sg91

.

.

.

TWO of the other

2

--

the

lady

with

3

not be counting

4

complications

multiple
all

6

DR. SIEGEL:

7

point

8

nuch whether

9

:o the

correctly,
all

drug

11

prescribing,

of those

12

>enchmark

13

necessarily

14

receiving

it,

15

ind those

serious

16

xactice

it

is

so that

know if

factor.
bit

important

we should
as

looser

we can see,

18

MR. HAMMES:

:oday are going

22

-et's

23

irom here

too

that,

especially
of the
of a

when patients
these

related

who aren't

drugs

you know,

are

how constipation

change when those

kind

of

are established.

DR. HANAUER:

21

this

matters

in terms

for

complications

17

)ff

it

to have some sort

whether

20

I am getting

I think

patients

zomplications

Siegel?

were specifically

we can see that

patterns

Dr.

think

patients

the perfect

19

Yes,

to me', I don't

becomes a little

that

some flags.

like

I think

indiscriminately

Thank you.

in a causal

>nce it

rould

So,

patients

I don't

but

10

25

very

of constipation.
DR. HANAUER:

24

were very,

adhesions.

these

5

start

cases

201
complicated

Yes?
Obviously,

we are
I would

seeing
like

to decrease

where

the

rate

enough were enough

to think
that

problem,

DR. HANAUER:

Any other

that

rate.

we are and monitor

we have a real

of serious

efforts

So, I would
it,

and it
goals

it

should

go down.

that

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

the

of

say

and if

to address?

MILLER

the

to set

goes up

committee

w-g

202
1

DR. KENT:

2

DR. HANAUER:

3

DR. KENT:

That

I think

is very

4

before

that

5

before,

Dr.

6

medicine,

7.

for

8

complications

9

stricture

is put

on the

your

of what

that

10

12

Hanauer,

and the

whom the

view

11
risk

is

is

should

that

someone with
that

indicated

agency

But what

mean?

means that

compared
That

a
What is

drug?

we have to compare

of it.

made to the

the

in patients

we are getting

what'does

means for

outside

DR. KENT:

So, if

comment

be practicing

be judged

because

drug,

you said

You made the

FDA shouldn't

indicated.

is

something

important.
the

that

in whom it

personally

into

risk-benefit

drug

management

16
17

that

leads

of constipation

complications
15

Yes?

DR. HAWAUER: Well,

patients

my view

the

risk

to those

was the point

of the

to
who have

that

I

before.
is

the

rate

we are trying

to

decrease?

18

.

I have a question.

DR. HANAUER:

Of complications.

19

of the

complications

20

outside

of them.

So, I think

21

are all

grappling

with.

22

in clinical

DR. KENT:

23

ischemic

24

whole aura

25

extremely

colitis,
around
rare

Okay.

trials
that

Just

and that

is

ischemic

colitis

event

and this

MILLER

Well,

and we saw some

your

question

one comment,

the whole
is

is very

we saw some

is what we

very

discussion
as if

unusual.

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

it

brief,

on

and the

is

an

But what

the

w-g

203
1

data

are beginning

2

occurs

3

epidemiologic

4

not

5

of these

relatively

studies

100 percent

sure

cases,

but

that

DR. LAINE:

colitis

actually

Lotronex

that

is

your

actually

and it

is

causing

all

comments.

We understand
There

rate,

of

that.

were zero

in the placebo

group.

so.
DR. GURWITZ:

9

I think

10

stipulate

benchmarks

11

condition

in the population

12

may be acceptable

13

millions

without

under

of people,

unless

we know that,

the

fact

that

prescribed

drug

we have to look
drug whether
about

the

or not

it

it

to

the prevalence
level

of use,
but

is potentially

if

of the
and l/1000
used among

unacceptable,

and

is an issue.
to take

only

in the

look

some disagreement

at those

risk-benefit
that

is

indication

for

the

who are properly

equation.

the people

with

I think

are prescribed

the

when we think

risk-benefits.
DR. KRAMER:

essence,

and the

I want

at all

is challenging

knowing

that

we should

the

it

some circumstances

then

DR. WEISS:

18

and get

we do take

7

ischemic

We have a huge program

to try

DR. HANAUER:

16

that

freq.uently.

6

8

.

to show is

I want

is a reformation

23

earlier.

24

Feople

25

nisdiagnosis,

In my opinion,
who get

the

drug

or whatever,
MILLER

to second

of what
if
get

the
it

I said

that.

That,

a little

overwhelming

and therefore,

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

bit

majority

inappropriately

because
the

in

of
of a

overwhelming

SW

i

I

1

majority

of consequences

2

on the

3

risk

management.

4

risk

management,

5

perfectly

drug

first

not

so hard

what

diagnosis

to really

who didn't

that

we ought

just

represents
to

take

happens

a failure

a look

in people

at

of

it

as

who have a

and have a complication.

Especially

DR. WELTON:

is

in people

place,

I think

accurate

6
7

in the

is

204
need to be

in a disease

process

that

diagnose.

8

DR. HANAUER:

9

DR. AVORN:

Thank you.
I have another

10

management,

11

want to come back

12

benefit.

13

thinking

about

14

reassess

patients

15

systematically

16

benefiting,

17

see if

18

deteriorates.

19

possibility

20

benefiting

21

not Glaxo's

22

axpose people

to any risk

23

perhaps

ought

24

after

25

time

in response

goal

of risk

to you question,

and that

is

that

I

.

to the

concept

of risk

in the

absence

of

.

.

.

I wonder
the

there

ought

to be a way of

labeling

that

would

encourage

after
study

continues

the

favorite

twelve
which

is

a lot
drug

off

they

after

is data,

MILLER

I realize

are not

all
saying

that
is

getting
is

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

the

be

that

of not

is

wanting
a benefit,

recommended

the main

there

and

to pay for

who may not

in terms

tb be a protocol
which

there

if

but

is

were or

price

the drug.

to

of therapy,

as they

of patients

concept,

weeks,

cessation

a small

doctors

and

the patient

as well

that

of getting

there

or not

by a temporary

I think

from

ten weeks of therapy

whether

perhaps

the patient

for

whether

ought

amount

of

to be a

to

sgg

205
1

drug

holiday

3

recommended

4

have a maintenance

5

trial?

.

which

we will

DR. WELTON:

that

12

withdrawal

the patients

all

of placebo

DR. WELTON:

15

DR. HANAUER:

17
18

like

with

That

than ,three-month

efficacy

study

of

Welton?
the

I thought

drug

your

of their

was average;

Average,

holiday

graph

symptoms

it

wasn't

--

showed
with

goals

for

risk

agency

of?

all.

okay.

Any other
the

I have a question

management

on death

in terms

of

a goal.

19

DR. HANAUER:

20

[Laughter]

21

Should

22

DR. LAINE:

23

is obviously

24

look

25

likelihood

at it,

Death?

we be looking
You should

the most objective
I am not
of showing

sure

that

difference

MILLER
.

The problem

to inform

DR. HOUN:

You guys

end of July.

Dr.

but

we

and drug.

14

we would

drug.

a longer

at the

had return

DR. AVORN:

that

another

Thank you.

I am wrong,

13

16

.

results

9

11

yesterday

We have a 12-month

have the

me if

on,

that.

lines,

for

going

DR. HANAUER:

correct

those

trial

trial

8

10

Along

a maintenance

DR. MANGEL:

6
7

X weeks after

DR. HANAUER:

2

.

and reassess

That

is not

a goal.

at deaths?
always

look

I would

outcome.
I would

at death.

include

in death,

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

it

it.

It

obviously
The

seems to me,

.
SW

\

206
1

at this

2

small.

time,

3
4

studies

mentioned,

We are not

worried

is

extremely

about

dying

in a

to do with

bowel

composite.
DR. BLUM:
disease

--

Unless

a perforation
DR. HOUN:

7.
8

of the

9

megacolon,

That

assume there

11

wanted

12

that

13

of your

will

to just

the deaths

16

old with

diarrhea

17

ischemic

event

18

Eactors,

versus

19

liverticular

within

the

zhe constipation

22

patient.

predominant
that

didn't

:hat

it

is

toxic

reasonable

was discussed
future

it

the

to

in,

and I

here

so

we have some

irritable

old

patient,

with

bowel

the

But I definitely

MILLER

from

because

who has a
us differently.

to see it

ischemic

think

outcomes

with

colitis

you need to
of the people

I think

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

an

predisposing

to impact

not with

conditions

of a 20-year

diverticulitis

is going

and the

to have to see

we see death

You are more likely

complications

do have those

If

have any other

a 75-year

DR. WEISS:

25

colectomy,

we are going

context.

abscess,

21

nonitor

w&s in terms

or more coming

that

I think

DR. WELTON:

24

future,

nature.

guidance.

15

23

you know,

report

that

of that

the question

does come in the

DR. HANAUER:

20

is what

be a death

report

something

something

In the

make sure

when that

is

show,

perforation.

10

it

etc.,

complications.now

14

.

the

DR. HANAUER:

5
6

even in

that

is going

SST3

207
1

I

to be very

important.
DR. HANAUER:

2
3

was released

4

the

agency

5

that

they

6

regarding

this

.

is

the

When is

be looking

should

sooner?

next
the

Later?

The drug

time

point

when

The company tells

by the

trials.

question.
next

at that?

have some data

some of their

end of this

Is that

year

satisfactory?

We are happy with

us

the

Do
end of

year.

9

.

in February.
should

we need it
8

That

Anything

else,

.lO

We can move on?

11

interventions

12

undertaken

regarding

13

management

tools

14

achieve

the

15

various

tools

16

tools

17

product

18

programs,

19

epidemiologic

20

sponsor,

21

the agency,

22

7atients

that

risk'management
Lotronex.

should

desired

Please

labeling

including

the potential

include

and limiting

that

guide,

could

distribution

risk
and to

potential
in the

special

have been discussed

studies

risk

changes

boxed warnings,

that

and potential

the

be

which

various

of a medication

studies

should

As outlined,

today

to but

what

discuss

and outcomes.

limited

category?

about

be used to reduce

goals

are not

first

program

-- we have discussed

also

education

and the
by the
be done by

of Lotronex

to certain

or physicians.
I think

23

Houn, 'on that

now we are talking

Okay,

in the

Dr.

24

:ime for

discussion.

25

nost important

what we will

do is take

The first,

to everybody,

MILLER

since
is

these

one at a

it

is probably

the

the. issue

of labeling

and

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

.

SW

208
1

whether

boxed warnings

2

heard

from

the

3

don't

think

it

4

the

5

warning

6

that.

7

Do you have anything

1

sponsor,

for

to discuss

is necessary.
Dr.

Wolfe,

advocating

you already

it

the

hear

written

11

mentioned

12

Past performance

is not

13

should

future.

14

have a proper

15

prevent

16

disagrees

that

17

sure

doesn't

disagree

do in the

that

this

18

warning
from

that

some kind

20

the warnings,

21

etc.

22

toward

23

3ne of the

24

poignant

25

is a sense that

Kramer,
Well,

a boxed warning.
things

stories

of what we
that

think

along

warnings

didn't

to
anybody

to make

the

labeling

or highlighting

of

do you have a comment?

I will

tell
quite

you why I lean
a bit

I learned

from

listening

who suffer

with

the problem

MILLER

was

drugs.

wants

is necessary

I learned

even their

that

recently

options

are increased

DR. KRAMER:

is

become a problem.
The other

Dr.

I am

at past

I don't

of warning

actually

it

aspect

everyone

again.

a boxed

Again,

an indication

and obviously

for

comments.

saying

looking

We had a drug

occurring

we have heard

is

necessarily

DR. HANAUER:

19

with

The other
with

time

a box?

I am just

down as a consideration.
I really

this

is

they

regarding

I do have one comment.

10

that

feels

discussions

to add about

necessarily,

We have

now it

committee

preceded

further

point.

of reasons,

certainly

whether
Let's

DR. WOLFE:
not

but

this

at

a variety

is necessary

committee

8
9

are necessary

physicians

don't

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

this

morning.

to the very
is

that

have all

there
the

appropriate

information

prevent

their

looking

for

suffering

and the physician

5

primary

6

warning.
That
morning

what

9

professional

10

recognize

it

11

company,

12

educational

that

is

both

to help

I asked

to having

is not

an attractive

SO, I am

the

them,
yet

sufferer

and one of the
is

the boxed

specifically

in terms

public,

this

of educating

a boxed warning.
thing

a specific

but

itself.

been pursued

reason

hear

treatment

trying

is the downside,

I didn't

them benefit

to educate

hasn't

the

help

the

avenues
who is

avenues

8

from

multiple

4

7

to really

209
also

the
Although

I

to a pharmaceutical

downside

as part

of an

,

13

.

DR. HANAUER:

14

warning

15

around

16

labeling

to a vote
it.

I am going

unless

I presume

there

that

is

to bring

the boxed

any other

discussion

you guys want

an opinion

DR. HOUN:

Well,

this

committee

18

charged

19

nere.

20

session,

21

nbout

advantages

or disadvantages

of boxed

22

wring

out

who haven't

things,

23
24
25

on

issues.

17

.

program.

with

voting

because

So, what we wanted
and I suggest

people

that

is not

most of the people

if

you did

said

want people

You don't

to

you can do that.

have to vote

have to vote.

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

to talk

and you want

:his?

MILLER

are guests

to have was a brainstorming

DR. HANAUER': So, we don't

DR. HOUN:

really

on any of

ssw

210
DR. HANAUER:
sense of the

A sense

DR. HAVLIK:

5

company had at least

6

I interpreted

7

in bold

8

to worry

9

what I think

10

is

revision

I am not

I would

actually,

of the

labeling,

that

constipation

in practice

do, but

that

the

the way to a box because,

as number one warning
about.

fine.

I was impressed,
gone half

their

that

they

so it

have it

is
is

would

certainly

side,

it

if

the

thing

easy for
get

me
my

attention.

11

From the drug

company's

12

now that

13

that

14

to the

company's

advantage.

15

saying

that

I see in the

16

not really-now

17

respond

18

,uith

19

speak for

him but

20

night

be enough

as much preventive

would

not

what

knowing

a practicing

not

labeling

23

I had the

feeling
his

Well,
for

internist

25

:he data

and I think

--

being

MILLER

between

are going

to

I had a discussion

like

I won't

even a warning

attention.
take

it

discussions
want

right
off

to the
of that.

to comment briefly.

referred

we also

is

good versus

bombarded.

let's

DR. HOMBOE: I just
:he general

of caught

the physicians

who gets

and asked

the drug

is pretty

In fact,

seem right
be exercised

to promote

labeling

internist

24

could

So, I am kind

to that.

to get

would

that

ability

whether

DR. HANAUER:
>roposed

medicine

undercut'the

adequately

21
22

Do you want a

committee?

DR. HOUN:
4

Do you want us to?

heard

to,

but

if

some this

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

I am

you look

at

morning,

the

211

printed

.

materials,

whether

provider"

letter,

3

seen that

in other

4

which

are not

5

black

box,

6

highlight

7,

it

8

to have to take

it

9

that

the

the

11

be part

box,

medication
another
stuff

13

irritable

14

management

is

15

everything

we are going

16

things.

it

is

program
Well,

about,
but

it

believe
is

to have to

and that

at solution,
is

that

about.

We have heard

disease

about

One point

don't

has been,talked

attempt

to talk

you are going

going

we agree.

a multi-component

,whether

in as inserts

really

that

you use the
to have to

I honestly

is a multi-component

DR. WOLFE:

17

etc.,

We have

guidelines

whether

and putting

education

bowel

guide

I think

well.

you are going

step.

healthcare

including

So, regardless

DR. HANAUER:

12

of medicine,

you are most concerned

to be enough.
of the

work very

at a minimum

things

publishing

going

areas

I think

be a box or a,"dear

necessarily

followed.

be a black

10

don't

it

assuming

was alluded

that
risk

and
other

to before

.

18

was the

19

place,

20

because

21

rep.

22

they

23

appropriately.

.

24
25

role

of the drug

and I think
a lot

that

have to really

tell

DR. HANAUER:
on this.

I think

is very

of physicians

They have to pass

some comments

rep.

laudable

get

their

a test

and very
information

to make sure

physicians

Let's

you have a program

just

Indications

and usages

the

know --

to prescribe

go to the

important
from

they

in

this

label
--

drug

and get
is

this

.
MILLER

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

,,.‘

.,__

r.

wg
1

or do you want

okay,

2

DR. HOUN:

3

DR. HANAUER:

4

DR. HOUN:

5

but

the

is

7

indications

8

women --

--

10

Got that

Lotronex

is

11

Lotronex

12

Carrhea-predominant

13

predominant

14

recurrent

15

discomfort

16

increase

in frequency.

17

describes

the wrong

18

liarrhea-predominant

19

;tool

is

indicated

20

abnormal

stool

21

lassage,

urgency

22

rithout

'ou know,

with

Don't

edit

IBS is

the

the

it.
words,

for

bowel

the

treatment

of

with

greater

that

urgency

loose

about

three

It

months
criteria

MILLER

bowel

months

pain

or

and/or

an

'of

abnormal

movements

and abnormal
evacuation.

per

day;

stool
So,

--

interesting

because

of basically
talk

about

pain

the
and diarrhea.

any 12 weeks within

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

of

appendix

diagnosis

of incomplete

is

three

syndrome,

or watery;

the words

Diarrhea-

and the

support

bowel

than

or feeling

say three

syndrome.

See appendix,

irritable

form,

of women with

of abdominal

either

criteria

of the draft.

by at least

symptoms

and diarrhea

diagnostic

So, the

treatment

characterized

or continuous

talking

charge?

We are on page five
for

DR. LAINE!:

25

suggestions.

thrilled

indicated

irritable

frequency,

ndications

do you want

Where are we?

DR. HANAUER:

24

to get

The concepts.

DR. LAINE:

23

fine

or what

You are not

DR. JrIANAmR:

9

.

It

it

concepts.

6

I

to modify

212
to do?

s9-g

213
1

the

2

exclusive

3

talking

4

while

the

know,

somebody

last

one year.
but

one is

about

diarrhea

other

I am not

saying

that

stronger,

if

you will,

predominant

one could
had diarrhea

DR. KENT:
7

was stronger

8
9
.

.

.

the way it

which

12

constipation

13

intestinal

14

perforation

15

known hypersensitivity.

16

initiated

17

describe

18

hard or lumpy

19

movement.

are patients

I like

in the

recent

as six

months

ago,

is

as it

it

resolved

past,
you

now.

is because

better

with

The next

in the

obstruction

from
and/or

or adhesions;

in patients
as less

we felt

it

indications

is

than

instance

--

22

wo I I wouldn't

23

chose lines.

in other

nave constipation

stricture,

toxic

megacolon,

In addition,

should

be

words,,
them,

bowel

those

movements

which
per week,

during

recent

who had it

as an example,

with

not

constipation

straining

What about

MILLER

of

colitis;

Now we are in the

alternating

history

of ischemic

and/or

include

DR. WOLFE:

constipation;

or severe

a history

three

stools

contraindications,

of chronic

experiencing

DR. LAINE:

21

are the

a history

or sequelae

20

25

of

is.

DR. HANAUER:

11

24

in terms

I am,saying.

10

.

it

are absolutely

right

and it

We put

DR. LAINE:
what

be read

they

alternators,
diarrhea?

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

or

they
and/or

a bowel

past,
three

for
weeks

something

people

along

who

SW

214

DR. HANAUER:

1
2

alternating

diarrhea

4

had constipation
had it

six

would

but
10

but
if

be;

be.

they

it

ago --

had it

had it

I am not

is what

recently

months

if

they

Again,
that

fairly

sure

I would

to say is

would

that

be,

I mean,

a couple

months

IS

a contraindication?

What I was trying

or eight

statements,

a contraindication?

and constipation

DR. LAINE:

3

Is that

but

if

they

if

they

I am making

broad

of weeks ago,

and months
is based

maybe suggest

ago,

it

on great

it

wouldn't
evidence

to handle

that

a

little.
MR. LEVIN:

11

Is there

another

way to deal

with

.

12

that?

Going

back

13

safety

and effective

14

Should

something

15

been established

16

we just

to the

indications

and usage,

has not been established
be said

--

the

safety

we said

the

in men.

and effective

has not

.

pick

for
men.

alternating
What about

DR. HANAUER:

17
18

Thank you.

19

this

whole

Warnings
thing.

-- gee,
It

is

21

DR. RACZKOWSKI':
has come up in the

23

notion

24

moderate

25

constipation

of severe

being

I really

don't

Hanauer,

MILLER

to read
--

is good.

one of the

as opposed

one.

want

it

issues

section

is

to mild

and

and the definition
a subjective

good point.

of page six
it;

know why

conditions?

is a very

contraindications

constipation

constipation,

that

We have read
Dr.

I don't

the other

on the bottom

DR. SURAWICZ:

that

all

I think

20

22

diarrhea?

of severe
I wonder

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

if

the

the

sgg

215
1

committee

2

level

3

enough

could

with

or is

5

the

6

severe

7

moved up,

which

8

in anybody

with

is a small
current

DR.

13

measure

14

group.

Which

which
they

move it

17

simplicity

closer

together

for

that

20
company,

22

that

23

can correct

24

assessed

25

presentation

I think

severe

specific

atthe

it

top

of

of chronic

-- maybe it

but

is

should

shouldn't

fit

have the

less

or
be

be given

it

days.

doesn't

way that

into

four

defined.

have if

is another

the

people

severe

I mean,

the

because

we have heard

they

And,

smart

resolve
can

constipation

way would
that

be to
we want

that

definition

In our discussions

one of the main points

constipation,
me if

I think

is

have.

DR. RACZKOWSKI:

21

it

people.

DR. LAINE:
acceptable

that

a history

part

You also

would

DR. HANAUER:

16

19

days,

mentioned

point,

SURAWICZ:

whether

15

Is

is

And you also

SURAWICZ:

11

four

comfort

constipation.

DR. HANAUER:

within

my view

The lower

10

12

their

of terminology.

Well,
they

constipation.

DR.

about

satisfactory?

contraindications

18

e

it

some input

sort

DR. HANAUER:

9

.

give

use of that

4

.

just

as intended

I am wrong,

by any objective
of the patient
MILLER

but

criteria
saying

it

that
here

is
but
that

with

the

has come out
and the

intended
by the

company

not

to be

subjective

he or she --

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

is

in this

wg

216

case she has severe
severe

migraine

constipation,

or a mild

DR. LAINE:
4

Steve

5

constipation

constipation.

8

has a complication.

be just

12

contraindications

13

or current

15

suggesting

16

just

ago shouldn't

question

21

surgery.

to us.

24

committee?

25

I thought

So, as
of

know how to define

a subjective

that

condition

is his

severe

unless

point.

it

Then it

constipation.

No, we are talking
a history

about

of severe

the
constipation

But what
drop

I am saying
the modifier

Special

that

that

he is

l'severe"

and

SO, anyone

who was constipated

20

be contraindicated.

education

First

is

of constipation.

DR. HANAUER:

23

here.

a definition

That

is what his

question

is do we know what we are saying,

22

i

a history

DR. WELTON:

20

is

we don't

not

we should

DR. HANAUER:

19

it

constipation.

say with

years

up there

I think

now, with

that

17

.

is

constipation,

DR. WELTON:

14

18

It

DR. HANAUER:

11

you have a

migraine.

now define

Frankly,

DR. WELTON:
should

if

here.

severe

10

they

you move this

7

9

like

to moderate

But,

DR. HANAUER

6

.

if

says,

just

The next
programs

of all,

what

I heard

MILLER

I will
from

is

sort
--

give
the

is,

his

especially

in

of no-brainer

any comments
my personal
sponsor

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

stuff
from

the

view

that

was really

an

1

217

ET3

1

Dutstanding
{our

standpoint.

zhat we were prompted

4

incorporated

both

5

physicians.

The key,

6

you follow

8

regarding

9

ldditions?

12

focus

13

like

14

a step

15

different,

that

16

They could

work with

17

work with

a few minutes
the program

that

or two beyond

the

be something

different

20

five

of the

21

educational

22

written

23

of people

24

just

25

simple

it

education

time

or didn't

level

understand
into

it;

MILLER

directly.

really,

but

of ways..

to succeed
found

at all.

really

really

as possible.

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

it

has to

worked
So,

that

use of visuals,

languages
oriented

work

new and

They could

are a lot

to patients
--

really

foundation.

going

I

to see them go

is

what we already

addressed
five

and consumer

really

is

it

while

to patients

There

than

materials
at a grade

is

like

that

to

we could

because,

Nancy Norton's

if

you that

is where

I would

have,

able

about?

with

brain-storming

societies.

19

translating

I disagree

that

comments

we heard

maybe this

they

provides

I think

will

that

and

we are being

and do something

specialty

percent

Yes,

of things

to know is

Any other

the way.

from

and to the

we want

and that

that
with

a lot

the meeting,

that

program

I-think

a no-brainer.

18

.

along

11

program

to the patients

that,

DR. SURAWICZ:

.lO

into

I guess,

education

management

encompassed

on coming

with

effect

the

it

education

through
that

of a risk

I thought

3

qonitor

.

conglomerate

would

be

simple;

lots
Not

cartoons.
making
If

it

you look

as
at

.

218

sm
1

.ot drug

2

,eally,

3

.dvertising

advertising
really

but

the

of advertising,

Maybe building

effective.
agencies

rest

that

it

is

teams with

know how to get

to the

entire

ropulation.
In one of these
one,

societies

are part

system.

9

societies

was that

none of the

four

was a real

List

11

these

12

3f reporting

of complications.

13

drug or this

company,

14

Look at sometime

societies

in the

I would

so,

16

directing

17

especially

18

your

two hugest

19

And,

something

2c

to me, of the patient

21

were five

2;

me, if

22

tiny

24

as a doctor

2:

education

like

is

are

in that

to me, that

all

to do some sort
not

that

specific

we might

to see really

and your

to this
want

to

that

that

looked

and would

read

DR. HANAUER:
MILLER

material

to patients.

--

read.

exactly

like

even less
It

in the book,

I think

was one that

I would

I agree.

Those are

the examples

and there

examples,

but

dots.

directly

I mean,

ways of

physicians
care

then

education

innovative

all

primary

And,

different.

types

That

specialty

future.

I were a patient,
little

of the

together

something

markets.

or six

reporting

GI societies

to physicians,

GI dots,

specialty

of all

surprise

have gotten

but

of the

and I can't

complication

list

10

other

I read,

was a list

in that

and that

at all,

that

of a drug

What I noticed

8

15

.

there

yemember which
that

books

there
looked

The rest
what

I don't

as a patient.
is

a real

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

brainer.

to

were
read

.

wg

219

1

That

is why she is going
DR. LAINE:

2

to be the next

And to follow

3

fortunately

or unfortunately

4

information

on drugs

5

things

the

6

web visits,

7

for.

8

one of the

9

from

that

to which

Although

the

doesn't

quantitative

10

number of visits

11

particular

12

just

to monitor

13

are,

indeed,

14

doctors,

tell

really

drug

having

with

these

that

and just

drug

I guess,

per physician

get

the

is monitor
they

the

area

particular

drug

were there
it

is,

FDA could

company commit

or per

since

their

you how effective

things,

company is

well

and what

too,

I mean one of the

do extremely

doctors

that

of doctors

representatives,

companies

here.

up on a point

a lot

from

chairman

get
to X

to discuss

educational

this

tools,

and

.

up with

or educational

educational

Regarding

there

17

can be made to have warnings

18

see them,

consumers

19

education,

I think

20

do give

21

given

freedom

to say what we want

22

hand,

this

something

23

physicians

24

If

25

contraindications

they

are new avenues.

is

mention

You mentioned

I can safely
that

to

As far
assume that

I think

therapy,

during

MILLER

their

should

as physician
all

of us here

On the

be mandated

on irritable
they

can actually

sponsored

to say.

should

lectures.

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

also

Websites

so people

are occasionally

be speaking

drug

really

material,

websites.

flashing

and physicians.

who will

they

programs

educational

16

lectures

that

material.

