;
93:25; 94: 13,20; 96:22;
97:11;99:16,20;
103:16,
25; 107:2; 1ll:G; 112:16;
113:3; 1lG:lG; 122:24;
127:G; 128~21; 144:11,18;

callers - circulate

cardiovascular

145 12; 150:23; 155:19;
161:20,24; 162:6; 164:lS;
166:17, 18; 168:4; 182:22;
183.14, 17; 188:3; 194:25;
195:17; 196:8; 198.x.
201:12; 202:8; 203:5;
206-14; 211:8; 213:11,17;
215.2, 15; 217:20; 218:3,
10; X9:15, 17; 221:23;
223: 17, 18; 225~8; 227:3,
19; 229:9; 231:13; 232:3;
234115; 242:4; 244:17;
247:3; 249:lS; 253:13;
254:19; 255:25; 256:lS;
260:22; 261:24,2S;
262: I 8,23; 266:3; 267: 16;
271:16, 16; 272:l; 273122;
275:ll;
27717

14l:G. 11; 144:17; 147:13;
160:12; 163:lO; 184:2;
185:4; 217:16; 227:10,24;
0:19; 234:13; 247:ll;
,912; 27G:22

cancelled

181:25; 230:21; 235:2;
244:7; 249:10

3514, I2
, candida
~ candidate
1751
~ candidates
171:6; 172:3;
, 232:20; 239:G
1 Caner 247:11
capability
229116
149:13; 257:21
1 captured
carcinoma
157:17
; card 194 19
~ cardiotoxicity
261:12

(6)

career
careful

216:23
102:12; 175:8

carefully
146:lG; 180:7;
181:19; 230:22; 254~6;
268:5,17
caring 177:16
carinii 35:9
Carl 135:5; 136:ll; 197:4;
24514~8
Carol 136:19
Carole 6: 1
CARPENTER
5:13,13;
134:1G, 16; 274:22,23
carried 117:23
cartoon
195:7
case 32:7; 38:ll; 63:25;
33:11;86:11;92:7;
116:5;
120:12; 140:5; 141:3;
162:23; 163:5,22; 172:19;
197:3,5; 208:7; 225:22;
242:13; 257~24; 260:24;
261: 11,20; 266:3
:ase-report
231:23;
132:4
:ases 34:13;35:13;
57:19; 58:12,65:18;
32:18;86:14,90:12;92:6;
Il4:22; 116: I; 118:16,23;
119:6; 140:21; 149:8;
193:1,1, 1; 176:4,8;
2ll:lO;
219%; 225:19;
236: 14; 249:23,24;
250:15; 252:22,24; 253:3,
15,20; 257122; 263:7, 10,
11,12
catch 73:18; 133:5; 215:8
categories
21: 16

177:24

Cancer 5:7,9, 10;6:11;
8:5; 133:19; 135:1,3,6;
136:7, 12, 14; 137:19;
138:7,24; 139:14,18;
147:12,21; 148:1,3,25;
149:25; 150:13; 151:20;
153:4,22,25;
154:2,3,4,
5; 155:11,20; 15G:19;
157:5,22; 159:3; 160:1,6,
10, 12,14,19,20,21,23,
24,25; 161:7,13,25;
162:17; 163:7; lG4:25;
165:12; 166:25; 167:l;
169:19,22; 171:15; 173:5,
25; 174:6, 176:5,6;
177:21; 179:16,25; 181:1,
3,23; 182:14; 183:3, 11;
184:/i: 185:12.15: 187.12:
198:li;, 17; 2dO:i8;
202: 16; 207:9,19; 208.7,
14; 209:23,24; 210:23;
213:5,7; 214:2; 216:3,13,
15; 22l:l’);
227:19;
230:24; 231:6, 18; 233.8;
234:ll;
235:l; 23G:l, 3,
10; 237:3; 238:1, 25;
239:3,19; 241:21,22;
242:3,24; 243125; 24412;
245:8,9, II, 13, 14,23,
24, 25; 246:1,2, II, 21,
24718; 248:2, 17; 249:9;
250&G; 251:13; 253:11,
16; 254:l’; 256:20;
257:ll;
258:14, 20,20,21;
259:2,3; 260:24; 261:20,
21; 262:20; 265:4; 267:5;
263:20; 275: 15; 276: 10
cancerS
155:17; 166:25.

226:21

Care 5:25; 63:6; 109:18;
122:l; 123:12; 124:lS;
134:6; 142:8, 10,12;
143:25; 144:19; 148:6;
149:25; 162:22; 163:4,5,
8; 164:17; 190:5; 191:23;
193:24; 194:13,20; 196:4;
200: 15,15; 246:s; 273:5,
11; 274:15; 275:4; 279:4,4

category
61:24; 67:3;
150:16
catheter
177: 12
caught 112:l; 236:20
CaUSal
107:21
cause 33122; 34:5;99:25;
148:25; 1496; 160:19;
j 203:7; 243:15, 22
~

caused
i 181:14

35:1,3;

174:G;

1 causes
15:7; 32:4,5, 11;
/ 81:20; 127:3
1 causing
15:25; 34:7;
I 59:ll; 203:2
caution
112:17
: CBER 6:15, 17;71:3
CBER’s 70:14
cD91:13,15.23
CD4 31:13; 36:14,19,25;

Min-U-Script@

190:14; 195:l; 203:5;
240:13; 250~7; 270:5

37:1,3,6,9;56:5;57:12,
14, 15; 82:2; 85:4,24;
91:8, 11, 19,20,22; 93:12,
13; 105:5,13; 118:l

changed
143:7,8; I 14:4;
195:19, 19; 200:l; 214:7

CD52 11:25; 36:12;
50:16; 65:18; 70:24; 71:6,
11;81:12;85:4

changes
39:4; 137:9, IO;
191:14; 202:17; 240:10,
11,ll

CD52-negative

65:20

changing

CD52-positive
70:25
CD8 57: 15

65:22;

CDRs

11:20,21,24

celebrities

235:9,13

Cell 6:7; 12:3; 14:17;
4519; 50:23,24; 57:7;
58:10; 71:12; 85:25;
90:24; 118:l; 133:23;
141:s; 147:17; 152:2;
155:ll;
157:17;235:1;
236:1,3; 237:2; 238:24
cells 10:3; 12:l; 65:17;
70:25;71:12,15;85:4;
90:20; 147:15; 198:16;
241:21
cellular
105:14; 149:18
censored
74: 18; SO:2
censoring
80: 1
Center 5:7, 12,lG; G:2,
11,25;46:25;98:12;
121:21; 122:l; 133:15,17,
19,23; 134:2,5, 14, 19;
135:19; 139:14; 179:5;
198:7,24; 199:19; 209:22;
235:6; 238:17
centers
17:23;74:21;
117:4; 176:5; 209:25;
262:20
central
187:3; 191:ll
century
190:25; 191:1,
16
CEO 224:4; 236:17
cerebral
81:25
certain 98:7; 114:22;
116:4; 229:10, 12; 246:19;
254122; 25513; 271123
certainly
46:15; 52:21;
61:8; 65:14; 67:8; 79:8;
64:6; 96:24; 100:12;
123:2; 190:14;203:16,23;
215:14,16; 218:19;
224:12; 228:10; 261:7,11,
23; 264:7; 265:23
certainty
251:12
certificate
cessation

174:21
103:23

Chair 45:24
Chairman
178:18
challenges
239: 16
challenging
149:21;
201:12,16
chance
144:24; 173:25;
175:lO; 176:15; 251:18,
20; 252:13; 270:21;
272:22
change 29:lS; 38:7;
84~18; 120:6; 137:ll;

95:22

characteristics
25:19;45:14;79:15;
254:22
characterize
33:14

30121;

characterizing
charge

20:20;

23714

128:14; 223:8

charged

164:9

Chelsea

162:14,15

chemo 139:19,20,23,23
chemoresistant
14l:l
chemotherapeutic
20:25

12:6;

chemotherapy
8:12,14,
16,23,23,24;
9:18; 14:22;
18:14; 26:3; 38:22; 139:7,
10; 140:15; 147:14;
148:23; 150:6; 152:7;
165:21; 175:18; 176:9;
177:ll; 214:14; 239: j
chemotherapy-free
69:5
Chesson
79:12
Chicago
134:19
Chief 135:8, 10; 142:7;
216:l; 233:4
child 156:9, 16; 243:19
child’s 156:12
childhood
244:2
children
178:11;243:24;
244:G, 16,21,24
Children’s
243:15,22;
244:10
chills 47:1
chlorambucil
15: 11;
122:20; 130:17,20; 131:8,
25
chlorodioxy
57:6
choice 63:5; 65:8; 112:5;
117:ll;
122:17; 123:ll;
130:22; 132:l; 170:22,23;
174:l; 177:3; 268:s
choices
63:13
choose
67:17; 100:23;
25217; 257:20,23
CHOP 44:3, 15; 69:2/i;
279:13,17
chose 15,t:G
Christian
176:20
Christmas
175:13
Chronic
5:9; 13:7;
198: 15; 234:8
church
174:9; 176:24
circle 258:5
circular
252:19
circulate
2OG:l4

Food and Drug Administration
Oncologic Drugs Advisory Committee
--~
circulated

264:20

circulating
46:3,14
circumstances
16:20;
212:4; 254:2,21; 256:ll;
259~24
cisplatin
233:7; 2G5:4
cited 154:19; 192:2;
248:11
City 165:ll
civil 209:4
cladribine

17:23

claim 266:7,8
claimed
139:2,6
claims 190:13; 193:s;
266:9; 268:G
clarification
53:s; 262: 14
clarify 99:12; 131:22;
256:11
class 147:12
classical
78:7
classified
l73:5
clause 228: 18
clear 54:12; 55:21; 61:ll;
63:2;65:24;82:1;
101:25,
102:5, 14; 104:21; 120:20;
158:25; 188:13; 187:24;
222:3; 232: 12,17; 250:20;
257:17, 18; 25&l, 2;
263: 14; 2G5:6
clearance
51:3
clearly 23:4; 28:10;
34:18;52:15;65:22;67:1,
2;68:12; 102:7; 105:14;
125:10, 12; 128:5; 161:18,
23; 162:7; 187:ll; 193:16;
198:18; 233:14; 242:4;
247:3; 250:6; 252:10
clears
client

49:4
1659

clients
164:14,lG;
233:21
climate 259: 10
clinic 193:11;204:15;
222:l; 257:15
Clinical 6:15. IG; 11:4,7;
14:14; 16:7,21; 18:21;
19:3; 21%; 24:15; 27:25;
28:1,13; 29:20,21,24;
30:12; 43:2; 49:7; 59:lS;
61:2;62:18;G3:18;66:15;
72:2;74:2,14,
15;80:16;
106:4,5, 10; 107:3,G, 7,
10.12, 114:19,21,22,24;
116:15; 117:24; 133:15,
16; 136:17; 139:ll;
140:13; 141:2; 143:ll;
1411:14,22; 145:?, 14,25;
148:4,4, 16,20; 149:7;
151:2; 153:12; 155:19;
157:2,21; 158:l; 159.7,9;
160:1,8; 164:11, 12,13,
16.20; 167:1,7; 168:25;
169:3; 174:14,24; 175:25;
181:17; 182:9, 18,25;
183:3; 186:20,22; 196:15;
198:7,24; 200:16; 201:4,
22,22; 204~24; 20614;

-.

208:6,7; 209:2,4; 210:23,
25;211:8;213:20;223:11;
226:8,10; 228:25; 229:5;
230:13,22; 23l:lS;
234:16, 18; 23fk7; 240:9,
25.244~4 9 17 24 ?A.
24;:20; 2k6’:9, il, i4;”
247124; 248: I, 3; 269:ll;
252:7,23; 25418; 255:2;
256:2,8; 257:7; 258:25;
259:15,19; 260:1,20,21,
22; 262:6; 267:23; 268: 11;
274:16,17; 276:22; 277~4

collection

213:19

collectively
250:2
College 6:6; 133:22
colorectal
234 11

167:19;

combination
17:23;
26:3; 138:14; 239:4
combinations
116:4

55:16;

comfortable
103:24;
113.17; 176:9; 178:l;
219.11,ll
coming 7:lS; 26:4; 48:16,
69:4,5; 96:17; 101:s;
104:25; 124:25; 127:12;
128:lS; 255:22; 279:8,21
command
140: I 2
commend
245:lS; 249:1
commensurable
266:15
comment
7:17; 46:20;
47:12; 51:14; 55:12; 57:5;
90:6; 101:20; 105:4;
111:15; 112:15; 116:14;
117:19; 12O:lO; 12l:lS;
122:#,6; 137:3; 163:17;
256: 15; 258:lG; 279:7
comments
64:4,7;
76:17; 105:24; lOG:l6,24;
113:2,4; 116:13; 121:4;
122:22; 129:14; 136:6;
186:14; 188:13; 206:16.
18; 249:13; 25d:lO; 274:3;
279:6

clinically
25.12; 58:3;
102:23; 209:lS
clinician
16G:lO; 194:21;
2Ol:lS; 205:s; 266:19;
267:23

I
I Iclinicians 46:16;63:10;
I 154:s; 196:22; 198:21;
201:17; 206:7; 267:l;
277:lO

cLLS:ll;
11:3,12; 12:6,
25; 13:3,8,22; 14:2; 15:3,
9, 15,23; 16:lS; 19:9;
20:4,7,9;23:3;28:11;
30:4,19,32:6,12;
33:23;
34:2; 37.24; 41:9; 43:16;
~4:6,8;46:1;48:14;56:11;
I (;1:24; G3:17; 64:23; 65:l;
j (i9:lS; 7214; 74:10;
35:21; 8G:l; 96:20; 97:10;
i ()8:14; 106:3, 12, 19;
I’
1 ;107:5; 109:l; 112:lS;
121:25; 122:12, 18;
I] 125:ll; 128:G, 16; 129:6,
$9
c:lone G5:20

commercial
170: 16;
218:7, 11; 228:25; 229:16,
19
COtTImerCially
52:15
commission
199:5,13,
15,17
Commissioner
154:19
commit 115:s
commitment
72:25;
112:24; 113:21; 115:9;
228:20,22; 230:2; 242:12;
258: 18
commitments
116:s
committed
152:22;
168:7; 163:lO; 191:7;
227:6

(dose 91:16; 194:2; 224:5
:losely 42:12; 131:14;
179:5; 237:25
:loser 125:G
Aosest 131:9
:losing
157:4; 212:lS
:lothes
193:13
:lothing
174:ll
:m 28:20,25
:MV 34:4; 35:3,9
>oalition
135:2; 136:14;
!08:9; 258:14; 259:16
:oat 196:23; 201:14
:ocktait 239118
:ode 156:22; 197:5,15
:ohort 36:19
:oin 201:15
>olata 204:s
:ollaborate
238: 13
:ollaboration
12: 16;
;32:15
:olleagues
216:6
:ollect 66:ll; 231:25;
!32:3
:ollected
5G:lS; 166:9;
!09:18; 213:ll; 240:20,
!4,24
:ollecting
56:23; 236:6

Hearing Volume 2
December 14,200O

-.

committee
5:23; 7:25;
10:12,22; 11:9; 13:5;
43:22; 94:4; 98~1; 105:18,
21; 108:13; 113:15;
126:21; 133:2; 134:s;
135:24; 146:16; 165:l;
178: 12,lS; 179:7; 180:4;
187: L7,25; 189:17;
192:13,17; 197:12;
203: 15; 217:3; 219:ll;
221:20; 232:s; 243:9, 11;
262:14; 279:21
committee’s
142:23
Committees
192:9,12
common
13:s; 32:4, 13,
25; 33:4; 34:5,7,9, 10, 11;
35:3,9,25; 39:10; 41:23,
24; 45:7; 118:lS; 169:20;

Min-U-Scripti

17O:ll; 193:9,19; 199:1o;
203:14,14; 234:l; 239:4
commonly
16:9;61:1;
105:12, 13; 179:7
communicate
156:G;
172:21; 186:9, 15; 203:6;
277:14
communicated
180:l;
186:12
communicates

185:2

communications
14l:ll
community
110:20;
118:22; 134:24; 153:7;
154:17,25; 161:13,21;
169:9,13; 174:9; 176:25;
199:3; 207:7,13; 208:9,9;
211:24; 229125; 243:8,17;
244:15; 245:3; 248:23;
255:15; 257:10; 262:17,
20; 263:14; 276:23;
277:24
companies
137:17;
142:4; 143:2; 145:21;
150:23; 153:19; 159:21;
16l:ZO; 170:17; 171:3;
179:25; 188:4,8; 214:s;
216:6,8,16,20;
218:13;
219:1,13; 226:3; 230:3;
248:12; 255:5; 256:lS;
257:1,6,8, 17,23,25;
25918; 264:6; 26916
companion
162:24
company
11:20; 75:4;
104:13; 115:s; 128:15;
129:s; 136:8,9; 142:9;
146:9; 152:9; 158:9, 10;
180:14; 209:8,21,22;
210:10; 216:2,5; 217:4,5;
118:6,21,23;
220:11, 13,
17; 223:6,6,9,10;
224:3,
;,8,21; 225:15; 226:1,2,
Lb; 227:s; 229:17,21,22;
!30:9; 235:3; 236:7,25;
?38:8; 240: 10; 242: 13;
!47:14,15;248:3,13,19;
!57:20; 264:3; 265:9
:ompany’s
126:23;
158:25
:omparable
27:20; 43: 1;
L7:23; 68:2; 163:20
:omparative
17:21;
!3:2,6; G3:11, 15;65:7;
)4:1; 98:3; 99:7
:omparator
120:5
:ompare
63:20; 69:13;
102:16
:ompared
51:21; 57:6;
34:ll; 102:6, 13; 132:5;
L48:24; 266:s
:omparing
62:23,23;
;%&2;
12O:lS; 15l:ll;
:omparison
27:4; 64:ll;
,9:14; 101:21,22; 102:16,
17,19; 103:3; 117:16
:omparisons
41:16
:ompartment
47: 11