DR. WOLFE:

15
.

following

to make sure

bowel
mention

and we are
other
for
syndrome.

b

sgg

220

The other

1
2

--

Chris

3

for

4

scenarios

mentioned

example,

should
that

is

for

kind

there

programs
certain

and the

kind

education.

with

conditions

avenues
One way,

different

of patient

So, there
is

are certain

case
and.how

they

who would

not

are ways to reenforce

appropriately

the

used and when it

is

get
idea

not

used.
MR. LEVIN:

10

comments

11

people

12

of people

13

a lot

14

we are looking

15

the

about

the

are going

I just
Internet

to get

are getting

of people

don't

their

18

Wellcome

19

has information

20

product

21

concerned

22

am not

23

reflects

24

our concerns.

25

is another

is

from

have access

to the

down the

the

really

where

a tremendous

information

in the

connection
but

that

is

that

the

road,

that

number

Internet.

Internet

when I dialed

left-hand

banner

is

I know
yet

really

but

if

where

to their

it

is

available
is

going

to tell

you about

for

treating

IBS.

So, I am

a lot

of push electronically,
can dial

we are having

For example,
of the major

MILLER

URL, and it

also

what people

discussion

up web MD and on

is an IBS Glaxo

and you go right

there

that

the

that

and already

my surprise

home page,

sure

to reemphasize

is.

Imagine

17

want
because

it,

ten years

information

16

.

drug

that

with

of drug.

9

.

computer

them,

appropriately

is

new ways of doing

people

treat

of when the
8

thing

if

websites,

a new

and I

up necessarily
today

about

some of

you go on to medscape,
and you go to the

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

which
drug

221
1

information

patient

handout

2

mild-manner

statement

3

be aware

for

of the

alosetron,

risks.

So,

it

is a very

I think

we have to

you read

it

to us,

if

of all,

it

says,

-DR. HANAUER:

Why don't

it

is brief?
MR. LEVIN:
important

1

*

note

8

substitute,

9

side

may occur.

11

doctor

12

temporary.

13

on,

14

presentation

15

are hearing

.

this

it

promptly.

If

If

it

about

18

people

19

is a critical

kind

that

it

upset

notify

your

may only

be

may recommend

is a very

of potential

with

the

the data

that

up is

. . . and

mild-mannered

severe

risks

that

we

accurate

information
many,

revolution

many millions

and presents

risk

of
I think

issue.

20

DR. HANAUER:

21

DR. KENT:

22

[Laughter]

23

DR. HANAUER:

25

doctor
it

or stomach

or worsen,
occurs,

and under

today.

are dialing

standards

persist

I think

not

a one-pager,

headache,

your

So, how to deal
and to make sure

is

constipation

occurs,

of the

to supplement,

It

effects

I mean,

17

24

intended

is constipation,
these

and on.

is

First

your.doctor.

If

16
*

for

effects

10

--

Sure.

We understand

That

that.

is based on the

We are not

holding

original

label.

you to proactive

yet.
MR. HAMMES:

MILLER

I want

to reemphasize

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

here

the

role

222
1

of the pharmacist

2

pharmacist

3

that

4

the professional

5

laxatives

6

problem

7.

this,

8

patient's

9

the pharmacist

in all

in this

is going

education

to see this
that

and,

if

if

they

-and it

they

is

guide

than

12

disillusioned

13

any information

because

14

to do something

about

to get

our'young

community,

and if

able

23

communicate

24

-- better

25

information

than

lady

is

up on a

related

the

to

into

the

education

of

intrigued

in this.

who told

by this
the

less

I was very

us she didn't

mail

order.

that

brings

get

I mean, we need

that.
I guess
taking

a vote

I would

like

you mention

but

us to medication

are there

speaks
the

opinions

are usually

about

the

in the

barriers

and being

in a foreign-speaking
language

individual.

any type

across.

the

to say one thing

language

the pharmacist

usually
with

pick

the,information

involved

The pharmacists

to educate,

community

them their

members?

DR. BLUM:
also.

They are

you need to force

she got

and we are not
committee

the person

will

an OTC that

I think

pharmacist

pharmacists

they

and I am'really

thing.

with

18

to be selling

are any good,

DR. HANAUER:

the

likely

off,

11

from

They are

So, you have to include

first

the

most frequently.

a good way to get

medication

guides,

process.

are selling

hands..

perfect

and to include

patient

is

10

16

of this,

of print

of that

So, they
media

But the pharmacist

--

community

would
to get

also

to

be the best
the

has access

not

MILLER

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

223

SW
1

only

to the

2

Mhich could

interact

with

4

over

the

this

5

that

the

FDA think

6

medication

7

guides,

8

content,

9

and I think

guide

that

risk

11

somewhere

12

approach

13

opportunity

14

public

decade,
very
for

would

17

imposed

establish

they

important,
it

than

requires
buried

we have this

I think

this

guide

is

limited

a wonderful

regulation

you assess

assess

the benefit

I mean, you would
it

21

medication

as a

that
if

How

then?
they

22

in one managed care

So, would

group

you suggest

I am not
medication

regulation

authorizes

25

regulation

that

currently
MILLER

versus

a study

another

of a

to test

or another?

MR. LEVIN:

24

have to have some

--

in one population

is

that

rather

How would

DR. HANAUER:

23

and

guide?

to compare

guide

medication

measure.

MR. LEVIN:

20

a

are really

facet,is

guides,

that

a medication

requiring

presentation

Even though

line.

protection

you suggest

control

for

to use the medication

health

urge

to strongly

I think

be up front

down the

like

graphics

the most important
information

wars

product.

and the

may be taking,

of the med guide

about

standards

to medication

18

I would

this

they

of this.

seriously

DR. HANAUER:

16

all

that

As a veteran

and format

10

19

last

which

15

.

the herbals

MR. LEVIN:

3

.

OTCs but

sure

that

guides

there,

is how the
to be used.

from

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

'98,

I think

The
says

it

w-g

224

1

I

that

you can select

that

a medication

must be dispensed

4

can parse

5

would

6

We have been there;

7

comments

8

everybody,

9

certain

10

guide.

suggest

12

the

15

require

16

55 miles

17

or not

18

checked

or whether

is

where

or less

there

yet

again.

these

years

of

drugs

comments

present

do it

a

in a medication

be to do an audit

is

force

you know,

pharmacists

of

Even
of law to
you to drive

whether

or not,

people

that.could

do it
be

Do we have data

that

these

guides

make an impact?
My name is Louis

DR. MORRIS:
for

23

the medication
responsible
some of these

for

Glaxo,

but

guide

wars.

heading

I am also

just

questions,
MILLER

Morris.

I am a

one of the veterans

I worked

up that

by

to have a medication

of law to require

and,

I

guides

agency,

be useful

would

you

think

is actually,happening.

force

DR. HANAUER:

consultant

25

and the

and

on.

22

.24

that

means that
there

all

is appropriate

What would

to see if

an hour

21
.

it

evaluation

regulation

19
20

of risk

this,

After

was that

require

know if

I don't

medication

by Congress

intervention

though

So, I don't

populations.

done that.

decision

and then

by the manufacturer

drug.

we need to study

and actions

pharmacies

that

specific

DR. HOUN:
guide

to ten drugs

be provided

with
into

level

11

.

guide

3

that

up to five

at FDA and was
Just

project.
a couple

of

in terms

of comments.

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

of

225

The first

1
2

guarantee

that

3

results

4

mentioned,

5

studies,.where

6

estrogen

patient

7

specific

regulation,

8

people

On the

.

11

of the

12

significant

13

patient

14

in how that

15

attached

16

The pharmacist

17

off

18

In the

19

separate

20

itself.

went

that

hand,
is

Glaxo

to this

current

did

that

is being

23

preventing

24

the

25

whoever

one that

plan,

is

between

for

the

by a

20-40

percent

of

will

things

errors

most easily
it.

MILLER

that

solution,
detail

and one

over

into
In this

routine

case,

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

the

approach

the best
the

will

be a

to the bottle

we know from

that

tear

to the patient.

and systems
is

insert.

insert,

insert

be attached

new

is

the physician

package

is

change

insert

and hand it

that

that

in the proposed

the physician

the patient

distributing

some evidence

go into

with

insert

It

is

The current

out

done on systems

fits

shopping

has been a significant

sheet

package

medication

Ostrove

is required

is that

there

has to pull

One of the

22

not

be packaged.

document.

21

pharmacy

a more effective

in a perforated

the patient

there

discussion

insert

would

actually

prescriptions

which

no

document.

other

package

filled

insert,

the packaging
things

in,

is

As Dr.

done,

and somewhere

that

there

of information.

package

received

guess,

by FDA regulation

have been studies
people

changing

it

distribution

there

10

as you might

requiring

in the

9

is,

new work
to

solution
practice

is
of

what we have is a

wg

226
1

pharmacist

who simply,

2

shelf.

3

which

4

are at that

5

the

The bottle
is

doesn't

for

a month's
rate.

bottle

off

has to pull

the bottle

Lotronex,

the

average

supply,

and the majority

So, all

the pharmacist

and put

it

in the bag.

have to do anything

special

down off
size'is

a
60,

of prescriptions
has to do is

take

The pharmacist

to distribute

the

medication

guide.
It is actually
attached
to the bottle.
C.
I think
that packaging
solution
goes a long way in terms

so,

of concerns
10

historically

11

than

I

regulatory

is

that

there

is

13

guides

14

that

15

guide

16

follow

17

plans

18

message is getting

19

actually

20

would

21

in the

25

it

is not

the

if

of a medication

guide

if

the

information

and having

flexibility

is one of the

to

company has

to make sure
the

is

a medication

be required

Currently,

is a medication

Lou,

I think

any standard

issued,

a science,

medication

the
to

concerns

guide,

it

is

argument

that

has to be

format.

used with
are

it

it.

to make about

company would

the

across,

require

and that

format.
test

MR. LEVIN:

guidelines

I wanted

format,

then

standardized

24

simply

the message right

have where,

is always

point

and I think

have been more effective

that

a standard

to thoroughly

23

solutions

standardized

get

distributed,

one of the downsides

is required,
the

it

solutions

The second

22
.

getting

packaging

12

.

about

people

say,

and you can't
MILLER

that

the

or guideline.
well,

When

medicine

stifle

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

that

innovation.

is an art;
So,

I

sgg

227
1

there

is

always

2

think

we have to recognize

3

other.
I think

4

.

a tension

the

between
that

when people

go in an survey,

6

completeness

of the voluntary

7.

available

8

that

9

develop

in pharmacies
left

out.

guide

in time

to be evaluated.

12

with

13

of the

Keystone

14

players

at the

15

to debate

16

standard

medication

guide.

17

for

particular

drug

18

concerned

the permutations,

with

process

which

table,

1995 with
all

and I don't

there

is

think

is

the

two years

all

the

continue

to have a
appropriate

issue

that

or not
we are

today.

19

DR. HANAUER:

Go ahead.

20

DR. OSTROVE:

Can I just

21

concerning

the

standardization

22

there

23

is

24

exemptions

and deferrals

25

nanufacturer

ha8 data

has been a large

issue?

history

to recognize

had one additional

that

with
the

Dr.
this.

Levin
But,

regulation

is

point
right,

I think
permits

.

and that
and is doing

MILLER
.

we

guides

--

we should

it

is

stuff

I think

of with

to try

Whether

are

in a

the parties

a reason

I think

that

medication

I was part

and

you have to

is

ad nauseam'since

the

because

important

and how it

have done that

important

of

to be included

11

with

guides

a lot

I

preclude

accuracy

is

medication

whether

the

medication
is

and

important

what

.lO

this

is

even today,

there

for

two sides,

one doesn't

So, at some point

a standard

all

but

standardization

5

is

those

if,

in fact,

research

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

the

on what best

it

wg
1

communicates

2

that

3

population,

4

into

5

one that

6

particular

7

information

8

is data,

9

into

a slightly

account

then

account,

12

.

they

that

is

something

that

what

is

out

that
where

absolutely

known to industry

about

15

the message got

16

working

how do we change

17

That

fine.

18

established

approaches

also

19

information

to doctors

and patients

20

drug,

21

companies

know how to do and I think

22

they

do it.

23

tie don't

24

people

25

nrhether

is

I think

out,

it

to make sure

take

those

approaches,

to sell

and if

time

at the

a product

that

to put

service
about

it

isn't

it

works.

those

well-

of getting
problems

with

the

.

.

and that

will

say it
and not
the

is

completely

within

the purview
we should

When we have a drug
makes as a drug,
see if

it

intervention

works.

let's

MILLER

that
just

give

and I think

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

of what
expect

that

is on the market

We demand that

is working

in

there

how do you make sure

working

just

if

in

established

it

is

is

can look

always

under

is

it

take

format

restrictive

when one wants

information

through,

we will

are well

14

that

we would

However,

necessary

very

how do you get

for.

that

13

for

the particular

not be overly

There

better

way people

are looking

and we will

that

The standardized

something

DR. AVORN:
well

work

at it.

to find

population

would

is good because

is that

circumstances.

is

in looking

sections

11

format

certainly

we feel

determining

patient

different
that

10
1

to a particular

228
shows

it

to

we know
we need to

s!xT

229
1

4

.

do the

same thing

2

.

informational

DR. FISHER:

Hi.

interventions.

I am Rosemary

3

actually

here

4

as Dr.

Blum did,

5

things

getting

6

attached

as a consultant

7

instruction

8

a more guaranteed

was of known that

9

prescription

that

would

10

was attached

to the bottle,

11

who is

12

medication

about

throwing
guide

got

14

medication

15

had mentioned,

16

the patient

17

that

10

and seek treatment

19

thing

20

educating

21

treatment.

22

that.

23
24
25

guide,

goes to the

has to recognize

is

guide

having

in a box,

be

because

it

to have somebody

making

sure

leaning

that

something

doctqr

that

is

the

really

for,

and it

or not

they

And,

toward

a

I think

more than

So, I can see that

something
is

The med. guide

is

have constipation
that

is

another

could

MILLER

we do both?

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

the

kind

of

guide,
to seek
way to do

be attached

PPI.

MR. HAMMES: And why can't

that

the patient

the doctors,

that

the

company reps.

need to have in a medication

as the

would

order.

to the patient

condition

it.

the patients,

just

the

medication

in the mail

and not

whether
for

DR. HOUN:
mottle,

whether

60-pill

I am definitely

this

we really

and

in there.

and it

that

prescriptions

wonder

be getting

I am

I have a concern,

to a medication

things

DR. WEISS:

that

order

I actually

as opposed

Fisher.

Glaxo.

on the bottle,

sheet

just

for

the mail

across.

tear-off

i3

.

with

to the

.

%v3

230
1
2

DR. HANAUER:
everything

--

3
4

6

are hearing

7

us that

a composite

a

everything

9

better,

worse

10

variety

of different

11

for

12

these

13

best

they

are doing,
that

risk

Gastroenterologic

17

research

18

education

I think

effect

Wellcome

that

Glaxo
certain

you are not

like

also

to take

should

also

that

we

has told
adding
to be

to look

this.

at a

You are asking
it

and imposing

to know which

all

is

the

now.
with

part

Association,

group

is

going

right

agree

that

that

now is going

means studying

an impact

would

Dr.
--

Surawicz

involved

I would

give

the

the American

the ACG, and the
get

that

with

functional

assessments

and

as well.
DR. SURAWICZ:

19
20

Ereedom to come up with

21

If

22

vith

23

standard

24

;ime.

25

Not necessarily.

which

I certainly

is

guide.

means to assess

way of making

16

consensus

and I am not

at once,

organization

we are doing

or -- my recommendation

things

15

the

you can do up front

management

.

like

a medication

DR. HANAUER:

14

I

So, I guess

are recommending

5

sounds

to them.

DR. HOUN:
people

It

we don't

mandate

something
for

what

really
the

something
they

companies

DR. HANAUER:
MILLER

I would

better

company the
than

do, maybe they

creative

other

the

and better
when this

like

a med. guide.
will

that

will

come up
set

comes up next

to see some studies

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

a

out

sgg

231
1

of it,

which

2

unless

you are evaluating

3

different

is what you are proposing.
it

can't

You

in some controlled

assess

manner

DR. KRAMER:

5

about

6

one by one single

7.

in handy

8

psychosocial

9

that,

a strategy

I do have a little

in risk

management

interventions,

to talk

much like

would

test

and this

where

it

researcher

My understanding

where

often

of a concern

which

to a communications

researcher.

bit

one drug

may come

or a

of the

at a time

one by

field

isn't

is
the way

10

to treat

the whole

disease,

you need multiple

approaches,

11

multiple

avenues.

So, that

issue

have been

12

sufficiently

studied

13

know that

we should

14

intervention,

15
16

guidelines,

17

telephone

18

report

expect

Just

does that

25

number

for

patients

in the med. guide,

certainly

could

are looking

at for

professional

with

so that

we

a single

the

the Med Watch number,
to report

and should

or anyone

that

The regulation

be included.
other

labeling

around

on the med.
the
else

to

even be considered

data?

table
MILLER

Besides

doesn't

That

regulations

at this

DR. HANAUER:
anyone

increments

one question

include

DR. OSTROVE:

24

poor

research

one at a time.

as a way of gathering

23

may already

in communications

DR. BLUM:

It

--

modalities.

4

.

it

is

include

something

having

that.

that

we

to do with

point.
what we have discussed,

have ideas

or opinions

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

as to how

does

232

.

1
2
3

they

could

II

talked

improve

a lot

today

about

DR. WOLFE:

4

consumer

5

their

6

it.

7.

benefit

magazine

Just

they

DR. HANAUER:
improve

the

10

have heard

11

the

that

indicated

12
don't

14

get

give
the

what

17

think,

18

from

19

controlled

20

or preference

21

Yes,

22

is

again,
the

Dr.

is

and what

treatments.

opinions?
to try

the best

is going

How can we
I think

and limit

you

the use to

and uncontrolled

is

way because

if

you are only

to give

Any guidance

There

the

disease

on the up-side?

population

we have heard

from

the

the different

is

way to evaluate

company.

write

is one way of approaching

what

is

right

and it

the best

is a

where we have seen benefit.

DR. HANAUER:

16

actually

from

That

to the

downside

15

could

the education
population

it

patients

Any specific'

DR. BLUM:

13

there

Anything

efficacy?

We have

risk.

that

it,

drug?

idea,

state

have from

of the

one last

I think

They can actually

side

the

in which

own stories.

a
9

the benefit

it

from

these

the

committee

to

committee

interventions?

variety

studies.

going

a bad rep.

a number of proposed
a whole

you

on
I

studies

of different

Anything

in addition

members or our consultants?

Welton?
DR. WELTON:

23

had any suggestions

24

me, and I don't

25

area

of expertise

When you asked

about

whether

I

else

to look

at,

know how to do this

because

I have my own

which

MILLER

what

me earlier

is very

limited,

but

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

it

it

occurs

occurs

to

to me

SW
.

233
1

that

2

studies,

3

because

although

you may not

you may have a relative
the

suggested

studies

that

cellular

that

activity

you could

7

mucosa.

8

a mouse or a rate

9

scans.

I can't

As far

11

look

12

netabolic

at mucosal

information,

ischemia

15

question

of the

particularly
about

the

work because

but

there

and relative

DR. HANAUER:
regarding

a

may be a

hypoperfusion

in
PET
there
way

is
to

from

activity.

13
14

with

ischemia
that

doesn'.t

in November

inflow

to relative

that

mucosa

and increased

I have a concern

as I know,

too much background

back

of water

you how to study

model.

10

of the

have a fixed

leading

tell

ischemia

uptake

state,

in some of these

were presented

increased

hypermetabolic

evaluation?
for

16
17

interventions

18

1s and the

19

ior

20

:hange

21

ire

22

reaffirm.

Dr.
It

is

that

I think

any other

aspects

a very

open,

broad-based

one is

to reaffirm

we do institute,

company evaluate

FDA because

we don't

that

expecting

to happen

DR. HANAUER:

24

:he committee,

25

rays,

I think

would

MILLER

That

that

is

evaluate

is.something

that

certainly

effect.

So, I think

Speaking

that

you are looking

traditionally

or an intervention.

and it

Houn,

us.

DR. HOUN:

23

see vasospasm

the

that

for

myself

would

be useful

to have
a new step

a labeling

fact

I want

that
to

as a member of

be one of the
to have an

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

you

better

234
1

independent

2

hear

3

company but

4

model,

demonstration

about

a series

of interventions

I think

that

and no drug

wants

be useful
validate

if

.

management

10

will

change

11

contraindications

12

evaluate,

1'3

databases,

14

patients

15

contraindications,

16

could

do that

17

would

be recommending

18

that

19

*

21

the

22

probably

23

care

either

kind

with

indications,

by a chart

audit

there,

nedication

guide

like,

as a
would

and

side.
like

to know is

of some of the
our

labeling
for

automated

ten percent

or less

and is

medications.
that

We

something

of appropriate

you

and safe

use,

of practice?
Yes,

but

specialty

because,

are going

to try

I would
like

also

urge

in anything

else,

and push the bubble

in doing

that

than

you to do

more,

the primary

comments?
I would

or package

MILLER

of

having

of a study,
in terms

the

and we could

or other

DR. WEISS:

other

recommendations

conditions,

Other

to assess

or the

Lotronex

more experience

physicians.

it

I am assuming

of an evaluation

specialists

the

some of your

is

I am sure,

I would

and for

fact,

by physician

24
25

to outline

this

evaluation

interventions,

DR. HANAUER:
it

from

to

from

are using

own tools

So, one thing

who are receiving

type

20

your

an independent

risk

in

as.you

to be a model,

what you are hearing

we do undertake

You are going
and studies

as long

you developed

DR. HOUN:
if

of an effect.

like
insert,

to see,
that

if

you do a

the patient

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

St3g

235
1

actually

2

think,

3

probably

gets
from

it

and that

what

Dr.

step

DR. AVORN:

5

of both

patients

6

their

7

what

8

the

9

and ask how they

the

but

doctor

side

10

advertising

11

methodology.

I think

telling

effects.

if

you don't

14

to know,

Dr.

people

16

for

17

in the

last

18

terms,

and we find

19

percent

of patients

20

contraindications

21

adverse

22

which

23

ef contraindications

24

If

25

acceptable

that

the

turn

a direct

The last

point

say,

what next.

just

what

you want

are

to know

office

about

to the

industry

to consumer

and use that

Let's

exact

same

we need to go over

three

weeks

--

that,

constipation

in this

--

study

levels

on adverse
happen

and if

to achieve,
MILLER

who had,

the drug,

right

had constipation,

doesn't

are very

defined

when we do our evaluation

were getting
reporting

or constipation

I mean, those

gee,

in

or we look

we look

events,
you could
and if

those

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

at

cases,

of

at the numbers

are they
set

50

fact,

now we have six

and if

is

What do you want

say we do make contraindications

who have had severe

event
three

is

Houn?

DR. HOUN:

15

I

methodology

not

in

just

how well

they

it.

that

some survey

know because

is working

do what

that

to understand

I would

evaluate

DR. HANAUER:

13

also

the patient

Again,

campaign

12

showed us,

what they

is

understand

to take.

and doctors

behaviors

actually

Rodriguez

an important

4

they

decreasing?

up some
levels

are not

sg9-

236

1

achieved,

what would

you recommend?

2

that

going

for

3

you recommend

4

to reassess

5

have less

rates

6

ones that

prescribe

7

tie want

8

about

9

setter

10

next?

time

back
--

shall

another

If

this

drug?

do right,

how about

It

13

4hen they

14

study,

is

if

just

no more,

it

doesn't

come to us with
what

to as that

17

of these

without
maneuvers.

Dr.

DR. FERRY:

18

year

that

GI people

they

be the

these

lofty

is going
of the

to be
we do

to be

sponsors.
from

each

is bad and then

is going

information

--

goals

What should

and we learn

it

specific

next

you are going

my answer

I think

the

all

happen?

studies

DO

is what we want

is good and what

based on that.

16

should

what we are asking

and we learn

redesign

finding

So, that

at

education?

committee

You said

DR. HAWAUER: Well,
simple.

the

of contraindications,

education,

12

doing

we are

to push you further.

11

year

we reconvene

the programs?

--

Would you recommend

we

to be difficult
that

we get

out

that.

I

Ferry?

Yes,

I would

like

to second

.

19

nean,

this

has been difficult

20

[Laughter]

21

--

it

22

lawn the

road

23

reassess

it

24

:oming

25

lave to take

may not
either.

at the

up with

enough

be that
I think

time.

some other

MILLER

clear-cut,
we are going

I would

some pre-plan
major

today

that

--

you know,

a year

to have to

have a terrible

time

if

work YOU

this

step.

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

doesn't

237
DR.

of tension
really

SIEGEL:

between,

being

the people

you know,

sure
for

that

6

a little

bit

7.

it. in different

8

front,

9

the line,

and they

it

11

a little

12

physician.

13

tying

it

14

that

point,

15

tiell,

if

16

defined

17

yrou are not

18

different

that

rates
it

we find

did

the

whether

later
that

up

want

to hold

the

that

you are

if

down
line

or

prescribing
or by any
comes down to

we sit

seeing
here

on, but

we haven't

a rigid

goal

at

and say,
actually

that

we have,

to say anything

from now.

20

DR.

I don't
Let

21

lave made some points

here

22

Irug

23

it

24

laving

25

factors

be prescribed

understand

me see if

SIEGEL:

is

of constipation

MILLER

for

to say,

potentially

that.

I can clarify

on how important

precisely

that

would

clear

of an evaluation

there

to be in a position

DR. HAJYAUER:

a history

is

there

to be prescribing

'issue

of problems

a problem

going

indicated,

real

to

to push the bubble

of physicians

seems to me that

in a year

that

kind

of

yet,

we have to be very

subgroups

19

is

and,

know enough

at that

a lot

correctly

was okay to push some of this

up front

to

importance

who want

you really

I think

but

the

indicated

I think

by certain

to the

I am hearing

is prescribed

really

looking

really
bit

hearing

drug

really

ways.

of whether

whether

is

on that,

of physicians

you are

.10

the

whom it

may be some groups

if

One point

those

in terms
and other

give

it

it.
is

patients
of,

this

for

you know,

predisposing

them problems.

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

for

We

whom
not
risk

Yet,

if

SW

238

1

it‘is

2

misunderstood

3

a patient

who does have a history

4

something

like

5

else,

6

and they

7

drug,

8

tension

9

for

10
.

.

being

it

suffering

there.

and they
this

have a problem.

is

to

that

it

is
are

may have
or

really

nothing

in terrible

patient

a trial

I think

that

that

be restricted

I

shape,
on the
we have a

a critical

goal

and prescribed

--

12

saying,

13

ways to assess

14

the

15

thing,

that

16

coming

and where

which

I think

was that

since

indications.

you misunderstood

you are studying

is by physician

group

So, we are

saying

we need to evaluate
the benefits

DR. SIEGEL:

It

what

it

one of the

and within
very

where

and without

much the

the

I was

same

complications

are

are coming.

may be that

we are

saying

the

same

--

19

DR. HANAUER..

20

DR. SIEGEL:

21

you are thinking

22

oe confusing

23

>f the benchmarks

24

zhe reason

for

25

vith

consideration,

great

I don't

about

data

that

a year
that

feel

That

is good.

what

is the

from

tense

is because

next

now if

certain

decided

about

it.

No, my concern

we were aiming

MILLER
.

whom there

to give

DR. HANAUER:

thing

for

practices

as an alternator,

I mean, we have said

drug

11

18

are

they

you made, unless

some specialty

but

do want

and then

according

and the point

that,

really

this

--

was that

and they

17

.

prescribed

step,

we haven't
towards,
people

to use the

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

it

is

if

is going
reached
but

part

have really,
drug

in

to
some
of

239

!

1

different

2

this

ways,

is no barrier

to that

happening

at

point.

3
4

and there

DR. WOLFE:

50 percent

of the

incorrectly

Are

cases

and next

So, that

you

that

saying

now,

were due to people

year

you want

shows an improvement

it

for

using

example,
the

drug

to be 25 percent

and that

the program

only?

is

working.
DR. HOUN:

8

9

.

exactly

what
about

those

I can't

guidelines'will

10

talk

11

improvement

12

think

13

be in any way restricted

14

for

15

indicated,

and with

16

have a lot

of choices,

17

will

that

having

a benchmark

toward
there

that

I think

and looking

benchmark

for

but,

think

an illness

like

I think

it

through

that

we did

towards
at the
here

people

whom they

same time,

that

won't

it

should

be using

it

is particularly

this

where people

is very

likely

19

DR. HOUN:

20

DR. WOLFE:

it

don't

that

people

How else

Dr.

Wolfe,

can we advise
did

Are you looking

you?

you have a question?
for

guidelines

from

IS?
DR. HOUN:

22

That

would

be great,

if

people

have

some suggestions.
DR. WOLFE:

24

The only

way to assess

this

is

c
25

I

boundaries.

DR. HANAUER:

23

be.

so that

18

21

I have thought

has been no statement

some patients

push those

say that

Looking,

I guess,

at prescribing

MILLER

practices

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

to see who is

240

1

getting

the

2

is what we are'going

the

drug.

Again,
up,
they

physicians
going

11

to report,

12

really

13

that

that

some people

possibly

could.

in the

to occur,

There

office

I think

at to see if

factor,

who

prescribed

as has been

may just

want

is

one other

to try
case a consent

thing,

most of these

the

constipation

trying'to

get

complications

are

-- getting

to Med Watch or someone else

population

them

because

that

is

will

occur

in

of under-reporting.

It

The web MD interface

that

population.
DR. AVORN:

15

told

16

eager

17

talk

18

collection

19

address

20

data proactively,

21

could

22

different

us about
to take
with

the

is

advantage

company about

are being

be a very

24

are going

25

- again,

of,

which,

clearly,

and maybe the
other

assembled

as well
nice

tool

as for
that

the

Mr.

Levin

company

agency

ways in which

of names and addresses,
which

23

something

is

may want

to

that

phone numbers

and e-mail

can be used for

collecting

marketing,
could

and I think

be used for

that

a number

of

purposes.
DR. WELTON:

Is there

to say needs

to be done when a diagnosis

a minimum

L

ischemic

colitis?
MILLER

.

that

people

inappropriately

Maybe in that

but

especially

say,

your

14

.

indeed,
confounding

DR. BLUM:

10

complications.

be necessary.

8

.

is

the

to be looking

the

form would

*

also

were,

anything

.

but

had complications

brought

9

drug

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

of workup

that

we

is made -

wg

241
1

DR. HANAUER:

2

DR. WELTON:

3

are having

4

have to work

If

a.patient

.some bleeding,

5
6

By the physician?

that

calls

in and says they

does the prescribing

physician

up?

DR. HANAUER:

That

can't

Yes,

the

be regulated.

Do you

have a comment?

7,

DR. GURWITZ:

8

reiterate

9

to find

as far
out

10

the

11

complications,

12

that

as next

what

educational

steps

the patients
program.

then

only

thing

I just

is how important
and providers

If

it

want

to

will

be

understand

you see a reduction

you can say the program

about

in

is working

and

t

it

would
was about

so,
.

it

it

would

15

in a year

16

don't

17

despite

18

hard

19

because

20

they

did

company,

23

willingness

24

compact

25

negative

Glaxo

not

going

potentially

know that
if

aren't

and stuff
next

is worked.

you get
better,

and patients

what

back here
and if

understand

you are going
steps

you

are going

to know what part

to have a
to be

of the message

get.

Wellcome,

to work with
discussions.

way.

things

what your

you are not
or did

out

databases

deciding

just

important

the providers

your

the

but

be particularly

DR. HANAUER:

22

understanding

worked

and you find

all
time

without

that

know what

21

4

be okay,

Okay.
for

I want
their

us and the

to thank

presentations
committee

I hope we have not

I think

we squeezed

MILLER

this

again

and their
to try

and

influenced

lemon as much

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

the

in a
as

you

.
SW

242
1

can get

out

of

it

I want

2
supporting
4

Torres,

5

the

next

today.
to thank

me during
and we look

my chairmanship
forward

to the

Thank you,

meetings.

6

DR. HOUN:

7’

[Whereupon,

8

personally

all.

Dr.

Talarico

here,
reign

for

and Dr.
of Dr.

Gallo-

Surawicz

Have a good night.

Thank you so much.
at 3:30

p.m.,

the proceedings

adjourned.]

9

.

MILLER

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

735 ElthStreet,

were

for

243

CERTIFICATE

I, ALICE TOIGO, the Official Court Reporter for Miller Reporting Company,
Inc., hereby certify that I recorded the foregoing proceedings; that the
proceedings have been reduced to typewriting by me, or under my direction and
that the foregoing transcript is a correct and accurate’ record of the proceedings
to the best of my knowledge, ability and belief.

ALICE TOIGO

Food and Dmg Administration
-- Gastrointestinal Drug Advsiory Committee
,.”
-

-10023:9

,.

80 114:7;117:19
IO-year185:23
8000153:20
85 161:7
883S:iO

250,000145:14

14,47843:4
1400 151:s
1570:20;112:25;166:25;

0

Y

Hearing Volume 2
June 27,200O
5

259111:21
26 lS4:2

5 22:8;34:24;40:18;

-.

45:23; 11617; 164:20

,',~,".~?ir;~~~,l.~,~,~~
.q+>"':.x-3,i:"v
rc*:*.+
8p '"/1;!p+*,<~,~
.ym
*,+zri5tr:~,&-'y~~~~;~*$>
+<3;,;?*,;,
p>,,?+&
.$
: ':$$ jx&g
&.)K&z
pg.&.: <:p
:.3?
_.L *,, '.".:+.?,p,,,#j
~~~~~~~~~~~~~~~~~~~~~~
; '.<Y
,$;~~,~Pb~~,
-?, / .::I..

j;:>4~:1;?~?~~~~~2~~~~~~~?~~
1..?,~&~~W~,?~>~
~~:i"i~~~i~.~sli/;;i-l..13
,17..&
,",...*>-.:t,.'
..".:-r;,'L.? ;'-.+;:,h
118:2,:f:r,~~~-;.‘l1~i~
..,e>;
,a-,r :s?;-ir.
.=.
-.‘.

12l:io; 122:iq; u9:21;‘p~

1Sa:24;151~~~13;14:'rS~~
18; 173:l,
'. " 1 -2:

E

!

1.4 55:19
1.542:10
1/10,000 145:s
l/1000 145:5;194:21;
195:2,15,16,23; 196:14,
24;197:12;203:11
i/1500 195:23
114 161:4,8;162:5
,1/450 195:9
l/750 194:25;195:10
l/900 195:1;196:14,19
l/98040:11
10 35:7,11;41:24;42:15;
43:23;45:25;70:21;
113:12; 114:3; 129:7;
164:19
10,000 S2:6;54:21;
56:12;73:14;87:11;99:15
10-20 111:lS
100 158:3; 164:23; 203:4
11 45:21;112:22
110,00042:24
115,02777:3,5
11:lO 106:11
12 20:17;22:5,8;29:5;
32:7;79:18;113:24;
116:22,25; 117:l; 118:20,
22; 129:22; 159:11,24;
1764; 212:25
12-A304:21
la-month 205:6
12-week70:17;82:21
120,000 187:lS
121,000 187:9
123164:21
'12:45 163:lO
1379:18
13.5 22:8
13043:s
130,000 34:12;40:17;
45:6;7624;77:2,4
14173:18

- . .._a- -

-

-

1990 53:4
1901 172:20
1993 152:lO
1994 152:14
1995 227:ll
1998 152:22,25;153:8,
18;154:8
1999 13:10;33:21;
142:23
1:30 163:8,11

A4493:6

abd 88:8
160:2,3; 164:23

6i8 24:14
60 87:8; 113:l; 154:3;
2262
60-pill229:6
600 28:24;31:17
61 161:6
85 35:1;180:17
68 113:8;114:7;160:25
68-year38:8
6852 34:10;40:10
69-year41:3

2
2 36:2;38:9,20;44:25;
45:24; 112:23; 113:15,24;
114:2; 116~20; 117:3,13,
14,17; 118:2,17; 119:17;
120:12; 121:10,25; 122:6;
151:1,14,16
2-3 119:17
P-day38:21
2-fold44:21
P-week 29:s
2.6 151:15,18
20 77:24;79:18;216:17
20,000 58:10;73:14;
99:lS
20-40 225:7
20-year206:15
20070:18
2000 13:9;34:6;40:16;
42:24;129:21;160:18
201 45:21
208(b4:17
21 38:3
22 41:5;83:17;117:20
23 38:7;164:19
2307150:25
24151:8
25128:18;239:S
25,000 58: 10
25-30129:6
*---.

-I/

abdomen41:19
abdominal
19:16,21;
37:5,6;38:11;41:5;46:1;
87:24;112:6;115:7,10,
14,16;120:11,13; 121:17,
18,19; 122:12,16,17,18;
137:22; 186:9; 212:14
ability 103:22;210:13
able 67:19;68:6;69:10;
103:16;127:9;145:4;
1619; 166:1,2; 167:14;
168:6; 170:11,15; 171:3;
178:12; 181:s; 183:23;
217~6; 222:21
abnormal 118:8; 212:18,
20,20
abnormalities
15:25;
19:23; 173:lS
abnormalityl80:18,19
abscess 39:10;97:16;
121:23;2O6:19
absence204:ll
absenteeism22:4,7;
27:21;28:6;175:2
absolutely
103:1,16;
141:5;160:7,13,20;
166:7;196:3;213:1;
228:lO
abstract103:22
abstraction
51:13;149:8
abut11:14
academic 19:ll
accept 19O:S; 195:ll;
196:17; 198:lS
acceptable10:23;

6 35:6; 111:22;117:1,5;
121:s; 129:13; 13O:lO;

M/Z.

a

4
4 32:14;35:15,19;36:3;
37:20;38:4;40:4;41:25;
45:23;56:13; 116:16;
118~21; 129:19; 151:20
4-20 2O:l
4day35:20
4-week29:s
40 36:21;90:17; 111:12;
112:17; 113:22
41 9O:lS; 113:l; 173:20
4287:l
43 112:24
44 24:8
45 1Sl:lO; 152:3
47 113:22
46 161:2
4&year37:21
4800153:19
---

---

-

7 36:12;37:22;40:10;
113:13; 116:19,21,25;
117:l; 121:4,5,15;
129:12; 13O:lO
7.3 151:18
70-year97:ll
7os2OO:20
72-year 39:4;97:25
74 21:ll
75 35:3; 117:19; 161:3
75-year 206: 18
75040~8
78 113:8
78-year185:4
783 32:6

195:17,23; 198~23;
203:12; 215:19; 235:25

8

acceptance64:20
accepted70:23
access 187:18;193:1;
220:13;222:25
accommodatel75:9

8 23:10;39:2;83:18;
84:17;113:13;116:20;
117:2;118:21,21;129:22
8-13148~4
I_.

-

_--

a

Hearing Vohme 2
Juice 27,200O
accomplish 69:9; 154:18
accomplished
l4:l

_... .,.,,.
additional 5:14,20; 167;
4S:S, 25; 56:13,20; 57:6;
63:9; 65:10,18; 77:9;

Food and Drug AdminIstration
Drug Advsiory Committee

chstrointestinal
I .,- ._

131:11,12,17,17; 193:18,
21; 218:1,1,3; 23S:lo
advice l&l 5; 11:4

agent 160:1,22; 161:2,5
agents 2O:lO; 31:21;
32:3;73:18;74:3; 128:lS;
157:17; 160:6,7
aggregate 4k16; i84:7
aggressive79:6
-’ ’
Ag,ngi~~~~~~~~~~
.:,_s.dw$+s:::?!,q*: g+

altered 19:16,17,19;
133:10,10
alternate 84: 12
alternating
29:4; 39:6;
109:21; 121:ll; 213:25;

214:2, 15
.-“.= ’ : 5
aher.Lt.f...+&~21 i7:21
~.~.‘~~~,-+&~~‘
;;.;?--..~“,.,.
‘.* _
afternator.84:8,21.,
23;
~g&:7;~j‘:‘t;j(gl;
‘-1’
8~,@~~ily:‘L2~~238~3
,,, ..a:./. :’ 5
13c:3~ra7:~~‘~ij:~~~~~~~ :.. ,;.-,,?y7;;.,>
80:18; 8X:6;
214:5, fji.7; ? 16:18 ~;;:/$$ aiternators
yjq,
29,
: ;.$ “‘: ).’s.:;;...
3 :” $$g$y
agh$S(~~i9,20;33:1t$ :: 2!@$@q$8;lS,
14,
y$l;hj.e~~;
:pJ&w~jq
p;p~g@fei ix ., p”:;‘*$.
‘i89:S; “,
21; I ; 2j324; xt~~~~~~~~~~~~~~~~~
~~~.$:.qq~~ZPs:?,
_
~~~~~~,~~~~~~~~~~~~~~~. ~~~~~~~~~~~~~~,~~~~~. ,.
~@:$5:~3~~,~;l
:;ppq@$. ‘<bhy;>
(...
I.. .4$$
i-,y,,FV“&.&,‘, .,~,~~~~>,

;;Q<y$4!.
.:‘7~~?~~~~~;Zi~~:1.‘~~‘~.,~,~,;
~~~~~~wis:~l,~~‘~21--;~~,~:,:
** /. 37*.. *=“,.~.1.p:> * -(
14~12;“1;80:“r3’:g4’:, :1,+x$: ‘,
~~~~~‘~~~~~~~~~~~
~~~~~~~~~~~~~~~~~~~~~~:. ~:;. ,
ag&nif@f
~~~$k$$$$.
. _i.~~~~~.~~.,~~-~%~;~:,:
cc.
q.,..^.,,‘,. ‘ $ $$y*&#&~l
““{ 1:Ar‘._.
agi&%nernt

52~8; 72:lS;”

ati;i:“i’~@;

~,&,&
“:‘w,,,.;&&
l-.g;q
.::;~;

13&20;i& <2jr”:“~“:$4g3r

acid 161:2
across 23:17; 24:14;
48:2s; 100~13; 151:18;
222~25; 22618; 22915
ACs 912
action 14:18; l&6; 50:2;
61:15
actions 59:22; 63:8;
66: l&224:7

activities 11:2; 17:1,11;
49:19; 140:24
activity 30:7; 74:25; 96:6;
233:5,12
actual 10:7; 48:16; 50:22;
52:1;91:13;99:11; 105:6;
172:7
actually 10:3; 21:23;
26:10;41:12;78:11;
82:21;84:11; 85:6;87:7;
89:3,13;90:12,25; 93:12,
14; 94:4; m&7; 136:6,21;
142:21; 14616; 148:19;
158~19; 159:22; 160:17;
162:23; 163:2; 165:21;
169:23; 170:11,15; 1775;
182:16,25; 189:2; 194:lo;
198:20; 203:1,4; 208:17;
210:4; 219:17; 224:13;
225~2; 226:7,19; 229:3,5;
232:4,6; 235:1,1; 237:15
acute 40:12,19; 43:17;
51:19;71:15,18; 103:14;
150:3,4
ad 227:ll
198:l; 208~7
0; 179: 14;
./
addition 22:20; 23:2;
58:l; 60~2; 72:2; 74:17;
75:18;76:12;78:10;88:4,
7;90:4; 131:ll; 14S:l;
173:s; 179:1;213:15;
232:19

93:14,17; 112:5; 161ili:”
162:12
adequately 72:8; 176:4;
210~17
adherence 49:13; 138~0
adhesed 37:7
adhesions 37:s; 20~2;
213:14
adjourned 242:8
adjusted 21:13; 25:16,
16
adjustments
175:9
administered
110:13
Administration
8:14;
47:lS; 52:8; 57:2,19; 58:2,
23; 108:24,25; 109:ll;
111:s; 115:19,21; 138:14;
170:23
administrative
16623
administrator
169:8
admission 38:22
admitted 37: 1; 38:s;
41:7; 186~9
ads 127:8,9,10
adult 25:7
advance 47:20; 58:13
advantage 162: 10;
210:14; 240:16
advantages
209:21
adverse 9:9,12; 10:23;
11:12; 17:12,17; 18:7;
34:23; 36:l; 39:18; 48:l;
49:25; 57:8; 74~4; 76:3;
108~4; 116:1,3,7; 117:13,
20; 118:21; 121:12; 124:9;
126:6,9,11,12; 127:5,17,
25; 128:20; 129:5,12,24;
130:12; 131:18; 137:19;
144:23; 145:9,13,19;
146:7,10,12,14; 147:9,
10,16; 148:3,5; 150:4;
194:17,20; 197:12;
235:21,23
advertising
9:22;
107:13; 124:5; 1278;

; ,‘l- - -r% ahead 165:& & @i&
184:ll; 196:6; 198:6;
affects 20~2; 196:4

gg..6;.15:16

affiliated 135:2
affirmative 173:25; 174:s
afflict 7O:lO
afflicted 76:2
afford 51:8
afraid 163:l; 199:2
Africa 98: 14
afternoon 133:22; 134:4;
164:l
afterwards 28:lO;
153:21; 158:20
again 25:5,14,20; 266;
272; 31:8,25; 33:7,23;
38:17; 39:24; 40:14,20;
41:18; 42:15; 43:24;
83:12;84:19;87:8;89:14;
90:13;96:10,13;99:4,12;
103:21; loG:3,7; 110:15;
112:15; 113:20,25;
115:13; 11625; 117:12;
118:2,20; 119:22; 128:24;
129:17; 130:8; 13S:l;
136:14,24; 138:3; 141:18;
146:12; 150:12; 158:6;
159:4,25; 161:4; 170:17;
172:2,5; 175:4; 179:6,14,
17; 183:9,13; 184:2;
187:17; 189:ll; 194:15;
197:19; 208:8,15; 214:8;
224:S; 232:17; 235:8;
240:4,25; 241:21
against 7O:lo; 72~24;
75:6,7; 87:l
age 21:13; 25~6; 53:19;
144:19; 181:18; 188:7,9;
194:7
aged 144:8
agencies 155:2; 218:3
agency 4:13; 13:8; 14:19;
16:s; 17:18; 106:10;
136:21; 157:ll; 189:12;
196:12; 202:lS; 205:16;
207~4~21; 224:7; 240:16
agenda 4: 12,23

--

---

-

227: 19
aid 62~4
aim 25:3
aimed 47:12
aiming 100:9; 238:23
Alabama 166~22
alarm 199:24
algorithms 53:8; 149:5,6
alkaline 44:20; 118:lO
Allan 57:21
alleged 146:14
Allen 18:14; 28:3,4
allergies 4S:lO
allow 5:s; 51:9; 68:25;
693
allowed 191:9
allows 173:8
alluded 124:7; 148:14;
149:4,17; 193:23; 211:17
almost 25:7,25; 154:3;
165:10; 17O:l; 186:20
alone 10:9
along 10:16; 37:7; 62:lO;
64:9; 69:7; 162:25;
173:ll; 205:2; 208:lS;
213:22; 217:7
alosetron 28:14,17,21;
29:6; 30:&S, 17,19,25;
31:2,6,14,20; 32:2,8,21;
33:3,18; 34:5,7,8,11,12,
21,24; 35:17; 36:5,12,17,
25; 37:22; 38:3,10,10,20;
39:7,14,18,20,24;
40:5,
7; 41:4,7,25; 42:14,16;
43:21,23,24; 44:2,15,23;
45:3,6,9,17,17;
46:3,8,
16; 91:12; 96:13; 118:13;
119:16; 159:14; 1m12,
14; 221:l
alosetron-treated
44:12,18
ALT 44:9,11,14,17,24;
118:lO

- --..

-

_.

-

_..A
““.>l;p.~:p;~‘
\...LawI*$,C:“2. I
@Js 45; 17 ;&$+;+
I’
~
t+~.. . “:‘;.,‘EQ”.<
‘-~‘.;i,s;.i
:
~~&qy22:21;
i$li9;
205~22; 226323; 227:l;
228~8
American 173:lS;
23O:lS
Americans 172: 15
amino 185:9; 186:1,3,
lo, 17,19,24; 187:11,15
among 53:ll; 145:24;
151314; 175:18; 203:12
amount 102:lS; 162:3;
204:24
amplitude 968
analyses 55:2; 109:18;
112:7; 153:22
analysis 57:8; 93:14,18;
112:9
analytic 183:2
analyze 34:4
anaphylaxis
185:22
anasarca 185:7
anatomic 180:17,18,22
and/or 33:16; 43:16;
46:12;80:17; 108:24;
123:24; 130:16; 212:lS;
213:13,17,18
Andrews 18:17,17;
46:19,22,25; 59:5; 60:13;
69:8; 78:6; 91:7; 101:21;
102:24; 103:l; 104:4
anecdotal 136:22
Angeles 6: 11
animal 95:23; 127:3;
197:17
animals 95:24
announcement
4:9
announcing
62:l
annual 175:3
annually 137:12
answered 62:14
antagonist 28~18
antibiotic 119:9
antibiotics
39:ll
anticipate 12:13; 61:2
anticipation
33:12; 143:7
/....a.

IL / /r-/x-

Food and Drug AdmWstration
Gastrointestinal Drug Advsiory Committee

Hearing Vohme 2
JuQe 27,200O
945; 134:8; 135:22;
1556; 157:24; 167:3;
170:9,14; 174:3; 176~6;
; 182:24; 19514;
3; 22S:23;‘22?:i?Sf

16,20,21,25;74:7; 7S:l,
5; 91:20,22; 92:3,5,8,10,
13,23; 129:2,3; 152:19;
157:8; 197:20; 198:l;
211:5,7
bleeding 119:18,20;
120~10; 241:3
bloating 19:21; 174:12
blood 57:18; 94:20,25;
95:13;96:1,2,12; 158:10,
13; 187:16
bloody 77:7,11; 120:11;
137:22
blue 5:21,22
BLUM 6:18,18; 76:23,
24; 100:17,18; 103:24;
158:1,2; l&13,16;
183:17; 184:l; 187:14;
192:23; 206:5; 222:18;
229:4; 231:15; 232:12;
240:8
Board 6:23
boards 102~2
iiy 23: 12; 26:8,15,20

- Ang 26:25
bold 210:7
bolded 74:7; 75:18
bolding 139:24
bombarded
210~18
book 21819

-

books 2185
boss 167:8
Boston 7~8~18; S5:6
both 16:11;20:6; 28:14;’

97125; 106:24,2S;‘108~16,
17; 110:4,6,15; 120~15;
121:24; 122:17,18,23;
123:13; 128A6; 132:14;
144:13; 149:lo; 156:19;
157:23; 164:S, 7; 165:14;
166:25; 167~17; 168:21,
24; 169:18; 180:1S, 16;
199:l; 206:5,16; 211:13;
212:12,18,19; 213:17,18;
219:23
box 17:18,20;72:12,16,
20,21,25; 74:7;75:1,5;
91:20,22;92:3,8,11,13,
23; 129:2; lS2:19; 157:8;
197:20; 198:l; 208:7;
210:5;211:1,5,7;229:11
boxed 74:13; 126:20,22;
127:6,7,14,16; 128:3;
129:16; 131:21; 207:17;
208:1,4,22; 209:5,9,13,
21
boxes 92~5; 129:3
brain 173:8
brain-gut l73:4
brain-storming
217:12
brainer 218:25
brainstorming
209:19
branches 96:5
Brandt 43:9; 76:16;
180:5,5; 181:7; 182:7;
195:2,4,13
breadth SO:18; 98:lO
break lOS:23; l06:ll;
163:6
breakdown 85:8
brief 19:4,6,13,14;
35:16; 69:20; 87:22;
106~12; 123:(i; 131:17;
144:lS; 202:22; 221:s
briefing 5:16,21; 14:19;
15:21; 17:25; 18:2; 369;
40:24; 45:5,22; 75:15;
95:22; 101:23; 111:18,19,
21; 124:2

17,21; 142:1,4,7; 145:21;
146:l6,16; 147:25;
155:20; 158:20; 159:18;
167:1,20; 170:23; 172:8,
19; 173:10; 174:2; 175:12;
ln:l;
180:18; 184:9,15;
187:9; 189:19; 195:6,14,
22; ?oo:ll, 17; 201:12,14;
207:lO; 209:22; 215:1i,
23; 219:17,17,19; ?20:22;
224~1.4; 227:20; 228:5; ‘,
229~21; 23018; 232:6, S;--:‘;:
237:20;239:18; 24OA9; ‘^’
24i’:iij~~~:!~~~~~~~~~~~~
&g&gy~@~
II:..s.+$i’j&
*b?& e;&:&o.
~~~~~~~~~~~~~~~~6.
-;$;
; 1,-,*.:*. ’ ;.h >$t“a,-:+‘>,J,.
&.-r:$:
62&+66~$ +.~~~~~~j:~~~~~~~
‘.:~;::“‘.B&>;~**”
*,.?..-3

C
2 153:6,20; 154:4
:a:culated 21:4
California 7:24
Zall4:2,3; 9:3; 64:19;
;6:4,6;82:20; 131:20;
137:3; 166:3
:alled 111:14; 135:15;
L45:9; 167:17; 191:13;
L93:23
:alling 77:13
:alls 66:5; 241:2
:ame 22~7; 23:23; 40:22;
j4:6; 77:13; 109:17;
135:8; 149:11,12; 168:14;
185:2,4,24
campaign 235:lO
can 20:3,5,25; 21:2,4;
22:12,19; 27:17,19,20;
29:25; 32:l; 44122; 50:2,8,
11,14; 51:10,13;64:19;
65:18;73:17;74:4; 80:21;
B1:11;82:23;85:5;86:14;
B7:lo; all,
25; 89:21;
91:4; 99:9; 102:lS; 103:3,
lo; 104:2; llO:ll,
12;
111:20; 113:7; 114:19,23;
116:11; 124:19; 125:5,11,
18; 126:21,24; 130:14,16,
25; 131:11,12,16,24;
132:3,6,7,7; 134:ll;
135:15; 136:6,7; 141:12,

fin-U-schwa

146:19,24; 147:1,2;
148:9,11,21; 179:lO;
180:17,22; 181:12,13;
184:24; 195:5,8; 200:12;
2Ol:l; 203:S; 235:21;
239:4
cast 14823
castins si:a$;
-. y

casiid i i0:7,16
categori&li6:14
cat~go<&
&$
“ :..
2 j..>?
“.~;-s”~~~~~~~,~~~~~~‘.
z, ‘:
categorized
116:
11,;r: * ,‘
.;“:.,&
‘.i~I;+,7’,
*t?.,?~-5’4

‘c*g&yj3&
i&.8;, .,:
id~~~~~~.~~~s~~~;:~~~~~~~
, ,,l.$
,.$vl,‘$+.
ep.A,$
7:-y,.
‘” .:
,,yp&“.C’S
~..%;w>.,
__*
<q*.
-,>I
i&.