(7)

compassion
159:23;
170:24; 171:1,4,5,7,8,
12, 15, 17,22,23,25;
172:2,7, 13; 214:lS
compassionate
4918;
55:9;140:2; 142:20;
143:3,13; 144:4,21,23;
145:24; 146:12; 150:5,17;
153:24; 154:15; 158:17;
159:12; 161:12;208:10;
211:1, 12; 212:17; 214:23;
217:6,7,19;
218:14,24;
219:6,20; 220:2,7;
221:16; 222:22; 226:14;
227:1,7, 22; 230:10;
231:6; 232:4; 245:7;
246:22,25; 247:13; 248:4,
12,16,20,21,25;
249:3,
6; 25715, 12; 273:20; 274:2
compatible
58: 12;
213:22
compelling
73:9; 259:18;
260:9
compete
169:2; 218:14
competed
209: 16
competes

226: 17

competing
117:lO;
164:19; 190.12; 191:22;
193:s; 196:s; 275:19
competition
171:7;
191:21; 218:17,18
complement
12:3; 70:25
comptementarity
70:20;
71:23
complementary
15o:l;
152:l
Eompfete 2 1:7; 28:23;
S2:lG; 55:25; 71:4; 73:19;
75:3; 79:5; 84: 12; 8G:G;
37:6; 92:4,11; 12417;
138:17; 149:9; 232:lS
completed
73:13; 78:18,
19; 151:3; 166:3; 223:12;
230:25; 2GO:6
completely
101:23;
lG8:7; 2GO:l4; 266:21;
267:3
completeness
29:20
completion
SO:*, 15;
81:13; 118:4; 168:20
complex
167:16; 249:2,
16; 253:16
complicaw!
! 22: 14;
161:23; 243:13; 274:7
complicates
278: 12
complication
40:18;
221:9
complications
13:24;
15:G, 25; 17:l; 5O:ll; 56:7;
66:9; 108:23; 113: 11
comply
188:5
component
193:23
components
19:lO
compound
65:13;
112:17, 19; 124:14;
153:23; 154:l; 155:23;
I 156:2, 10; 157:l; 222:12;
-

circulated

_.compound

Food and Drug Administration
Oncologic Drugs Advisory Committee

Hearing Volume 2
December -14, 2000
235:8; 237:14; 242:ll
compounds
57:3;
‘“621;
154:13; 155:2;
‘:I& 15
comprehensive
83:l;
133:19; 209:24
compromise

42:lO

compromised
14:ll;
31:15;40:7;43:9;51:5;
109:4; 213:ZO; 275:8
computer

209: 17

computerized

155:7

concept
23:s; 20114;
202: 11; 225125; 260:15;
263:22
concepts

195:4

concern
15:2;69:19;
75:1;82:3;99:5,6,
11;
111:15; 125:22; 144:l;
236:5; 265321; 273:ll
concerned
9:13; 59:ll;
98:25; 108:20,23; 109:2,
6, 17; 112:21; 123:13;
125:18; 147:10; 218:1, 13;
219:l; 246:lO; 256:12
concerning
22:1;66:11;
137:17; 238:2
concerns
69:19; 85:23;
121:2; 125:15; 128:20;
166:19; 241:l; 266:19
conclude
19:7
eludes
71:25
Lonclusion
18:8; 206:2;
249:3; 260:14
conclusions
166:16
concomitant

41:22;
25:7; 239:3

concordance
concurrence
concurrent
condition
l/11:17,25;

224: 16
185:25
166:25
13:19; 138:ll;
165:24; 225:2

conditions
183:lO;
213:12
conduct
28: 1; 64:2;
115:3; 154:7
conducted
19:19; 20:15;
21:2; 23:7; 26:lO; 27~24;
28:13; 29:2, 19; 31:12;
56:9;73:4,16;74:15,20;
75:1;77:4; 115:13;
121:18; 19622; 197:13;
198:lO; 244:5
conducting
186:20;
207%; 225:9
conducts
136:9
Conference
199:19;
200:9; 213:23; 215:17
conferences
151:16
ferred 108:15; 114:l
,dnfidence
2215; 27:7,
12,21; 30:9; 79:7; 80:4
confident
240:17
confidential
175:25;
186: 12; 26516

compounds

confidentiality
178:4;
254:4
confirm
115:12; 116.5;
121:l; 126:6
confirmation

126:3

confirmatory
72:22;
73:il; 104:20; 113:ll;
115:7; 118:6; 120:2;
121:18
confirmed
118:l; 126:19
confirming
126:12

119:l;

confirms
129:2
Conflict
6:18,20; 7:l;
135:12, 14,20; 196:ll;
253:14; 254:3; 256:7;
265:15, 18,24
conflicts
265:23
confront
251:23
confronted
14 l:9
confused
276: 1
confuses
276~3
confusing
183:14;
188:23; 247~20
confusion
275:18
congressional
224:2;
269: 19
conjunction
53:2
conjunctival
137:19
Connecticut
5.21;
134: 10
consensus
22 12,25;
65:l; 216:9; 244:15
consent
185:24; 196:5;
197:14; 198:17;201:25;
204:20, 23; 205:1, 2;
214:20,21; 22517; 239:12;
240:7, 10, 15, 15; 266:25;
277:5; 279: 1
consequences
175:5;
218:5; 219:17
Consequently
109:18;
149:lO
conserving
212: 13
consider
31:17;41:5;
102113; 146:16; 148:17;
149:17; 152:1,6; 153:2,
14; 157:5; 168:18; 172:6;
175:3; 180:7; 186:17;
187:5,8, 19; 209:8;
247:18; 249~25; 277:3
considerable
27:14,21;
63:9; 200:4; 276:5
consideration
164:5,23;
175:8; 182:15; 187:ll;
228:4; 2.i9: 19
considerations
104:5;
130:8; 167:14; 184:15;
189:21
considered
23:2; 67: 13;
7224; 119:21; 161:9;
188:17; 189:3; 237:20;
2429; 244:14
considering
128:l;
/ 206:2; 250:3; 255:8
considers
l39:l; 251:21;
.------.----I

- CRs (8s)

254:14
consigned

271: 17

consistencies
consistent
58:14;91:1;

75:lO
30:13;42:24;
106:11; 166:1

consistently

l&7,

12

consisting
259, 17;
32:20; 35:12
constellation
268:3
constituents
construct

155:3
I1:21

constructs

71:24

consult

188:ll

consultants
consulted

135:24
243:l

126:25;.155:19;
157:2;
168:25; 169:3; 171:25;
2193; 235:5; 271:5
convene
128: 15; 129:9;
132:14; 162:l; 242:l
convenience

conversation
225:19

211:5,7;

convincing

46:13

consumers
250:21
consuming

cooperate
cooperation

contact

223:3

contacted
173: l I;
175:11,24
contains
181:17
content
240: 12
context
22~6; 26:25; 2715;
40:19;41:5; 57:3; 11O:l;
145:25; 201:4; 244:14;
259:19; 268:5; 27013
continual
258:3
continually
143:4;
151:14
continue
16:12;48:22,
23; 49:2; 74:6; 77: 14;
1OO:lO; 108:6; 117:6;
151:16; 155:12; 158:18,
165:17; 214:12; 215:8;
228:19
continued
49:7; 58125;
75:23, 25; 141:17; 15117;
20917; 262~23
continues
156:19;
257:14
continuing
141:15;
151:18
continuum
251:15
contradictory
139:21
contraindications
277:2
contrary
219:18; 220:12
contrast
contribute

208:2
15:2; 172:18

contributed
contributes
contribution
lO4:2
contributions
contributory

172:17
17:13; 204:2
38:20’
126:24
105:8

control
64:2; 105:3;
117:13; 118.21; 119:2;
123:11; 139.10; 172:l;
177:12; 203:25; 271:14,
I 15; 272:13
controlled
6323;
I 104:13 17 I20:13,20,22;

Min-U-Script@

224:9;

convinced
276:15
convincingly

212:l

68:13

conventional
73:8;
114:17; 148:23; 151:22;
157:20; 173:14; 177:24;
210:25; 221:14

consumer
5: 16; 46:3;
134:14; 250:24
213:17;

172:6

convenient

Coomb’s

222:ll
58:2
213:17
242: 12

cooperative
17:21;
244:6,19
copies 247: 12
copy 7:5; 135:24; 247:lO
core 19:25
corner 256:21,22
corollary
199:24
corporate
247:23; 248:6;
256:19
corporation
138:2; 1409
Corporations

136:s;
140:6

Correctly
119:2
corrects
195:18
correlate
55:23; 100: 15
correlation
46:8; 54:12,
13; 56:4,5
corticosteroids
15:13
cos 191:3
COSmetiC
251:l
Cosmetics
197:25;
202:23
cost 144:3; 181:13;
218:ll; 229:7,20,23
costal 28:20,25
costs 144:11,19
Counsel
188:16
counseling
162:23;
266:21
count 24:3; 36:25; 37:9,
10; 38:5,6,7,12,13,16;
40:4,12; 46:9,14,18;
47:2,4,4,5,8;
48:15,20;
49:3; 51:25; 56:5; 57:12,
’ 14. 58:l0. 59:14.81:17.
~ 86:25; 88:23; 90:4,5,13;
1 91:11,15,20;94:25;
95:10,11; 105:5; 138:24;
222:2,8; 232~15
counted
95:13
counting
235: 11
1 countless
173:24
countries
69:21
1 country
64:25;74:16;

16O:ZO; 192:lO;
197:12; 199:2

194:2;

counts 31:10,13; 36:14,
20; 37: 1,3,6,22,23;
38:12, 18,23,25; 39:2, 14;
45:9,9,10; 46:17; 53:13;
57: 15; 85:24; 87: 15;
89:11;90:10,11;91:8,
13,
19,23,23; 93:13; 118:l;
131:6; 194:23; 221:23;
22214; 232:16
couple 10: 1; 27:9; 36:23;
38:8;60:12;91:14;99:12;
137:lO; 157:24; 190:23;
192:5; 206:13; 215:22;
221:l; 223:19; 224:18;
226:6; 22712; 266: 1;
272: 14; 277:22
course
12:22; 57:9; 82:7;
87:lO; 190:20; 2099;
210:19; 269:s; 279:16
court

197:3,5
140:2; 142:18;
143:12,19; 144:4; 1,15:2,
14,16; 146:6; 224:4
COUSit’I

cousins
156:21
cover 144:18; 264:19
coverage
147:23; 252:19
covered
240:18; 263:7

CR 23:14; 121:22;
123:20; 124:12; 125.?0
crawl 151:16
crawling
151:11
create 27:4; 167:24;
171:20; 201:9; 226:12;
232:4; 26414
created 171:14; 218:20,
21; 237:19; 241:lO;
259: 10
XeateS 272~2
Xeating
171:6; 259:9
creation
171:9; 264:16
credibility
269:16
credible
211:8
zres 174:21
crisis 223116
criteria 16:17; 17:4; 21:4,
6,6; 23124; 24~8; 28122;
30:1;75:19;78:3,3;79:11;
122:6,8; 124:12; 150:8,
14,24; 168:2,21; 169:2,3;
209:14; 219:23; 231:4&;.
254:19
critical
149:16; 193:23;
206:8; 229:18; 239:14,23,
24
critically
239:ll; 240:6
criticized
272:7
cross 271:9,21,23
cross-over
256:3; 271:8,
13, 18,19; 272~25; 274:24,
24,25; 275:3
cross-section
254:17
crossed
233: 11
crosses
218:23
! CRs 62:13; 124~6
------.---.----

..

Hearing Volume 2
December 14,200O

Food and Drug Administration
Oncologic Drugs Advisory Committee
-.-__.__
crucial
206:25; 275:19
cry 200:20
_

cryptoccocal35:13;
86:20
Cryptococcus
35:2
CTC 39:3
culminated

34: 13;

140:7

cultures
152:2
cumulative
14:24; 38:21;
68:2; 100:6
curable

123:20; 124:5

cure 152:23; 161:lO;
172:12; 174:14; 176:12;
267: 5
curing 244:16
curious
87:25; 263:2
current
7:15; 55:ll;
124:2; 126:15; 132:3;
137:l; 19:22; 151:17;
166:18; 222:14; 250:4,6,
16;25 1:8;
- 254:3
--‘currently . 1 48:8; 155:9;
.-R.71 241:25;
I>U:II;. . m4:l;
77L.1
&;\I.,
Curricular
134:22; 207:3
curriculum
225:6
curve60:15,
15,18
customer
198:6
cut l/17:18
cut-off 91:12
CVP 70: 1
cycle 76:19; 97:23,24;
101:24; 17O:lO
cycles 76:20,22,23;
84:5
cyclophosphamide
15:12
cytokines
51:6

25; 19:5,16,20;
22:lO;
41:17,17;43:15;48:9;
49:16; 52:7, 18; 53:23;
54:13,25;55:1,8;56:17,
23; 61:12,22;62:2;
68:24;
72:6;73:18,21,22;74:1,
9, 17,24;75:5,
IO; SO:&
21;85:20;86:6;92:1,8;
94:22; 95:17,21; 96:15;
97:s; 98:3,9,14,19;
102:5; 103:3,8, 15;
104:15,20; 106:25;
109:19,21; 112:20;
114:lO; 115:7; 124:23;
l-12:2; 166:4,8,12;
167:22,22; 168:20; 171:9;
172:6.7.8,9;
173:ll;
181:li, 12; l&2:20; 187:6,
‘),15; 204:ll; 205:16;
209:18;211:9;212:20;
213:10,20; 235:22; 236:6;
23914; 240:20,21,23;
212:16; 248:13,15, 19,20;
253:2,11,24;
254:l;
/ 259:21; 260:4,6,7; 261:s;
263:24,25; 26717; 277:25
: database
30:16; 236:4
~ databases
20:18
, date 80: 2; 138:9
dates?:16
dating 2653
Dave 133:24
David 6:4; 192:22
day 9:7; 24125; 25:2,2;
95:14; 108:22; 141:7;
160:10; 199:12; 202:19;
215:15;226:17,24;
234:15; 24915; 272114
day-to-day
23819
days 32 3,9,10; 51:24;
54: 18; 59:16; 76:3; 78:13;
80:23,25;81:1,3,5,
15,
16; 87:18; 88:24, 25;
89:13;91:18;
118:25;
137:23; 177:25; 22217;
26514; 27919
De 126:16

cytometry
31:12;36:16;
78:8
cytopenia
l6:14; 81:21
cytopenias
17:lO; 45:2,
3,s; 53:5
cytostatic
147:13,13;
148:17, 17,22; 149:15

dead-end
170~25
deadly 1734; 174:6

cytotoxic
12:5; 66:22;
14714; 148:24; 149:19;
152:3; 214:13; 239:5
cytotoxicity
12:4

deal 112:9; 140:6; 16O:l;
219:20,21; 220:12;
225:lO; 245:12; 265:18
dealing
142:18; 146:18;
158:ll; 159:ll; 191:9;
238:2,16; 239 14; 278:20

D
dacarbazine
daily 16:12

deals 188:10, 11
dealt 24O:l; 2,41:5;
2.19: 17

138: 13

dales 25712
damage 268:14
damaged
51:7
damaging
l7l:lo
dancer 213:7
dangerous
142:15
dangers
159:20
Daniel 174:23
data 11:4; 12:17; 18:21,

-I

dear 97:18; 14O:ll
death 32:4; 54:10,14;
57:22; 80:9; 81:17,20;
98:23; 99:13; 112:2;
160:20; 173:18; 176:21;
196:25; 203:12; 227:12;
278~24
deaths 32:l; 54:9, 18;
78:24; 81:14; 98:15,25;
99:22,24,25;
101:12,17

debate
249:20
debates

123:21; 132:14;

decade
deceive

126:20; 245110
220:14

200: 18

December
12:21; 73:12;
137:23; 175:13; 209:3;
235%
decide 15:22; 83:3;
192:7; 231:13
decided
175:9; 231:7;
237: 16; 238:7
decision
126:12; 167:24;
174:1; 175:6; 192:14, 19;
201:15, 217:5. 218:7 21.
1 >
224122; 226:23; 229:18;
235:22; 241:23; 251:22;
252:2; 268:20
decision-making
167:20; 19O:lS; 201:14;
212:15;268:3
decisions
163:23;
, 173:20; 192:15;247:11;
i 250: I
/ Declaration
177:16;
! 228: 17; 276:2
: decline
33:4; 36:7; 39:23;
40:4; 41:25
declined
40:12
declines
38:10;40:12
decrease
15:1,24;
33:lG; 38:17; 93:24;
1Ol:lO
decreased
37:1; l13:3,4
decreases
14:21; 113:5
decreasing
95:23
dedicated
147:s; 152:20;
237:19; 245:ll
dedication
126:24
deed 192:13,17
deep-seated
194:22
deeply 191:7
defer 126: 5
define 21:7; 125:13;
161:18
defined
21:13; 23:24;
24:1, 12; 28:19; 32:3; 53:9;
254:18
definitely
221:5; 269:7
definition
2O:lo; 22:16;
23:13, 18; 34:25; 35:7;
38:25;75:13;77:3;78:10,
16; 109:8; 261:7
definitions
132:2; 180:7
definitive
105:17;
270: I 5; 279: 16
degree 60:7; 103:ZO;
124:I3
Delaney 200:16; 206:23;
237125; 242124; 24914
Delaware
144:10
delay 81:5; 166:16;
241:24
delayed
40:5; 93:6;
94:17,24

Min-U-Script@

delavs 80:22,23,25;
81:1,-2,3,7
deleterious
l6:15
deleting
23311
deliberate
206:6
deliberation

206: 1

deliberations
207:2

192: 12;

delineated
delineation
delivered
191:15
delivery

110: 13
123:23
40:20; 41:2;
142:lO; 214:12

demand
168:13; 241:lO;
255~24; 257:12; 267:16,
17; 268:11, 19
demands
209:3,11
Demerol33:10
demographics
30:23
demonstrate
28:3;
80:19; 128:3,5; 182:8;
222:ll; 255:23
demonstrated
27:4;
67:2; 94:l; 148:21; 149:2;
252:25
demonstrates
demonstration

67:l
209:4

denied 156:13; 173:25;
176:12; 178:3; 213:4;
251:20
deny 257120
denying
151:21; 248:12
Department
12:12;
134:3,23; 188:10,10;
207:7; 226:3,18
I 1depend 177:14; 244:9
~Idependent 12:3; 14:21;
119:12; 177:17