.,.
,caught
:, .j&.$
.:_)%‘iX88:21;
:~@*xg,
i$$.C#$l$
!-“W+&z
*y,::;+
;. .:,:
.+..sQ$fQ:71;
,!.p:+ !S,
cap)uf* 23: 10 _ .;,::‘T
~~~~~~~
2S; f$S; l,@?$; 201~9, ,,,.I;
.:.,__‘1
.~..;,~~~~,;~~~‘~.,~~,.,
car
168:2
_ ^.~
” $$#$?p.; cau“L&~;;iiiii*g@$fy..y?%?;
_. .:c3
12 ‘y.: ,“:::~~.,y-:p,,‘:. i jc.
card 62:9; 64:5,13; 65:14
cause
i&4; 74:1,4;98:4,
cardiovascular
152:205,
S;
99:9;‘i45:21;
147:7;
cards 62:3,4
186~24; 187:1,7
Care 8:7,21; 12:l; 15:9;
caused 762; 95:20
20:17,18; 21:18; 23:2S;
causes
76:l; 162:4
38:6; 52:25; S3:1,16; 98:2;
causing 196:14; 203:4
15O:ll; 153:13; 172:14;
173:17; 176:6; 192:3,8,8;
CDC 99:16
193:ll; 218:17; 223:22;
celecoxib 70:19
234:23
cell 57:16; 95:9
cared 192:3
ceils 94:21; 95:3
careful 102:19; 103:5;
cellular
233:5
128:3; 14S:24; 147:2;
Center
4:14;
7:20; 15:8;
162:2
66:4,4,6; 77~24; 192~25
carefully 169; 58:ll;
Centers 49: 14
89:9;90:11; 1468; 197:16
central 173:2
caring 37~13
Cerebral 6: 19
Carolina 66:7
certain 81:16; 82:4,6;
carried 93:20; 112:8;
LO2:15; 128:6; 136:lO;
168:2,2; 176:8
138:22; 158:23; 182:18;
cartoons 217:23
t91:7; 194:21; 207:21;
case 36: 18,18; 38:2,8;
220:1,4; 224:9; 230:7;
3914; 40:8,22,25; 41:2;
237: 11; 238:24
43:1,19; 45:7,8,12; 51:7,
certainly 18:24; 85:17;
8; 55:4; 56:2; 77~8; 88:19;
97:24;98:4; 102:16;
97:13;99:23; 103:12;
104:6; 123:16,17; 134:2;
108:ll; 117:7,8,9;
144:16,16; 174:22;
118:23; 119:1,12,23;
189:17; 190:6; 191:3;
120:3,17,23; 121:1,5;
208:3; 2lO:9; 228:3;
122:lO; 123:l; 135:16;
230:14; 231:21; 233:25
136:14; 137:18; 13814;
CERTS
49:14
144:20; 146:20,22;
cessation 132:19;
149:22,25; 155:20;
159:14; 186:21; 204:16
186:14; 187:4; 188:24;
198:l; 199:20; 216:l;
chains 63:16
220:3; 225:25; 240:6
Chairman 6:20,22; 76:9;
case-controlled
183:l
123:19; 219:l
cases 16:17; 33:19,19,
chairmanship
242:3
23; 36:8,9; 37:16,20;
challenge 51:22; 118:17
40:11;42:21,25;43:5,17;
challenges
51:17,17,23
45:23,23,24; 51:20,25;
challenging
155:23;
56:4; 71:13,15; 77:7,25;
203:9
78:12,13; 80:23; 86~23;
chance 98:19
90:17; 99:2; 103:14,15,
change 14:17,18; 33:16;
17,18,18; 116: 15,16,19,
40~13; 43:lS; 4612; 54~8;
20,23; 117:2,4,6,15;
118:ll; 119:2,4,10;
83:6,10;%:12;
133:13;
122:14,22; 129:19; 130:4;
150:17,18; lS2:3; 154:s;
134:12; 135:4; 139:9;
- 187:6; 193:14; 201:15;

Miller Reuortimz Comnanv

(202) 546-6666

Food and Drug Admhistrtion
‘- Gastrointestinal Drug Advsiory Committee
_
*-

225:13; 228:16; 233:20;
234:lO
changed 14:16;79:19;
.,+7:1s
cha”.b’& ‘lB;~;~;~~~;,.

Hearing Volume 2
June 27,200O

clear 5:18; 38~16; 46:15;
52:2; 72:25; 81:8; 85:13;
88:18; 129:4; 130:8;
136:20; 178:6; 18S:25;
186:l; 191:16; 197121; .‘.
2377
‘, ’ .I?.y- ,;$~$;$~;f
+&&if
‘g$;ii;fjl _, ! ,;.;.:‘.s2:
&‘+.
5&.$.3++g~?.yi~

50:1,24; 51:16; 52:10,17;
210:23; 241~6
53:IO; 55:1,15; 564;
i commented 18S:4
57:14; 59:21;61:14; 63:8;
comments 5:5; 8:ll;
66zi&W13;‘1&,
lg;
97:22; 164:3; 184:21,22;
75:17;77:12;80:17;
185:6; 191:lo; 193:2;
86:20,23;
87:14;
90:2S;
*’ 60:25; 67:20; 68~7; 69:$
198:12,18; 203:5; 208:6;
95:19;98:4; 103:12;
I
79:24; 107:1,2; 169zi6; ‘**”
211325; 21623; 217:7; ;
104:2;
105:19;
116:13,16,
: 15O:lO~ 152.25?;fS;f:&;‘::“;:
220~10; 224:7,7,24;
-1&.18,19,2$<8j:l
r;‘t$; 39:28;43~~~~~~:7~if:2~~” 20,22; 117z2,7, lo;
23&‘3 ,. :. .;;,‘1 ,,;..-‘fCf
- a*.“-i:*d”,&s+,.Wi $5; &2St&fis;
118:20;
119:1,11,15,19,
i,39:22j‘,’
207:16 ” ,,,,‘~~~~~.:~~~~~~~~~~~~~
commercial
S9:1.- “’ i.
22,22,25; 120:1,3,4,18;
140:17;
y&l+;
1&;14;
cOmmit 21&J’-” ‘: “:^ ;y
changing 91:16;?25:10
121:2S;
122:1;123:2,17;
d.I _,,_:& :I.@‘:y$fp;x&$ !97;23; .240: 1S :$y:;-: $,$
cbr;imii.4~-djz6,“;;.
L,.‘_
~0492 ,;;+;L+;;
s i .**. i r::i, ; .*,*~~~~3y+>~129:17,20; l?O:?, 5;. ..;;.
,. channels
!‘;“:~s:,~~~“~Rr*~~~~,
-*y* q;:
Clink ‘21~8;14&:3 .’ yF;,-$
$ppjy$jy~
~~p3,~&$~~:.
“c~Y2g#&yp~~
‘g.@y
132t16;:!‘~3t;!4910,‘~2,
characteristics,47$6;
:-*sy.s7L$+&&
.W’iiS*&>1&-*r
,A,:<
.l.~&a*.:$*<“&>y;.:!.
y’+-~&b
-;: &:
:;k$.,@0;6
&x&;.
‘;,?.c,. s~~2:“3&;& :9; &!&(p&
I’ B.*;,,
:“I x.C&J
“.$
‘?($$49:2; ~.5,6~23;.~~~2$$ y:,
Iq,,.~&+i2
~~‘~,~.~‘~~~~i:~~~~~~~,
commitments
175:,19J$
.::~~~~~~~~~~~~~~~~~~3~19~
2p: .(
~$‘:<-~‘$~i-““i”4
&~~G
j;
?+:$:&.>
“:;’
<.e;
‘, ...A .t !e.,./ _!. ,.,!..&
t80$$$$~~;
!94.:25; 5
.p.:-,*;i+.;:;;,
<.”i , c-,@o,-+.
N.>.g
./ 7,*i,-*WA
gg37.3; 405,9; 42:2Q;;j$!g 195:1,$ @3;,$4,22~‘,;;~-:
SC;;lg
a.. bq’,.<.$d,$9>?
/ ~~i;8;‘~7~~~,“i;irS~~~~~~:.T
,;~&p#q~‘~’ , :,,,
’ &$/“ ,,-:‘.,~.~~i.:;zJ?~
”committed4f:l4;
F.I,“‘1,;&‘.~~”
p+>.?qq<:f’
+.<Q
i “‘“‘*c$,p
a:~~~~,~~~~~~~.~~~~
“2.
.~
.;\
\..
:
A:,:
:,p,<,c.
‘+
, : ;; ;** .~~~~;~:;;~:iB.~~~~:L

i~~~~3~~~i~~~~r;‘206:21; cotnpq,ee~‘7;
(t::?;zyy$
~~~~,~.ii;‘~6,“li;‘~6;
;;$$&~~~~,
~23.f~”
2~~;~4 24023 -.?fg$$$ _’ ‘i~;iiJi~, ?p3j~,~;g@
.“~r,.~~-;;.‘“-...-.r t *I* ~~~‘~.i;,.:~,..‘.i:~.
L;.?,,
‘">;^\p ._ '~7"
c<-+
~~~~~~~~~~~~~~~~~~~~~~~~~~~~
$$p tj3;gf,‘;i2;‘54:iii
sZj:l(jF’:
“-ii<*> .L,,%
p r .+.* ,&<.%%
-?<;&:
15:22; 19:9;‘2&1?; 33:21:
collaboratron, 5225;. ’
‘y?$harge 12:7,1S; 1773 :
43:ll; 4512;^46:23; “.“%stZ
22; 24; 56~4, is, 19; Sf:s,‘+’ SS:5, IS’-- “"I
'... i:.;;
“& 2 135 ~~~~~~~~~-~~~~~~~~~~58:9;66;10; 7!:22; 77:21;
.,:t
S&22; 76:20,22; 100: 11;
collaborative
55:6; .’
8025; 86:16,23; 87:2;
charged 177;1~~$$$
106:18,20; 110:19; 1166;
c.
131:6
9O:lS; 91:5,8; 112:4;
charges l77:5
“”
118:13; 124:18; 129:3;
collaborators
178:24
126:25; 128~7; 129:7,8,
133:4,21; 134:5; 143:2S;
chart 234:12
17; 138~12; 146:21;
collate 147:l
150~21; lS4:lS; 157:lO;
Chattanooga
l64:17
159:23,23; 160:2; 164:20,
colleague 200:22
163:5; l64:4; 172:3;
check 62:4; 168~5
22; 170:8,13,18; 174:16;
colleagues 21:7; 8S:6
177:14,23; 178:ll;
18921; 202:19
checked 90:6; 224:18
201:24; 208:4,4; 209:17;
collected so:17
ciinicaiiy 24:13; 27:14;
checks 102:13
210:2; 215:l; 21624;
Collecting 178:18;
50:13;71:8
Chey 76: 16
22217; 232:15,20;
24019
clinicians 17619
233:24; 236:3; 241:23
Chicago 7:5
collection 240:18
close 97:4; 164:22;
committee’s
110: 11;
Chief 716; 12:24
College 6:13
180~17
114:17; 115:23; 19913
children 14~1
colon 37:6,8,25; 38:23;
closely 1461
committees
ll2:ll
choice 168~1
39:2,9; 41:9; 42:3,4,6,8,
Aoser 215:16
common 71:19; 175:18;
9,9; 43~22; 121:23; 122:5,
choices 239:16
186:2
:m36:21;42:10
7,19,25; 180:11,13,21;
choose 127:21
:ommonly 31:21; 93:6
ZME
155:10
181:l;
182:12,12;
200:23
chose I 19:4
:ommunicate
14:7;
3lS-4
16o:l
colonic
42:13,14;43:20;
Chris 220:2
j9: 15,17,19; 67:20,24;
97:15; 123:15; 156:22;
ZNS
S8:24
Christina 6:14
72~4;92:9; 98:15,20,24;
180:16
:o 58:l
chronic 204; 22:23;
tO5:16; 124:23; 128:lO;
colonopathies
116:12,
Zo-Chair 7:21
24:l; 25:7; 69:25; 7024;
130:20; 222:23
12,15,22; 118:19
:o-medications
117:24;
72:24; 73:18; 82:3,6;
communicated
125:13
colonopathy
121:3
119:ll
85:ll; 88:2,4,23; 173: 1;
communicates
228:l
colonoscopies
43:4;
175:24; 176:2; 213:ll;
:o-morbidities
153:3
communicating
50:4;
195:7,10
215:s
:oagulation
57:25; 58:1
52:23
colonoscopy
36:20,20,
chronically
ll4:13;
12022
communication
8:5;
23; 37124; 38:25; 41:ll;
181:24
:odes 51:24; 523; 53:9;
17:23;
47~9;
48:14;
60:1,5;
119:2S;
120:3,17;
195:ll;
cigarette 180:20
148~22; 150:13,13
51:ll; 64:15,21;66:20;
198:25
circulation
180:15
:oding 51:23
67:15,25;91:17;92:4;
cotorectat 7:23; 198:20
circumferential
42%
:otactor 182:6; 18819
98:8; 99:l; 100:4,13;
CdOStOmy
38:23; 97:9;
circumstance
137:25;
130:15
:otactors 181:25; 182:3
122:6
138:9,19
communications
18:19;
:ohort 22:2; 23:15,21;
column 113:6
circumstances
132:7;
48~4; 53:25; 54:16; 58:14,
24:6,13,20; 25:20,21;
combination
78:23;
137:15;203:12;228:11
17,19; S9:7,25; 60:11,22;
26:7; 27:3; 51:6; 52:6;
174:3
61:7,17; 63:24; 67:8,10,
i4:23; 150:24; 151:1,4,8,
cisapride78:21;79:11,
combined 107:9
23; 68~2; 69:6; 104:13,21,
3,10,13,14,l9,20;
21
comfort 7923; 215:l
22; 105:9; 124:4; 130:22;
153:16,21; 183:l
cisepride 198:2
231:7,12
comfortable
198:2
cohorts 23:23; 150:24;
claims 9:22; 53:20;
community
10:5; 172:22;
151:9,13,17
coming
27:19,23;
89:7;
101:16,18; 150:12
173:19,23; 176:10,19;
106:10;206:10;217:3;
colectomy
37:ll;
97:3,
clarification
159:19,21
193:ll; 222:20,22,22
236~24; 238:16,16
?; 122:7; 123:3; 130:3;
Clarify
237:20
compact 241:24
206:8
commensurate
72:9
Class 73:17; 128:12;
companies 9:7; 92:2;
colitis 167.8; 33:10,17,
comment 5:13; 79:3,9;
145:21,23,25
98:23; 176:9; 219:s;
19,23; 34:2; 391; 402.5,
87~10; 94:2,3; 98~25; 99:l;
classic 7023
228~21; 230:23
12,18;41:14;42:19,22,
100:7,18; 101:13; 104:ll;
classically
1761
25; 43:5,7,10,15,16,1~7,
143:6; 162:2,24; 198:14;
1 company
47:14; 49:4;
_^
classification
13:s
18; 45:23; 4613; 48:8;
202:4,22; 208:8,20;
I 53:2;91:16; 112:ll;

Miller Revorthsz Comvany

(202) 546-6666

Mirm-u-script@

149:3,17; 155:9; 188:4;
189:8,11,20; 207:4;
209:ll; 210:5; 215:21,22;
218:13; 219:9,9; 226:l5,
16; 229:14; 230:19;
232:18; 233:18; 234:3;
240:1S, 17; 241:22
company’s
21O:ll. 14
comparable
16: 13;
21:12;24:25;26:11,15;
276; 701.5; 71:13; 86:lO
comparative
31:17;
?,28ilS; 159:2S
c6*~tgh&2si:3;
160:6
.~jll:::i:i:r~?!l~.~~~~,~”
%,“.I, ..
cqmparato>fQ%&
5, 10
&~pg~g~g?~3;
25:4;

i$3-;7@3?32:12;
2 ~3~~,@$$* 1;;#
comgared 22/2,8; 23:15,
20; 24:7;19,20; 25:11,19,
24; 26:5;~y9;~27:4,11;
31:20; 32:12,22; 5024;
99:12; 154:2; 157:12;
202:13
compares 69:24
comparing 2613; 93:6
comparison
27:ll;
157:16,21,24
comparisons
25:17;
52:20; 53:13; lS7:18
compatible
119:22
compelling
186:6;
187:12
zompensated
167:l
:ompetency
67:18
:omplain 9:19; 19:20
:omplaining
41:17
:omplaint 89:8
:omplaints
19:15,21;
11:22,24; 38:11,17
:omplete 18:20; 64:7;
149:3
I :ompleted
32:5; 44:13;
I
55:11,25; 71:2
zompletely 5:18; 228:20
zompleteness
227:6
:ompleting
43:24
completion 29:7; 38:21
:omplex 10:8; 173:2;
174: 17
compliance 11:2; 50:13;
151:12,24; 152:l
complicated
9:20; 36:lS;
37:ll; 40:25; 175:21;
200~19; 2Ol:l
complication
24:lO;
37:17; 81:l; 82:ll; 95:2;
186:12; 193:5; l%:l;
200:3,8,14,24; 204:5;
216:8; 218:7
complications
17:19;
34:18; 39:19,21; 46:14;
49:22; 50:22; 52:11,15;
54:25;71:21,21; 72:18;
74:5;77:10;81:24;82:5;
94:13; 97:23,24;98:3,6;

(5) changed - complications

Food and Drug AdminIstration
Gastrointestinal Drug Advsiory Committee

Hearing Vohune 2
Jude 27,200O

141:23; 161:14
216:7; 229:15
constraints
147:17,18
99:s. lo; 102:s; 103:19,
20;.ir21:22; 130:6; 132:lS;
consistent 20:19,22;
conditions 9:l; 24:2,21;
construct 22:14
12; l&:12,17;
51~8; 57:5;79:14,16;
41:13;49:9;69:2;72:21;
consult so:25
j3; 178~13; 181:5;,
114:21; 132:6,11; 147:3;
73:s; 112:9; 138:24;
consultant 8:2; 180:6;
20,21; 183$; !&1:5;
152:17,21; 206~25; :‘:.:;T.
139:6,G; 173:23
:
181:4; 184:20; 224~22;
1r(S:15; 188:12,13; 1892,
: ?.(,.
214:1,; 220~4; 2jklS+‘.”
consistently
139:!3. ; :
229:3
conduc~,.~~~~~~~~~::;i’
,-: i.._,)i.;,.:
19; 192: 14; 1?~:15;,‘i’$$
consisting
19315 .,1, _
consultants
??lO, 14; .’
198:15,16; 199:a,i; i’s:
69:3; 15918 ‘.:‘,‘$&@‘$~,
~32~20
‘. “-. 5
.
;:*..:‘_; &-?>.&@z
$J#* , +r< consists 19:17; 55:i‘; ’
19, 2S1201:4,.15~~,lq;;x4i-9
:> >__,::,
con*ubtion
54~4 ‘” .’.’ +::J
ioivducted
2$23,2$
;, _,, loo:20
‘.
.
:
202:8,14,18,19; 2%;8;”
$$j-@$&$
$j $4; 53 ;6;
Consortium 722;
24; 218:12; 238~15; 24O:l;
54:ii~;55:ili-~~~i~r~,~~~
153:24
.,:,.,, ,‘.: g:;j;>
3,9; 24 1: 11 _ ;~~~~~~~~~~~
&ii;l~&@.+
&;2$<.
compone~
i&g, l$T$,$.
.&.24; 27: f -3 ‘2-6 y(y:@.
l&j: 1‘ ~~~~~~~~~~~~~~~~~~4b
*j, ,!,..,t .%,a~>!<k..‘,;
i .*
; .v*:.A*
coasti~~~~~~~~~~~
,,
542; y7;11; ~ogf~f$?&y!:::
*.* ii ..,.,V&L.,/:%,,LBxi2*,
189:4;,tlel~~~~.~~~~~~~~~
36:~~~~~~~~$~~~~.~~~~:i’“‘,:db~x;+ ,V”‘,,j~
‘i.,:.;.?:hx
/ -r-,
comp&e*.,.~
j3;!?$*
82:J,+.‘,F,p; 83% 9; $2’ :
\,,._.a
y...!Q;;.,
_.....!.J$,.:
.,c3%
confider$,&@; 69:6 is;;,
477; 4@fi; s!qgq
7:’..“” ~~~~~~~~~;~~~~~~~~~~~~,
“. 868; 88iri,,6,?, 9; &s:2!;:~ _’
23.24; 98:6; 100:22;‘ “’ -.
65: ~~,~~~~~~~~~~~.~~~~~~~~;
c.~f,i;-2b&“”
!f :__ ‘”..,.
158:4; 165:10,16,24;
composite 71:2;
206:4;
..~,;.-^..Ee.-‘A,“‘,;;
;:l’;;+;.
‘5r>;$,:
r~‘!$%;
~~~“.~..~l’:~~~r
230:6
166:1,9; 21617
.-/*‘,,<>>‘, confirm rl:25
confirm&i
14&i& -’ I’- constipation
comprehension
68:5,“-16: 15;
64:18; 67~7
11,17;72:S
17:3,19; 33:10,20; 34:16,
contained 14:2; 64:4
confirmatory
147:15
17,18,22,24; 35:2,4,6,
comprehenshre
13:23;
container 124:13; 141:14
confirmed 120:1,4
104X2; 10520; 139:12,
13; 36:1,13,15,25; 37:17,
containers 13625
confirms
17S:4
18,23; 38:1,9,12; 39:13,
19
contamination
97~6
conflict
4:9,16
17,17,19,22,24;
45:23;
comprise 17:l
contemporary
13:22;
46:14;
48~7;
49:21,22;
confound
14616
computer 63:16; 135:3;
SO:l, 22; S2:12,16; 53:20;
52:22
confounders
147:4
220:3
S4:2S;
S6:21,24;
S9:18,
contend 174: 11
confounding
45:8; 240~4
computerized
145: 10
19;61:13; 63:7,14; 65:13;
content 135:22; 136:17;
confused 154:19
ceivable 72:7
66:16;71:21;72:17;74:1,
139:4; 142:13; 223:8
confusing 199:21;
cept 16:24; 189:25;
2,5; 75:17; 77:17,18,23;
context 73:4; 80:22; 82:l;
238:22
jl, 21
78:7,15; 80117,23;81:1.
99:20; 100:3; 206:lS
24:22; 118:s
6,15,25; 82:3,6,10,11,
wncepts
11:25; 212:4, S congestive
continually
175:9
18; 83:13,16,17,17,22;
conglomerate
217:l
concern 86:13,14;
continue
86:9;
114:9;
84:1,4,10,11,1S,l8;
94:14; 97:20; 13S:7;
Congress 224:7
138:3; 170:13; 176:21;
8S:ll, 13,15,18,20,21;
137:8; 140:7; X42:4,12;
congressionally
134~21
227:14
86:1,11,19,21,24;87:8,
147:21; 162:18; 190:12;
connection
220:18
15,18; 8&2,3,4,10,24;
continued 14:4; l7:l;
19614; 198:22; 199:16;
Conner 169:14,15,15;
89:S, 17,18; 94:6,8,10,
48:21; 72:2; 188:2
229:3; 231:4; 233:8;
17l:lS, 17,20,23; 172:l
11,12,15;97:2;98:5;
continues 204:17
238:20
99:9, IO; 100:20; 103:19;
consecutive
35:16,19
continuous 87:24;
concerned 103; 86:13;
104:l; 105:18; 109:21;
consensus
2303
212:14
13&l; 1463; 181:17;
116:13,19,21; 122:10,12,
211:6; 220:21; 227:18
consent 101:9; 102:1,4;
contraceptive
58:2
16;
123:17;
128:20,20,22;
240:6
concerning
227:21
contraceptives
90:16;
129:4,12; 130:8; 132:15;
consequence
91:lO;
concerns 94:4; 147:21;
135:23; 181:8,13
137:23; 146:2; 148:10,12,
127:7
lS5:7; 176:20; 220:24;
20,2S; 149:5,8; 155:lS;
contractile 96:6
consequences
174:18;
226:9,19
lS6:23; 157:14; 160:8;
contraction
96:7
204:l
concert 134:20
165:5,6,11; 171:17;
contractions
96:9
conservative
89:23
174:12; 178:14,21; 179:2,
conclude 16:1,11;71:7
contraindicate
88:1,5
3; 183:11,14; 184:S, 11;
consider ~8:l6; 100:14;
concludes 76:9
contraindicated
82:2;
187:2S,
25;
189:4,5;
143:25; 159:12; 174:21;
concluding
18:21
128:9; lS3:2,24; 154:l;
194:22; 198:16,16; 199:2,
194:14
conclusion
17:14; 43:7;
216:18
S,7,17,25;200:1,8,12,
consideration
5:24;
69:19; 70:8; 132:23;
contraindication
74:23;
15,16,18,21,24;
201:4,
17:7;
143:2;
145:22;
14210; lS1:24
75:19;
152:19;
155:15;
14;
202:8;
206:21;
210:7;
208:lO; 238:2S
conclusions
33:l; 39:16;
214:1,2
213:12,12,16,2S; 214:2,
considerations
143:24;
43:14;45:15;46:6;71:12;
4,23,24,25; 215:6,8,13,
contraindications
154:14
:S; 115:l; 143:23;
22; 216:&S, 7,10,10,12,
79:13,18;88:1; 1265;
considered
54:3,S, 13;
:7
13,16; 221:9,11; 229:17;
131:19; 140:15,16;
127:19; 133:l; 142:6;
235:16,16,22; 237124;
>omitant J28:6;
lS2:16; 153:l; lS4:9;
231:18
24O:lO
- A15
lSS:13; 213:10; 214:22;
considers 8S:21
215:s; 216:12; 219:25;
constipationconcrete 1755
consist 118~8
assoctated 116~15;
234:11,15; 235:15,20,23;
condition 14:X& 38:15,
117:6; 121:3
236:5
consisted 118:9; 120:21;
25;41:15;67:5;74:15;
121:22; 122:4
contrast 38:22; 125:18;
constipation-diarrhea
132:9; 140:14; 168~9;
128:21
39:6
173:l; 17512; 176:15;
consistency
19:18; 31:8;
190:16; 200:17; 203:ll;
70:9;81:18;82:25;83:2,7;
I
contribute
146:14,16;
constituting
28:20

167:lO
contributed
79:14
contribution
SS:S
control 22:2; 51:7,8;
55:4; 563; 9O:l; 161:2;
170~10; 171:9,10; i79:5,

~&h~yZJ$JgW22~
-*&$L~du‘ctmg
pi1$.w-g?$p:~
~ff$$!
$+&(.ig
;*r,j‘~~~&Q~~:~~~~;~&~;
*;;I$
.&<+j+.
T’:
I
qonfer@j:5
~~~~~~~~~~~~~~~~~~~
&+;.:.
*,.*...Y&“..*
g$q
.:
:’,jOg:.G
ij.,~~~~~:
?.-~~~~~~.~~~~~~~~~~:;;1
$5:
?$<“?$
g:&‘c
q.Ly
?TZi:i;

w:~~~~sari~+m

~l1h-r

Rt~~tiin~

&n&nv~

correlate 8si
cost l&23,24,24;
145:12
costs 21:1,2,9,12,18;
22:3; 27:20,21; 28:6
counseling
101:1,3,6,
B; 102:6; 134:14
count 41:6
counting 201:3
country 2O:l; 24:l
County 21:10,16; SS:24;
98:13
couple 94:3; 9722;
149:21; 183:15; 184:21;
214:6; 224~25
coupled 17:22; 131:24;
157:5
course 5:7; 8:22; 13:2S;
31:10; 35:4,18,23; 37:ll;
38:21; 40:23; 41:25;
43~24; 44:8; 48:20; 81:15;
B4:6; 87:? 1; 96:6; 122:23;
145:22; 159:24; 165:24;
166:7; 178:23; 186:19;
187:19; 193:13
courses 155:lO
cover 188:23
coverage 53:4,5
covered 88:13
COX 70: 22
CPT 150:13
cramping 41:5; 121:17
crave 175:17
create lo:14
creates 140:8
creative 230:22
crisis lo:12
criteria 25:9,9; 81:3;
82:23; 87:21; 89:20;
110~20; 120~10; 127:17;
144:12; 173:6,11,17,21;
189:2; 190:14; 197:16,17,
18; 212:17,2S; 215:24
critical 16:18; 138:ll;
141:5; 221:19; 238:8
critically 54:14

‘(2&<‘5‘46-6666

Food and Drug Administration
-- Gastrointestinal Drug Advsbry

Committee

4 5:20; 48:18; 52:2S; 53:3,
3; SS:2,7,9; 78: 12; 87:6;
39:1S; 103:10,21; 129:18;
14S:9; lSO:24; 153:s
dlatabases 51:12,13;
101:14,17,17,21; 102:2s;
103:2,3,5,11,2,5; 148:22;
153:6; 15S:19;;‘156:i;‘” ..
183:19; 23;f:i3; i41:li
dlat~~gf&~~~;$$2; 40:8;

.i

edicated 48:9
edication.8:21
eeper 120125
efect 42:ll
efer 91:4; 95:ll; 188:20
eferrals 227:24
efine 2o:i4;‘2i:i9;
2:14,16; 54:3;81:12;

16:3,6

I Idescribed

-

Idiabetics 23:21; 24:4,7,
,3; 265
Idiagnose 204:7
diagnosed 167:s
diagnoses 97:20,21;
149:6
diagnosing
173:24;
?0:15
iagnosis 19:14; 2014,
B, 21; 38:14,18;41:21;
2:l; 110:3,5,7,14,16;
20~2; 132:13,14; 1468,

9:11,12; 14:7;
16:24; 54:20; 58:8; 6025;
62:15;64:9,21;65:1,
lo;
69:8;74:12; 118:12;
119:23; 120:23; 121:l;
147:3; 152:15; 181:22;
2oo:lS
‘escribes 62:7; 74~22;
12:17
escrfbing 62:2
escried 18:‘16 ... ’ ‘1,’
.,l_.,
/
esc&tidn
IS&
..

lefined 32:17; 84:23;
29:21,,_,;::. ;,, “, ,’
latlng 5$;8 “.; .:<i’:.-‘”;;y
3:16; 103:11,!8; !05:25;
: “.s;r”,>,iry,.ili;*v.;, ,;i- ;: ~&i;=.
oG:4;215: 10; 235: 17; -‘I
dla)i 89@; l!@l; [ ;:i::<
37: 16 ~~~~~~~~j-~~,~~;~;~~~
:e..~$&$-Q-‘*
,I /.V~. *.r~~~\-.ip&?
~~~$~i i6~:+;;rgy;$‘:
Ief!ne$.
124 13 ,C;
:.s:;;;.E:.~~
:l:r.;*liiL-~lil,il~.~~-.C--C
.‘n&”
‘ir*,d~,
_...‘.I.T<
,$.yy;:”
7.1:$, g$$;
~p?i -1.:
.~5;21..21~1i9~~~~~~~~~~~‘Iefining 438 .:;: && *?:$,$