/ depending

25:5
depends
101:2; 187:9
deployed
208: 19
zferived 70:19,21;
111:21;249:13
Iderives 196:17
Idescribe
46:7; 183: 15,
23; 184:19; 193:6; 175:4;
217:17; 234:12
described
86:ll;
184:14
j: describing
271:8
description
84:16;
207:25; 219:23; 224:25;
234:3
deserve 30:24; 156:16
Design 6:15; 19:23;
22:13,22,23;
27124;
36:15;62:15;63:1;67:21;
72:3;74:2;75:6,
11;77:11;
127:lS; 129:21; 130:18,
21,25; 131:1,7; 132:14;
167:8; 169:12; 202:7,12;
205: 10; 256:4; 271: 10,19;
274125; 275:3,23,25;
276: 18
designated
11:18
designed
22:12, 14;

68:l; 110:18; 147:4;
182:8; 201:9; 210:15;
212:9; 252:ll; 253:14;
258:25
designs
58:lS; 121:17;
132:16; 246:16; 271:8;
27216; 274:24; 275:18, 17
desirable

184:25; 202:2

desire 141:20; 256:9;
267:21
desperate
155:6; 161:14
desperately
210:20
despite
destroy

137:2; 216:14
228:13

detail 20:2; 31:21,23;
32:23; 34:ll; 156:22
detailed
65:15; 84:16
DETEC 138:20
detect 275:s
detection
161:3
deter 218:4
determination
164:4
determine
29:18; 55:3;
&9:20; 107:21; 163:ZO;
164:2; 168:25; 174:25;
181:20,21; 182:18,21;
183:l; 240:20
determined
6:24; 83: 12;
57:15;88:24; 108:lO;
118:5; 119:5; 135:18
determining
70:20;
71:23; 164:lO; 166:4;
260:7
detOUt’ 171:24
devastating
157: 16;
177: 1; 200:20; 276: 14
LieVelOp
13:22; 14:10, 19,
23; 17:10,12; 39:6; 45:2;
36:2; 153:20; 213:17;
24017; 24615; 247:7;
256:2; 261:18; 262:3;
27813
developed
I4:4; 35:8;
11:12, 13; 57:24; 58:2,4,
18;78:14;81:24;82:8;
33:6;85:25;88:17;90:15,
22; 103:13; 104:16;
159: 16; 208: 19; 212:24;
229:3; 230:20; 263:23
developers
256: 16
developing
14:17; 16:9;
142:12; 216:3; 222:lS;
226:19; 229:5; 242:6;
24715
development
14:2; 15:3;
19:9;71:16,20;88:2,15;
103:23; 123:25; 127:l;
137:13; 162:12; 167:22;
168:ll; 181:5,7,9,23;
182:6,13, 14; 184:12;
187:5; 208:l; 214:7;
218:5, 12,15; 220:16,23;
221:24; 224:15;232:10,
20; 239:15; 242:3; 245:1,
17; 250:9; 256:l
develops
15:4
k?ViSe 95:25

9)

crucial

- devise

Volume 2
December 14, 2000

Hearing

devised

83:s; 209:lO

devote 237: 11
‘--voted 176:23; 261:21
voting

151:2

- _---

---

direct 27:4; 41:16; 46:3;
100:21; 114:19; 144:l;
201:24; 208:24; 223:3
directed
11:24; 25:16;
36:12; 142:2; 150:8,
201:6; 245:15
direction
142:3; 243:14;
245: 1
directly
5O:ZO; 57:21;
120:15; 123:1,126:19;
17l:ll;
186:9;201:7;
244:3
Director
133:ll, 14;
134:1,5,22,25;
135:6;
136:6, 11, 13; 139:14;
147:6; 152:18; 174:24;
207:3; 245:9
Directors
165:4
disadvantage
103:12
disagree
72: 12; 109:25
disagreement
273:3
disagreements
26: 11

-

256:lO; 262:12, 18,25;
274:19; 276:17
discussions
7%; 1922;
63:8; 97:12; 126:20;
136:19; 161:12; 1806

Food and Drug Administration
Oncologic Drugs Advisory Committee
distribution
100:12;
155:14; 184:8; 213:5;
259:20

97:2; 100:6,6; 111:5;
113:3; 181:20; 229:23;
235:23,24

diversion

dose-ranging
67:19

218:19; 227:l

divert 221:7; 226:23
disease
13:2,10, 12,17,
divided
183:17
21,24;14.15,22;
15:5,24;
dividing
94:11
16:8; 18:9; 19:6; 21: 1,8,
Division
6:15,16;70:14;
10, 13,14,14,15;
23:20,
72:2; 74:2; 133:10, 14,16;
diagnosis
13:15;62:10;
23,25; 24:1,14, 17,17;
179:3,4; 188:16; 237:23;
140:5; 169:23; 17O:ll;
25:24; 28:5, 10; 32:7,13;
242~25
174:8,12
37:20,24,25;
38:21,24;
DIXON 135:5,5; 136:ll;
diagram
11:20
39:6; 42:14; 43:6; 51:3;
245:5,6,8; 268:24, 25;
57:22;
58:17;62:21;78:1,
dialogue
166:21; 179:23
272124; 277:16, 17
6,21,22;79:17,
18,18,
dialysis
192:3, 14,21,23;
20; 83: 19; 85: 10, 12;
DNA 203:15
196:l
89:18;99:1,3,4,23;
doctor 8:21; 9:4; 139:17;
Diane 152:15, 17
101:9,13, 19; 102:20;
140:3,11,18,22;
141:17;
die 8:24,25; 17:13; 53:24;
103:7,8; 105:1,4,16;
146:6; 153:23; lS6:15;
139:12; 175:9; 176:15,16;
106:20; 107:23; 108:25;
186:s
177:1,2; 245:25; 248:17
109:13; 117:21; 118:6;
Doctors
16:2; 156: 16;
119:10,12,20;
120:15, 18;
died 31:20; 3212, 10;
157:s; 191:22; 193:3;
122:21;
123:20;
124:5,9,
41:12;53:23;59:4;86:16,
194:25; 195:8; 196:22;
15; 126:25; 127:23;
19; 108:7; 160:24; 177:5;
disappearance
47:ll
197:6,8,9; 198:lS; 220:9,
128:12;
129:lS;
131:4;
243:20
discharge
225:2,3
11,17
139:7,10; 149:6, 10,21;
dies 228:9; 248:21
disciplines
71:3
document
32:18; 47:9;
151:21; 153:6; 151:4, 17;
diet 203:24,25
126:16; 145:17; 188:21;
disclose
254 1; 269:8
155:9; 153:8,11; 161:1;
189:l; 217:25; 230:23;
differ 193:lo
167:18; 169:5; 176:10, 12;
disclosure
167:8
240:8
177:l; 182:2; 198:14,15;
difference
9:24; 10:2;
disconnect
102:22;
documentation
72: 10
200:20; 219:23; 236:ll;
54122; 84:3,5, 19; 87:7;
127:B
239:1;242:10;
244:21;
documented
13:22;
93:9
88: 14; 89:5; 94:7,8; 97:21;
discontinuation
33: 17’;
24523; 246:5; 248:7;
107:25; 213:13, 13;
documents
72:ll;
37: 15; .40: 10, 14; 78-25;
249:21; 256:6; 271:15;
X24; 241:15,16; 275:5
118:13; 127:lO
90:17; loo:14
275:1,7
lerences
76: 16;
Doe
193:1
discontinuations
82:‘~;
disease-related
28:6,8;
195:25; 20216; 265:2,7
92:19
doers 192:13,17
29:3; 99:25
different
12:s; 14:l4;
discontinue
4O:ll; 42:l
dollars
229:23
diseases
78:s; 98:7;
19:12, 13; 47:7;48:6;
discontinued
31:22;
domain
213:7; 264:9;
265: 1
106:19; 126:21; 146:13,
56124; 59:23;61:25;
33: 18; 37:7; 40: 17; 49: 12;
19; 152:21, 153:21;
63:13; 73125; 76:22; 94:9;
58125; 78:23; 79:2; 80:7;
~ done 818; 48:12; 51:23;
154:21; 155:17; 164:25;
96:15;78:17,
17;99:15;
82:10, 11, 17, 19; 108:4
63:23;65:12;67:23;
183:lO;
18i:4;
187:12;
101:23; 111:25; 114:15;
72:23;74:1,19;80:1;
discount
221 21
258:s
115:8; 116:15,23; 118:12,
96:19;
100:s; 103:19;
discourage
259:14
disingenuous
247:21
20; 120: 13, 14; 122: 10,24;
104:14,16; 111:lO;
discourse
203:11, 13;
124:23; 1286; 172:8;
disobedience
209:4
113:12; 115:18; 116:1,16;
204:2
180:12; 181:25; 183:15;
15:6
discovered
170:4
I disorder
, 119:8,20; 120:2; 122:19;
189:12; 190:3; 192:10, 18;
Disorders
152:19,23;
, 125:8.12; 128:22; 131:14:
193:14, 14,15; 194:3;
discovering
151:4
153:17; 238:14; 253~17
141:li; 147:l; 17i:ld;
195~25; 196:4,8, 13;
I 176:8; 181:19; 194:13;
discovery
162:12
displayed
1591
197:10~206:19~ 207121,
201:20; 231:3; 255:7;
discriminate
170:17
disposition
78: 18
212:12; 214:5; &:‘20;

259:19; 262:lO; 266:5;
discuss
10:23;
11:ll;
221~4; 223:7; 226:l;
disqualified
170:15;
267:/i; 271: 12; 273: 17;
23:9; 30:14; 31:24; 34:17;
246:6,12; 254:21; 255:lS;
171 :I9
278: 1
72:13;?9:3;
121:17;
262:2; 264:6; 266:lO;
disrupt
2273
Donna 6:6; 133:22
140:23; 173:l; 180:5;
269: 18; 275: 1; 277:23;
disrupted
164:13
187:18,188:2.4; 190:7, 18;
door 230: 14
278:19,22,25;
27912
dissect
38:19
206:ZO; 232:9; 245: 19
Doran 172:23,24
differently61:14
disseminate
248:24
discussed
2315;
29122;
Dorman
152: 16,17,17
difficult
6514; 69:2; 75:15;
distance
194:1; 215:4
63:8; 108:1,12; 117.18;
76:16; 92: 15; 106:20;
dosage8:17;
19:13
23s: 17
distinct
20:24
107:21; 123:16; 143:lS;
dose 19: 17,19, 24;
discusses
107:19; 187:2
distinctive
172:9
150:3; 158:12; 197:20
22:18; 23:lG; 24:22; 25:1,
discussing
17:l; 18:23;
1 distinguish
253:8
difficulties
104:14
l,ll,
11;32:4,9;40:23;
30:17,22; 151:2
47:15,23; 48:6,10; 54:19;
distinguishing
220:3
difficulty
255:19
discussion
27:23; 28:12;
distorted
139~25; 141:16
57:25; 58:1S, 16, 17,18,
mma 254:5; 271:7
31:18; 32:24; 36:ll;
21; 59:16; 67:17. 18; 68:2,
distracted
24
1:6
h,lninish
8~19
~ 37:14; 41:4; 54:9; 106:13;
6, 15,15,16,17;
75:22,
distribute
247:ll
diminishes
74:6,8
108:15.113:18,22;
117:2;
22,24,25; 76:1, 1,4, 10,
distributed
105:22;
1 121:3; 127:25; 131.11;
diminutions
87:9
12; 77:4; 80:22,23,25;
213:25
~ 178:25,188:15;212:17,
81:1,2,3,4,7;91:18;
diphenhydramine
224:14; 232:25; 243:ll;
distributing
205:23
93:17,19; 95:9, 10.11;
25:10;76:25
diagnosed
8: 10,13;
13:13; 14:12;67:10;
137:18; 160:5,22; 161:l;
169:19; 1745; 243:20

devised - DR (10)

Min-U-Script@

19:11,15;

dose-related

222:3

doses 19:12; 47:14,22,
24; 67:23,25,25;
68: 14;
9518; lOO:ll, 16; 230:12
dosing 47:21; 48:3,5,6,
22,23;49:2;
67:21,22;
68:8, lo, 11, 14;74:3,7,
10;76:2,3,9,
17,18;
93:20; 95:18,25; 96:21
dost 30:20
dotted
double

48: I 5
146:17

double-blind
27114

226:9;

double-edged
doubling

264:l

243

doubt 151:18; 213:21
Douglas
6:8; 13320
Dow 142:8
down 10:4; 39:15; 454;
48:16,21;49:3;
51:10;
52:6; 7O:lO; 87:20, 23;
88:6;90:13;95:15;
143:23; 157:24; 204:s;
223:23; 22417; 239:s;
249:18; 255122
downside
doxorubicin

267:21
44:7

DR 5:3,4,6,6,
11,13, 15,
18,20,22,24;
6:1,4,6,8,
10, 12,14, 16, 19; 7:20,
24;8:3; 10:12,19; 11:2,3,
7,8,8; 12:25; 13:4, 18:20,
~ 22;21:4,5;26:7,8,9,12,
13; 43:21,22,25;
44:4,21;
45:5,23,23,24,24;
46:12,
17,21,22,24;
47:9, 13;
48:3,8,20,23,25;
49: 1,
13,16; 50:1,2,2,3,
12,14,
/ 15; 51:14,17; 52:2,12, 14,
20,23; 53:1,2,8, 15,22;
54:6,8, 15,24; 55:12, 14;
56:8;57:1,1,2,2,8,10,
17,23; 58:4,6,8, 11; 59:3,
5,7,9,20; 60:2,4, 11, 11,
12,17,20,24;
61:4,8, 10,
lO,ll,
18,21;62:1,14,
l,f, 15; 63:7,17,2?;
64:5,
7,8,12, 16,19, 19,20,20,
22,23;
65:6,9,9, 10,14;
__
~ 66:3,3,4,10,25;
67:7,16,
18;68:19,20,20,22;
69~2,
16; 70:6,9,13; 72:2,4,5;
7,1:1;75:21;77:21,85:21;
94:3,4,5,15,
17,19,23;
95:1,8,13,20,20,21;
96:2,3,5,7,8,10,
12,14;
97:5,8,13,16,18,25,25;
98:1,9,18,23,24;99:12,
16,17,20,21;
100:3,3,4,
8, 19,19,20,21;
lOl:l,
15,15, 16,20; 103:10, 10,
11; 104:4,8, 11; 105:2, 19,

Food and Drug Administration
Oncologic Drugs Advisory Committee
--_

24. 24; 106:l. 2,9. 16. 17,
18; 24; 108:15, 17; 109:10,
24,24,25; 110:16,16, 17;
111:8,13,13,~4,14,23;
112:12, 12,13,23; 113:h
6,7, 13,17,24; 114:14;
115:14,14,15,17;
llG:ll,
11,12; 117:19; 118:20;
119:25,25; 120:1,9,20;
121:4; 122:8,9, 15,22,22,
23; 123:5,17,25;
124:2,4,
18, 21, 21, 22; 125:4,4, 5,
5.25,25,25;
126:1,13;
127:11, 11, 12, 13, 14, 14,
17,19,21,22,24;
128:8,
8, 23; 129:13, 13, 14;
130:2,2,3,3,14,
19;
131:10,10,11,21,21,22,
24; 132:4,8,8, 10, 10, 18;
133:2,7, 10, 10, 12, 14,
16, IS, 20,22,24; 134:1,
4,7,9,11,13,16,13,20,
22; 135:7,7, 10, 13;
136:1/i, 16; 137:4,8;
139:11, 14; 140:8,12, 17;
141:6,9,9, 10; 142:5;
147:3; 149:23; 152:12,14,
15; 154:19; 157:10,12;
160:3; 162:14; 165~2;
167:3; 169:14,15; 172:23;
174:16,23; 175:5, 11;
176:19; 178:10, 13: 18;
184:17, 17; 187:25; 188:1,
2,9,15,20,23;
189:6,7,
16, 15),22; 195:17; 198:24;
206:10, 11,12,23; 2156,
9, 12, 23; 217:14, 17, 19;
220:9; 222~24; 224:23;
233:2, 2,3; 240: 19;
241:19; 243:2,7; 245:4;
249:7; 258: 11; 262:9;
263:19,20; 264:5, 11,23;
265: 1 1, 1 1, 12,22; 267:9,
10; 268:24; 269:12, 12, 13;
271:3,/i; 272:5,23; 273:8,
8.9; 274122, 22,23;
275:16, 16,17; 277:16, 19,
13,20; 278:6,6,7,7,
10,
11, 17, 17, 18; 279:6,6,8,
20, 23
drafted
153:9
dramatic
36:7; 253:3;
256:20; 265:2,8
dramatically
37:4; 214 7;
250125; 25117
drastically
174:4
draw 118:20; 144:22;
196:21; 252:20;260:15;
264:s
drawn 183:22;
223:19
drive 228:2.1
driven 147:23
driving
19O:lO;
drop 61:1;99:8;
dropped
37:4;
drove 9:9
Drs 7:4
Drug 6:25; 8:s;
---___

184:20;

235:21
105:j
111:2

9:14;