1; $@i5‘; +24;
5OCl3;173:3/,11,13,25;
%&;~;pm3,,
17,22;
$;;$@%
W:24
lagnios@$@$i; 52:3;

ii“: :T$.?*
..*..*:*,..,I
T,,“$Y?f:.
.~;~~~.$$
‘&,<,,#
<‘...&$.p . .s.>“f’,d+$&“~~~

179:f7 ‘~$~~~~~$
lap;2?:f+$29:14;
:,+i .’ lefinrte
leii;~w&y&.g-.
,g:$;~35:6;7;~&; is;‘,“”
,. <;.,;-.5q$- 2.;::; 6
29:13
,&:i2,24; 37:22; 38:3,&
6

:

dad 170:20
daily 206; 82:20,21;
89:lS
danger 102:23
dangerous 92:7,17;
99:13
dangers 74:24
data 9:s; 14:2,16; l6:l;
17:10,14,16,20; 18:lS;
23:6,16,21,22; 24:20;
25:6,11,19,21; 27:5,12;
30112; 33:7; 42:23; 46:17;
49:17; S&17; 51:lO;
S4:12,21; 58:14; 69:4,23,
25; 70:7,8; 71:1,6,97;
72:12;76:3;82:25;86:12,
15; 92:9; 93:4; %:18;
99:11; 100:19; 110:23;
111:2, lo, 17,19,20,23,
24,25; 112:2,3, lo;
113:19; 115:11,15; 117:5;
1271; 128:14; 13O:lO;
150:20; lS7:19; 159:14,
16; 165:18; 166:18;
174:2S; 17S:l,S; 178:12,
17; 179:2S; 181:6; 184:3,
6; 19S:ll, 13; 203:l;
204:25; 207:s; 210:2S;
221:17; 224:19; 227:2S;
228:8; 231:19; 238:22;
240:20
database 364; 37:21;
4016; 43:2; 44:5,16;
~,lL=r

Rennftilnu

‘,‘lO, 15,20,21; 39:7;
‘7:21,24; 83:18,18;
.17:20,22; 119:17,17;
.20:13; 121:13,14,15,lS;
.65:14; 168125; 186~21;
!lS:9,12
Cal 214:ll; 221:16
fealing 87:3,9
leak 149:25
fear 60:11,23; 80:9;
130:17; 150:s; 151:1,2,3;
152:14,22; lS3:7,9,18,
!5; 154:8,16; lSS:4;
158:7,8; 2ll:l
death 100~2; 126:24;
L30:3; 205:17,19,22,25;
!06:10,15
deaths 11:15; 365;
)9:23;40:14,20;73:11,
14; 74:17,18; 97:23;
J9:15; 205:21; 206:lS
debatable 191:6
debate 227: 15
debates 187:21
decade 223~4
decades 13:12; 55:23
December 49:2; S4:17,
22; 151:2; lS2:14
dechallenge
146:9
decide80:13; 101:3;
195:21; 196:ll; 198:3
decided 103:25; 238:2S
deciding 241:18
decision 138:2; 170:9;
224:8
decision-making
8:3
decisions 92:19
decompaction
184:10
decompressed
38:24
decompression
122:6,
24
decrease 19623;
201:21; 202:17
decreased7O:l;
128:l;
1S4:3; 199:18
decreasing
196:18,25;
I 235:23

rnmnanv

(202)

~46-6666

lefinition 47~24; 5617;
17:ll; 58:s; 81:4,8,14,
5; 87:22; 100:19; 106:7;
19:3; 14620; 180:7;
83:10,13; 199:ll;
!14:24; 215:18; 216~4
lefinitions 81:16; 88:18;
19:13,20
lefinitively 81:12
legree 3013
legrees 120:14
leliberate 12:13
deliberations 15:24
fel’ver 48:5
delivery lS3:12; 155:24
feiving 11:7
femand 228~24
iemographics
85:7
demonstrate S9:8; 76:4
lemonstrated
111:15
jemonstrates
47:5;
175:l
demonstrating
lll:lO;
112:l; lS9:15
demonstration
234:1
denominator 76:2S;
L99:7
dense 37:4
densely 37:7
department 62: 12; 66: 1 I
depend 16810
dependent 138:14
depending 82: 13;
175:19; 195:9
Depends 168: 1,2
depicts 151:12
depressed 24:14; 27:14
depression
23:22; 24:2;
26:19; 27:s; 118:4; 161:6
depth SO:17; 51:lO; 56:9
derived 14:2
describe 1617; 47:2;
48:10; 507; 52:5,18;
54:10;55:15;61:6,21;
65:5,24; 6&l; 126:9,10,
12; 152:24; 213:17

Mh-U-St!dd@

Hearing Volume 2
June 27,200O

F&)..(ji’yij;~4’y$)~14;
lgii
~$--?&~~‘~
,j

d esire 147:18
d
1’08:12; 109:ll; 149:19;
207:14
0resk 9:s
Crespite 191:22; 241:17
dletail 16:17;60:12;
6#1:22; 103:22; 104:5;
1 18:12; 12S:3,17; 168:14 9
16; 225:ll
dletailed 368; 105:4;
133:3
dletails 185:3
dletect 14S:4
dletected 14S:5
Cletection 48:7
37:3
Cleteriorated
cZcteriorates 204: 18
cdetermination 127:15
cletermine 14:11;42:18;
4;7:11;80:19; 1Ol:lo;
I.38:13; 155:3,5,12
cietermined 4~3; 9:7,9;
e;8:3; 138:21
tdetermining 93:2;
I128:lO
1
Idevastated 170:24
174:W
Ijevastating
175:lS
Idevelop 11:21; 47:15;
1j3:7; 77:23; 98: 15,20,24 I;
103:9; 146:20,22,25;
149:4; 18l:ll; 183:s;
227:9
developed 36: 10,13,2! 5;
37:14,23; 38:9; 39:7; 47: 5;
61:7; 76:s; 77:18,18;
78:15;83:17; 146:23;
149:7; 234:s
developing
49:lO; 179: 2,
19; l%:lS
development
12: 1; 34:’9,
9; 36:3,10;40:5,9; 41:li 3;
53:8; 57:23; 77~17; 86Z215;
180:14
diabetes 24:2,10; 261 2;
1 27:7; 70:2

(7)

ial 220:22

ialed 22016
vialing 221:18
lialogue 1623
Iialysisdependent
5:14; 2617
!iameter 39:2
liarrhea 8:19; 19:18;
32:6; 41:17,23; 59:15;
7 1:9; 77:7,11; 80:15; 81:5
14; 83:l; 84:4,10,13,18;
8‘6:1,5; 87:20,22,25;
8#9:5,8,10,19; 94:6,8,1S
100:20,22; 106~24;
108:17; 109:21; 12O:ll;
16S:2; 168:25; 169:21;
170:10; 174:11; 206:16;
2!12:12,1S, 24; 213:3,5,
215;214:2,15
Cliarrhea-predominant
3:3; lS:5; 29:3; 3l:lO;
: ,3:3; 46:lO; 7O:ll; 84:7;
e1S:23; 109:15; 110:5,14;
I.11:11; 112:3,16; 114:6;
i !12:12,18
119:6
cGarrhea-type
cdiary 65:11,11
IXck6:18;7:13
Idictated SO:14
160:7,9
Idicyclamine
Idie 98:l
’died 99:24
Idietary 20:9
Idiffer lS7:22; 173:9
/difference 71:3; 93:8,9
96:3,10; 112:22,23;
180:15; 181:19; 193:5;
205:25
differences
lSS:22;
186~23; 191:16; 197:22
different 21:19; 23:1,1(
25; 24~1; S4:5; 5714; 83:l
87:4,8; 90:18; 94:5,7;
%:17; 100:14,15; 135:2
21; 153:11,11; 155:24;
175:8; 181:24; 187:9;
217:15,19; 218:19; 220:
I 228:2; 23O:lO; 231:3;

&oh&

- differe:

Hearing VOhme 2
Ju&e 27,200O

Food and Drug Administration
Gastrointestinal Drug Advkory Committee

-

I:

8 , lO,lO, 11,12,18,18,
19; 199:3,6,10,12,14,
16; 200:4,10,10,11;
202:1,
201:5,5,6,17,24;
2 ,3,5,11,16,18,22;
2:03:6,7,9,lS, 21; 204:6,
8t,9; 205:2,6,8,8,9,13,
4, rfj, 17,19,22; 206:3,
: i, 7;14,2b;23,2077:&9;
2108:6,8,18,20,21;
09:13,17,23,25;~210:1,
; i, 4,21,23; 211:12,17,
i !4;‘?12:2,3,4,6, ?,‘lO, 23;
i13~6,8;:16,2i);‘i4;i!4:1,
1,1~~~0,21,2r,'%r~~,9,
0. rl9.~~'i?i~+2~~~f~3~ ii.-,
, ,!*p;$,~~.? ,(. ' .,,.' ,,w:. ', I

lownside 178:4; 209:8,
1; 232:14
lownsides 226:13
)R 4:3,18,18; 5:6,25;
i:2,4,6,8,10,12,14,18;
Cl, 8,10,13,16,23,25;
1:2,4,6,9,10,12; 12:6, ~
!l, X,24; 15:8,15; 16~16;
!8:12,13,16,17,23,24,
-’
!4,25;19:6,6,9;28:3,'4,
,,9,12;30:16;33:2,8;
)6:4;4~~~;h~:11;lii:i~~~5

dimension
4~:23f48,i3,$>;,
). ,..*,;,, ...s,,*iigw ,.c,q> ,*" /

distribute 226:6
Gstributed 63:3,22;
104:14; 1iSi11,22;
134:19; 135:25; 137:13;
142:15;226:9
distributing
134:21;
-.‘
225:25
distribution 63:lO;
107:13;124:5;125:24;
131:23;132:3;135:6;
136:1,21,23;141:7,9;
194:15;207321;22513':":'~~
distr~~;8~~i"4‘r~,i~~~~~~
; &$, h, :"" . ." >>4&&#
.?,>.;.*gix
Jiy$@$57:4
f,~,;,:fq&;"&$
,.,
,<:":.&,:
,pp&.,~".f*,<~.
~ir"%~>.f..~
r(
jll~~~i~ulai‘~i~~'~~~~~

ki, 11;754g$r_,,iq;:; 1~9,i,l, 14,:17;1p;22;1::1~~“.F-:
:rr~...r.i:,~~‘a.~~~~~
:s~,~!.~?c~.~;,,~.~=~~
2% 19 :~~~~~‘;E~~:~~~~“~.~
!17:;lo~?~~i~~;‘~~~~~;. 15;
. ,ew;;“,;:,$
.‘@!--.$& &?:&.>Q;%3 16,,@, rr;gt;17, i&q,,r:,.,