______

/ 11:lB: 17:15; 37:6;40:20;
41:2;42:1;4;:12;55:3;
57:25; 58:24; 81:18,20;
83:3; 102:23; 103:7,13;
105:2; 107:22; 108:24;
109:2,4; 110:14, 17, ?;
11l:ll;
112:7, 14; 115:11,
12,16,22; 116:2, 10,20,
21; 117:3,5,7,9;
118:7;
120:7; 123:6,8,14,18,2S;
126:7, 11; 127:2; 129:20,
20; 130:s; 13519; 137:17,
24; 138:2,13; 14O:l;
141:18,19; 142:4,21;
144:4,15,21;
145:7, 13,
21,24; 146:2,25; 150:9,
20,22,23;
153:8, 11,19,
22; lj4:ll;
155:8,19;
156:16; 158:2,5,6, 17,19,
20,23,24;
159:2,13;
161:8,7,20;
162:ll;
163:13, 19,21,23; 164:3,
8, 10, 166:2,3,4,7,11,15;
167:23,25; 168:1, 10;
170:6,21; 171:4,6,12;
172:11,16; 179:4,24;
180:11,18,21,25;
181:1,
5,8,7, 11, 14,20, 22,23;
182:3,6,8,11,
16,18,21,
22; 183: 1,6; 184:8,24;
185:20, 21; 186:18,21,23;
187:2, 5,9; 188A, 8;
197:25; 214:12; 216:16;
217:4, ,4; 218:2,5,7,10,
15,21; 219:2; 220:6, 11,
23; 22117, IS, 22,25;
222:2; 223:9; 224:15,21;
226:3,6,13,
19; 228:6,7,
8,12; 19,23; 223:17,17;
230:2, 12, 15,19,20;
231:5,9,20;
232:l;
234:13,25; 235:6,25;
236:19,22;237:18;
238:20,239: 14; 240:9,22;
241:8, 11,21,25; 242:3,6,
7,13,17,25;
246:20,20;
247:1, 14,1S, 15,19,19,
23; 248:3,12, 14,19;
249:21,250:7;
251:1,2;
254:14,19,24;
256:12,16,
257:21; 259:12; 260:3,8,
17,23; 261:22; 264:2,3,
21; 269:4; 270:22,24;
271:1, 16, 18,20,21,24;
;72:1,22; 275:6,7; 279:3,
drug’s 171:lO; 183:s;
186:l; 187:4
drug-related
82:19;
83:13; 92:22
drugs 65:3; 116:9;
118:14, 130:13; 133:13;
137:17, 143:3; 147:12,20;
148:6, 15; 149:8,151:9,
10,20; 153:2,7,20;
154:18,20,23;
155:5,14;
lS7:21; 159:19; 160:1;
161:6,7; 162:19; 163:ll;
! ;6;:;;,
;“,‘;‘,‘,l2;;;K$,
/ 1?2:1 jr 17kl<,
--l-.--L

1;9:1,2,’

Hearing Volume 2
December 14,200O

3,4,8, 11, 15,25; 180:8,
10; 182:14; 183:14, 17;
184:ll;
185:12,15; 186:5;
198:1,3; 214:2; 216:3, 15,
17,21;217:12;
221:12,12;
225:13; 22614; 229:22;
232:19; 237:22; 238:19;
239:5; 245:-7, 17,19;
246:14,22; 247:8,11;
248:s; 251:6, 10,ll;
255:6,22; 257:6,7; 25914,
4, 10,15,18; 263:5,22;
270:15; 273:12; 275:13;
278:3
duality

ease

durable
118:lB

252:15

134:3; 194:6
21:24; 26:22;

duration
24:14; 25:5;
10.24; 4919; 51:23; 69:6,
11,13,15;76:19;79:10,
22;92:11; 106:4,10;
107:5; 109: 17; 113:3
during 12:21; 24:21,22;
27123; 32:lO; 33:2; 35:17;
36:17; 37:4; 38:lO; 41:24;
j8:21;60:25;61:8;
63:s;
;4:2; 66:13; 74:19; 83:14;
>3:9; 145:ll; 168:lO;
L7’:15; 210:3; 213:2;
!18:2; 261:13; 263:s
JWell
228:23
fying 13:24; 15:6; 323;
zoo: 14
( fyscrasia
86.1
dysfunction
105:13
-

E
e 153:10
e-mails 237:23
eager 155:6; 157:l
EAP 237:19
earlier 9:17,21; 26:23;
27:1;33:22;56:16;62:12;
104:25; 116:21; 119:18,
19; 120:2; 170:20; 186:10,
14; 207:17; 21O:lO;
212:23; 217:14; 219:4;
220:12; 230:19; 232:19;
233:lS; 237:17; 238:15;
239:13; 240:3; 255:20;
256:17; 261:s
early 46:s; 51:s; 61:s;
115:5; 118:25; 142:12;
161:2; 173:s; 192:s;
19616; 207:lO; 219:24;
229:5, 12,24; 230:4,6;
237:14; 242:18; 253:4;
~ 255124; 263:22,25; 265:l;
269:24; 272:9; 275:l
-.

Min-U-Script@

176:23; 194:s; 217:20;
253: 17
either/or
90:20
elaborate
198:2

64:s

easily 227:3
Easter 8: 19,20
easy 189:15; 195:3;
264: 10
echo 112:14; 113:s;
124:lB; 216:9; 224:ll

due 31:22; 32:11;33:17,
18;34:12,22;35:8;42:1,
4; 80:6; 81:18,22,22,23;
93:24; 102:lS; 128:lO;
137:s; 149:20; 173:17;
17j:2j; 178:4; 244:3
Duke

150:9

easiest

/

Elderly

198:15;274:18

elected
238:13

235:9; 236:l;

elegant

202: 12; 277:23

Edinborough
276:3
editorials
279:14

element

67:21

Edmund
educate

elevated

elements

134:20
179:lo

educated
179:12; 214:22
educates
149:25
education
152:24; 215:l;
227:14; 243:23; 255:13;
277:15
educational
16514;
274:ll
effect 10:9; 50:7; 87125;
88: 1; 89:20,20; 104:9;
131:4; 141:1; 146:19,21;
187:4
’effective 30:3; 42: 17;
13: 10, 11; 44:s; 55:5,19;
37:3; 128:14; 130:9, 11;
138:24; 141:21; 142:3;
148:5,7; 182:19; 183:2,8;
1X6:23; 200:3; 204:s;
233:21; 250:23; 259:l;
?60:11; 261:2; 273:16

eligibility
169:1,3;

effort 142:19; 236:12;
240:14; 277:15
efforts
126:24; 139:20;
141:15; 142:2; 164:12;
167:s; 208~21; 209:l;
237: 18; 258: 19; 262:s
EGFR 234:14; 241:20,
23,23
eight 10:s
either 23:25; 29:16;
49:15; 57:20; 63:19;
101:6; 10417; 109:20;
114:19;115:12;
117:6;
132:5; 166:3; 172:3;

61:16; 109:s;
246:15; 26O:l

eligible 78:2,5; 145:4;
150:7; 157:25; 167:l;
168:15; 218:17; 272:20
eliminate
25O:l
eliminated
14S:14
elimination
Ellin 5:6

21:7

else63:19,
19; 112:16;
150:19; 162:13; 266:6;
279:24
i ’eke’s 178:9
Embarrassing
199:1
Embittered
1 s9:4
smerge

I

I ,:

&feCtiVeneSS
18:25
effector
6S:25
effects 9:19; 14:22;
16:15; 50:8,9; 62:20,20,
21; 75:24; 103:25; 108:5;
151:24; 175:2; 232:3,6,
13; 272:9
efficacious
166:5;
220:23; 222:15, 16;
246:21,23; 260:s
efficacy
18:24; 20: 13;
30:2;42:17;73:15;79:4,
24;80:10;93:20;
106:13,
21; 108:l; 115:12; 128:6;
147:19; 149:l; 152:24;
162:ll; 164:3; 167:22;
168:19; 186:2; 198:l;
219:24; 220:6,15,21,
23;
251:4; 253:ll; 254:20;
255:23; 256:2
efficient
185:11;234:4;
245:17

22: 13,22
4S:14

!

261:lo.

12

’emerged 19:23; 170:23;
196:13
emergence
65: 19
emergency
226:lG
emerges 42:s
emerging
143:l
Emili
21:5
?motionaf
245:12
emphasis
30:25
?mphasize
75:s; 124:9;
I174:7; 220:s
f?mpiriCal 201:20; 268: 18
f employed
202:s
employee
167:5
employers
163:3
employs
239:17
empowered
I 59:s;
205:21
empowerment
empty-handed
enabled
238:5
enacted
152.”
d,

14 5: 16
177:22

encephalopathy
81125
encourage
112:21;
255125
encouraged
45125;
15,i:15; 157:15; 170:12
encouragement
104:22
encourages
154:12;
255:lO
encouraging
19:20;
22:9; 26:24; 24j:17
end 9:7; 13:23; 15:s; 16:s;
74:8;94:18;
120:9; l45:l;
151:23,25; 192:25; 197:2;
21515; 232:20; 279~9
---

(11)

drafted

- end

Hearing Volume 2
December l&2000
end-all
end-stage
ding

231:16
141:8; 146:14

dorsement
endorses

-

.- --.--~

277: 1

8:7
182:24

entry 22:17; 29:l; 37:23;
39:21; 43:8,9; 53:12;
87:14;88:11,
l&90:19,
150:8, 14; 151:5; 209:14;
219:23; 254:18
environment

255:10

en‘dostatin

204:6

eosinophils

endothelial

147:17

epidemic

2006

episodes

83: 16,17

endpoint
22117; 24:6;
72:24; 106:13; 116:18;
122:5; 272:s
endpoints
24: 13; 107:9,
9; 114:20, 23,24; 115:6,6;
265:7; 272:12
energetic
enforce

174:8
236:18

engage 267:8
England
122:15; 128:24
enhance
220:5
enhancement
152:5
enhancing

266:16, 17

enlarged

16:18

enlargement

14:8,9

enormous
189:25;
202:19; 204:;1; 206:6;
238:11;240:14
enough 76:15; 113:15;
114:lO; 12l:G; 140:21;
143:20; 158:20; 162:l;
1929; 218:s; 221:10;
9:8, 14, 15; 230:4;
I : 19; 266:20
enrich 150:25
enroll 252:12;271:11
enrolled
19:15; 20:4,7,9,
12,21,23;22:2;25:13,20;
28: 15, 18; 29:s; 30: 17;
31:s; 33:24; 36:6,24; 38:6;
39:12; 43:5; 48:13; 60:10;
62:9; 118:3;210:1;
242~22; 277:7,7
enrolling
29:14; 37:18;
11:11;74:16,22;249:11;
270125
enrollment
167:7; 244:4;
25218; 253:15
ensure
155:2; 162:21;
164:12,20; 205:3; 251:4
ensuring
157:5,7;
213:19
enter 39:3;42:11;64:11;
150:16
entered 31:13;91:10;
159:7; 209: 15,22
entering
129:6
enterprise
164: 13;
200:4; 206:8; 215:21
entertain

218:24; 224~22

wthusiasm
204:4
ire 218:5; 221:6; 227:3
entirely
51:l; 128:16;
207:21; 211:21
entities
1299
entitled
entrants

138:5; 153:lO
209: 16

end-all - experimental

50:17

equal 195:24; 212:16,l6;
236:8, 12; 273:10
equals 195:24,24
equation
I1 1:20; 221:4,
4
equipoise
276122; 277:4,
8; 278: 19,22
Equity 241:13
equivalent
25:18; 129:20
era 214:6; 229:2
erhythrocytes
71:14
erroneous
62:22
error 62:17;64:6; 77:21
ERWIN 135:3,3; 136:6;
249:7,8; 263: 1; 272:23,
24; 277: 17
erythropoietin
29:12;
51.19
escalated
75.24; 76:4,9;
95:9,16
escalation
24:22; 25:ll;
58:21; 73:17
ESHAP 69:25
esophagitis
35:12
especially
42:12; 46:17;
59.14;84:24;
102:lO;
110:7; 15O:l; 171:l;
173:13; 186:24; 191:16;
192:1, 12; 200 5; 242:10;
256:25; 262:16; 264:15;
26512
essentially
11:22,23;
28:2; 48:12; 62:22,25;
63:5,15; 68:6,7; 116:22;
170:19; 251:21; 263:17
established
147:20;
170:17; 1x:13
estimated
estimates

86.12
74:11

estimation
97:3
et 18:3; 35:20;79:12;
198:23
’ etc 32 21;66:14; 126:5,5;
I 140:7; 190:17
~ ethic 190:22,24
ethical
189:21;
193:18;
j 199:22;

Food and Drug Administration
Oncologic Drugs Advisory Committee

140:17,19; 178:2;
190:2,2,4,15,
18;
195:19; 196:3, 11;
200~22; 206:4,5;

/ 211:8;231:19
I ethically
217:il
/ ethicist
195:8
~ ethicists
179:21
! Ethics 134:2,21; 190:9,
1 10, 12,20; 193:6; 195:3;
/ 196:9,13,18,
19; 197:23;
--

(12)

199:4; 200:10; 242:l;
275:18,20,22;
276:21

evidence-based
260: 15

Europe 31:5; 60:9,10;
75:1,4; 159:15; 197:9

evolved
119:11,14,23;
126:20
exact 53:7; 204: 12

European
56:16

20:3; 31:4;

evaluable

138: 15

evaluate
19:17; 13O:lO;
136:5; 180:7; 214:2;
244:17; 253:2

258: 18;

exactly
35:22; 67:7;
104:lO; 123:23; 127:19;
131:22; 144:5; 280:1
exaggerate
exaggerated

270:7,8
270:3

evaluated
17:25;77:25;
97:ll; 174:23; 182:l

exaggeration
examination

evaluating
182:15;
186:16; 187:l; 244:13

examinations
13:14
example
57:6; 101:5;
115:23; 117:24; 153:22;
155:7; 219:7; 230: 18;
232:11;248:21;276:10,
11; 277~24; 278:2,5;
279: 11
examples
145:12;
146:23; 229122; 265:3;
277:22,23; 279:9,10, 18
exceed 30:7; 38: 13
exceeded
27:18; 30:5,7;
42:21; 255:3
exceeds
26: 15

Evaluation
7: 1; 79:lO;
86:3; 135:20; 174:17;
176:7
evaluations
64:6
evaluators

149:16

even 6:22; 9:13, 18; 10:5;
14:12; 15:21; 18:9, 14;
63:14;65:23;
110:9;
116:24; 124:6; 128123;
135:16; 138:19; 139:24;
145:24; 149:l; 151:22;
156:24,25; 158:18;
175:21; 186:4; 197:18;
198:21,21; 202:9; 207:22;
211:6,24; 216:6; 219:25;
220:18; 222:5; 226:25;
232:17; 240:23; 244:9,18;
246122; 250:7; 253:3,22;
261:8; 264:17; 272:6, 12;
274:17; 275:21
event 7:8; 21:21; 26:19;
33:19; 37:15,16,18;
46:19;59:1;67:1;75:2;
79:2; 83:1, 11; 92:22;
136:19; 139:2;227:11,25;
248:22; 269:7
event-free
60: 14
events
12:9; 14:16;
24124; 259; 31:19,22,24;
32: 16,20, 25; 33: 1, 1,3,5,
11, 12.15, 15, 17;38:2;
41:23,24; 42:2; 46:7,10,
15;54:17, 18,21;60:21,
24,25;78:24;
81:3, 10;
82:4,20, 25; 83:2,3,10,
13,13,24,25;
84:4,7;
92:19,20,23,24;
100:12,
14,17; 220:20; 256:13
eventually
8:14; 70:2;
208:12; 210:13
everybody
185:l; 240:8;
243:3; 27924
everyone
70:9; 132:20;
133:7; 137:5; 141:6;
151:25; 157:18; 173:13;
272:14, 17
evidence
44:6; 50:21;
52:3;59:18;66:15;99:1;
102:5; 114:19; 118:24;
138:lS; l/15:7; 148:16;
149:8; 164:2; 182:3,4,8;
186:1, 17; 187:3,20,21;
197:20; 222:15; 261:22;
265:6

-I

Min-U-Script@

230:8
193:7

excellent
94:5; 97: 13;
234:8; 249:5
Except 132:lO; 146:4;
176:8; 247124
exception
70:20; 158:5;
185:5,7
exceptions
7:2; 135:21;
168:9; 232:23
excess
125:23; 230:4
exchanged
237:23
excited
138:8; 174:22;
175:14; 230:5
exciting
128:13; 139:13
exclude
7: I 1; 136:22
excluded
87:24; 88:20
exclusion
7:12;75:19;
136:23; 150:24
exclusive
36:19
exclusively
20:7,9;
37:19; 43:5
exclusivity
154:9;
244:20
excuse
excuses

140:24; 255:20
154: 12

Executive
5:22; 134:7;
135:5; 136:ll;
142:7;
245:9
exemplified
190:24
exemption
217:6,19;
22017; 222124; 244~22;
270: 24
exemptions
253:21;
’ 270:14
exercise
165:18; 212:17;
223:2
exhausted
139:7,9,20;
1 170:14; 171:18; 211:2
i exhausting
234:l
1 exist 157:6; 166:13;

204:25; 264:17
existing
15l:lO; 154:14;
166:9,16; 185:5,5,6,9
expand
257:14

68:22; 214:12;

expanded
155:1,12;
163:12; 167:7,11, 14;
183:18,19,23,25;
184:5,
10, 14; 185:16; 207:18,20;
208:1,5,19,22;
209:9,11,
20; 210:2,4,7,
14,19,22,
24; 211:lO; 213:10, 18,23;
214:2; 217:15, 16,18;
219:21; 220:4; 222124;
230:17; 231:11, 14;
233124; 235: 15,21,22;
236:2; 237:4,4,8,
19;
238:21; 239:7,22; 241:6;
242:8,22; 250:14; 253:8,
10,17,23; 254:11, 15;
255:ll; 259:20,23; 260:2,
5; 262:6; 263:5
expanding
24 I:24
expect 27:5; 32:12;
41:18,20;70:5;84:6;
109:3; 129:8; 181:1
expectancy
14:13;
17:16; 18:6;75:18; 161:2
expectation
18:5, 12;
104:11,12; 161:10; 252:6,
17; 253:9
expectations
17:24;
193:15; 233:14; 259:9
expected
42~5; 98:5;
109:13; 139:12; 232:3;
248:17
expects
3215
expediting
23510
I
expense
15916
i
I expenses
167:9
experience
8:3; 16:5,25;
33:10;44:1;45:17;46:18;
49: 11; 52:24; 58:20;
69:15;107:22;
112:19;
128:9; 142:16; 149:9;
158:8; 167:12; 169:8,18,
19; 172:22; 179:20;
180:25; 181:3; 207:13,22;
212:22; 219:5;221:11,16;
224:12; 225:12; 234:12,
13; 235:18; 238:15;
239:10; 249:14; 254:19;
257:22
cnexperienced
28:17,21,
24; 33:25; 37:22; 49:14;
56:13; 108:6; 110:21;
113:18; 169:25; 177:19;
227:13; 244:7
experiences
46: 16;
108:7; 110:18; 184:18;
271:15
experiment
202: 14;
203:13,21
experimental
9:l; 155:5,
7; 157:1,21,24;
165:19;
177:2; 179~11, 15; 18O:lO;
182:11,16; 183:14, 17;
I 187:15; 2016; 216:17;

,

Food and Drug Administration
Oncologic Drugs Advisory Committee
__-___.--_~--

.