162il$'i4
~~~~~~~~~~~~~~~~~~~
; *,~,.,:.i i~.l.~~~~~~~~.lxr,~,~,
dinner 1”:12,,-~~~~~~~~
direct 2i:l, 8, i’L.17; :_-.:;t
27:20;46:25;59iJ24,25;‘;?
62:25;64:3;95:21;96:3;‘
18:13; 2b:2,‘iS, 25; 21-2,
131:16;235:9
4;22:19,24;24:24; 25:13,
14;26:14,17;27:8,16,18;
directed 605; 104:22;
33:2;40:19;41:21;46:7;
130:25
51:19,19,20,21;70:2;
directing 218~16
72:25;100:21;103:13;
directions 54315; 138:ll;
119:6,8; 123:16; 131:15;
139:16,17,19;143:25;
138:7; 140~13; 153:25;
1SS:l
154:2; lS6:22; 162:24;
directly SO:3; 88:21;
172:7,8,1S, 16; 173:12,
95:17; 137:23; 217:15;
25;174:17,21,23;175:24;
:18
176:2;179:4;180:11,13,
“1
ctor 6:5,19; 7:20;
14; 181:ll; 187:2; 18954;
,15:8
195:18,20; 196~21;
19812s; 204:6; 206~6;
disability 167:16,18
211:13; 231:lo; 232:6
disabling 165:3
diseases 2S:7; 2712;
disadvantages
209:21
69:25;146:13
disagree 160~17; 182:7;
disenfranchise
192:23
208~11; 217:lO
disillusioned
222:12
disagreement
203: 15
disimpaction
36:14,16;
disagreements
15:2
200:6,7,13,14
disagrees 208:16
dismissed 172:13
discharge 20:18
disorder 30:17; 123:13;
discharged 37:12; 38:6,
156:20,21; 160:12;
lS,24; 39:12;41:14
162:13; 172:12; 173:l
disclose S:6; 139:14,15;
disorders
70:13; 176:18
164:13
dispensed
34:13; 40:17;
disclosure
135:12
45:6;63:4;77:3,3;125:12,
discomfort
lS:l4; 19:16;
23;224:3
20:4;29:12,16;87:25;
dispenser
141:15,19;
ll2:6; 115:8,10,14,17;
142:1
212:15
dispensers
141:lO
disconnect
172:6
dispensing
63:18
discontinuation
42:15;
display 65:25; 66:lS
118:14
disregulation
173:3
discontinue
82: 15;
129:9; 160:4; 161:24
disrupt 20:6
tinued 146:9;
dissect 95:20
disseminated
177:19,22
.covered 15i:7
dissemination
177:17
discuss 28113; 34:15;
dissent 177:19; 1785
46:17; 60:12; 88:25;
distal 41:9; 122:19
106:20; 107:6,11,15;
distention 38~12; 121:19
108:3,6,8,10;116:1;
distinct lS3:7
125:l; 129:3; 133:18;
_ .
6~16
143:11;164:8;169:6,9;
1 distinctive
-

divertux&trs
38~13(~4~‘$~
L8; i I$y~;i&;fjy;.;;
,;;,:

!l ‘Zl;;i3,~~~~:‘2;‘~,6,7,’
1i~i4;1~,16,20;78:i..'G"
;,17,17,18;79:3; S;;‘ri;,“’
!1;80:2,8,12,12,21;

$1:14,22,22; 82:1,8;
%3:8,23;84:6,9,16;85:1,

177:13;207:12;208:4;
232:7,18;237:7,18;
219:lO
239:-l;240:22
discussed 15:23; 34:2;
differential 161:1,3
52:7;S8:18;60:19;81:2;
106:2;206:11;207:15,19;
23124 _,.‘d..,,;"*.,i
\ ',,.,I;:'::'-;;.-j*;;
. #.I.1yx;.
148:21; 149:13; 175:13;
discussing
4925;
1.
183:3; 236:1%"19 ,.;i;,~:;~g:-,:.
10!:22;.125:3; 1’43:22 ..i.;’
difficulty 103:13 'jE??$$$
discusslon-i0:2p~~:~~;
d,,fus~
l97:5
: -;;;;;,-'>
Digestive 15:9
:':'~: "~'~: 13:18; 16:25;-33:9;:57:1;dig&&$

148;1 ..; +~~:~~~$$k
, ..;*;-i::
"'.L' :r: : "&,

dilatation 96:22*
186$.,~
““; .J..;,“.
I_.>:21itaf
37:j; 4@ $i@$$~$
dil&d
., /f.'";:

>y; i,$,h:;;::'6-r;'??i,.~.,~,~~

12,k~,~~~,~~~~~~~~::~~~~~~~~~~~
-.;,&& r.:;:p _..iii :"E;Ir, ,~,&%&:.r>~;~,.
@3)2;‘9!$
dimn$&nal
‘ ",=.‘sq ,A4%>qi:, +::'$T

differential

- Drug

(8)

diverticulum
2W25
divide 866; 88~8
divided 20:2S
dividing 113:7
Division 6:5,9; 7:17;
58:2S
dots 218:17,17
doctor 80:9; 137:24;
1So:d; 151:1,2,4; 152:22;
153:7,9,18,25;154:8,16;
LSS:4;158:7,12;168:19,
20; l69:6,9,10; 170:7,20;
171:20; 218~24; 221:8,11,
12;229:16;235:7
doctor’s 169:8; 170:24
doctors 192:9; 193:12;
204:13; 219:3,6,14;
228:19; 229:20; 235:s
document 5:16,18,22;
14:19; 17:25; 36:9; 40:24;
45:5,22;95:22;101:23;
111:18,20,21; 124:2;
225:8,19
documentation
93:s
documented
1O:ll;
99:15;191:16
documenting
198:21
dollars 21:17
domains 2310; 26:7
done 21:9; 37:24; 68:25;
91:2; 94:19; 96:5;97:4;
112:7; 150:s; 164:21;
197:21; 207:20; 224~6;
225:4,22; 227:11;240:24
dosages 1 lo:25
dose 5625; 78:3,4,5,9,
10,16; 95:23,24; 131:24;
136:24; 185:8
dose-related
129:s;
l46:4
doses 199: 18
dosing 29~7; 185:7
double-blind
5622
double-check
146:24
down 2625; 201:23;
208~10; 220:14; 223:Pl;
226:1;236:22;237:8,12

Min-U-Script@

!2,22;56:1$5?,2!;"
-.
is:2j;'$&60:13,1!J~'~~~
;9;is,,~?,'io;~~~~~~?;,.,~~~

i,9,17,25;86:3,4,6,20,
12;87:13,16,16;88:20;
19:2,2,2,3,12,25;90:3,
j, 12,22;91:4,6,7,14,14,
15,25;92:12, lS,25,2S;
)3:1,1,12,23,24,25,25,
!5;94:1,2,4;95:5,5,7,8,
14,14;96:15,24;97:1,11,
15,18,19,22; 98:2S;
)9:17,19,21,22,25;
100:1,6,17,17,17,18;
101:20,21; 102:24; 103:1,

!3,24;104:4,9,11,19,
19,20;105:22;106:2,9,
13,14,17,17;108:2,7,
10; 115:25; 116:S, 5;
117:8; 119:13,23;120:23;
123:22; 125:16; 127:8;
129:ll; 133:20,20; 134:4;
138:S, 5; 142:18,21;
143:1,3,5,6,12,14;
148:13;156:5,7;157:3,7,
7,11,12,12,19; 158:1,1,
2,18,18,19;159:13,18,
18,20,22,22;161:9,11,
16,18,25,25;162:1,2,8,
3,16,16,17,18;163:4;
164:2,12,16;165:18,21;
166:5,7,10,13,15,16,
18,19; 168:12,16,18,23;
169:2,4,6,12,14;
171:11,
16,18,21,25;172:2;
176:23;178:2,5,14,25,
25;179:1,7,9,12,14,24;
180:3,5;181:3,7,21;
182:2,4,7,14,14,15,16;
183:7,7,8,17,23;184:1,
2,2,7,9,14,16,17,19;
185:15,18,20,22;187:14
17,21,23;188:6,8,9,14,
17,22;189:7, l&22,23;
190:5,7,23; 191:6,11,14
lS,25; 192:1,7,11,17,
17,18,23; 193:2,2,7,9,
17,20,22; 194:1,4,5,9,
12,13,19,24; 195:2,2,4,
l&13,15,25,25;
l%:l,
12,14; 197:1,1.16; 198~6

Miller Reporting

Corn

$~.@$I, qg‘ii’2;~.5,
‘~
8; 223:1$2G;~i%ii11[; 19,
!l; 225:4; 227:19$0,‘21;
!28:12;229:2,4,13,23;
!30:1,3,5,14,19,2s;
!31:4,1S, 20,24; 232:3,8,
.2,15,21,22;233:13,13,
.6,23;234:7,19,24;
!35:2,4,12,14, 15;
!36:11,17,18; 237: 1,19,
!O;238:11,17,19,20;
!39:3,8,18,19, l9,20,
!2,24;240:8,14,23;
!41:1,2,5,7,21; 242:2,3,

i, 6
Iraft 137:4;161:19;
!12:10
frafts 135:17; 13615
frainage 97:10
irained 97:8,17
frasticaliy
167:lS; 168:9
fraw 114:S
jrew 187: 16
irink 138:16; 175:21
drive 170:4,5; 187:12;
Z24:lS
driven 50:14
drop 83: 1,14; 86:9;
216:15
Drossman 21:19; 22:l
drove 159:17
Drs lS:21
Drug 4:15;6:5,7,23;
B:l4,18; 9:6; 10:6,10,14,
24;11:9,13,15,23;12:l;
14:10;39:22;45:10;
47:15,19;52:8;53:5;55:6;
S7:2;58:23;72:19;74:14,
16,22;78:21;79:12;
80:19,20;81:25;82:5;
84:3,6;85:2,14,19,20;
86:2;88:7,7,9,11,11,17,
18; 89:ll; 92:7,7,10,17,
19,23; 94~20; 98:4,23;
99:ll; 103:7; 105:s;
106z7; 107:13; 109:2,3,4,
S,6; 110:17; 111:7,9;
114:10,14,15,15,21;
llS:21; 125:6,12,13,23;
126:4,17; 127:12,19,23;
128:7,11,11; 129:9;

my (202) 546-6666

Food and Drug Administration
Gastrointestinal Drug Advsbry Committee

Hearing VOlUme 2
.Jutie 27, 2000
238:15
evafuated 16:10;21:3,8;
,4;25:7;31:2;32:9;

-

exactly 87:12; 163:8;
199:16;218:23;239:9
examined 187:15
example 10:22; 22:23;
72:10;73:25;74:10;
:‘, ;,,
105:5; x19:16; 111:13;.’ ‘.’
127:11,20; i28:-2,4,1‘~; ‘- :
131:24;132:!2;‘i33:@+ "-'
137;20;144:20; i;4$23;,;-.
146~2; 155:20; 15&!,5;
162:11;‘1?$18; ?O$$
,;’

21
familiarity l73:16
family60:3;10o:l6;
175:11;177:25
far 859; 99:8; 1302;
135:12; 183:z; 184:ll;
192:!2; 199:l; 219:18;

experts 10:16;49:11;
54:5
expiration 124:16
explain 111:9
explained 19:21
explaining
129:24 ..
Exploratory
42:5
explore 4&l; 55:4,15;
84:24
explored 104:5

233:9;241.

.-; .~;

fashion 138:18 .fast 89:20


.I‘::’

17:18
erret 87:12
:erry 4:18;6:12,12;
5:21;78:17,18;80:2;
94:5; 236:17,18
etuses i4i:l’
ever 41:6; 12X:19
ew~$i~yg..;i$4:s;

expose i@:22 I: :,::I‘ii;:
213s ?g~;:$;~~&;l~
~&q@&$73:~$+75p~“~$%$y exdos..~d;8;‘i.y t - - -::.
~~r~~;~i~~‘~~i~?:.~~~‘~~~
;i77~~6.2@..9”2~$$+~~~
?c.+:+~~“.
.$*~-$~~Q?&,~
:~$.&gy$

136:10;155:10;159:6;
162:19;163:3;170:1,5;
173:8;174:18;180:21;
181:12; 190:9; 192:25;
199:20,22; 200:5; 206:l;
208:25;210:19;218:24;
223:11;224:13;227:5;
231:18
event 4:4,22; 9:12;
5,23;39:18;43:23;
:12;144:23;145:9,21;
r46:7,12,14;147:9,10,
10; 179:25,25; 195:16;
197:13; 202:25; 206~17;
23521
events 9:lO; 10:23;
11:12,16,19;16:12;
17:17;36:1,2,3;37:12;
41:1;46:4;47:9;48:1;
49:25;50:15;52:2,19;
56:7,14;57:9;73:21,21;
74:4,8,11,18,20; 75:2,7;
87:14;108:4;116:1,3,8,
10,ll; 117~13; 118:21;
124:9; 126:6; 128:20;
145:2,14,20; 147:14,16;
150:4; 179:20; 180:2;
194:17,20; 235:23
eventually 36:23; 134:2
everybody 8:9; 178:3,5;
207:25;224:8
everybody's78:22
everyday170:
12
everyone 101:7;189:6;
208~14
everyone's
11:20
dence l5:13; 16:2;
20;58:13;93:7;
::16; 136~22; 179:7,9;
180:25; 186~13; 196:18;
214:8;225:9
evidence-based
5:7
evident 185:l
evolving 10:19
exact 235: 10

evahated - Fbhman

&cel)ence
4914 1~.t+k&.~
l;,&w.. ~&$p&Q”.‘.
,j&q~*;*.‘~~&*.a‘i
excell,elii44:7
‘160:@ $
‘i’8~~~~~~“~~~~~~~~~~~~~~~~~~~~
<.;r*.
*jr<
.,,.,.?.,>,~
..:,:;‘*.
ii2:6 y<“?FZ;
&:::. :%ed
“@w. ?_
.,i expre&a
“;<ir
“:‘;;
$
:;.
5,
except 14$3 ‘I-’ y=, ‘I:r_;;;
.r
expression
175:18
exception 30:7 ’

extension 125:lO
exceptions
4:17 ’
‘extensive 4724; 49:16;
exclude 4:25; 188:5
55:l; 58:6; 67:23; 71:25
excluded 115:8,12,14
extent 90:24
excluding 62:6
extracted 73: 17
exclusion 5: 1; 144: 12;
extrapolate
148:6;
173:13
16Oz19
exclusive 213:2
extrapolated
21:14
exclusively
28:25
extremely 202:25; 206: 1;
executive 4:5;7:6;8:6;
219:5
171:6
eye188:21
exemplify 188:25
exempt 141321
exemptions
227:24
exercised 210:12
face-to-face 33: 14; 67: 15
exertion 74:18,24
facet223:9
existence 55:lO
facilitate 173:6
existing 13:7;51:12;
facilitates 173:25
56:3;64:3;65:8;132:5,8
fact91:13;124:10;136:7,
exists 9:8;172:6
19;141:6;149:4;183:5;
expand 75:19; 144:19,19
185:23; 186:22; 191:21;
expanded 57:7; 189:22
203:16; 210:17; 227:24;
expands 144: 18
233:20;234:13;235:19
expect 91:10; 95:2;
factor 149:1,8; 180:14,
157:15;228:21; 231:13
22,25; 181:ll; 186117;
expectation
137:lO
201:9; 24014
expecting 233:21
factors 45:8; 48~1; 50:15;
51:2,7; 52:15,17; 55:5,
expenses164:17;
16;56:6,7;58:1;79:13;
169:16
experience
43: 12; 47: 17; 87:13; 111:13; 113:6,10,
11,15; 114:8,11; 120:6,7;
54:lO; 56:8; 57:4,7; 58:8,
124:9;129:25;145:17;
9; 101:15; 109:4; 132:13;
147:4;173:12;178:18;
136:6;156:13;164:25;
179:16; 181:14,20; 182:9,
172:7;174:16;175:10;
19,19,22; 183:4,8,24;
194:8;234:22
186:20; 188:l; 189:20;
experienced
112: 5;
206:18; 237:25
119:20; 122:12; 131:14
fail 114:18
experiences
109:7;
failure 24:22; 45:9; 118:6,
15616
6; 122:2;150:3,5;173:22;
experiencing
114:14;
204:2
213:16
fairly
90:24; 135:6; 214:4
experiment
95:9,13
fairness
5:11
expert 43:9; 45:13;
fall 253; 27:24; 106:7
76:10,13;95:16; 188:21
false 114:9
expertise 12:1;76:15;
familiar 173:18,19,20,
232:25
-

F

(10)

Min-U-Script@

9:5,25;10:3,9; 11:3,17;
12:10;13:6,14;14:19,21,
22;15:3,20;16:4,9,24;
"'
17:18;33:13,18,24;34:1,
6;40:21;61:4;64:15;
72:13,16,21;74:21,25;
75:5,11;79:12,24;80:11;
91:25; 92:2; 93:2; 95:10,
11,12; 101:23; 106:2,5,
13,15,18,23; 107:1,16,
25;112:8;123:23;125:18;
126:25;127:15;130:1,16,
19;132:7,8,10,20;
134:25; 135:15,17; 1362,
13,15,19;137:5,16;
138:21; 141:21; 143:9;
147:13,20; 155:2; 156:ll;
161:18,22; 190:24; 191:2;
202:5;219:8; 223:5;
224:23;225:2;233:19
FDA's4:20;5:3;8:24;
16:21;17:25;70:5;74:12;
79:4; 107:5; 111:19; 143:7
fear 147:18
fearful147:20
feasibility 155:15
feasible149:2
feature 73:2
February 11:18; 13:9;
106:25; 207:3
fecal 121:17,18; 122:11,
14; 174:13
feedback 166:3
feel 92:6; 104:5; 160:5;
161:20; 165:2; 175:13;
181:4; 198:2; 228:5;
238:19
feeling 97:24;210:19;
212:21
feels 142:6;208:4
feh32:13;79:22;159:7;
170:12;213:6
female29:1;31:18;32:6;
33:3;36:12,19;37:22;
38:2,8;39:4;41:3;46:10;
70:10;97:11; 119:5;
121:ll
females 20:2; 84:7;

Miller Reporting

illed 22535
inal 613; 74:lO; 106:9;
71:5
inalized 64:14
inalizing 65:4
:inally 31:8; 97:5;
07:15; 108:13; 112:25;
15:21;122:22;132:18;
41:2;157:2;171:3
inancial4:24;
5:12;
64:14
ind 1.84:1 I; 194:17;
!28:6;235:18;237:15;
!41:9,15
inding 71:5; 110:19;
.30:4;142:13;236:4
indings 19:22;21:15;
.20:21;146:1;147:19;
.55:25
ine 11:3;134:2;210:3;
!12:2;228:17
,inish l23:6; 143:23
'inished 12:13;25:2
‘irm 5:8,12
‘irms 4:14,23
‘irst 13:11,24; 15:25;
50:9,23;31:4;34:15;
36:11;37:21;47:23;49:1;
j3:7;54:16;57:14;60:22;
77:23,25;80:14;82:22;
34:2;87:19;90:6;101:20;
107:6;109:2,10;117:9,
21; 118:11,12; 119:7;
125:3; 134:17,19; 135:16,
18; 139:7; 140:4; 149:25;
150:2,20,25; 152:12;
153:12; 158:2; 161:15;
164:12; 177:12,17;
179:18; 185:4; x86:14;
190:17; 193:23,24; 204:2;
207:9,24;216:24;221:6;
222:9;225:1
first-line 128:13
Firstly 64:2
Fisher 76: 16; 229:2,2
I Fishman 57:21
^ ..
,,._ .~<.
./

Company

(202) 546-6666

Hearing Volume :
June 27,200(

and Drug Administration
Gastrointestinal Drug Advsiory Committee

Food

-

fii 215:13
_.- fits 225:24
Fiie 21:7; 54:19; 80:24;
87:6,9; 137:ll; 143:8;
212:lO; 217:20,22;
;;
218:21; 224: 1
“’ .“-“‘;‘;;;fii6:l
fled

- _ ‘-.;,*“.yij,;:>
233~5
‘: ‘-; <‘;‘G

flag 181:9; 187:8
flags 6316; 201:20’

,f,r
I;.,

ormats 100:14
arms 124:19
‘ormulated 174:2
:orth 149:12; 155:25
&tunate
167:13; 176:18

brtunately

219:3

172:14
kum163:9; 1643
forward 8:16; 28:5;
>3:20; 112:9; 1766; 242~4
Forty

iii:lO;

Qrther 14:22; 5321;
i4:16; 61:7; 85:4; 100:8;
.03:22; 123:12; 133:3;
140:9; 155:3; 174:8;
!08:7; 2367
Wthermore
7~17
‘uture 64:20; 67:6;
143:25; 154:14; 155:l;
L78:20; 196:17; 206:9,12;
108:13; 218:14

generated 135:3
generic 23:7
generous 167:9
genetic 566
gentlemen 19:lO; 28:13;
1623; 106:18; 116:6;
134:4
‘.
genuine 110:5,!4
geographical
69:l
“’
George 4:18; 6:12

found 21;10,20; 2215;. ‘_
.: ;.:.$5..;;;;2.:
d .,?n IT;;?
yg$+;
~~:~~.v GO; _
‘ <“.a>:,
i 4;:.& ;I ( ‘:;,I.I:
~:~~~~~~~~~~
C@Z ~~~~~S~~~~.i~~~~~ 3a&jgf;
,I <-&
:++-r i.‘$?Y
‘,&T“&;:$~.
47~8;
?17:16.
tfQu,ndajlon,
q:.;)@1i+;’ ~~,:~*.+
j !. .,;A$<$4
q’#+ Salloz~!S;:zZ~j
?4?!3 ;._I,.j;,
(o’&d& 172:l~,~;3~~~2~$3~l~A~&..&@lt$,5.8
8;
Z,di$$<,“Jr+.;i:<+; $2:.&%<{*y,,,p>..‘+ >I
./I ,I .._,..,..,.,‘.W.
*:~)
fodr 68.2% &$&fS9;2;“.
. . ..: ..,-.:

fluoroquinolones
145:23
fly 168:6
flying 170:19
focal 120:22
focus 15:20; 1618; 19:l;
33:15,24; 52:lo; 90:20;
133:24; 198:13; 217:12
focused 137:21
focusing 13:23; 124:17
folks 145:3
follow 54:16; 92:12;
98:23; 103:23,24; 139:lS;
151:20; 162:25; 165:22;
184:2; 217:6; 219:2;
226:16
follow-up 29:8; 38:25;
104:lO; 161:6; 189:18
followed 9:21; 12:9; 29:5;
55:23; 107:22; 108:2;
188:16; 211:4
following 4:8,16; 13:9;
29:7,14; 32:12; 36: 12,24;
37:22; 38:2; 40125; 41:2;
42:15; 62~25; 71:12; 73:6;
76113; 111:17; 125:2;
140:12;219:13
follows 62:3
Food 8:14; 47:14; 52:8;
57:2; 58:22; 170:2,22;
175:17
forbid 177:lO
force 131:8; 222:lO;
224:14,15
foreign-speaking
222:2i
form 13:3; 15:6;71:9,15;
87:21; 104:15; 111:19;
212:20; 2407
format 106:l; 111:20;
135:21; 136:17,19;
142:12; 155:6; 223:8;
226:14,16,21; 228:2,4
formation 101:24

MLuet Reporting

t61:20; 167:1^2;‘177i5;9;
179:10; 18618; 187119; ”
215:9,12; 218:9
1four-week 93:17; 161:22
1four-year 23:24
1fourth 30:2; 161:13
1frame 15: 16; 80:23;
177:2; 183:15
1framework 75:9
IFrancis 6:20
IFrancisco 7:24
1frankly 185:5; 216:6
1free 62:12
IFreedom 4:20; 219:21;
230:20
1frequency 16:12; 19:19;
31:3; 33:16; 42:18; 43:13,
15; 46:12; 50:21,23;
56:14; 69:12; 71:14;
61:17; 82:24; 83:2,7,11;
127:4; 128:l; 129:23;
161:14; 212:16,19
4
frequent 34:22; 39:17;
72:13; 181:lO
frequently 43:8; 62:lO;
98:7; 203:2; 222:3
friable 120:18
friends 1662
front 142:15; 223:lO;
230:8; 237:8,16
frustrations
15: 11
fulfill 5:19
full 4:17; 54:23; 78:3,5;
151:12,25; 198:25
full-well 174:9
function 19:17; 22:25;
33:10; 35:8; 4417; 45:7,24;
82:21; 89:15; 118:9,15,
16; 128:4; 173:9; 187:6
functional 22:15,21,22;
123:13; 15619; 172:25;
176:17; 23016
Functioning 20:6; 23:11,
13; 24:4,16,23; 26:1,9,
16
Functions 45:15; 49:3;
59:l
fundamental 14:15; 15:2 -

Company

108:2; 116:5; 129:ll; ,-‘“”
/
L38:5
game 171:5; 175:21
games 170:16
gamut 148:4; 178:3
gangrenous 121:25;
123:2
gap 55:16
gas 174:12
gastric 160:22
gastroenterologic
193:19; 230:16
gastroenterologist
S:13; 19:ll; 20:16,21;
194:3
gastroenterologists
167:4; 173:20; 191:12,14,
17,18; 192:2,5,13,16,
19,21,22; 193:1,13,16,
24; 194:2
Gastroenterology
6:lO;
25:3;49:12; 193:11,22
gastroesophageal
25:13
Gastrointestinal
58:25;
100:16; 106:19; 108:3;
116:2,3; 123:13; 156:20
gastronoma 94:17
gather 34~4
gathering 8:20; 231:19
gatroenterologists
192: 14
gave 78:24; 92:6; 99:5,1:
geared 130:23
gee 214:18; 235:18
gender 21:13; 25:16;
53:19
general 8:5; 19:2; 23:12;
25:6,11; 2611; 27:5; 51:1
52:9,19; 53:14; 54:7; 55:;
16; 5722; 58:24; 72:15;
79:3,7; 127:4; 131:13,17
139:14; 172:lO; 17611;
181:15; 188:ll; 189:24;
195:3,4; 210:24
generalized
187:8
generally 135:2; 13617;
157:13
generate 145:13
-

(202) 546-6666 Mh-U-Script@

14:17,20; 222:5,7;
28:5; 236:14; 238:20;
4215
loodly 81:23
government 10:9; ll:l,
6

;PRD 55:3,6
grabbing 195:24
graciously 164:lO
grade 40:13; 217:22
;ralnek 15:8; l&12,23,
:$; lg$, 10;‘30:16; 33:2;
9:23j.76:17
;raln&$~$~6
i;g5s&$@wti*
168: 5
x&g&.$.s~~6
_I;<~~:~~.~
,;;e-d.“;~~~.~
-4_;.

lraph205:lo
-‘I :
,~4’~~lFar~f.-.+~

94:25; 1168; 149:9; ‘’
164:19; 172:25; 173:19;
176:17; 218:9,17; 236:4
given 29:7; 39:22; 78:3;
94:15; 112:18; 134:14;
148:6; 155:5; 158:25;
N-4:23; 178:12; 181:6;
187:18; 189:13; 194:21;
199:22; 200~21; 215:7;
219:21
gives 1Ol:l
giving 83:24
glad 4312; 46:17; 184:14
Glaxo 5:15;8:15,16;
12:9,18,19,25; 13:21;
16:9,21; 18:2,15,20;
33:12,18,22; 34:1; 47:l;
57:l; 58:25; 59:9; 60:16,
19;61:17;62:12;66:3,10,
ll,22;67:5,11;71:24;
75:13,15;76:12; 111:22;
123:24; 126:3; 164:18;
166:21; 167:2; 169:16;
178:17,23; 184:20;
220:17; 224:22; 225:ll;
229:3; 2306; 241:22
Glaxo’s 204:21
global 32:8,11,16; 71:3;
181:19
glycocyamine
157:17
goal 18:6; 54:3; 75:8;
107:20; 178:8; 189:7,10;
204:9; 205:18,19; 237:16;
238~8
goals 107:21,22; 133:6;
134:21; 149:19; 176:15;
177:4,6,13; 194:16;
201:24; 205:15; 207:14;
236:7
God 177:9
goes 128:24; 201:22;
226:8; 229:16
Good 4:8; 8~12; 12:21;
19:10;28:13;38:15,25;
41:15;46:22;89:13;98:2;
101:18; 104:4; 123:7;
134:4; 142:21; 161:5;
165:4; 169:lO; 170:25;
198:19,20; 210:15;

graphically 111:23
graphics 61:16; 223:8
graphs 32: 1
grappling 202:21
jreat 20:4; 51:8; 92:21;
I5:7; 102:22; 104:5;
!14:8; 238:25; 239:22
greater 44:9,11,15,17,
!1,24,25;60:12;61:22;
‘4:2;84:17; 212:19
jreen 5:20,22
grocery 169:25
Iround l97:lO
grounded 11:8
group 21:10,12; 22:2;
!4:8; 25:12,15; 26:6,12,
13,14,19; 27:14; 76:21;
%1:8,9; 82:7; 85:14;
109:23,23; 184:18; 200::
!03:7; 215:14; 223:22;
!30:17; 238:13
Jroups 21:14; 24:5;
25:17; 26:l; 53:14; 131:i
144:25; 237:5
guarantee 225:2
guaranteed 229:8
guess 85:12,14,25;
33:1; 94:2; 95:3; 162:24;
178:ll; 190:9; 198:19;
199:6; 200:4; 217:5;
219:8; 222:15; 225:l;
230:3; 239:25
guessing 175:21
guests 5:3; 58:22;
106:17; 116:5; 133:4,21
163:5; 209:18
guidance 73:lO; 206:l
232:15
guide 49:7; 51:2; 56:20
100:24; 105:25; 106:4;
125:16,19; 131:25;
137:16,17; 138:22,23;
140:3,8; 141:6,14,16, :
24; 142:3,5; 155:8;
207:18;211:7; 222:lO;
223:3,6,13,17,21;
224
10,12,23; 226:7,13,15
20; 227:10,16; 229:7,1

(11) fit - gui

Hearing Volume 2
Jude 27,200O

-~ -~~

Food and Drug Administration
Gastrointestinal Drug Advsiory Committee

-

histories 14922
144:13; 164:5,5; 182:16;
238:11,19; 239:18; 241:1,
58:18,21,23;99:1; 100:4,
188:25; 189:3; 192:7;
10; 104:9,10; 105:8;
5,21
history 3615; 37:18,25;
195:17,18; 196~4; 208:2,
193:20
39:12,22;42:13,14;
hand 92:2,4; 146~24;
19;210:25;211:12;
45:lO; 53:20; 55:11,24;
Human 10:12; 174:24;
219:22; 225:9,17
215:16; 216:25; 217:8;
80:25; 82:5,9,10; 86~19,
175:4; 197:18
handful 11:15; 128:19
232:10,17
25; 88:2,3; 94:13; 119:6;
humans
57:19;96:11,12
handle 133:22; 184:12;
123:14; 143:21; 149:25;
hearing 1lO:lO; 132:25;
214:9 _, :::.~~-,-.‘r’~:;r-l.:~‘~~~~~~~~
hundred
hydro;;i$“g ii8122 y5
:
. : ““n;~;
.,\ i, b,*,I.
152::; 156:20; 178:21; .I
164:15; 172:4; 182:17;
12424; 125:4; 133:ls;‘*‘~~
handles ‘664
,.~.‘. 187:23; 221:15; 230:6;
183:ll; 184:lO; 189:5;
hyd$~6~&i.g.i”zo~~~
134:3,9; 137:3; 141:lO; -;, handoiit 22iji
em‘,r:.,,.:: 234:6; 237:1,2
213:11,12,14; 215:5;
,... ”
142:11,15,19,24,25;
.t-:: hands,222:8
216:12,16; 227~22;
24:22; 45:9; 118:5;
,~.,>,,*,,.
.~i~~,,,~,~~?,~~~,~~~,~
~.;&$“&& heart
l,j2:2 i’- : L...* ‘--“ryi,~&,~~,~, 237:24; 238:.
.‘r,+ .‘;;
tiiindy 231:7, .:$$;;;;$;c.
:., ~.>_,
~~,&;;a~;:<: ha l‘@,
,> 8’~,‘V?.
‘yqJ.&,‘,,:l,~~~,~;:
.__i ~??;~*$$;$~
.
“:~~:,~~.~~~..;~~~.p
h&g 1@;23 :.r:,‘;; ,~~;:-;p&$ heavy8cm
,; ;& y,<.
. .&&
,&&y&rt.~~
L.ii%.(.
*L;;- I I<..‘,
.>$‘..,..
i’<*,A,,..;<?.;&
,s.s
I t “);lT,.
. , . >+!‘.,A’:
: .l<,.,,-: ;,;.T.
a*.A%?
+y. -y Hl)i~~~&@~~51?~
held
189~fi"‘~~~~~~~~~~~~:~~~~~
jix
Mfipan. 1.00:3; 187:9; :i.‘;
j
~~~&y.~~,r~~.:
I","'.!~~~.:,;~~~~~~~-~~
;p~&d~
y??
"X
:i
i
3..
:
i ?‘1~“.*aGB’y;;;>,*;a
r9~tl;‘~~~~~~~~~~~~~~~~~
h+ @8; 237:9
..++&&:+‘.
Hell6
169:
15
j@&~&+
-.
+%&,$y~*;
~:&$yi
_ aL.“{,“S
m&&c
y.-,:‘:.
;ip’p”;
<s:
&g$:&.*;* /7tLp*,‘,,& ho~d~,Qf+&fb~!J4;+z&$~~~
$$a:9
.;,.+
+/ +L>.;
..,++:I,
&,“j- ~;GQ&%+P;,$,.~.+
“,*3*
‘B,/.&>::
,y_‘,.:.__.i
i ,a.:,~~“r..&:
-x:h?~~~;~&
I:>~,$:;~;~.c*,.
,,,,
k.‘\~r”h,~
,.?i.~“r.r.A.,&v.
,/”#,,: help S:1~,,22119.15;~:~~;~~
f f”“rpi ~~~~T&$
hapji$#k@+&j; 118:16;‘, 22~19; 41:2fqP’i:55:ii;i
/ holi&y’&
i&T. <+p$
65:j2; 69:p5is’91:21; ‘~~~;‘$, 19cy191‘205:^1;
-i~~~~~;t;~~~~js;‘i9:~~~~,~:
Holmboe
5:6;
&4;‘4 ” ‘“Y
haprs~~;nr;;$Pitij;224:i3;
98~17; 115:20,22; 132:24;
23Q:l ,: :,Ir ” ” .I-,;:2::%;,.:. 137~19; 174:15; 181:4;
HOMBOE21O:23
h&p~e&.&:18;
204~4
i.e 869
209:1,4
home 20:6; 37:12; 38:6,
Ian 15:8; 18:12; 19:10;
helpful 9:20; 139:14,15
15,24;39:12;41:15;
happy 167:21; 207:7
76:17
167:9; 17013; 220:17
helping 80:13
hard 54:3;8920; 100:19;
IBS 8:19; 13:12; 14:20,
honestly
211:8
helps 59:20; 87:18
138:13; 148:6; 149:9;
half 176:2,3,3; 193:15,
25; 15:3,7,15,17; 19:3,5,
honesty
l66:12
157~8; 169:21; 170:5;
15; 199~1; 210:5
hematocetia
119:20;
13,14; 20:1,3,12,14,19,
187:6;
1%:20;
204~7;
12O:ll
hope
l&25;
164:9;
HAMMES 6:16,16;
21,22;
21:9,11,16,18,
X%:22; 172:4; 174:22;
213:18; 241:18
hemorrhagic
90:25;
190:23,24; 195:19; 1%:9;
20; 22:2,6; 23:15,17,20;
176:20;
24l:24
120:20
201:18; 221:25; 229:25
hard-formed 19: 18
24:3,5,13,15,20,22;
hopefully 196:16
hemorrhoids
162:22;
HANAUER 4:3; 5:25; 7:1, Harvard 7:18
25:4,8,9,21; 26:2,6,13,
198~24
Hopkins 8:1
4;8:9; 12:6,21; 15:21;
hat 181:4
14,20; 27:3,10,17; 29:3,
; 19:7,9; 28:4,9,12;
hepatic 15:25; 16:2;
hormone 90:16; 181:8,
12; 30:16; 32:7,14; 33:2;
HAVLlK7:13,13;
188:14;
58:21;76:21; 77:6,
33:lO; 41:lo; 44:5; 45:15,
14
39:6; 41~4; 46:7,10; 47:17;
210:4
:17; 79:9; 80:21;
16;71:12
49:8,8; 50~25; 52:19; 53:9,
Hospital 621; 7:18;
hazard 126:17; 132:21
81:22; 82:l; 89:2;91:14;
14,21; 58:16; 59:14;62:9;
hepatitis 45:4
37:ll;
41:7;
57:22;
60~5;
hazards 12610
92:25; 93:25; 96~24;
68:18; 69:25; 70:3,11;
62:22;98:13; 105:14;
hepatologist
45:11
head 167:8
97:19; 99:17,21,25;
71:9;76:1,2;80:15;87:21,
185:5
hepatology 45:13
100:17; 103:23; 104:9,19;
headache 83:19; 221:9
23; 99:9; 109:15,16,20;
hospitalization
117:1,2,
hepatotoxicity
104: 1,2,
105:22; 106:9,13,17;
heading 191:l; 224:24
110:7,9,9,17;111:11;
3,4,14;
118~22;
121:6;
8; 116:12,17,21,23;
116:5; 133:20; 142:18;
112:16; 114:6; 115:2,3;
headings l40:3
122:ll; 128:24; 148:l;
117:12; 128:5; 150~4;
143:l; 156:5; 1577;
119:6; 121:12; 123:7;
199:13;
200:5,7
healed
161:5;
162:5,6
158:14; 183:18,24;
158:1,18; 159:13,18,20;
148:15; 149:5; 156:25;
hospitalizations
116:17
184:20,24; 185:11,13;
healing 160:24
161:16,25; 162:16; 163:4;
160:11; 170:6; 171:9,10;
187:8; 188:3; 189:3
hospitalized
36:13,16;
164:2; 165:18; 166:5,10,
Health 7:12; 8:15,22,24;
172:6,11,15,16,16,23;
37:24; 38:14; 42:l; 46:1,2;
19; 168:12,16,18,23;
10:12,20,24; l5:9; 22:25;
heralding 73:22
173:1,9,11,15,24,25;
119:17; 122:15,23;
169:2,4,6,12,14;
171:11,
23:12,14; 24:16; 25:4;
herbals 223:l
174:9,17,23; 175:2,7,8,
129:14; 13O:ll; 181:22;
26:10,11,15,22; 28:6;
16,18,21,25; 172:2;
12,14,24; 176:22; 191:8;
heterogeneous
50:12
182:10,11; 185:21,25;
48:17; 51:12; 52:25; 53:1,
176:23; 178:5,25; 179:7,
192:8; X2:13; 220:17,20
HFD-118
6:9
1861
12; 181:3; 182:2,14;
16; 56:20; 130:19,20;
ICD-9 51:23; 53:8;
Hi
180:5;
229:2
183:7,23; 184:17; 185:15,
137:8; 138:lO; 140:7;
hot 175:16
148:22; 150:12
high 30:13; 49:9; 70:14;
20; 187:21; 188:6,9,22;
142:12; 223:14
HOUN 6:6,6; 8:10,12;
idea
118:16; 199:lO;
95:23; 178:9,13
189:ll; 190:5,23; 191:6,
health-related 22:13,18;
3614;79:ll; 187:23;
220:6; 232:3
14,25; 192:7,17; 193:2,7,
higher 22:6; 23:9; 181:l
23:2,8,9,18; 24:6,23;
188:8; 189:7; 194:13,24;
ideal 192:4
17,20; 194:4,12,19;
27:25
205: 17; 206:7; 207:9;
highlight 66:25;73:7;
ideas 11:24; 231:25
195:2,15,25; 196:12;
209:17,25;210:3; 212:2,
2l1:6
healthcare 14:8; 15: 14;
197:l; 198:6,10,11,18;
identical 22:24; 25:25;
4;
224:ll;
229:23;
230:3;
21:12,21; 28:6;47:9; 53:2; highlighted
59:5
199:3,12; 200:10; 201:5,
31:9,19;
44:17; 139:8
233:13,16;
234:7;
235:14,
59:20;60:1,11,23,24;
highlighting
65:17;
17,24; 202:2,5,11,18;
15; 239:8,19,22; 242:6
61:24; 62:4,7,13,18,24;
identifiable
19:22;
139:23;
208:19
203:6; 204:8; 205:2,8,15,
64:10; 66:5,21; 67:2,21;
191:ll
hour 224:16
highlights 60:10; 64:1,
19; 206:3,14; 207:2;
69:15; 105:13,21; 126:22;
identification
59:12;
hour’s 170:4
25; 68:9; 74~12
:18; 209:13,23; 210:1,
130:17,23,25; 134:14;
66:17; 105:19; 149:l
hours 38:7
11:12,24; 212:3,6,
highly
71:7;
138:14
152:15; 153:12; 155:24;
identified 15:20; 114:19,
3:lo; 214:1,17,21;
Householders
21:20
hip 41:20
175:3; 211:l
23; 146:19; 15611; 1762,
,Lj:4,10, 15;216:6,11,
Houston 613
Ihistopathological
HealthGroup 150:23
3; 178:11,22; 179:16;
17,22; 218~25; 221:4,20,
huge 148~16; 192:23;
12021
184:23; 191:10
hear 12:12; 91:21; 133:4;
23; 222:15; 223:15,20;
203:2
120~4
Ihistopathology
159:20; 162:23; 178:6,22;
identify 9:4; 51:24; 53:9;
224:19; 227:19; 230:1,5,
hugest 218:18
208~5; 209:ll; 234:2
Ihistorical 23:21; 25:15
69:14;75:19; 87:13;
25; 231:24; 232:8,15;
Hugo 68; 108~2; 115:25
95:17; 103:21; 114:24;
heard 19:~ 3; 48~16;
Ihistorically 172: 12;
233:13,23; 234~19;
149:5; 179:16; 180:18;
64:9;92:5; 119:l; 138:4; - 226:lO
I Hull l&17,18; 48~10;
235:12; 23611; 237:19;
14,19,23; 230:4,20;
23X8; 234:25

guided - identify

(12)

a-U-Sdpt@

Milk

Reporting

Company

(202) 546-6666

--

Food and Drug Administration
Gastrointestinal Drug Advsiory
183:23; l&34:17
identifying 625; 827;
114:20; 179:3
identity 124:i4
,..__
idiopathic 3O$OOj~$:+
IFFGD 172: 18; 174: 14; .-

46:8: 1Ol:ll; 174:20; : ‘.
239:i5

illustrate 143:20
illustrated 45:25; 73:12
illustration 62:17; 65:21
imagine 85: 1; 220: 16
imaging 173:8
imetrex 119:13
imfiiximab 194:2
immediate 124:13
immediately 78:3;
137~24
imminent 132:21
immunoaiiergic
187:l
lmodium 128:16,21
impact 15:7,15; 18:25;
25~4; 2724; 70:4; 763;
107:15,19; 108:12;
15O:lo; 152:24; 164:6;
172:8; 175:2; 177:9,10;
206:19; 224:20; 230:13
impacted 28:5
impactfui 1S:l
impaction 34:18; 38:5;
74:s; 121:17,18; 122:11,
14
impede 91:22,23; 92:13,
15
implement 65:G; 67:18
implementation
68:10,
13; 131:l; 154:23; 177:lS
implemented
133:15
implementing
65:4;
149:15
implicate 187:7
imply 162:5
importance 237:2
important 5:23; 8:lS;
9:22; 35:8;49:6,25; 51:l;
57:11; 59:17; 60:6,22;
62:23; 63:13; 64:4,5,13;
66:15,25;68:12;70:10;
73:4; 82:17; 98:9; 102:7;
104:23; 105:16,20;
117~23; 125:13,21;

iWller Reporthg

Committee

incomplete
19:20; 119::
212:21
incompleteness
93:19
inconvenient
175:15
incorporated
61:l;
217~4~
incorrect 16O:13;
18S:12; 186:ll; 190:3
191:20,23;’
44:23; 107j9; 133:6
., incorrectly
239:5
impose ‘i27:16.
increase 75:17; 197:6;
irn+d
i&if;
2&L; j
“;;:;
img&&.,“&@q.~j
,.;t.; : .. 212:16’~“‘&,;:<.:;,$
incti~zf3d;
iiii‘ ‘.I?
:,,i Pm_
qz<*~j ~“isw:
,q::‘.<*y<{,;~<y&
impoSsible‘l92:l
,..~
.,AI-d~~+&;,~‘~~;A
p.$~%d I i,,.^.&,”
9s:ldc2!@4~,
84:19;‘,i9~@z2~ j47:21
i
“i-2),,v& +w:$;p 1.“1.I ,.,<+:p,;
.,$d 175:2;:‘jT$@ji79:6,
S,~?
[gpre&lon
,j3&2~~~~~~$:,:.&+~+
‘-2;j
i- *_ .“~~~‘“‘~“?,.;,
,Y&‘...:*““,&v.-,.,i Isi;’ ji&)(& 3; f&‘f&
improve 8:17; 1OW‘ .,- 192320; 208:1% 233:4,4
increas-g”+2
..y
1ll:ii;
114:1,6,7;
176:21; 190:22; 232:1,9
increasing 50:5
improved 32:16; 111:12;
incredible 78:22; 79:23
lSl:lO, 17,18,19; 152:2;
increment 112:20
168z9
incremental 70:19,21
improvement
13:7; 30:1,
increments 231:13
3,8,9,18,23; 31:4,5;
incurred 21:ll
32:9,11,16,18,18;
33:4;
46:9;71:3; 111:14;
indeed 75:4; 119:lO;
113:11,21; 114:10,11;
120:24; 147:ll; 200:22;
135:9; 239:6,11
219:13; 240:3
improving
113:13,14,
independent
30: 12;
16; 1264
13S:l; 234:1,8
imputed 93:18
Indiana 45:ll; 184:19
in-depth 57:8
indicate 14:17; 128:21
inability 79~4
indicated 83:3; 87:20;
88:14; 107:3; 108:16;
inadequate 93:3
109:14,15; 110:23; 111:l
inadvertently
5:17
144:21; 188:24; 189:8;
inappropriate
62:6;
202:7,13; 212:7,11;
69:14; 78:23; 92:19;
232:ll; 237:4,23; 239:15
110:16; 128:13
indicates 64:12; 136:23
inappropriately
39:23;
indicating 69:23
203~24; 240:3
indication 85:23; 108:ls
incidence 51:6; 52:15,
109: 14; 144:7; 149: 11;
17,18; 53:ll; 55:3,1S;
152~21; 157:21,22; 189:s
74:2,19; 148:19,19;
21; 191:4; 203:19; 208:12
194:20,24; 195:3; 197:7
indications 9: 17; 57:6;
include 17:8; 20:9; 51:17;
87119; 126:s; 158:21;
52:11,21; 58:9;60:3;
159:8; 189:14; 2OO:2;
65:10,14; 72~6; 7417;
211:25; 212:7,24; 213:8;
89:lO; 124:4,21; 1264;
214:12;234:11; 238:14
130:17; 131:4; 177:24;
indirect 21:2; 22:3; 27:2
183:14; 205:24; 207:lG;
213:22; 222:1,8; 231:16,
indiscriminately
201:3
20
individual 10:24; 22:16;
included 24:2; 40:23;
23:13; 29:23; 36:ll;
45:4; 50:16; 6219; 64:7,13;
37:10,18,21; 38:19; 46:8
75:15; 120:13; 124:6;
62:2; 77:5; 81:19,20;
127:6; 128~3; 140:3;
89:21; 93:13; 99:2; 109:6
150:6; 227:9; 231:21
148:5; lS6:15; 174:4;
195:20; 222:23
includes 47:7; 48:3,13;
53~4; 55:19; 56:17; 72:3;
individual’s
22:21;
140:2,7; 174:2
23:ll; 27:25
including 34:18; 45:9;
individually
196:22
53:8; 566; 74:5; 8025;
individuals
20~17; 22:2i
103:10,14; 105:2; 107:12;
29:22; 30:20; 32:17;
108:ll; 124:16; 158:13;
35:15; 39:20,21; 45~6;
197:17; 207:17; 211:3
46: 1; 53:9; S5:8,20; 78~1,
inclusion 49:18; 144:12
82:9,10,11,13,20;
83:9,
incoming 66:5
13,15;86:8,10,11,18,
I
128:lO; 130:22; 138:lO;
139:17; 140:4,5,18,22;
142:6,14; 149:2; 154:21;
174:17; 178:16; 185:3;
187:13; 201:11;202:4;
207:1,25; 211:19; 221:7;
223:8,9; 227:4,7,23;.
2353; 237~21; 241;!, 14
impo~&ri’tly’35:20;
r-‘-- f ’

Company

(202) 546-6666 Min-U-Scrbt@

Hearing Volume 2
June 27,200C
24; 89:16; 90:1S, 18;
initiative 16:21
93:16,19
injuries 73:11
induce 34: 17
injury 162; 126:24
induced %:9
innovation 22625
industry 155:2; 228~13;
innovative 98:20; 218:lf
,.
235:8
input 11O:ll; 115:23;
ineffective99:8
_ 215:l
infants 141:l
inquiring 42:21
insert 9:3; 63:10,18;
infiamm#0rjr‘41:21;
.’ - 64:5,6; 91:16; X10:24;
51:18; 173:!4- .’ -. *: : ‘:j’;~ 101:22,25; 104:12,12,15
infio$ $j;$
._‘-.:.-,&,.: i:.j 105:25; 106~3; 108:lS;
..\^+,*“$?~
.m**,.:,e
\.<
‘, >$.
2:-yt ;&,:,
2;2j ‘i^i2:12;
infiu&c,~
241:24 ~+-~::~~ 1;;@%,
&:2O;22;;$2$8,9;
._ .c,,,~j;‘~:~.~~~i.~
.,.~-,,.j-:s~.-~..~:~~~
inform 125:5,20; 155:6; -j: Q&k13j:25$55:7;
20~:‘~Gc”.‘:~,:~~~~~~.~~~~.~~
rrtu
,,4$i*+#&<7:
“_. t$.,*,v 1,&.!*.i’~+j. 8 &:$; 139:$4,‘5; 225~6,
in~r~~~~4~~~~~~~
~Z~i4,.f$lG; iy,1$3;
13:17,24; f4:$p’+7:4,
;:g; 234:2F,‘l;Sf
::r :
: I.,.,.?“.,$. I.
21; 34:5,6;‘&23;
43;:2:; ” inserts 65:9; 124:21;
49:2; 50~9; 51:25;53:24;’
125:4,18; 133:19; 13S:lS
55:10; 59:17,18,20; 60~7,
211:9
20; 61:l; 62:9,23,25;
inside 64:4,6,8; 105:4, ;
G3:4,13; 64:4,5,7,12,13,
insight 90:14
22;65:2,11,18;66:1,11,
install 63:16
15,21,25;67:4,4,7,21;
69:11,12,21;73:3,5,16,
instance 83:8; 135:4;
25; 75:23; 77:9; 78:13,13,
136:3; 137:18,21; 138:l:
24; 79:6; 80:4,12; 83:4;
139:3,22; 140:13; 213:21
54:2; 85:7; 97:13; 104:18,
instances 188~25
23; 105:4,17,20; 124:18;
instead 79:19; 153:5
125:13,17; 127:12;
Institute 7: 14; 8:7; 1O:ll
128:ll; 132:l; 134:10,13,
j3:l; 107:17; 233:17
18,19,22,24; 135:1,9,
institutes 7: 11
10,14,17; 136:8,10,13,
15; 137:4,12; 140:6,10,
instruction 229:7
12,18; 142:2,7,14,14;
instructions
139:16;
155:4,8,12; 158:13,15,
140:20,22
22; 159:l; 16O:lO; 172:20;
instrument 29:13; 32:ll
17616; 177:18,22;
instruments 21:5
183:19; 184:15; 186:6;
integrated 47~23; 48:24
192:ll; 193:7; 194:lO;
19:9; 59:6; 76~5
209:l; 211:20; 219:4;
integration 105:ll
220:12, IS, 19; 221:1,16;
222:7,13,25; 223:lO;
integrity 57:16
225:3; 226:17; 228:7,14,
intellect 8:21
19; 233:lO; 236:16
intend 1320; 64:2; 65:2
informational
229:l
66:9,24; 67:1,18; 68:4
informed 101:9,11;
intended 15:16; 62:22;
102:1,4
63~2;64~20; 68~4; 69:9,1
infrequent 16:s; 50: 15
132:2; 134:13; 215:22,2:
221:7
lngieheim S:9
inhibition 91:8,9
intent 33:14; 62~1; 82:8;
172: 19
inhibitor 153:2
inter-bowel 97:16
inhibitors 70:22
inter-species
197:21
Initial 54:21; 129:17;
interact 223:2
146:21; 166:17
initially 186:15; 187:4;
interaction 72:13; 74:l
23;90:10;91:10; 152:13
193:12,22,24; 194:13;
173:3
197:20
interactions
79:13,16;
initiate 10:20; 12:18;
90:5; 91:2
82:12
intercourse
74:19
initiated 17:3; 41:4;
57:17; 85:19,20; lO6:14;
interest 4:16,24; 5:4,1
132:20; 213:16
8:5; 11:20; 16:14; 49:8;
S6:14
initiating 39:7; 55:14
interested 16:22; 43:l:
initiation 36:16; 42:13;
1 lO:lO, 18; 114:20;
43:21;45:10; 117:21;
115:23: 132:25: 150:18
121:13

(13) i&ntifdnfz

- interest4

Food and Drug Administration
Gastrointestinal Drug Advsiory Committee

Hearing VOlUme 2
Jude 27,200O
interesting 28:lO; 83:3;
147~9; 166:lO; 186:15;

involved 11:2;71:15;
222:ll; 230:17
invoive,ment S:l, 12
involving 173Z!; 197:i7,; ._
l8
: ~;-:..“.:-,-:.1.:.~~1”
IPA
153:12-’
II i$-$:,6y-;-; i. &@&$ 7;
iRB
. , ,‘ *z,, .*.
ir;t;bi&
“$h; &;‘::
:.>:

15:12;28:1:29:15; 31:22;
international
31:16
.’
35:9;
633:s;64322365:i?;
Internet 131:6; 220fl0,
69:24;81:4;‘5; H&:24;-“.
;,;’
&:
:
I
12.13
l~.&@&$,
6,‘~9;~7’$$$’
,>‘)&&
internist 6;19,21;85(‘,‘
12j:12;y&“J6;
;32:!4;(“-*
210:18,24 ,,,~~:,~~~~~~~:,I, 144: 1.3;;$@]0; 156: r9; .,inteipret ~s~~~:‘“:~~~~~~~~,.
.-. ,,.~.@,
,...,.
-^;.~.c~~~~~~~~~~~!.i,
:.:: i5%23@$5,6;,+6;24;
l~~:r’~$=&:Jl,
23; /;giji+
inte;tfr@ti
$!Q:e$@$:
_,.;:.,;.p.
~:~;~-~~~‘i”~~~:~~.~
&, :~:,: l&<fj~~~~~~;
21 q”‘:;
interrupted,
$4;l,&&“&$
11 ~~+$_.
sP,&
-:p‘I;~y;-‘:~,~~.~.,
“: _
p&q-~
~’
interruption ,35:‘17,2OT-‘,
/(,..p$
ischem*a 37:15;122:1; ‘.
2.; 54~25j‘f&9‘-.:fii,::
: ; ..,y%+
~&+.~~;~ 123:3; 180:16,16,16,21;
inbrfwinitij-i$:21
;$
181:l; 182:12,13; 233:2,
interval 32:22; 15220 ‘”
6,11
intervals 68: 15
ischemic 16:7,8; 33:10,
intervene 79:25
.‘ 17,19,23; 34~2; 40:2,5,
12,18; 41:14; 42:19,22,
intervention
10:18;
25; 43:5,7,9,14,16,17,
43:22,25; 44:l; 107:18,
18; 45:23; 46:13; 4818;
19; 108~11; 143:12,13,19,
SO:l, 23; 51:16; 52:10,17;
20; 144:l; 149:22; 150:9;
53:10; %:I, 15; 56:4;
lS2:9; 154:15; 155:18;
57:14; 59:21;61:14;63:8;
157:4; 200:6; 224:12;
66:18;71:13,18; 75:17;
22825; 231:14; 233:20
77:12;80:17;86:20,22;
+*srventions
11:22;
87:13;95:19;98:4;
‘4~“,6
20.132:2S
103:12; 104:l; 105:19;
f-b16:
18; 157:s; ;77:7,
116:13,16,20,22;117:2,
y; 197:4; 207:ll; 229:l;
7,lO; 118:20; 119:1,11,
231:6; 232:16; 233:17;
14,19,22,24; 120:1,2,4,
234:2,9
17,18; 122:19; 123:16;
intestinal 173:7; 213:13
129:17,19; 130:2,5;
into 11:7; 20:25; 27:l;
i32:l6; 146:3; 148:10,11,
29:1,5; 36:19;61:1; 81:5,
20; 149:2; lS6:22; 162:19;
23; 88:8; 90: 14; 106:8;
180:2,6,11,12; 185:6;
133:9; 134:7; 138:23;
188:19; 194:25; 195:1,3,
142:22; 145:22; 146:23;
16; 198:13,21; 202:23,24;
157:20; 165:10,17; 166:5;
203:l; 206:17,21; 213:14;
168:14; 185:5; 187:21;
240:25
202:3; 215:13; 217:3,24;
island 148:2
222~7; 224~4; 225: 11,24;
isolating 175:12
228:4,9
issue 4:9; 15:25; 16:18;
intrigued 222:9
49:21; 73:7; 79:21; 82:17;
introduce6:1,3;
18:ll;
86:21; 89:3; 90:22; 100:4;
59:7; 61:25
103:8; 109:2,5,10; 111:4,
introduced 193:23,25;
9; 127:15; 139:20; 158:20;
197:20
159:s; 187:24; 188:G;
194:15; 195:21;203:14;
introducing
63: 1
207:2S; 221:19; 227:17,
Introduction
4:2; 12:20;
21; 231:ll; 237:12
S2:21; 70:s; 75:13
issued 226:24
introductory
62:l; 63:1
issues 9:lO; 10:21,21;
intuitive 183:9
11:8; 13:21; 14:lS; 15:7;
49~20; 58:6; 72:16; 74:lO;
>$$,,~~:e,:,,
78:20; 84:22; 103:7;
.pl*:stigations
9:8
108:13,22; 115:24;
investigators
23:20;
144:23; 1568,ll;
158:21;
SS:22; 66~10; 103:4;
184:20; 187:22; 209:16;
152:s; 154:ll; 172:24
214:21
invite 12:17
item 65: 17; 124:6
invited 5:3; 58:22
items 62:ll; 125:1,4,5;
143:lO
involve 4:22

terative lo:19
v 95:9,11’

J

Journa,

iy&i

194:7

I aparotomy

I anguages

217:24
425
I arge 11:7; 31:16; 36:21;
442:20,22; 467; SO:,lo;
ejl:ll;
52:s; 55:20;70:3;
.
71:17;78:13; 84:21;
i 37:11;90:13,24; 120:15;
150~11; 227:22
ilarge-&&Y34:20.,
la;s;Giji;i:ry
F:.:y+.. 1. :*.(
I
,a;gGF ii$~yl<;sye~f .y;:. _.
I“**;.:.“$. .!..c:;‘.=~~.~~~,~~~~~~~~~~~~
,-

‘_iI~~~~~?~~~~~~“~~~~~~~~~;-;.
iLal;ry
:
.<I”.2
‘%.,,:~,~~~~~r~~:~~~r,~
“:li. . .‘*,,
39$gkig;mi3;
ilast
=1~4:,i~-~~~~~4~~,~~2~~~,~~~
105i22; 112j~i@j~8~
+“’“,’

r-:.-,

ournais 147:20; 19331%
21,22
udge 82:14; 160:21 .’
iudged 202~6
iudgment 88:17
juggle 175:20
Juiy 43:3; 152:lO; 205:7
jumping ll:l6
Jun 41:25
juncture 41:18
June 34:6,10,11; 362;
10:8,16; 117:4,7; 129:21;
152:22,25; 153:8,17,18;
L54:8

K
Kay 76:18
keep 12:14,14; 38:19;
102:9; 191:5
keeping 12:ll
Kent 12:17,21,24; 18:24;
33:8; 56:18; 60:19; 69:17,
20; 76:21; 79:3,21; 808;
B7:16; 91:25; 92:lS;
98~25; 99:19,22; 1OO:l;
101:20; 106:2; 193:9,22;
194:9; 202:1,3,16,22;
213:G; 221:21
Kent’s 104:ll
kept 168:3
key 31:25; 47:3; 48:6,20;
50:10; 6O:lo; 90:5,20;
103:8; 217:5
Keystone 227:13
kill 172:11,17
killer 172:15
kind 136:13; 155:8;
168:23; 182:4; X%:12;
191:l; 197:6; 201:15;
208:16; 210:14; 220:5,6;
221:14; 229:18; 234:16;
237:8
kii 63:22
kits 64:18; 67:7
knew 169:l
knowing 105:3; 174:9;

win-U-Szritsti

138:2S; 139:1,7;

2!22:20,22

known 9:14;‘11:11;
78:19;79:1;94:13;
11s:lo; 127:s; 135:22;
144:25; 145:21; 213A.5;
228:13;229:8
1.

lames 45:11;76:18
lanet7S:S
3X
lanuary 15O:l.
aundice 45:4

1.25:14;

103:io; 210:16
(nowledge 5S:l7; 67:4;
%:6,23; 104:25; 191%

label 10:2; 45:3; 79:20;
124:12; 141:14; 151:22;
154:9; 159:23; 16018;
211:24; 221:21
labeled 9:14; 31:ll;
75:lO; 85:23; 147:16
labeling 9:2,15,17,19,
21; 11:3; 14:1,2,8; 16:3,
4; 17:22; 18:1,3,4; 61:3;
72:4,14; 73:2,17; 74:12,
22;75:12,14,21; 79:17;
82:2,9;87:17; 107:12;
108:12,12,18; 124:4,12,
21; 125:10,11; 126:1,2;
135:16,19,23,24,24;
136:4,9,13,14,20;
1373,
6,9,11,19,21; 139:6,8;
141:24; 142:5; 143:9,21;
149:lG; lSO:lO, 17,18;
152:1,2,25; 154:8,16,17,
18; 155:16,23; 157:3;
161:19; 204:13; 207:17,
25; 208:18; 209:16; 2106,
15,22; 231:23; 233:19;
234:9
laboratory
118:8
lack 15:12; 111:2; 129:24;
13O:l
ladies 19:9; 28:13; 4623;
106~18; 1166; 134:4
lady 200:20; 201:2;
222:12
lags 54:ll
LAINE 6:10,10; 15:21;
80:12;81:22; 83:23; 84:9;
85:1,9,25; 86:4,20;
87:13,16;88:20; 158:18,
19; lS9:22; 161:9; 178~2;
183:7,8; 192:17,18;
195:11; 196:14; 199:6;
203:7; 205:22; 212:9,23;
213:8,20; 214:3; 215:18;
2163; 219:2
Laine’s 94:4; l&1:2
lamina 120:22
1 language 9&16; 100:14;

MI&T Reoorting

143i14; 144:15; qxk17;
LS8:22; X+4:19,20,23;
16617; 167:4; 176113;
183:15; 199:20; 213:l;
223:4; 232:3; 235:12,17
Lastly 26:19; 27~22;
59:19;62:11;67:6;69:14
late 198:2
lately 171:s
later 38:10,15,16; 39:l;
41:16,22;88:25; 120:19;
147:15; 150:l; 156:4;
185:8; 187:lO; 189:9;
194:14; 198:l; 207:7;
237:15
latest 97: 12
laudable 211:19
Laughter 7:3; 157:9;
160~23; 167:24; 185:17;
198:7; 205:20; 221:22;
236:20
launched 498; 15O:l;
193:10,10
lavatory 168:8
law 5:19; 141:6; 224:14,
1s
Lawrence 43:9; 7616
lawyers 102: 13
laxative 35:10,11; 56:24;
78:9
laxatives 82:lS; 222:5
lay 125:13
lead 27:19,20; 9823;
126:24; 18O:l
Leader 6:9
leaders 98:19,22
leading 233:G
leads 202:3
leaflet 125:17
lean 208:21
leaning 229:13
learn 11:25; 167:6;
236:13,14
learned 79:12; 208:22,

23
least 43:8,19; 81:23;
I 87:23; 93:16; 96%;

Company

(202) 546-6666

Hqring Vohune 2
June 27,200O
215:21;218:5,6,21;
219?4,8;220:2;222:18;

~5,6,6,9;:14,15;
2;2:3,5;233:16,24;
234:7;237:1;238:12; ‘?
‘j :, .+&
240~8
.- .",+:';1.&
one-pager 221:8 .:.:,‘:-‘i;:;
on*year
l,*:ia
!+;$ij

13523; 181:8,13
Order 4:2,4; 32:24; 356;
73:3;77:4,21;90:17;
107:20;124:8,23;125:20;
126:15;131:13;134:~~ *j_..
143:lo; 170:2;171:23; '>-.,
195:8;222:13;.229:;1,8
odinarily.'i~b:~~.‘"
~::pm;

Ones 11:12; loi:ig;~';y;

ll9:2; l35:2* $$$6 jS$~
ongoin.g 56~3,$gp~~~
58:13;‘~:la;M.8,~~~~,~~~~
:“,~.T.
i&J -*.;..$qty!+.:j$
:&.f
only ll:l~;~~~;~~;&@~
29: 1; 32:$, 11; 4F$s;6$$i
7O:i;;.~~~~~:~~~~?~~,..~~
94:24;98:16;2?;',l~~~~~
104:14; 105~~0; 1‘083_2~,~
110:4; 111:1~~112:3,22;”
25; 113:2,15,23; 114:2;;’
115:19,21; 126:lS;
128:12,23; 129:19;
130:23; 131:21; 132:7;
151:15,21;152:3;157:l3;
159:8,24;161:4,7;162:5,
l&22; 163:2; 164:25;
165:1;172:24;173:17;
174:6;176:1,2,3,4;
179:9;182:24;187:14;
19O:15; 191:7; 192:2,9;

.22;134:9;194:18
OPtiOnS 15:17;17:8;
20:9,11;49:18; 107:ll;
108:7; 123:20,23; 124:3,
11; 130:16; 131:4,23;
132:23; 177324; 2O8:18
oral 58:2;90:16;134:13;

142:21;143:3,6; 2?5:3;
227:20;231:20
OTC 73:9.“23; 99:14;
222:6
OTCs 223:l
others 93:23; 137:4;
147:19; 17517; 19O:lO
otherwise 179:15
ought 204:3,12,23,25
ours 27:23
ourselves 63; 78~24;
175:11;176:14
out 14:20; 22:7; 27:23;
37:l; 40:8,10; 77~2; 78:24;
80:8,9,24;81:22;83:14;
84:22;86:9,25;87:3,6,
12;88:4;93:17;94:11;
95:20,22;99:6; 101:5;
113:12; 114:2; 136:11;
140:24; 141:18,19; 142:2;
149:11,13; 151:20; x57:3;
158:24;160:1;166:1,2;
170:15;173:~2;175:19;
181:25;184:11;191:18;
195:8,9;198:8;209:22;
215:21;225:16;227:8;
228:6,14;230:25;236:16;
241:9,15; 242:l
outcome 23:23,24; 2419,
19,21;25:15;26:6;27:7;
55:17;205:23
Outcomes 15:9;23:3,25;
51:2,6;53:11,13;55:3;
103:10;138:13;148:20;
149:9;177:4,6,14;
!06:24;207:14
>uter 124:13
Miine 234:lO
outlined 338; 207:14
Butpatient 137:7; 2005
outreach 131:8; 133:12
Butside 39:9; 202:14,20
xrtstanding
217:f
Butweigh 9: 13
Wer 13:7; 18:23; 205;
Z8:3,24;31:17;32:14,23;
iG:19;54:14;55:8;70:19,
21;72:12;79:18;81:17;

one-pager - patienti

(18)

onset 30:7; 35:7; 77:20;
83:15;120:12;146:7
open 76:22;163:9;164:3,
15;191:5;233:14
open-label 57:24
Opening 8:10,11
operate 138:19
operation 97:4
opinion 45:13; 160:20;
203:23;209:15
opinions 222:16; 231:25;
232:9
Opium 128:17,18
OPPOt'tUnitieS 53:25
opportunity
56:8; S7:7;
65:15;79:25;129:2;
223:13
opposed 105:l; 135:16;
162:4; 214:23; 22917
optimal 131:l
optimally 176:s
optimize 115:20,22
optimized 17:2