217:12;225:13;226:4,6,
10, 13, 19; 228:8; 234:2;
249:12; 252:14; 253:5;
256:9; 257:5,21; 263:5
experimentation
196:16,17
experiments
196:21,24.,
197:7, 12, 14, 19; 198:ll;
202:14
expert 20:19; 71:2;
164:18
experts
11:7; 98:4;
112:18; 126:5; 127:21,21,
129:9; 180:25
explain 5l:l; 218:3,6
explained
145:S; 170:10
explaining
140:8
explanation
51:1,13;
55:21
explicit
206:l
explicitly
183: 15; 206:8
explore
213:15
explored
l5:13
exponential
13:16
expose
137:16
exposed
15:19;78:10;
174: 10
exposure
44:17; 78:9;
102:5,6; 174:6; 226:12
express
65:17; 178:19;
22617; 241:20,22; 249:3
expressed
11:25; 12: 1;
36: 12; 50: 16, 18; 69:20;
71:7
expression
71:11,24
exquisite

197:18
215:12
~n*-x?14~22
extendeo -A US+:~;.
ertnnd
-.._-..-

extending
l--77:25
extension
213:14;
249:22; 253:3
extensive
16:25; 1249;
249:17
extensively
50:22
extent 62:19,19; 116:7;
256:12
external
238:s; 265:9
extraordinarily
204:7
extraordinary
194:2;
208:23; 251:25
extremely
87:2; 138:25;
150:3; 176:24; 177:lO;
212:1,4; 219:l; 229:6;
252~15; 262~2; 263116;
269:23
exuberant
257:9
eye 137:20; 24214

F
F&D 44:3
fabulous
72: 12
face 202:19,22; 216:25;
247:2; 251:16

face-to-face
faced
facie

208:25

239: 16
196:9

facilitate

213118; 250:2

facilities

144:15; 229.9

facility

218:lO;

facing

104:14; 276:13

229:11

fact 11:16;31:1;36:9;
37:21; 39:24; 63:l; 68:24;
103:25; 104:17; 110:2,3,
8; 112:5; 113:9; 115:5,25;
118:5; 119:ll; 122:16,18;
124:14,25; 126:15; 127:8;
110:22; 145:20; 154:16;
168:6; 177:15; 183:19;
205:24; 211:23; 212:21;
220125; 249:25; 250~24;
251:9; 257:24; 261:3;
263:5,12; 268: 11
facto

126:17

factor 51:21,23,25;
52:1,
13,25;53:3;54:1,4;
59:22;60:1,5;90:11,12,
13, 14, 16; 105:8; 168:16;
252:18
factors
15,16;
53:21;
77:16;
168:l;

24:2; 50:6; 51:6,
52:5, 14; 53:18,19;
60:2,6;66:21;
90:7,8,9,167:21;
187:20

factory
236:16; 241:16
facts 139:3
faculty
207:6
fail 45:18; 51:16;69:21,
22; 151:7; 170:13,14;
2(>7: 11
failed I 1:13; 15:19;
1’:19; 18:l; 2O:S; 23:12,
1’~; 25:25; 30:4; 43:18;
65:2; 69:3; 72:15; 116:8,8;
120:7; 122:2; 138:9,13;
140:14,20; 157:20; 170:1,
1,171:21; 231:5; 239:l
failing 26:2,3; 4 1: 19;
43:7
fails 115:12, I2
failure 1.1:24; 2O:lO;
22: 16; 58: 19; 80:5,6;
116:2,5; 120:24; 138:19;
1+5:23; 249:15; 267:19
fair 88:23;97:1;
168:8;
205:17,17; 259:2!~?62:1
fairly 16:ll; 74:25;
103:24; 196:7; 204:21;
205:19; 260:3; 261:21
fairness
7:15; 137:l;
135:23; 205:15; 255:18;
261:16
faith 176:19
fall 105:lS; 142:14;
201:19; 215:l
fallen 82:23
falls 156.25
false 142:l; 252:7; 258:6,
22; 259:13; 264:4, 10, 17;
I 2’0:4

Hearing Volume 2
December 14, 2000

falsehood

l/10:7

familiar
77119; 158:3;
199:23; 221:22; 233:6;
263:10
families
155:22; 156:24;
165: 13; 169:22; 237:6;
238:17; 240:6; 245112
family 8:9,22; 134:24;
141:14; 157:16; 158:4,8;
173:7; 175:6,8, 17;
176: 17,22,23; 178:6;
20717; 22313; 224~20;
268: 1
famous
192:11,25;
195:7; 198:lO; 235:14
fatICy
199:21
far 127:3; 143:5; 189:24;
211:23; 241:3; 25517;
263:7
fascinated
127:25
fashion
63:11,23; 129:2
fast 11:17; 225:5
fatal 86:10; 93:5; 146:13,
18,25
fate 60: 13
father 8:2,5,10; 9:14,17,
24; 158:5,8; 203:16,21
father’s
8:3; 174:ll

-

7;255:7,9,11,14,21,25;
256:ll;
257:23,24,25;
258:5; 263:8; 265:16, 19;
270:17; 27217, 18

177:25; 232:7

FDA’s 136:3; 153:2;
212:22; 214:2; 215:l;
250:23; 254:3

Finally 110:25; 173:19;
179:25; 182:6; 19O:lS;
195:23;209.11,21;
214:21; 219:l; 220:8;
223:21; 228:14; 232:7;
256:15; 261:15

FDAMA
244:21

financial
7:10,16;
136:21; 137:2; 257:lO

163:19; 164:9;

fear 12918;
171:8

159:22;

fears 171:4,5,10,13
feasible
120:24
feat 208:23
features
14:13; 15:2;
16:16; 32:19; 149:17
febrile 83:17
February
74:18; 8O:l
federal 199:9; 226:7
federally
199: 1

find 32:18; 51:18; 57:lO;
63:24,24; 64:12,25; 69:7;
84:3,4; 89:4; 101:5; 138:8;
158:12; 160:23; 162:9;
170:3; 175:20; 186:13:
197:2b; 199:15;211:8;
224121; 22719; 239121;
261:24; 268: 12; 269:9;
270: 15
finding
151:19
findings
263:25

182:19; 230:6;

federation

152:20

fine 94:23; 264:8

Federico
feeding

26:8
177:8; 219:7

Finger 140:8,12,
141:7,9,9

feel 43:15; 52:5;62:15;
98:4,4,22; 103:24;
106:12; 117:3; 268:12;
270:2
feeling 87:6

fathers
156:20
feels 161:25; 240:12;
fatigue
16:ll; 24:18;
265:19
28:6, 16; 80: 18
ieft 53:19; 118:23;
favor 110:17; 112:13;
140:25; 178:2; 200:20;
121%; 124:3; 255:11
231:9; 236:4; 238:23;
favorable
182120
277125
favoritism
210:12
‘ever
16:lo; 32:21;47:2;
FDA 5:23; 7:lO; 10:22;
S4:24
12:20,23; 19:22; 22:11,
‘ew 30:24; 37:5; 63:13;
12,18; 23:5; 2416; 26:9;
i4:23;84:24;91:15;
28:1;62:16;63:9;70:11,
105:7; 106:21; 137:9;
15;71:25; 94:4; 104:4;
149:8; 160:14; 170:24;
105:20; 107:l; 110:4;
179:19; 180:9; 181:19;
I13:13; 114:lO; 115:2,16;
!02:4; 259: 1
Il8:13; 121:23; 126:2;
ewer 83:23
1283; 132:15; 133:11, 13,
ewest 211113
17; 134:8; 136:21; 143:4,
15, 17,21,25; 145:21;
ica 194:16; 195:3
146:17; 148:13,14,17;
iduciary
191:19; 205:8
149:14; 154:5, 15, 18,24;
‘ield 147:9,20; 151:12;
155:25; 156:3,5,9,11,21,
190:19; 193:16; 205:25
25; 161:6,11,20;
162:l;
-ifteen 32:l; 108:7
164:l; 166:20; 172:25;
Vty 90: 20
175:22, 23; 179:.1,20;
180:10, 16; 18l:ii; 182:21,
ight 160:9
24; 184:l; 185:22,25;
ighting 109:l; 141:21;
186:3,5,5,8,
12; 187:14;
173:4,25; 177:21
188:3; 206:22; 211:16,21;
igure 54:1,4; 195:ll;
212:7,11;213:4,6,15;
198:13,14
214:16; 215:16; 219:10;
,igured 77:25
220:18, 19; 221:8; 223:12;
,igures 112:l
224:6,7,9,
12, 14; 225:6,
,ile 227:10; 228:2; 248:14
18, 19,21; 226:4; 227:10,
12, 2,4; 22813; 22919;
,iled 12:21; 28:1;73:13
231:2, 10; 237:11,22;
,iles 181:16; 184:23
238125; 240:16; 242:14,
iling 73:5
15; 243:14; 244:ll;
ilings 242:17
245:18; 246:2; 247:7, 16,
‘illed lS4:4
17;248:8, 11, 15;249:1;
250:20; 253:6,24; 254:1,
1 f ilter 264:25

Min-U-Script@

final

(13)

18;

finish 55:22; 99:21;
242:21
finished
finite

222:10
155:5

firm7:16;
firmly

137:2; 173:ll
156:3; 211:7

firms 6:25; 719; 135:19;
136:20
first 8: 13; 9:3,11,22,24;
10:l; 14:12; 19:lO; 20:22;
22:14,22,23;
24:22,25;
25: 11; 30: I5,25; 33:3;
36:24; 37:5; 38:9,10;
41:25;43:25;47:13;50:4,
12; 51:4; 58:18,22;60:12;
65:16; 77:4;80:21; 84:24;
87:10;95:5,14,
14; 103:1,
16; 104:s; 105:23; 106:2,
25; 107:8; 112: 17; 122:9,
11,16,23; 123:18,24;
124:3; 125:3,9, 18;
130:14,16; 133:6; 137:11,
11; 143:lO; 148:1, 14;
149:lS; 150:19; 160:13;
171:17; 173:2; 174:20;
178:19; 179:19; 180:9,13;
181:10,13; 184:22; 187:3;
188:2,9; 192:3,4; 193:ll;
194:16; 135:8,13,20;
196:9; 197:4; 203:24;
204:7;208:12;211:12,17;
216:13; 242:7; 243:16;
267:12; 268:5; 271:12;
272:24; 279:14
first-line
15:10; 116:4;
129:23; 130:15; 131:24;
169:25; 170: 12
first-time
174:20
fit 61:24;78:15
fits 86:12; 119:lO
five 2318; 34:15; 78:22;
82:5; 209:25; 213:2
five-stage
14:5

experimentation

- five-stage

Food and Drug Administration
Oncologic Drugs Advisory Committee

Hearing Volume 2
December 14, 2000
fixation
fixed
“wed

following
6:19;7:2; 11:2;
20:5,81:11,13;
121:19;
135:13,21; 212:25;
22O:ll; 234:19,23; 235:3;
26914

I%:3
219:22
62: 17

w 174:19
flight

174:20,21

follows

23: 11; 25:8

ftrp 90:2; 94: 10

Fonfa

flipped

Food 163:13; 197:25;
203:l; 251:l

201:15

floor 943
flow 3 1: 12; 36: 15; 78:8;
257:3
Fludara

16:22,23;

18:9

forbad
force

forgetting
196:23
form 13:21; 159:2; 174:6;
209:s; 225:6; 230:24;
231:23; 232~4; 240:10, 15,
15,18
formal 100:8,17; 212:s
formalized
1843
format 184:13; 24o:ll
former
154:18
formidable
247.3
fOrtIE
83.1 I; 143:23;
153:d; 189:12; 208:13;
231:17; 238:9, IO
formulation
199:6
forth 72: 1 I; 165:6;
224:13; 235:l; 241:ll;
258:3
fortunate
143:20; 160.1 1
fortunately
110:24;
23624; 250:14
forum 128:1 1; 164:23;
270: 1
forward
61:4;63.15;
131:~~; 132:lG; 151:13;
155:lG; lG9:ll;
180:5;
187:23; 191:25; 197%;
212:13;219:14;274:12,
19; 276:17; 27815
forwards
225:17
foster 255:9; 257:lO
found 44.9; 55:17;71:11,

219:16

focuses
20:l; 19O:ll
focusing
19:7; 20:18;
24:16; 28:4
Foley 177:12

- Good

190:10

forever
15,4:5; 228:22,
271:17
forget 112.1

Flynne 53:2
focus 43:4; 233:23; 250:3

folks 160:25; 190:21;
200:7, 19; 202: 15; 204:6;
208:9; 238:/t, 12, 17;
LZC):lZ:276:16
I_ _,
follow 20:17; 22:l; 28:18;
29:18;36:17; 37:11, 21;
38:13; 12O:l; 140:3;
144:12; 166:ll; 176:l;
226:4; 260: 13; 279~18
follow-up
39:24; 74:17,
“~80:14;89:21;91:21;
7; 227:5,9, 16; 231:1,
L5
followed
35:9; 42:11;
119:17, 19; 137:12;
180:16; 200:19; 217:17;
260:4

2393

forced 269:8
forces 191:22
foreclose
202:3
foremost
211:12
foreseeing
10414

fluid ~21; 82:l
fluids 61:3
fly 1236
flyer’s 174:21

fvration

152:lO

foot 129:18
fooled 277: 12

fludarabine
8: 15; I I : 13;
15:16,20; 17:8, 19; l&l,
17; 20:8, lo; 22:8, 16;
23:12, 14, 16; 25:14,25;
26:2,4; 27:2; 30:4; 31:2,3,
5; 34:20; 35:22; 41:&S,
10; 42:7; 43:7,18; 44:19;
45:ll; 55:16,23; 57:19;
61:15, 19;62:3,4;65:2;
69: 1,8,22; 72: 16; 73:2;
75:12, 13;78:9, 11, 12, 15;
79:16,21;83:20;
846;
88:1,7,12;89:3,
19;
91:18; 94:9,12;98:10,
19,
20; 99:17; 100:23; 101:25;
102:3,4,5,7,10;
104:18,
19; 106:3; 107:5; 109:8;
111:17, 19; 112:3; 117:16;
120:5,7,25;
121:23,24,
25; 122:3, 12, 13,16, 19;
‘I:(;; 125:6, 14, 19;
7:17; 129:1, 10, 20,23;
130:lG; 131:7,23; 132:2,7
fludarabine-containing
62:7
fludarabine-resistant
12j:l

focused

14924;

15; 173:17;
~ ;ziT;;l’,
1
Foundation
5:lo; 135:4;
/ 136:‘; 147:7,10,25;
j 148:lO; lG2:17,25; 163:l;
1 249:3
I founded
160:13
1 founder
136:7; 149:24;
I 243~22
1 four 10:3; 18:2; 24:2;
/ 73:17; 137:18; 166:5;
/ 173:l; 192:20; 193:ZO;
I 226:ll
,_.____
---.-_--_.

(14)

four-cell

271:25

Fourteen

81:18; 137:20

fourth

160:19

fraction

71:9

frames

framing
France

220.9
236: 10; 241:15

Francisco
134:24; 138:6;
207:8, 15; 203:5
Frank
frankly

154:19
219:‘); 261:22

Freedom
7:7; 136: 1
frenzy 219:7
frequencies

19:14

frequency
33: 16; 35124;
67:22; 113:4
frequently
3&l; 183:16;
248:ll; 257:G; 261:24;
275: 1
Friday

25:4; 174:18

friend

224:4,5

friendly
72: 12
friends
15620; 165:13;
175:17; 176:22,24
front 45:7; 125:6; 127:17;
128:2,23; 129:1,6;
132:13; 145:17
front-line
55:22; 56:10,
19
frustrated
70: 1
frustrating
240:5
fueled 197:24; 2oo:ls
fulfilling
278:2
full
7:3; 10:7; 73:7,8;
114:13, 15; 128:16; 170:2,
;;yk,$
176:18; 234:ll;
full-day
162:2
full-scale
210:14
fully 64:4; 118:3; 147:20;
149:l; 173:21,23; 213:Zl;
251:lS
fun 199:11
function
15:1; 31:15;
66:7,12; 97:22; 252:s
functional
fundamental
funded
funding

177:17
258:lB

199: 1
261.21

3j:lO; j2:9; 55:G;
81:22; 84:20; 101:s;
103:22; 105:10, 11; 111:3;
222:14
fungi 34:12
further
.49:1 I; 55%;
73:14;76:17;94:14;
105:19; 121:2; 123:23;
129:lj; 140:24; 141:5,21;
166:18; 172:lS; 203:ll;
221:9; 222:20; 237:14;
25j:9; 2jG:lO; 261:9;
2796

fUllgal

Min-U-Script@

GentalG3;

G

251:2,3,5

framework
190:2,6;
1963; 206:5, 19

Genta 138:2; 140:6,8, 12;
141:15; 142:19,24;
143:lO 24, 145:5. 14615

future 97:l; 16911;
181:20; 186:15; 242:3;
250:5

-39 l&:2

Gentas

1471

gentlemen
g 29:5,10,10;

145:9; 178:19

geographic

51:lB

172:6

geographically

G31-39 138: 12; 139:8,
23; 142:ZO; 144:14

George

gag 156:6

Georgetown

gained

Gerard

210:17; 254:20

gains

151:15

game

145:18; 239:19

Gate 207: 14
253:12; 254:12
166:23; 253:l;

gave 8:23; 94:14; 22212;
233:7; 238:3
Gayle 169:14,15,16;
172:22

263:25

giving 10:8; 13:5; 109:17;
140:24; 144:21; 157:13;
196:5,6; 233:17
glad 167:lO; 187:23
glance 196:9
glass

204:8

151:12

Glaxo 103:14,14
Gleason
86:2
glioblastoma
230:25
global 147:7; 236:7
globulin
14:25
globulins
77:17
glycoprotein
71:6
gm 87:20
GM-CSF 51:19; 53:4,7;
221:21; 232:ll
goat 172:11;210:18;
215:4;217:1
goals 179:17; 213:21

gender 77: 19
Gene 6:7; 133:23; 173:1,
2,5,14,17,20;
174:14,
16,25;175:1,2,7,9,12,
19,22,24; 176:3, 18,19;
177:4,18,23;
178:7;
202:5,14; 203:5,13,21;
! 219:4,9;229:4
/ Genentech
167:X8;
1 168:7; 207: 17; 208: 10;
209:1, 5,6, 12,20; 210:8,
12; 235: 17; 263:s
Genentech’s
167:lO
general 65:3; 105:24;
135:23; 148:25; 15O:ll;
184:25; 188:16; 217:9;
239:lO; 263:13
General’s
150:25
generalizable
201:9;
232:19
generally
5214; 53:24;
115:2,19; 118:23; 122:17;
148:22; 181:18,25; 183%;
; 185:3; 194:24; 219:19;
220:6
generate
252:20; 255:23
generated
117:22;
186:11
generates
258:6
generation
214:15, 17;
255122; 279:15,15
generations
207:5
genetic 66:21
Genevive
72:2
Genny 6:14

2334;

gives 35:5;77:18;83:4;
273:25

gears 196:12
gee 143:12
Gehrig’s
l55:9
Gelsinger
203: 12
Gelsinger’s
203:16
Gena

136:16

2369

gets 102:25; 2054;
225: 17
given 25:8, 10; 65:ll;
71:5;75:13;
121:6; 157:2;
17O:ll; 174:ZO; 176:lS;
192:22; 220:24; 234: 15;
251:17; 258:22; 271:16;
279:13

gamma 14:25; 77:17
Gary 233:11
gathered
gathering
254:ll

134:21

135:lO;

Germany
Gerry

276:3

5:18; 134:11

I

gods 191:9
goes 106:25; 108:ll;
131:16,20; 195:5; 1963;
217:3; 225:16; 240:19;
241:18; 242:6; 266:16, 23;
274: 19
gold 129:4; 271:G
Golden 207: 14
Good 10:19; 50:24;
51:13; j2:21; 54:6;64:1C,
70:13; 102:19; 109:lG;
113:lO; 126:11,22; 147:5;
150:21; 151:4; 152:17;
lGo:il, 24; 162:15; 165:s;
167:4; 172:24; 191:13,23;
192:13, 17; 193:3; 19-416,
17, 23,24; 198122; 20514,
4; 221:25; 22314; 224.16;
229:13; 230:2; 231:9,20;
238:23; 245:6; 254:B;
255:7; 256:23; 257:4;
265125; 273:21; 274:lO;
276:16; 277124; 278:2,4;

Hearing Volume 2
December 14,2OOO

Food and Drug Administration
Oncologic Drugs Advisory Committee
111:19;113:8;122:8;
124:8; 125:24; 133:21;
17612; 184:2,7; 185:15;
131:5; 207:13,16; 208:8;
225:17; 226:18: 238~20;
243:23; 244~11, 19;
248:18; 251:20; 252:l;
273:20

279: 18
goods 194:24; 218:ll;
229:7,20
govern

193:15

governing

154:9

government
144:2;
197:3; 199:ZO; 269:2
grade 31:24,24; 33:5,16,
25; 39:3,6,9,13,16,
17,
19,21, 23, 25,25; 40:G;
41:12;45:10;54:17;
56:21; 82:lZ; 85:6,22;
86:4,25; 87:13, 16, 18, 18,
22,23; S&2,4,5, 5,9,11,
11, 15, 17,19,19,21,22,
25; 89:4,4,7,8,9,
13,22,
23,24; 95:3,6,7,7;
108:3
grading
94:7
gradings
gradual
gradually

groups
17:22; 103:4;
107:25; 113:lO; 1.47:24;
165:lZ; 167:6; 180:2;
183:18; 192:7; 216:8;
233:19; 235:7; 2,10:16;
242123; 244:6; 271124;
274:9
growth
50:6; 51:14,16,
20,23,24; 52: 1,5, 14,19,
25; 53:3, 17, 19,25; 54:3;
77:16;90:6,8,9,
11,12,
13,14,16;14718

94:lO
24:22; 93:17

gruelling

48:lS; 95:16

grafted

1121

grafting

71:23

grandfathered

261:5

guarantee

157:9; 163:6

guarantees
212:lG

guess 8:7; 912%; lO:l, 3;
100:20; 114:16; 116:13;
117:l; 119:22; 123:17;
125:7; 129:19; 130:3,20;
1 j8:22; 192:ZO; 231:ll;
263:25; 269:13

1~11

Grant 133: 12; 206:23;
259:18
granted 7:4; 11:17;
135:23; 259:17
grants 156: 15
granulocytes
50:17,18,
20;71:9;87:1
graph 27:11;32:15,
18;
33:l; 36:3,24; 38:5; 39:14,
15; 48:9
grassroots
160:15
grateful
153:14
grave 99:6; 267: 14;
278: 15
great 13:14;34:18;
112:9;
129:12,17; 138:3; 143:25;
144:18; 163:s; 164:23;
173:9; 199:20; 202:ll;
215:3, 19; 219:20, 21;
220: 11; 225:10; 273:6, 16;
274:4; 279:8,9, 11

173:6;

guests

/
I

136:3

guidance
2%: 1%; 107: I;
118:13; 126:16; 127:lO;
188:Zl; 189:l; 242:15;
247:6
:
!guide 249:19,25
guided 118:lO; 212:20
guideline
171:23
4guidelines
40:lo;
166:18; 171:14;256:3
guy 192:21

H

Hagar 195:?, 15
hair 177: 11
hairy 5717
Hale 12:11, 17
half 8:ll: 10:9; 74:10;
Sl:ll,
18,22;86:12;
95:22; 99:s; 109:ll;
117:8; 160:6
half-life 47:22; 74:5, 12;
green 36:5; 74:2
95:23; 96:18, 18
greeting
194:19
Hallmark
194: 18
grips 104:2
hand
114:2;
121:8,11;
grounded
214:17
151:6; 201:17,18; 253:15;
grounds
213:4
264:3; 266:13
groundwork
250:17
hand-holding
225:13
Group6:9;
11:14; 16:17;
handed
I 40:5
17:4; i9:l; 21:3; 23:19, 24;
’ handled
163:9; 205:19
24%; 25:21; 28:19, 22;
handling
184:21; 226:4
29:7;30:1;31:1,14;45:6;
52:18;61:25;78:5;79:11;
hands 107:11, 13,15;
90:23; 92:4; 94:13; 102:7,
1lO:ll;
114:3,5; 121:9,
12; 105:15; 106:15;
I 13; 15l:ll;
194:4
greater 29:5,9; 60:8;
79:22; 80:25; 81:1, 5; 93:3;
94:12,25; 266:5
greatest
162:lO; 204:9
greatly 141:16,19;
208:17
Greece l91:3

hang
happen

143:16; 156:18

Help 57:3; 63: 11; 72: lo,
18;97:14; 1ll:ll;
120:16
145:7; 157:22; 161:4;
189:4; 191:13; 195:14;
200:14; 203:15,23;
205:20, 22; 217:2,2;
218:19,22; 222:5; 228~20
25217; 268:23

36:14; 193:13

happened
8315; 199:19;
2279; 234124
happening
241:3
happens
14: 15; 201:8,9;
218:23; 269:25
happy 1 i:9,23:9; 43:20;
153:G; 154:8; 206:Zl;
208:4; 247:9
hard 98:16; 102:22;
105:3,7,17;
lS9:ll;
191:22; 200:7; 232:22;
275:21; 277:13
harder 275:21
hardship
177:17
harm 148:25; 191:14;
195:5,9,13,
15,20;
220:10;251:11,
12;
26O:lO; 267:13, 14

helpful
172:ll;
258:lO;

33:lZ; 159:23;
196:6; 199:16;
277:14

helping

152:21; 245:ll

hematopoietic
heme 82:13

hit 264:5
HIV 117:25; 208:5;
210:23; 271:13
Hodgkin’s
103:~
hold 109:22; 142:l;
172:2; 173:17; 175:22,25;
194:4; 260: 13; 261:9;
264:16
holding

honestly
honoring
hoopla

71:15

’I
I 1iemoglobins

29:8; 31:9
iemolysis
58:3
iemolytic
57: 18,20;
j6:17
ienry
192:22
’ Iiepatitis
198:11,13
Herceptin
167:13; 169:s;
207:22; 208:11,15,22;
209: 15,23; 210:9,17;
I 261:12,23; 263:5

health 142:8, 10,12;
149:25; 152:ZO; 162:3,22;
163:4.5; 165:13; 190:5;
193:2 i; 194:ZO; 19614;
214:25; 233:lS; 239:10;
267:ZO
healthcare
191:15;
250:22; 262:6

herpes 25:16; 34:4; 35:3,
10; 101:6
hesitate
129: 15
hey 143:17
hidden

-

162:s

high 33:15; 46:17; 47:4;
56:13; 58:9,19; 59:13;
71:7; 111:18; 124:lO;
158:22; 159:ll;
167:17;
22917; 235:10; 244:3,4;
246:ll; 251:10,21;
263: 17; 269:22
higher 45:17; 54:20;
55:18; 56:1,2; 68:12;
85:22; 86:4; 110:3; 178:2
highest 47:5; 6~16;
167:17
highly 114:22; 1203;
208:18; 222:14; 246:15
Hill 7218
hindered
164:14
hint 276:19
Hippocratic
190:24,25;
191:1,2,7,11;
195:14;
196:14

(15)

9:25; 245:lS

home 174:9; 175:3;
204:16; 228:24
honest8:12;9:11,12;
257:17

hemodialysis
192:5
hemoglobin
294; 38:5,
12,25; 39:2; 40:3; 46:2,6;
36:24; 87:10,13,20,23;
38:4; 89~24; 90:3

hate 116:14
hats 2%1:1,1
head 162:4; 167:5; 264:5
heading
142:15

153:19;

history
71:lG; 72:18;
103:12; 119:23; 126:14;
196:14, IG, 16; 198:13

hematological31:~;
32:22; 37:13; 3&l, 3; 40:2
44:14; 56:21; 128:9
hematopoiesis
21:ll

harmful
196:7; 205:14
Hartford
5:21; 134:lO
harvest
50:24
hasten 211:14

Min-U-Script@

242:24

12:10

Historically
183:24

Helsinki
197: 16; 228: 17;
276:2,3; 278:lO
hematologic
6:2; 38:20;
39:lO; 40:6; 42:8; 81:6;
83: 18; 87:5,6; 92: 14; 93:2
25; 94:6, 10; 108:ll;
109:3; 221:22

Harman 12: 10
harmed
197:20,22;
201:2; 263:12

healthful
%02:10
healthy
170:2,9
hear 45:25; 155:22;
166:20; 179:17; 18O:l;
215:18
heard 2217; 26:23; 27:l;
33:8,21; 46:15; 104:15;
112:18,25; 120:9; 127:13;
178:20; 186:lO; 189:24;
206: 17; 207: 17; 208:2;
211:20,22; 214:18;
215:lG, 18; 231:23;
233:14,19; 234:7,9;
238:1/i; 240:2; 245:22;
274:7,21
Hearing7:19,%1;
113:15;
127:16; 129:14; 137:6,7;
161:25; 162:4; 179:13,21,
23; 180:3; 184:17; 220:4;
265:14; 273:lZ
heavily
55: 1, 10; 74:4;
83:Zl; lo%:%, 25; 106:11;
150:12
height 47:2
heightened
141:20
held 12:19; 142:ll; 209:4
Hello 137:14; l47:5
--

helped

historical

/
I
I

156:4; 230:3
205:7
138:25; 141:12

hope 95; 112:8,9;
131:13; 141:25; 142:l;
143:19; 147:22; 158:7;
162:ll; 172:13; 173:4;
174:13; 206:13, 16, 18;
215:15; 218:2; 244:16, 25;
246~22; 247:4; 251:9;
252:7,21; 255%; 25817,
IO,%%; 259:12, 13; 260:24;
, 264:4, 10, 17; 270:4;
272:15; 27,1:19; 277:21
Iloped 201:~
IlOpefIJI 9:16,18; 174:22
Iiopefully
119:18;
1146:14; 223:12; 238:5;
‘!44:18; 250:ll; 264:23
tlopes 105:2; 137:23;
I161:16
10:8; 128: 1
tloping
Hopkins 6:2; 53:2
iormonal221:13
iormone
214:14

t
t
t
I trorrible
trorrified
tiospitaf

196:Zl
192:15

8:20; 9:3,4,21;
1 40:4; 142:9; 144:12,13,
I ’ 4, 19; 177:7; 198: 15;
j 2!25:2,3
! t iospitalizatinn
83:9
i t rospitalizations
177:19
i t lost 152:4
j t iotlines
165:16
/ t Iour 9:s; 199: 12; 234:9
I t iours74:11,12;75:21;
/ .!16:13;97:6,6; 206:13;
!15:23
1; louse 9:9; 197:ll
luge 202:21; 250:lo
1: luman 11:21;70:19;
‘1:21,24; 152:4; 196:16,
1; 7,24; 197:12,14; 199:14;
’ 2!29:3
ik humanities
134:2

goods - Humanities

Hearing Volume 2
December l&2000

---

humans
;2:13

II-IV 75:12

181:11,14;

11123:25,77:24; 79:18;
84:2; 101:3; 104:6; 111:9;
112:25; 113:14; 118-24;
171:6,20; 172:1,9; 182:7,
7; 187:6; 21O:l:; 229:15,
15; 235:5; 253: 15; 256~4;
261:11,14; 265:5; 275:3
III-IV 21: I; 39:9,12,21
lllbv 25.24; 37:20; 38:24;
39:5;84:4; 1Ol:lS
Ilk 166:25
ILEX 10.21; 12:18; 19:21;
20:16;72:10
ill 168:22; 201:13; 210:20;
214:24; 227:20; 239:11,
240 6; 248: 18; 260: 11

numbleness
128: 11
hundred
105:7
hundreds
182:lo;
184:23; 189:lO
hung 144:8; 197:6
hurdle 27:lS; 42:21
hurt 195:21; 203:16,23;
204:1, 14; 267:3
hurting 205:ll
husband
157:16,25;
159:7; 169:18; 172:13,19
husband’s
157:19;
158:23; 169:23
hybrid 70:22
hydrated
Hygeia

59: 14
191:~

hype 142:4; 234:20;
252:18, 20, 21; 256:24;
263:22
hypoplasia

76:ll;

hypoplastic
hypotension
82:6,7,9; 85:
hypotensive
hypotheses

99:2
60:22,25;
1
60:21
198:22

92:6

I
I-III 79: 19
i.e 149:5; 212:10
IAl 19:ll; 24:21; 58:13;
66:13; 83:24,24; 92:5
lb 167:l
ICU 8.20
idarubicin
44:8,9
idea 83:4; 150:21; 189:7,
14; 231:20; 25~4:8; 276:16
ideal 120:21,21; 213:23
ideas

279:8

identifiable
identification

267:14,15
152:23

identified
34: 15, 16;
67:9,11; 86:s; 224:20
identify
46:22; 86:5, 13;
9(x12; 181:14
IgG-1 11:21;70:17
lgG2b 71:lS
IgM 7t:ls
ignorance
129: 17
ignore 46:4
ignored
154.23
II 14:lO; 19:18,18;48:9;
-~14;68:18;78:1;79:17;
122; 102:3; 149~7;
166:3; 168:20; 171:6,20;
172:1,8; 181:24,24;
182:2,9; 187:6; 197:2;
22215; 229:8,13; 232:11,
16, 18,20; 235:4; 253:12;

humanized

-

254:12; 260:6; 261:13;
265:l; 269:6; 273:15

humanized
11:19; 12:16;
70:17,18;71:22

illness 46:1,5; 157:17,
19; 201:13; 222:9; 251:24;
276:14
illnesses
146:25; 153:16;
163 7
illogical
130:7
illustrates
32.19
imagination
224:2
imagine 45:18; 151:21;
152 8; 159:17; 210:16;
214.13; 225:8; 227:19
imaging
149:13
immediate
219:10;
220:19;223:15,
16;
~ 227:16
i immediately
8?:21;
139:25; 152:6; 158:14;
169:5; 219-14; 237:22,
243:5
immune 105:14; 109:5
immune-based
214:11
immunoacid
70: 19
immunocompromise
55:4
immunocompromised
23:20; 25 14;42:14;43:8;
108:25
immunosuppressed
23:21;31.16;82:22
immunosuppression
14:25; 17 12
immunosuppressive
25: 15; 34.23; 66:23;
103:25; 10X:12, 24
immunotherapy
14:23;
235:12
impact 29.2; 48:l; 50:24;
108:9; 146:24; 176:lO;
241:2,4;245:12;267:17;
268:8; 275:7
impartial
168:l
impediments
247:2
implement
207:17;
209:12; 261:19
implementation
163:14;
208: 1; 253:23
implications
153:14;

- influence

Food and Drug Administration
Oncologic Drugs Advisory Committee

(16)

190:16; 201:24

217:15; 244:23; 262:5

i importance
164:23;
24i:l4;245:16
important
12:7; 28: 10;
31:16; 36:23; 37:3; 38:8;
4313; 46:5; 55:5; 80:20;
102:23; 112:23; 114:23;
119:7; 127:3; 128:lO;
129:25; 146:24; 147:4;
153:l; 154:17; 155:15;
161:13; 162:l; 181:5;
182:14; 186:24; 187:lO;
189:23; 191:9; 202:12;
210:6; 225:25; 235:20;
237:3; 240:21; 24212;
243:13; 245:18,21;
248:24; 250:12,21; 25215,
16; 255:8; 256:lO; 263:l;
269:19; 270:2; 273:1,24;
276:s
importantly
20: 19;
212:15; 258~6

included
20:6; 75:8;
81:17; 87:22; 103:21;
153:8, 18; 163:13
includes
21:15; 30:17;
88:lO; 274:lS

improving

45:25; 46:5

incentive
260:21
inch 151:16,17
incidence
13:11,17;
24123; 25:8; 33:12; 35:16;
36:4,5,8; 52:9; 54:16;
56:1,1,3,14,20;57:18;
58:8,66:19;76:11;
92:20;
100:13,24; 101:4; 246:l
incident
173122
incidental
15:6
incisive
206.25
include 75:11; 8o:lo;
1OO:lO; 123:ll; 149:20;
152:3; 164:4; 214:22;

Min-U-Script@

-

individual
148:3; 157:17;
164:15,19; 165:24; 168:3,
9,13; 179:16; 180:14,20;
183:2,21,22;
21O:ll;
217:5; 219:20; 220:7;
223:s; 240:13; 251:19;
252:4, 13; 253:2,7,8,21,
22; 254:10, 16; 255:lO;
256:14; 257:23; 260:11,
16; 263~7; 273:3
164:6

individually

184:20

75:lo
36:15
2563

inCreaSeS
29:4
increasing
13~12;
220:14; 246:l; 255:23
inCreaSingly
147:21;
177:16; 267:23
incredible
218:20;
251:22
incredibly
1 I 2:22
Incremental
251:7;
!59:5
ncumbent
214:15
ND 147:11; 148:12;
149:15; 153:24; 154:20,
21; 155:1,4,24;
156:lO;
180:10,11,13,
13; 181:16,
L6; 182:17; 184:6,7, 13,
!2,23; 185:3,5, 10,15,
20; 186:11; 188:21,25;
202:9; 207:22; 211:17;
212:7; 217:16; 226:14;
227124; 22812; 26211;
267: 15

inaccessibility
156: 1
inaccessible
156:25
inappropriate
123:25;
200:5; 276: 12
InC 207:17
incapacitating
16:11,19

73:9
126:7; 147:16

individual’s

2579

increase
13:17; 14:20;
21:14; 37:6,7; 39:22; 46:2;
51:25; 74:5,7; 96:17,18;
100:9; 102:6; 105:6;
121:l; 150:23; 160:16;
209:20; 222:1,4; 232:14;
257:1,2,13;
27512
increased
34:21;76:10;
93:s; 100:13

impressed
111:ls
improve
16:13,16; 40:5;
214:25; 222:lO; 232:17
improved
29:9,15, 15;
87:23; 149:11,20; 167:19;
250:24
improvement
9:25;
21:ll; 28:8,9,22,25;
29:6,10,11;
37:22; 44:13;
46:2; 49:7,1 I; 80:18;
89:21,23,25,90:1,10;
92:13; 25915
improvements
21:12;
164:17; 244:6; 25O:lS;
251:8; 256:20
improves
82:7

indicative
indirectly

incongruence
incorporated
incorporation

impossible64:10;89:12;
116:23; 117:18; 118:8;
119:4; 130:24; 210:15;
252: 1; 253: 19; 272:8;
278:23
impoverished
278: 13

72: 13; 116: 1;

including
24:13,17;
26:2; 28:6; 31:24; 32:6, 12;
33:lO; 34:2,21; 42:4;
49124; 71:8,12, 14;
129:12; 136:9; 14O:l;
142:12; 153:16; 155:17;
163:7; 164:6; 165:18;
234:lS; 244:15; 248:16
incompleteness
73:19
inconsistencies

impose 115:3
imposed
251:6

indications
255:l

indeed 13:9; 132:ll;
158:14;211:7;236:16
indefinitely
228:16
independent
2 1:3, I?;
26:6; 62:ll; 109:2
Indian 5:16; 134:14
Indiana 5:lS; 134:12
indicate
95:2/i; 152:2
indicated
11:12; 25:12;
27:17; 80:24; 109: 10;
254:9
indicates
69:21; 211:9
indicating
27: 14; 36:25;
100:5
indication
11:5, 10,14;
116:3; 13O:ll; 231:14

individuals
162:21;
170:18; 171:17; 179:18,
24; 180:12; 196:l; 235:10;
25213; 259125; 26014;
268:7
INDs 156:5; 168:9;
184:24; 188:24; 189:13;
207:23; 210:9,14; 211:12;
212:3,22; 213:11, 18;
214:4; 233:23; 237:s;
253:7,9,22;
254:11, 16;
255:lO; 256:14; 259:16;
261:15; 262:8
inducing
85:24
Induction
12:4; 9323
industry
46:3; 142:to;
159:24,24; 162:3; 179:24;
188:17;213:16;215:9,11;
233:5; 244:12; 263:20;
264:1,4; 272:lS; 274:6
ineffective
1483
ineffiCaCiOUS
267:3
ineligible
185:8
infancy
243:20
infection
13:25; 15:4;
32:6; 33:25; 34: 1,6,21;
35:s; 53:23; 54:19; 55:23;
56:20; 67:4; 76: 11; 81:6;
82:15; 84:21; 222:9, 14,20
infections
17:12; 31:25;
32:14,21; 33:21,22; 34:3,
3,4,12,18,24;35:1,2,6,
10,16, 17,22; 36:1,9;
42:3,5; 52:lO; 54:18; 55:2,
6,7,15, 18; 56:14;67:3;
77:10;81:21;82:14;
83:16;84:9,
11,13,1.4, w;
17,18,20,21,21;91:12;
92:24,25; 93:24; 100:13,
22,24; 101:2,4,9,11;
103:6,19,21,22;
105:1,
10,11,11,15;108:13;
1 Il:S;i;
232:17
infectious
25:16; 34:14;
67:11;83:15;
108:23;
113:ll; 198:17
inference
118:21
inferior
75: 18; 80: 12;
279:14
infiltration
GO:8
influence
88:14; 168:16
--

c

Hearing Volume 2
December 14, 2000

Food and Drug Administration
Oncologic Drugs Advisory Committee
influenced
_
_

208: 17
influential

74:4; 162:22;
233:20

Inform 207:15
information
6:23; 7:7;
22:3,7; 26:25; 40:3,22;
47:20; 52:16,21; 55:20;
66: 11; 67:20; 69:9; 73: 14,
16;75:3;76:15,24;79:4;
83:12; 91:9, 22; 92:3,4,5;
93:11, 19;94:14; 121:5;
128:25,25; 131:2; 135:17;
136:l; 139:15,21,22;
141:10, 14,16,22; 142:s;
157:s; 162:23; 166:2,8,9,
23; 172:10, 10; 175:2;
181:7; 186:ll; 203:22;
215:17; 224:23;227:16;
228:4,5; 231:25; 233:17;
235:6; 241:25; 247:s;
248~24; 254:4,12; 257:13;
259:3; 264:s; 265:1, 5;
266:18;268:21;269:1,
19,
20; 273:lS; 274:9, 10,ll
informative
119:21
informed
173:21; 174:2;
185:24; 196:5; 201:24;
204:19,23; 205:1,2;
214:19,21,22;
22517;
233:16; 239: 12; 240:7;
265: 19; 266:25; 277:4;
279: 1
informs
119:25
infrequent
33:lS; 186:25
._
infusion
24120; 46: 14;
75:21; 82:9
infusion-related
24:24;
25:9; 32:20,25; 33:3, 14,
19; 41:24; 46:8,10, 19;
47:G; 54:10, 14; 67: 1;76:5;
85:6, 18; 93: 14
infusional
67:5; 75:24;
82:5; 83:15; 8422; 108:3,
21
infusions
84:25

164:ll;

263:24

j injustice
156:23
179
I innocuous

interleukin-2

276:ll

/ innovative

243:24

internal
217:3; 218:18;
225:23; 238:17, 17

inoculated

198:12

internally
internet
257:14

inquiries
156:5; 235:s
insert 41:s; 48:4; 1 lo:14
inserted
insight
insights
insisted

interpret

207:23

interpreting
142:21

207:l
153:7

271:9

Instead 147: 15; 149:5;
177:22; 204:15
Institute
136:16; 155:13;
209:23; 216:13; 248:3
instituted
155:12; 214:4
institution
18:l; 154:21;
180:14; 225:9
.
.
.
institutional
156: 14;
205: 10
institutions
171:16;
172:l; 198:lO; 234:20
instruments
149:22
insufficient
29:17
insurers
lG3:3
’ integrated
30:~6; 142:9

intended
184:7
~ intense 57: 14
I intensity
46: 14
intensively
20:23; 25:21;
31:1,14
intent-to-treat
75:7
interaction
193:14
interactions
250:20
Interest 6:18,20;7:2,11,
inherent
277:9
15;34:18;44:5;81:23;
135:12, 14,21; 136:21;
inherently
62~17
137:l; 15O:l; 170:6;
inhibiting
147:17
172:16; 188:12; 194:lO;
inhibitor
234:14
222:5; 228:16; 252:18;
inhibitors
148:21;
257:l; 268:2
149:16
interested
36: 14; 91: 10;
initial 49:22; 93:17;
103:15; 123:2; 128:lS;
102:3; 106:13; 140:5;
218:4; 220:13; 247.10;
169:23; 17O:ll; 234:lS;
263:14
235:3,4; 236:21; 237:16
interesting
55:21; 90:25;
initially
53:6; 75:22;
95:19,22; 119:6; 123:l;
103:13; 158:15;236:1,
14;
124:4,16; 128:14; 186:13;
240:3; 271:22
190%; 221~24; 228:14;
initials
198:23
263:13; 271:7
initiate 186:3; 235:4
interests
6:25; 135:19;
136:4; 182:25; 191:20;
initiated
12:20; 19:23;
198:9
31:6;64:3;91:17;212:8,
217:18,20, 21
interfere
168:24; 175:lS;
186:22; 237:lS; 270:14
initiating
16l:ll
interference
237: 1
initiation
52:l; 66:6
interferon
246:7
injected
198:12, 16
interim 220:21,232:16;
injuring
51:7

92: 15
63:2;
104:15;

interrupted
76:2; 164:21
interruption
82:lO;
93.18; 108:4
interruptions
95:lS
interstitial
34:14; 67:4,
10
interval
27:8,12; 3O:lO;
80:4; 97:23
intervals
22:5; 27:22;
79:7

Inspector
150:25
instance
87:17; 88:20;
89:s; 201:21; 270:21
instances

200:9

147:23; 157:23;

interpretation
73:25

114:9; 177:s

intervention
259:23;
261:l
interventions
107:22;
205:14; 258:23

/
i
i
/
/
/
/

147:20;
153:1,7,11,22;
154:6,13,
18,23; 155:18,23; 158:2;
162:19; 163:11,19,21;
164:3,&S, 10,15; 166:22;
168:19; 179:l; 180:8,11;
183:6; 184:l; 185:6,8, 12,
15; 187:2,18; 201:3;
206:3; 247:l; 249:21;
251:15; 257:7; 259:12,15,
21; 260:10,19,23;
261:7;
262:19; 264:21
investigations
153:10;
182:21

238:12; 240:17

international

input 178:23; 179:14;
189:4

Iinvestigational

246:3

/ innovation

intimately
207:5
into 8:25; 19:15; 20:2,12,
23,30: 17; 40: 19; 54:7;
57:3;64:11; 69:5; 71:24;
89:4;92:2; 105:15; 113:2;
117:2; 119:lO; 120:4;
125:6; 131:15,18; 144:22;
15721; 159:13; 168:22,
24; 178:22; 182:9; 183:17;
186:14; 194:11,23;
196:ll;
197:15,16;
198:23; 199:6; 204:9;

22812; 232113; 23917;
240:3; 258:3; 26l:lO;
262: 12; 264:9,25; 265: 17;
26815; 269:20; 278:7
intravenous
24:20
intrigued
67:3
introduce
70:15
introduced
118:14
introducing
133:7
introduction
5:4; 10: 18;
11.2; 12:24;70:12;71:25;
97:7; 178:13, 17
Introductions
5:2; 133:9;
215:23
introductory
179:20
inundated
259:2
inundation
86:20
invaluable
72:6; 238:1
invariably
1 la:2
invented
196:15
investigate
180:25
investigated
96:25
investigating
183:s
investigation
66120;

Min-U-Script@

270:20,20;

201:23

II

I:

investigator
37: 17;
jS:23; 59:1;65:21;68:10;
139:ll; 150:24; 180:19,
19,21; 181:2; 185:22,23;
201:19; 205:9; 225:7;
227~15; 228:9; 266:19

issued

273: 1

73: 14; 199: 17

issues 131:2; 147:4;
15O:l; 161:23; 167:7;
173:l; 178:21,22; 179:lO;
180:5; 186:23; 187:3;
190:7; 204:4; 205:19;
206:4,6,20;
207:s;
212:19; 217:24,25; 218:l;
221:19,231:24;
23812;
242:16; 261:10,15; 270:4,
19; 274:20; 275:23,24;
276: 18
items

186: 17

ITP 57:20,24;

58:4

Iv 23:25;75:20;76:16,18;
77:24;79:20;
84:2; 101:3;
121:20,23; 123:lS;
124:15; 126:lO; 139:17;
145:3,3,7; 160:5; 161:1

1:

j iinvestigators
11:7; 33:9;
J8:l; 40: 11; 49:23; 50:21;

j2:23; 63:24; 68:5;
126:23; 13l:l; 180:24;
181:13; 182:lS; 197:13,
13;201:16,21;
222:17;
227:13; 231:3; 26712;
! I
i ’176:14
126:23
I i nvesting
218:s;
i nvestment
15O:lO
i nvestors
224:3
i nvitation
169:17; 189:22
i nvited 116:13; 136:3;
:?07:12
inviting
206:23
involve 7:9; 136:19
involved
64:9; 68:5;
98:12; 179:25; 180:12;
207:5; 211:25; 216:3;
222:lS; 234:21; 237:7,22;
240:9; 242:13; 265:20;
270: 11
involvement
7:12,16;
21:10; 124:11,13; 136:23;
137:2; 270:6
involves
184:25
IRB 185:24; 225:s;
238:10; 240:10
lressa 155:10; 234:13;
235: 10; 236:9; 239:4,20;
241:21
Ironically
159:16
Island 9:3, ~4;46:25
Isle 191:3
isolated
81:25; 172:i9
issue 6:20; 102: 15;
104:25; 113:2; 135:14;
150:5; 161:12; 162:l;
164:23; 167:16; 179:19;
221:24; 230:16; 236:20,
23; 239:12,14,23,24;
241:s; 242:2; 243:13;
24916; 255:8, 18; 258:9;
260:25; 261:12,14,23,24;
26212; 264:6; 269:lS;

(171

J

Jackie 729
jail 197:6
James 137:12; 140:3
Jan 134:25; 136:12;
258:12, 13
Janssen
139: 11
January
173:s; 175:12;
177:4
Jeff l2:11
Jefferson
140:4
Jennifer
167:3,4; 2109
jeopardizing
219:2
Jeremy
r34:l; 268:s
Jesse 203:12,16,22
Jesse’s
203:17
Jewish 9:3; 46:25;
198:15
Jim 142:6
Joanne
2@:4
job 69:24; 255:7; 262:lo
Jody 134:13
John 5: 13; 1 1 :8,8; 26:7;
53:l; 134:16
Johns 6:2
Johnson
21:5
joined 140:5; 214:14
joining 233:5
Jones 139:14
Journal
122: 15; 128:24
journalist
199:4
judged 83:14,15
judgment
146:9; 212:17;
237:10
Judy 5:15
July 74:17
jUmp
189:13
juncture
214:13
June 73:13
jurisdiction
215:3
justice
193:21; 195:23;

influenced

- justice

Hearing Volume 2
December 14, 2000
196:7; 197:25; 200:21, 21,
22; 204:20; 205:15;
214:lS
ltifies 224:15
justify
248:5

168:21; 212:3;

K
Kansas
Kanti
kappa

-

5:25; 134:4
11%; 46:20,24
70: 17

Karalinska
56:lS
Karen 5:22; 133:14;
134:7; 172:23; 179:6;
173:l
Karnofsky
Kathy 5:ll;

2917
134:lB

Keating 11:3; 12:25;
13:4; 18:3; 21:4; 43:25;
44:4,21;45:5;
53:15,15;
55: 12, 13; 57:2,8; 64:8,
16,20; 85:21; 100:21;
1Ol:l; 109:lO; 127:22
Keating’s
11:4
KEEGAN 6:16, 16; 63:22;
64:7; 7215; 98:9, 23;
103:10, 11; 133:16, 16;
173:6
keep 31:16; 143:2; 157:7;
‘3124; 265:5; 269:l;
3:11, 18
Kelly 72:9
KELSEN 6:4,4; 97:25;
98:1, 18; 122:22,23;
124:4; 125:25; 126:l;
128:23; 133:24,24
Kelsen’s
124: 18
KENNEALEY
135:10,
lo; 136:16; 184:17;
217:17; 222125; 233:2,3,
4; 264:5,23
kept 8:17; 10:5; 196:23;
199:3
Kettering
5:7; 6:5
key 12:9; 20:22; 22 13,
22; 24: 12; 26: 19; 27:9;
;;;;;32:19;
33:20; 41:7;
kicked 227:2 1
kid 203:24
Kidd 162:14, 15, 15
Kidney 135:6; 136:12;
157:22; 245:9,11,13,14,
23,24, 25; 246:2, 11,21
kids 192:20
kill 147:14
kinase 234: 14
- :nd 9:19; 35:23; 70:4;
:14;84:17;87:25;
yO:25; 96:17; 123:21;
13l:l; 191:22; 204:2;
206:19; 213:13;258:5
kinds 62:22; 192:24;
197:7; 244:7; 252:21;

justifies

- lives

(18)

-

263:lB; 27215
Klebsiella
34:9
knees

151:11

knew 8:16; 9:14,20;
103:2,154:1,6;
176.,G,
15,16,221:25;
222:1,2;
239:20; 272: 14
knowing
127:2,2;
173:24; 195:24; 246:22
knowfedge
I 42: 15;
201:lO; 220~5; 259:22
knowledgeable
233:20;
26l:l’
known 34:20; 129.1;
177:23; 182:4; 197:3;
199:17; 201:4; 253:25;
254124; 255:13; 261:2;
263:s
knows 154: 1
Kroll 137:11,14,14;
14O:ll
Kurt 70:13

L
label

16:23

labeled 226:9
labeling
112:15,21;
188:5
labels 230: 12
laboratory
21:B; 38:3;
181:12
lacking
118:21; 220:23
LACKRITZ
5:8,8; 7:4;
68:21; 63:16, 17,17;
111:23,24
laden 151:24
ladies 145:9; 178:19
laid 217:24
1 language
179:22; 190:7;
I 202:8; 203~4; 206:5;
/ 248:10
large 14:17; 29:3; 35:20;
37:2;6,1:24; 103:17;
112:15; l/13:6; 158:20;
210:16; 216:2; 242:ll;
264:6; 269:2, 15; 270:6
large-scale
136:7;
210:22
larger 129:24; 155:14;
169:21; 182:7; 210.21;
219:22; 229:19; 261:14
fast 21:12;23:15;32:4,9;
45:3;49:13;54:19,24;
55:9; 57:25; 67: 16; 69: 11;
74:16,22;91:18;
108:22;
12O:ll; 121:16; 123:4;
124:17,24; 126:20;
128:12; 139:15; 146:14;
I 148:12; 161:8, i72:23;
177:6; 182:6; 202:4;
203:12; 221:ll;
229:l;
244:23; 258:ll;
259:12;
264:18,268:17;277:21;
lasted

190:25

Food and Drug Administration
Oncologic Drugs Advisory Committee

fasting

10:9; 52:B; 138:16

legs 233:ll
length

Lastly 59:3;91:8; 124:17;
136:16; 237:13
late 14:4; 1516; 141:23;
146:12; 178:8,9; 263:3;
272: 10
Late-Breaking

Latin

194:16; 195:16

latitude
I. 59:12
latter 105:15; 186:23
Laughter
64:15,18;
108:19; 128:17; 129:16;
152:ll; 194:7,9; 269:ll;
276:4; 277: 18
law 179:20
lawyer 224:4
lawyers
258:4
laying 250:17
lead 63:2; 115:6; 120:25;
12112; 229:15; 235:5
Leader
leading
214:9

133:13
160:19; 197:l;

leads 646; 164: 16; 270:4
leap 151:13
learn 138 21; 139:3;
213:12; 219:20, 21,25
learned
169:7; 174:15;
176:3; 260:24; 276:9
learning
197:1,2;
254122; 275122
feast 21:9,23:11,14;
24:9; 36:20,20,21;
37:ll;
50:10, 25; 51:6,7,8;
52:15; 54:23;61:23;62:6;
69:9, 13;8-‘:10;93:15;
97:3; 138:23; 142:7;
146 14; 177:20; 190:6;
191.14; 195:14;217:9;
239 9; 248:2; 251:12;
253:4; 262.18,25; 272:lB
leave41:4;
119:22;
194:l; 217 8; 224:l;
268: 20
leaving
137:25; 232:s
led 24:10; 102:3,6;
103.23; 116:9; 203:19
Lee 10:19, 13:4; 46:21;
47:4; 72: 1 I ; 75: 12; 80: 17;
96:14;97:18
left 28:20; 194:11;
223.25; 23219; 252~4
I left-hand
221:12
legacy 153:13
~
legal
185:18,18; 254:6
,
j Legally
I86:lo, 14
1 Legislative
162: 16,2 1
1 legitimate
171:11;234:4
-

Min-U-Script@

149: 11
95:23
253:7

limitations
267:12,12

263: 18;

limited 11:24;48:11,
12;
71:20; 97:9; 110:20;
118:22; 155:14; 161:5;
168:10; 174:13; 218:2,9;
231:14; 267:17

less 18:7,12; 23:7; 29:B;
31:9,10,10,13;
49:5;
55:10, 19;78:1;80:23;
84:1,8; 85:7; 87:20; 88:12,
13; 91:11,20,23,23;
93:13;94:11;
104:l;
124:15; 139:13; 148:23,
25; 158:13; 177:17;
184:25; 186:24; 214:9;
219:2; 241:9; 264:6

LINDEN 134:22,22;
184:17; 206:11, 12,21;
271:4; 278:6,7,11

lesson 260:24
fetter 73:13; 140:8, 11;
149:23; 157:lO; 169:16
letters 112:16; 137:lO;
188:4; 22719
Leukemia
5: 10; 13:7,8;
57:7; 233:B; 234:B

line 12:lO; 18:lO; 26:12;
34:3;45:4,7;
48:15;69:11;
103:l; 113:19; 120:3,25;
125:6,9; 128:2,23; 129:2,
6; 130:16,17; 131:23;
145:2; 162:B; 175:ll;
218:23; 26~16; 264:8,10

Leukeran
15:11
leukocyte
46:14; 47:2;
59:14
leukocytes
71:7
level 10:2,4; 46:13; 47:6;
53:lO; 76~4; 264:13

lines

late-stage
174:5
later 8:19; 9:2; 23:9; 45:4;
59: 16; 79.3; 86:3; 96:4,6;
115:6; 160:7,23; 169:24;
187:17; 232~25; 236:24;
254:23
139:21

lengthened
lengthening
leniently

138:5

latest

limit 148: 15; 236:2;
262125

57:5

levels 15:l; 37:l; 48:12,
18; 71:7; 74:6
Levine 196:20
Liaison
162:16; 1632;
224:2; 238:l; 242:25
liberty
19325; 194:lo
licensed
kenSee

12:15; 181:2
12:19; 20:17
102:4

licensing
tie 2153
lies 244:16
lieu 7:22
life 8:8,8; 14: 13; 18:6;
29:6;70:5;74:11;75:18;
81:12; 86:13; 95:23;
141:22; 144:l; 146:B;
149:11,20; 158:23; 161:2;
173:22; 177:7,25; 190:21;
192:25; 193:7; 203:24;
204:15; 213:14; 215:l;
222:B; 249:23; 253:3;
278124
life-threatening
15:3;
153:16; 163:7; 164:25;
165:25; 169:5; 184:5;
222:19; 227:ll; 228:l;
248:7
light 108:14; 114:l
likelihood
150:23;
201:22; 242:10
likely 39:6; 99:23; 106:5;
107:7,9, 12; 110:23;
114:21; 116:6; 120:3;
124:14; 130:9; 148:25;
149:6; 15l:l; 186:21;
202:l; 250:7; 252:22,23;
254:15
248~7; 267:l
/ ILikewise

I1
/’

/’

limits
Lincoln
Linda

272:1 I
72:7
72:8

147:16

lingering
204:lB
link 113:14
linked 113:20
LIPPMAN 6:10, lo; 7:5;
Q:lO, 11,21; 111:13,14;
119:25; 12O:l; 124:21,22;
125:25; 127:11, 12;
130:14; 131:21,22;
269:12, 13; 27215; 277:19,
20; 279:7,8
/ i iquid 132: 11
I ist 18:2; 64:16; 226:20
I isted 15:9; 24:2; 26:7;
Ii4:23;67:4;
130:18,25
isten
161:15
I i
~ I istening
143:5,22;
147:2; 215:5; 270:13
listing 67:1
lists 69:20
literally
229:23
literature
17:19; 35:21;
62:25; 6615
litigation
159:22
little 9:16; 10:s; 20:2;
44:1;50:4;65:11;68:22;
7014; 72:17; 73:24,25;
75:6, 15,17; 76:24; 79:14;
80:22; 83:7; 84:22; 97:21;
100:7; 101:2; 103.3;
116:21; 122:14; 125:21;
127:7; 142:15; 147:2;
151:lO; 184:16; 226:l;
233:12,22; 236:20,21;
240:12; 241:25; 256:25;
260:10,21; 264:24;
266:12; 275:1, 22
live 16:3;70:4; 175:lO;
192:25; 198:16
lived 192:21
liver 14:9; 49:5; 137:21,
24; 169:25
lives 146:21; 156:17, 17;
172:19; 174:4; 197:7;
--

Food and Drug Administration
Oncologic Drugs Advisory Committee
-.-___
-__-261:6; 262:3
living
.

70:5; 153:3; 159:20

Livingston
72:8
load 118:l
Loaded
175: 1
lobbied 200:7
local 77:B; 172:14;
174:16
located
165:lO
location
172:2
logical
130: 12; 260: 14
logistics
143: 15,lB;
144:6; 222~22
Long 9:3; 17:20; 45:2;
46:24; 52:3; 69:19; 8712;
10912; 132:20; 204~1;
215:14; 226:20; 251:4;
260: 17
long-run
264:16; 275 7,

13
long-term
1 lo:22
longer 1O:B; 163; 38:15;
51:11;68:25;69:15;
81:16;97:21;
109:12;
110:‘); 117:23; 177:9;
200:23; 251:2,3
longer-term
2639
look 17:lB; 18:2;31:7;
40:20;46:12;
51:2; 52:22;
53:22;54:1,7;55:5;61:14,
25; 69:4; 79:14, 15; 80: 16;
83:2; 84:2,22; 89:ll;
91:16;92:14;94:10;95:~1;
98:9; 100:16; 113:2;
117:5; 127:6,7; 131:14;
143:8,22; 151:6; 152:7;
157:21; 178:22; 186:14;
187:23; 189:ll; 191:19,
22; 199:6; 212:13; 219.24;
250:5, 16; 273:19; 274:20,
20
looked 19: 12; 32:B;
38:22; 44:9; 45:15; 52:7;
55:13, 17; 57:8;69:6;
79:2-i; 80:5; 81:9, 10;
82:24; 83:22; 84:9; 85:10;
87:12, 15;88:3,9;89:2,6;
1OO:l; 192:17,18; 202:20;
274: 1
looking
8:25; 27:l; 5918;
61:21; 74:3; 78:6;90:8,
92:8;94:11; 102:lB;
106:24; 112:lO; 113:ll;
180:5; 193:7; 213:7;
218:22,22; 229125; 23215;
254:G; 272:9; 274: 15
looks 142:25; 228:ll;
229:13; 231:22; 241:9;
273:24
loop 240:3; 258:3
Lorelei 157:13; 16O:l
lose 112:5
loses lo?:24
loss 16:10; 177:11
lost 120: 10; 158:23;
177:12
lot 63:11;66:22;
102:B;

- 122:24

110:21; 112:4; 118:7;
119:l; 123:9,17; 126:19;
131:15; 143:1; 146:13;
169:7; 189:14; 221:6;
225:13,20,232:12;
233:19; 234:20; 238:15,
18; 242:5; 250:19; 256:24;
262~20; 263:23; 269:9,21;
275: 18; 279: 17
lottery 207:16,16; 210:2

major 14:l; 15:2; 16:21;
17:12;33:22;41:14;
63: 16; 68:9; 154:22;
218:B; 223:13; 22612;
252:lB; 269:15; 270:9;
274:ll
majority
13:21,23;
20:25;25:23;34:19;41:3;
43:6; 7O:lB; 77:23;
122:20; 216:23; 235:24

Lou 155:9
lousy 92:16

makes 38:7; 130:24;
193:10; 202:2; 206:s;
213:14; 218:6; 224:17;
251~22; 253:6; 265:9;
270:7; 274:7
making 27:4; 41:16;
62:25; 116:15; 137:9;
148:17; 177:25; 192:15;
201: 15; 229:7, 10; 233: 14;
247123; 249: 10; 255: 16;
26O:lO; 263:14

love 103:9; 176:21
loved 156: 17; 157:7;
158:24; 178:9
low 33:16; 45:10; 47:3,7;
53:13; 56:1;73:10;
221:23; 273:16; 274:16
lower 26: 15; 27:7,16;
30:5,9; 35~17; 39:6,24;
56:14,20; 76:4; 218:lO
lowering
14:25
Loyola 5:12; 134:19
lunch 132 9,19
lung 155:ll; 173:4;
174:6; 235:l; 236:1,3, 10;
237:2; 238:24; 239:19;
241:22
IUngS 8:21
lying 141:3,12; 195:lB
lymph 14:9; 16:18;44:12;
49s
lymphadenopathy
24:4
lymphocyte
24:3; 46:9,
17; 48:15, 20; 49:2; 82:23
lymphocytes
11:25;
85:4; 105: 13
Lymphocytic
5:9; 13:7;
234:B
lymphocytosis
14:8
lymphoma
16:9; 653;
103:lB; 129:7; 279:12
lymphomas
85:22;86:5
lymphomatous
14:18
lysis 58:9,12, 19,24;
59:2, 11, 18; 70:25

male71:12;
maleficence

195:2
199:25

malignancies
612; 107:2;
128:9; 241:20
malignancy
85:25; 93:23
man 173:23; 192:20
manage 50:10; 131:17
manageable
19:7; 41:2;
42:13, 16; 171:16
manageably
43: 12
managed
11 l:7; l41:7
management
15: 15;
18:17; 23:l; 50:9; 131:13,
14; 162:24; 225:23;
236:17
manager
143:ll
managers
163:6
manages
23818
managing
5O:B

i

M
M.D (~11; 53:15; 55:13;
204:6,9
machine
192:14,21,22;
196.1
machines
192:3,6
macroglobulin
45:14
macrophages
7l:B
Madam 45:24; 178:lB
magazine
192:ll
magnitude
189:7
mailing 238:9
main 183:17; 233:23
maintain
254:3
maintained
29: 15; 88:5
maintenance
28:9; 76:l;

Hearing Volume 2
December 14, 2000

I

mandate
215: 1
mandated
25:17; 36:3
manner 166:l; 168:8;
222:3
manufactured
155:B
manufacturer
18O:lB;
185:20;211:17;212:6,10
manufacturer’s
211:19
manufacturers
154:6,
24; 211:15; 212:2; 213:9
manufacturing
228:25,
25; 229116
manuscripts
18:3
many 14:lO; 16:8, 18;
17:3; 45:B; 53:10; 54:10;
64:14;91:10;99:24;
101:lB; 104:25; 105:3;
117:21; 118:14,23; 119:5;
126:21; 132:13; 133:4;
142:ll; 149:9; 150:13;
155:5,17; 161:14; 164:24;
171:4; 172:14, 19; 175:16;
178:20; 179:10,13;
185:14; 188:17; 189:12,
15; 193:19; 208:15; 209:9,

Min-U-Script@

market 112:14; 131:17;
198:3; 205:12; 237:lB;
255:5; 257:5,8

177:13; 178:B; 179:lB;
180:12,17, 17; 181:4,11;
183:5; 186:8,23; 173:lO;
202:3; 205:20,23,24;
207:22; 211:14,22,25;
223:21,21; 234:16,17,23;
235:s; 248:9; 249125;
250:13; 253:17; 25.r.2;
257:15; 259124; 26O:B;
261:9; 263:7,12,21;
269:22; 270:21; 273:14;
274~21; 27512; 278:4,7;
279:4,5
maybe 10:5; 89:17;
108:lB; 125:20; 141:23;
147:l; 204:ll; 223:25;
265:15,21; 270:7,19
mean 52:4,6; 59:3;
112:lB; 113:lB; 124:24;
146:20; 148:19; 189:lO;
202:9; 205:5; 260:16;
267:6; 272113; 277:21

marketed

meaning

25; 211:10; 213:l; 216:3,
25; 220:16,16; 222~25;
229:2,2,22;
230~3; 231:2;
233:10; 236:19; 241:20;
246:13,16; 252:22;
259:lO; 264:ll;
269:5,8
map 249:14
March 73:6; 74:23;
243:12; 279122, 25
margin

28:20; 29: 1

marginal
mark

14l:l;

158:7

145:23; 279:25

marked
24714
markedly
markers
14

10:2; 154:21;
37: 1; 85:7
256:l; 278:13,

208: 12; 250:23

marketing
73:l; 182:22;
184:8,12; 186:20; 208:16;
254:14,20,25;
275:2,6
marrow
12:1;14:11,24;
31:15;37:24;40:8;42:10;
43:9; 49:4; 51:5,7; 60:7;
79:2; 109:4,5; 124:ll;
222~6; 260:25; 276:9
marrows
51:2
Martha 165:2,3
Marti 135:3; 136:6; 249:B
Martin 26:B; 74:2; 14321;
200:16
Maryland
6:3; 199:19
mass 144:5
tIWSSiVt? 24:19; 28:6,18;
58:17
material 226:7; 229:lo;
230: 1,4; 269:5,7
materials
2295
math 266: 14
matter 120:4; 145:20;
175:6; 193:12; 196:lO;
248:6; 252:l; 262122;
268: 11; 269:4
matters 163:4
maximal 76:12; 93:lB
IIWXhiZe
205:9
IIIaXhUm
23:18;76:20,
22; 97:16,19
may 7:6,17; 12:4,7;
38: 14; 40:5; 47: 12; 50:9,
25; 51:7; 54:12; 55:5, IO,
12; 61:13,22; 66:23; 75:3;
81:15; 85:3, 5,24; 97:1.4;
3912; 102:25; 105:2;
107:ll; 108:15; 114:l;
115:2; 118:9; 122:18, 19;
123:11,19; 125:8,16;
128:15; 130:7; 135:25;
137:3; 148:12; 149:11,12,
20,21; 150:20; 152:2,8;
155:13; 160:5; 163:lB;
165:9,19; 166:5,8, 15;
168:11, 12; 176:ll;

109:ll

meaningful
19:3; 29:5;
30:12; 43~2; 205:2;
209:lB; 213:ZO; 22O:l
meaningfulness
68:23
IIEaningleSS
124:20
means 21:9; 23:16;
114:12; 117:20; 126:17;
140:1,15; 157:5; 167:6;
202:lO; 207:4; 211:5;
216:7
meant 60:21; 131:23;
191:17,18; 196:24;
222:23
meanwhile
143:4
measurable
29:6; 30:ll;
61:1
measure
92:16; 125:21;
146:19; 149:21
measured
194:24
measures
202:7; 204:25
measuring
146:24
mechanics
23l:B
mechanism
12:2; 5015,
13;65:13,15;70:24;
116:25; 12O:B; 159:25;
184:2,5,22;
185:4,7,11,
16; 205:lB; 207:21;
213:10,12; 273:21
mechanisms
5l:B;
65:25; 184:21: 185:13, 16;
205:17,20; 214:23;
249:12; 275:25
media 141:12; 142:3,22;
l/17:23; 168:4; 173:16;
234:20, 25; 241:10;
252113.20; 259~8; 26316;
274:5
medial 17:16
median 13: 10; 17:6, 15;
18:6,10; 20:24; 21:22,24;
22:3,7; 25:22; 26:21,22;
27:3,6,19; 36:25; 37:9,9;
38:5,7,12,13,22;
39:2,
14; 40:24; 42122; 44:21,
24; 48:15; 51:23; 57:12;

(19)

living

- median