Food and Drug AdmInIstration
Gastrointestinal Drug Advsiory Committee
,_

135:15,19,19,23,23;
parameters 44~23;
136:4,12,14,18;137:2,8,
57:25;89:18
19;138:1,10;139:2;
Park 6616
140:5,8,23; 141:7,11,12,
Parklawn 4:21
18,25; 142:3,5,6,7;
parse 22414
1557; 156:15,16; 158:7,
part 4:10;11:4,5,8;
8,9,16,16; 160~4; 164:18;
14:lo;l(i:23;18:2;54:1;~
165:4,15; 174:1,4, lo;
78:7;81:11;98:11;~
..’
175:7;184:9;185:11,14,
101:20; 104:12;131:11; '.
23;186:7,16; 189:3;
overall 21:15; 33:l;
195:18,20;21;19~:21;
176A8;190:20;209:11;
39: 16; 43:7,14; 45: 15;
197:14;200:8,12;204:15,
211:11;21S:6;21~:7;
46:6,14;47:12;87:2; ‘+ ; 227:13;?30:15;238:23;".17;iO6:2i,22;215:25;
90;14; 11s:i ‘<k:
+-:‘:,;;:2:.
,Y 24,~“..,.;.,‘,;i~~,~~,~~~~
1:‘I9 ~~~~.~~;~~~~~~~~~~~~~~~~~;
218:20,22,24;22'&5;
L;‘+*,..
,,u,?.*
:*“*.~ic,...,r
&;*.: ‘i
ii~~~~2~~~3,~~25i6,.13,
overd+~Gi&$2
.$$A$
P"""'pant-14:24~~~~~~~~~~~~.
.a,.;i .,i;
:.::‘~-2.‘.I.
,*
,:
‘T;’
$99,
..,.A:
‘??>
i .; r;;;&ij&5@“4.~3 25.‘$$ ~?;,,~,,y$$&q
cverly
‘\~‘,..._22839
.;_,,_,
;.i . ;:*.y -<-J;Q&>;i $3 PO+<,-“;2f<<s;r<,,
, ,J
B>
L...<I.<
;*,?2<*$$,
1414;, 234~25;235:X,%.‘i:i
b,
,~,.r’“~@~.,-s&
6.:“:
‘;;$*>,@..
&“&?
~.
,”
..,y
.>
,(.
%38:3$; ~&2'&?@:$;‘::'1
._
ovec!~&t~.g
.;,.,~,;;;;~~~: ,~.r:C.:..i-,~~.~iC’
4 .&>-~~>$;%~@
i,,,^.xTi.b.,,r:x
.ij;;;;2,$c :';:‘,_,;
overview 13:lS; lSi10, ” patW=te 28:~@~;~g;~~ 2@-.il~?g;
..
-.
*
"~~$&k&:,>~;
-.:,:;:
16; 18:13;18; 19:13;47:2
participated
i52:S; ‘-I? 222:8
-:,:, ,‘~$+~%,.;;::: ,, ., ,'. '_CL1 pm&;;t4hfin.o&!w.&l
overweight
118:s
154:12
p&i&tG
i7d:ijl
, i: :.,
participating
16:22
overwhelming
203:23,
25
particular 33:9; 44:8;
patients 11:3; 14:8,24;
72:1,1; 112:7; 117:5;
own 78:24; 81:lO; 98:12;
15:4,8,11; 19:20; 20:16,
118:4; 119:9; 120:3;
134:lS; 167:2; 169:17;
20;21:18,20;22:2,6;
128:12; 133:8; 138:18;
232:5,24;234:5
23:3,17,22;24:3,14,15,
139:3,14; 140:9; 142:3;
22;25:4,8,8,12,13,15,
151:14; 162:ll; 181:14;
21;26:2,3,14,18,20;
219:11,11; 227:17; 228:1,
27:7,10,17; 28:25; 29:1,
3,4,16;31:18;32:7,15;
66
33:3;34:23,25,25;35:2,
p.m 163:10,11;242:7
particularly
126:22,23;
3,12,18,21;42:24;44:10,
146:3; 233:7; 239:14;
pd!% 91:8,12;153:1
12,14,20;46:10;47:10;
241:14
pA158:17
48:5;49:23;50: 10,12;
parties
227:
12
package9:3;63:10,18;
51:9; 52:7,16,18; 53:21;
pass 211:21
54:2,3,4,6,8;65:9;
56:12,21;58:1O;S9:12,
passage 212:21
100:24;101:22,25;
14,15,20; 60:7; 62:5,6,
104:11,12,15,21;105:24;
passed 186:8
25; 63:3,11,14,21,22;
106:3;108:15; 111:21,22;
64:14,19;65:1,12,14,16,
passing 141:13
112:12;124:13,20,21,22;
22;66:5;68:18;69:13,14,
past 29:14; 32:14; 103:6;
125:4,8,9,18;126:7;
25;70:1,2,7, 11;71:4;
208:11,12; 213:3,20
131:2S;l33:19;135:19;
73:23;75:20;76:2,3;77:5,
patchy
37:9;
120:18
155:7;159:9;225:6,13,
17,22;78:20,25;79:7;
pathology 33:25; 34:l
17,18;234:25
80:13,1S, 24; 81:3,5,9,
pathophysiology
173:2
23;82:3,4;85:2,24;88:2;
packaged 136:24;
patient8:21;12:1;22:11;
89:4,7,11,25; 90:2,7,25;
225:14
92:18; 94:12; 97:2,21;
30:14;36:14,22,22;
packages 64:6,10
98:7,12,13,16,21;
37:14,25;38:5, 11;39:5;
packaging 1245;
102:15;104:18;105:15,
41:3,14,16;42:6,12;
125:24;131:22,23,24;
21;109:4,24,25;110:8,
43:20,22;45:3;46:8;48:6;
136:5;225:10;226:8,10
12,13,15; 111:8,12,15;
49:13,22;50:13;53:19;
page80:3,6;111:21,22;
112:5,14,15;113:8,16;
61:12;62:3;63:6, 10,17,
212:10;214:19;220:17
114:2,9,13,18,19;
17;64:3,6,9,16;65:2,9;
pages111:18
115:11,15;117:18,24,24;
66:16;67:1;77:11;78:16;
paid 164:17
118:4;119:8,19;120:6;
80:3;81:19,20;82:22;
121:9,11,16; 124:19,23;
33:21;86:2;87:12;88:16;
lain 15:13;19:16;23:12;
125:5,11,18,20,23;
59:22;94:6,9,15;97:3,5;
!6:8, 15,20; 29: 12,15;
129:6,8,13,13; 13O:lO,
?8:17; 99:23; lOO:24,24,
56:13,25; 39:8; 41:6; 46:l;
10; 131:5;133:9;134:11,
25;101:9,22,24;102:6,
‘0:18,24; 73:19; 87:24;
22; 135:25;136:5,9;
19,21,22; 104:11,12,14,
L12:6; 115:8,10,14,16;
137:10,21; 141:l; 142:13,
l5,22;105:3,6,17,24;
12O:ll; 121:17,18,19;
16;144:6,7,9,10,13;
106:3;107:13;109:7,7;
122:12,16,17,18; 137:23;
145:5; 149:s; 150:25;
117:17,17,18,20,21,22;
174:ll; 186~9; 212:14,24
151:3,5,15,21; 153:16;
118:2,4,5,7,12,14,15,
aalliative 14:21; 1152;
154:1,19,22; 155:6;
17;119:5,9,16,21,25;
i23:8;156:25
156:13; 161:4,8,20;
121:10,10,10,11,12,14,
)alsy 6:19
162:5,6,20,21,23,25;
18,20,24,2S; 122:&S, 6,
BaneI 6:1; 19515
163:2; 164:22,23; 165:2,
7,12,16; 124:22; 125:2,4,
Baper 21:8; 135:4
8,19,23,24;l66:3,5,11,
8,9,18;126:7; 127:20,21,
14; 168:22; 172:13,21;
23;128:2;131:7,25;
aapers 94:22; 97:6;
173.9
132:1;133:11,19;134:14;
130:19;162:20
., 23.174.4.1X2
,
-t
.I, 6
82:21;115:25;132:4;
133:18; 158:10;161:1,12;
164:23;165:6;167:4;
169:19,19;171:9;i76:2<;
181:18; 182:s; 187:22;
193:4,14; 223:4; 225:ll;
235:12
: --I.._,.
/I :. .:’ .I
over-thtiounter
73:19
over~waiii’~~~2i.
-

I

P

Min-u-Script@

Miller Reporting

Cornpa

np'

~2&546-6666

Hearing Volume 2
June 27,200O

Fcicd and Drug Adminbtration
Gastrointestinal Drug Advsiory Committee

-

pharmaceutical
9:7;
92:l; 176:9; 209:lO
pharmacies 105:14;
13S:l; 224:13; 227:7
pharmacist 6:16; lOl:l,
4; 171:21; 222:1,2,9,11,
21,25; 225:16; 226:1,4,5
pharmacists
47:lO;
48~5; 60~6; 62:22,23;
63:11,17;68:18; 177:25;
222:19,19; 224:17
Pharmaco~ono~ics
7: 17. :i..-;‘+;;;y/;)’
:.
Pha ymacoepidei%’

logy 7fiy
j.1 .,:y-1.“““:‘df,
“#
:,r:..:@z<...
q.2
ph&~g&[‘,c
20:10 :
ph;a;~iig;~jti.~~,.~”
^
225:15~,“i-~~~~~,~li-“~~~.~~~~ pha”r~6%$+.~t~.%~~
p&Kigtion
34:l$igE~~

6,7; 162:7; 173:17,18,19,
13,20,22; 177:25; 178:9,
20; 176:s; 180:17; 191:20;
10; 181:21,22,23,25;
192:7,9; 193:9,12; 203:4;
182:10,11; 183:11,24;
217:20; 225~7; 234:13;
184:10,23; 185:3; 186:7;
235:19; 239:4,5
187:10,19,24; 188:18,20,
24; 189:1,4; 1$‘2:3,8;
percentage
14:24;
197:10,11; 200:18,19;
111:8; 112:S; 113:4;
201:3,8,12,13; 202:$, 13; 114:1; 160:14; 162:6
204:14,19; 2OS:gl;
.’
percentage-&se
192: I6
207:22; 213:11,16; 217:4,
perception
IS:3
15,21; 218:18; 228~19;
perceptions
23:!2;
229:20; 231:17; 232~4;.
2611; 172:7.
+.:lr, .$,,e?
234:14; 235:s. 19; ‘232.\?2;
Perez
4:5;8;7:6!
6 ’ : ”
239:14;,~~~j~“~~,;~~~~~l~~~~~p~~‘-l~~$~i~~3; 22;gip
pattcirn 2P:4;@; 41:$$
.*;.$9; .109:+&T’i75:4; r&2$, :>$;$y perfectjy.2~;fi~,~~~~~~~~~~
2.&.5;‘23y.,
y“:y,y,.(/ ‘.:,‘&p;t$.-:,*;*+s:
+..>;d:
“-<Qrr,&,< pg*?3&a

4‘

.1~;~~~pattttt~~~~3:1,,,24;
:@@
3~~34XT,~~=g;5tg.s; n~~icy$

a::.173:9;!75:22;
201:16
.T$
i .:$I
.‘,+a,.
.*. ,..‘~~~
‘-iji;;j;cil Iii **+
:s “I.*q>.:I
$.y:z.‘jj
q$$ 39: 10; 74:6; 97:6,7,8;12,
pay 169:‘& i‘&s;
_“.--” ‘.Z 15,25; 103:20; 121:23;
.
.
4i
.
122:5,25; 123:l; 199:20;
204:18
200:20; 206:6,9; 213:14
PDR 9:4; 74:;; 99:7,9; “’
performance
208:12
160:19
performed 36:24; 38:13,
pediatric 6~12; lll:l;
24,25;41:11;42:5;
109:19
144:8; 194: 11
performing
124:8
pediatricians
194:6
Perhaps 8S:S; 90:19;
pelvic 39:8
98~21; 155:10; 172:lO;
pen 127:ll
174:8,12; 17§:3; 182:19,
people 45:25; 7915;
24; 183:10,13; 187:19;
80:14;84:3,11, IS, 15;
188:2; 204:16,23
85:13,14; 88:22,24; 91:2;
pericolonic
97:16
139:17; 144:24; 157:14;
period
29:5,8;
31:s; 43:4;
172:17; 174:lS; 175:16;
52:21,22;
81:17;
82:21;
179:4,8,18,23; 181:1,2,
93:17; 138:16; 153:7;
1 I, 17; 182:19,22; 183:3,
158:23; 176:25; 184:13
14; 187:14,15; 188:10,10;
periodically
53:f 8
189:12; 190:2,8,19;
192:15,24; 198:2,14;
periods 9524
203:13,18,24; 204:1,4,
peripheral 173:2
22; 206:24; 209:18,20,22;
peritoneal 121:19
213:24; 215:12,17;
permanently
82:lS;
217:23; 219:17; 220:4,11,
129:9
12,13,22; 221:18; 224:16;
permissive
180:24
225:5,8; 226~24; 227:s;
permits 227:23
228:5,24; 230~4; 235:16;
236:4; 237:4; 238:24;
permitted 131:21
239:4,13, IS, 16,22;
permutations
227:12
240:2,5
persist 186:20; 221:lO
people’s 196:4
persisted 30:3,10;
Pepto 128:16,17; 160:s
161:13
per 39:s; 43:&l; 73:14;
persists 172:22
99:lS; 143:8; 145:14;
person 159:2; 169:23;
195:7,8; 212:19; 213:17;
175:8,19; 187:lO; 222:2
219:10,10
person’s 39: 12
percent 20:2,17; 21:11,
personal 21:3; 22:ll;
16; 24~8; 29~22; 32~24;
136:6; 199:ll; 216:24
34:23,24; 35:1,3,12,18,
Personally 192:20;
20; 44:10,12,14,15;
202:lS; 242~2
70:20,22; 71:3; 74:3;
84:17;87:1,2,8;90:15,
persons 50:25,25;
17; 109:25; lll:lO,
12,lS;
53:14; 188:lS
112:17,21,21,23,24,24,
perspective
92:23,24;
25; 113:1,1,2,7,8,8,22,
102:7; 110:12; 140:s
23,24,24; 114:7; 129:6,7;
perspectives
114:17
14&l, 2,4; 151:8,10,15,
pertinent
80:4
17,18,19,19,21;
152:3;
PFT96:11;233:8
154:1,3,3,4,4,5;
158:4;
160:24,25,25; 161:3,3,3,
PETER 91:7

Miller Reporting

Company

(202) 546-6666

pharmacy 6:20,24,25; ‘*
53:15,15; 101:2; 104:16;
22514
phase 28~24; 29:2,8,11,
20; 30:4,10,25; 34:21,21;
35:&S, lO,lO, 12,12,15,
18; 53:7,10,12; 65:1,3,5,
6,8,10,21; 69:2,3; 82:19,
19; 84:16;85:18;86:7;
95:9,11; 109: 19; 110:24;
112:l; 115:7,12,14;
144:4; 145:3,6; 146:l
phase-in 78:2
phases 536; 6512; 68:25
phenomenon
146: 11;
154:17; 197:23
Philadelphia
171:6
philosophically
160:17
phone 82:20; 169:23;
240:18
phosphatase
44~21;
118:lO
physical 22:lS; 23:11,
11; 24:4,22; 26:1,7,24;
27:1,4,6; 74:24
physician 7:14; 21:21;
38:4,11,17; 41:17,18,20,
22; 42:l; 53:22; 77:14;
78:16; 88:16; 94:7; 101:3;
102:8,20,22; 127:20;
133:lO; 147:8; 158:17;
165:9; 174:l; 192:9;
200:6,9; 209:4; 219:10,
18; 225:15,16; 234:20;
237:12; 238~13; 241:1,3
Physician’s
9:4; 73:lO;
102:18; 142:8; 166:24;
195:6
Physicians 9:19; 10:4;
11:3; 21:23; 37:13; 48:4;
60:2,4; 63:22; 68:18;
78:19; 79:7,22; 805; 89:7;
92:5,17,18; 98:21; 102:9;
104:14; 131:14; 132:13;
133:9; 14S:ll; 147:19;
16Or21; 173:16,18; 1768;
177:25; 187:16; 190:13;
191:7,10,22; 192:4;
207~22; 208:25; 210:16;
211:20,22; 217:s; 218~16,

Min-U-Script@

16; 219:18,23; 234:23;
237:5,11; 240:9
physiologic
22:20
pick 214:16; 222:s
piece 135:4; 13619
pill 185:20
pills 90:l; 179:5, il, 19;
180~1
pivotal 28~24; 29:20;
144:9
place 58:12;63:12;64:2;

aoints 10:12; 14:20; 89:4;
104:21; 119:4,7; 159:17;
165:1; 198:6; 215:21;
237:21
Politically 192:l
3olitics 12:l
soor 151:24; 190:15,16;
231:13
population 11:13; 21:15;
23:16; 25:6,X2,20,25;
27:5,12; 30114; 31:11,11;
18:15; 50~18; 51:l; 52:19;
53!14,19; 55:!9; 81:lS;
$?5! ii; %kTi3;‘87:2;

w~~“@p;.?“fJ:qA

70:14,19,21;71:4; 93:f
109:23,25; 111:14;
112:14,17; 113:5,21;
160:24; 161:1,7,12;
186~22; 203:7; 205:12
placebo-controlled
31:19; 56123
placebo-treated
34:25;
44:14
plan 13:16; 17:1,6,8,9,
23; 18:5,18,19; 33:lS;
49:9,11; 54:2; 55:4; 57:12;
58:12,19;65:5; 72:3,4;
76:s; 177:6; 225:18
plane 168:7
planned 49:3; 56:9;
58:14;68AO; 182:9; 183:l
planning 9:18
plans 16:25; 177:ll;
226:17
plausibility
145:20
play 8~24
players 227: 14
playing 92:l; 159:6;
182:l
Please 38:19; 164:13;
169:14; 184:17; 207:12
pleased 47:2; 178:22
pleasure 180:8
podium 18:23; 28:3;
46:19;69:18; 115:25;
133:17
poignant 208:24
point 19:25; 40:7; 41:7,8;
79:17,19; 80:8; 81:7;
86:25; 89:1,12; 1156;
117:23; 119:18; 12O:l;
130:4; 135:3; 139:21;
143:4; 162:8; 164:7;
165:2; 170:8; 180:10;
182:2; 188:22; 191:7;
194:14; 19623; 201:7;
202:14; 207:3; 208:l;
211:17; 214:17; 215:7;
216:9; 219:2; 226~12;
227:8,20; 231:23; 235:12;
237:‘1,14; 238:l; 239:2
pointed 81:22; 95:22;
157:3; 160:1

1%

17; 109;3,,11,13; 111:2;
n5:2qi+~,i,
18;
L55:22;‘156:13; f81:10,
24; 188:1-1; i&p!& 16;
190:18; 194:ll; 195:3,5;
203:ll; 21834; 223:21;
228:1,3; 232:11,13;
240:12,13
Population-based
19:25
Dopulations 42:19;
jO:24; 52~20; 57:4,6;
LOO:lS; 108:24; 189:22;
190: 11; 224:4
Jortions 139:25
sortrayed 102:20
Jose 80:21; 114:16;
137:7; 142:ll
loses 142:3
sosition 49:7; 70:s;
237: 17
positive 17:16; 173:ll;
174:l; 180:19; 196:s
Jositron 57:20
possibility 78:4; 129:16;
165:s; 179:3,21; 181:25;
204:19
Dossible 48:8; 50:18;
j1:17,24; 56:6; 65:6; 81:9;
103:18; 139:l; 140:20;
141:2; 147:14; 148:18;
149:lS; 157:24; 173:14;
176:6; 178:19; 179:16,17,
17; 182:8; 186:13; 217:25
possibly 114:13; 188:6;
240:6
post-approval
31:14;
116:21; 117:13; 118:21;
121:4
post-meeting
67:2
postapproval
194:25
postmarketing
14:s;
37:20; 45:20; 143:11,13,
18; 144:3; 145:8,18;
148:ll
potent 28:17
potential 4:lS; 13:7;
14:16; 59:17; 63:14;
73:20; 102:s; 107:7,8;
110:18; 12610; 127:18;
168:12; 174:22; 182:3;
183:18,20; 207:15,18,20
221:14
,

(19 ‘1 pal&n

- potentia

Food and Drug Administration
Gastrointestinal Drug Advsiory Committee

Hearing Vohune 2
Ju&e 27,200O
potentially 11:ll;
1743% 191:6; 203:13;
237125; 241:12
‘E 7:25,25
:rful57:3
1.
Prl229:24
practice 20:15, lb; .,
23:25; 43:l; S&23; SS:2; :’
78~24; 164:19; 189:15,20;
201:16; 210~8; 225:24; .-.
234:18
” ..\.i,A
,..+,.;
..,x.4.:;‘:
practice* 4i:.$g,,,‘yg;g
24; S-1:3;71: 17; l$;,l$;~~
191:~~~?~~~~~.~~~~~~~~~

148:9
prepared 76:11,14;
ls6:4
prescribe 79:lS; 102:3;
191:9; 211:22; 2366
prescribed 9:l; 63:23;
.
127:20,23; 131:14; 154:s;
188~23; 191:19,23; -“-‘;:’
192:12,13; 203:!7,18;
237:3,22; 238:1,9; 240~3
pri+cribe&42~;~,
2,4” :’
-....,,
$I‘,,>.,~.Y
prescri,,&$@&
‘-::,;+??&
‘1$4:22;1 $.#,i,“8 : ‘:;j’$;2;rf&
~~~~~j~~~~~~:~~~

produces 30:l7; 33:3;
preventing 8S:lO;
468; 160:12
225:23
producing
162:13
preventive 210:12
product
5:12;
9:2,23;
previous 5:12; 38~23;’
13:25; 14:s; 15:24; 17:21;
42:11;44:1; 82:5;93:20;
18:9; 476; 63:21; 72:14;
109:17; 112:10; 146:1;
74: 12,22; 76:6; 93:6, lo;
150:21; 198:13
,’
124:1-i, IS; 127:ll; 1376,
previously
16:16; 25:s;
17,24; 138:2,3,3,15,2l;
36:14,15; 59:5;10:14;
139:15; 140:6,14,17;
62:15;64:9;67:17;71:19;
141:3; 142:7; 159:16;
138:4; 200:13 _, “^,lj_._
-.zY*3?.>:-rL$<.
, 193:23,25; 207:17; ‘- 3%
>;..,-,,
price 204: is ’
‘.“’;’ :: &G, 220:20; 223~6; 228~13 ‘:;
priio~~-~‘bl~j ip’~~+$$~
prod~~~~ty
zi’~~~il~~~~

:; ,7.,_;F :y p”“:,:a.>
.:;‘*,...“$+~$
&:&‘f:-, _. ;;,z+;.;;$z +$@j$&

prqarrly
19:15; 2b:2; +g:
practicing 6&;,lk$Q~.
.$jIf~~‘S;;l~& fj;‘$$:i$: $J$$ l,8~i~‘111:;i~“126~i~;~~:‘:.:~-~
.._..’
.
)., 4&<..<&.~
s‘:v _
176..-2‘o.J.3“*i~&.l@.~ ‘<$&;T @i$+
~~;;~~~;&$~;~.ig
.I ‘~.~..^:a.;kg:,r,
i I j .:” ws
193:‘fO, 18,21 .,.$;;,g&-y$$y.
pracf&ioner @~~$$$ikik~, 3a?yFf31 .i: 1$3jjo. *L$Tz;T Prime~~~~~a~~~~_~~~,~,-,
. (. * ,.,*,,.-2.J ..’ _. __ :
62:1~~~~~~~~~1~~~~7;‘~~~- 191:!6; 1”9$:lc$l93:Sj~“-~~
15:11;20:i7,18,19;~
152:lS; ~58:‘!-1::~~~~~~~~ ~194:6;11;‘201:11; 2376,
29:11,12; 33:14;93:14;
practitioners
148;
’i
z-3:
lb; 239:25;‘241:3
- 108:22; 109:22; 112:4,19;
15:14; 4710; 5620; . ’ :;“r pr&rfption
126120; 173:17; 187:7;
53:s; 54:12;
59:20;60:1,3;61:24;62:4,
63:12; 124:20; 134:23;
192:3,8; 193:l I; 2095;
7,18,24; 66:5,21; 67:3;
135:s; 136:12; 137:2;
218:17; 234:22
105:13; 130:23,25; 150~6; 165:4; 166:16,17; 171:3,
principal 91:12; 108~23;
165:22; 172:25
23; 229:9
109:18; 11211; 127:7
pre67:l; 116:17; 118:21
prescriptions
34:12;
print 60:14; 65:24; 66:l;
pm-approval
121:s
40:17; 45:6;60:7;63:3,11,
222:24
19; 7625; 77~2,s; 85:7;
pre-plan 236:24
printed 5:17;9:4;211:1
100:2; 134:ll; 164:24;
precaution 160~9
prior
17:3; 36:16,19;
169:20; 225:s; 22613;
precautions
1266;
37:18; 39:13; 42:13;
229:4
131:2
43:20; 45~9; 52:21;71:14,
present 4:15;9:10;
f-yded
184:s; 208:6
22; 129:20; 167: 15
13:lS; 16:l; 17:6; 18:13,
ldence 78~2;
priori 54:9
17;81:16;84:22; lO2:16;
I, I .25,25
priorities 177323
131:17; 152:8; 224:8
precedent 72:22; 73:6;
priority 13:s
presentation
12:9,10,
75:11;81:1;92:1,7
privacy 147:21
19; 13:21; 14:14; 16:16;
preceding 22:5,8; 185:7
18:20; 28:s; 46:20; 76:9;
private 134:20; 13S:ll
precipitating
181:19;
91:19; 106:13,15; 120:9;
proactive 221:23
182:8
123:6; 156:3; 215:25;
proactively
240:20
221:14; 223:7
precise 85:8
probability
182:18,21,
presentations
12:8;
precisely 237:22
23; 183:s
18:12; 107:5,25; 163:s;
preclude 4:10; 227:2
probably
79:17,22,23;
241:22
predicate 91:15,18
80:7; 88:22; 89:21; 98~2;
presented
3l:lO;
33:22;
predict 178:20; 189:19
114:ll; 164:22; 165:16;
36:8;43:19; 69:21,23;
166:9; 180:7,17; 181:lO;
predictable
11:12;96:21
70:7;71:1,11,24;73:5,
186:8; 190:7; 2oO:l;
predictors 47:8
16;80:24;81:7;92:12;
207:24; 234:22; 235:3
93:4;96:18; 111:23;
predilection
90:9
problem 10:8,8; 1 l:6;
112:10; 131:8; 139:22;
predisposed
18l:ll
83:24; 84:9; 135:12;
150:20;
160:18;
184:3;
predisposes
180:23
165:8; 169:25; 191:22;
186:14; 199:4; 2333
predisposing
120:7;
199:9; 201:23; 205:9;
presenting 75:8; 99:13
206:17; 237124
208:17,24; 222~6; 237:15;
presents 51:16; 221:18
238:7
prednisone 41:20,23
President 58:24
problems 10:14; 84:19;
predominant
8:19; 32:7;
press 130:18
94:18; 106:6; 126:23;
59:14; 71:9; 81:6,6; 83:l;
138:8; 142:3; 187:l;
84:10,10,14,18; 87:21,
Presumably
190:2
228:19; 237: 13,25
23; 106:25; 108:17;
presume 189:6; 209:lS
; 212:13; 213:3
procedure 122:4
presumptive
41:21
sting 39:21;
PROCEEDINGS 4:1;
pretty 134:7; 139:13;
; 179:2; 187:24
163:lO; l64:l; 242:7
171:4; 21O:lS
)r.slace l64:4; 1653
process 10:19; 16:7;
prevalence
20:1,14;
42:13,14; 43:20; 204:6;
preference 232:20
21:16; 190:14; 203:lO
222~2; 227:13
pregnancy 14S:l
prevent 115:3; 123:9;
processes 23:ZS; 28~19
preliminary
96: 18;
137:19; 157:2; 208:lS;
produce 14l:ll
128:14,19,21
209:2
premarketing
1461;
preventable
128~1
- produced 134:24

-

potentially

- psychological

(20)

progressively
174:6
prohibited 35:10,11
Project 55:23,23; 224~24
prolongation
145:24
prolonging
152:20;
153:2
prominence
73:s; 74:ll;
75:18,23; 12621
prominent 75:12

e-U-Script@

p;~~~~~~~~~~6~~~~~~”
s~~i~~~~~~~.~2~~i~~~23~

!35:2b; 137~7~;2;Tz@i
142:f1,24
.x:.:,: 2$2~;
professional
18:3; 20:7;.
60:24; 124:21; 12S:ll;
126:1,2; 134:lS; 139:6,8;
209:9; 222:4; 231:23
professionals
60:24;
64:10;67:21; 68:19,24;
69:lS; 101:12; 10217;
105:21; 124:19
professor 7:25
profile 9:12; 1l:ll;
14:lS; 15:19; 17:lS;
47: 13; 49: 10.17; 58:7;
72:9; 75:22; 76:4; 84:25;
107:2
profiles 70:13
profound 172:8
prognosis 8l:ll
program 11:21; 17:4;
18:16; 29:2,11;34:9,9,
21; 35:&S, ll,lS, 18;
36:3,10; 40:6,10; 47:1,3,
5, lo, 12,15,17,22,24;
48:4,5,9,10,12,
IS, 25;
49:1,19; 50:3,8; 51:s;
54:1,16; 55:6; 56:11,17,
18; 57:6,12; 58:5,6,17,
19; 59:6,8,9,11,25;
60:13;61:6,10,11,12,15,
16,20,21,22,25; 62:1,2,
18,21;63:2; 65:1,4,22;
66:24; 67:23; 68:2,7,11,
12,13,14;69:10, IS;
7l:ZS; 72:6; 77:21; 79:6;
82: 19; 84: 16; 86:8,16,24;
90:15;91:17,18,20,23,
24; 92:14,14,16; 98:8,9;
102:17; 104:13; 105:9,10,
12; 123:25; 131:12; 133:7;
135:12; 177:8,15; 19O:21;
203:2; 207:ll; 209:12;
211:11,18;217:1,8,13;
239:6; 24l:lO, 11
programs 60:11,15;
67~3; 124:s; 130:15,24;
131:4; 207:18; 216:23;
219:13; 220:3; 2364
progress 175:25
progression
115:3;
123:10, IS; 138~7; 146:7;
156~22; 157:2

Miller

Reporting

promptly 221:ll
proof 179:22; 182:G
propagate 11:24
proper 59:18; 89:ll;
92:22,24; 138:14; 140:23;
196:20; 208:14
properly 203:16
proportion
115:4;
127:18
proposal 18:3; 161:19
proposed 9:2; 16:3;
17:18; 18:4;37:12;49:19;
60:6,20; 75:14,21; 79:s;
82:8; 87:17; 95:9; 210:22;
225:12; 232:17
proposing 75:16,19;
102:17; 188:4; 231:1
propria 120:22
prospectively
32:17;
93:16
protection 223:14
protocol 50:14; 56:2,25;
57:22; 204:23
proved 126:18
proven 28:20; 99: 11;
103:4; 179:lS
provide 13:17; 1S:lO;
18:14,18; SO:& 53:24;
56:19; 63:9,17; 64:8; 67~6;
142:12; 174:21; 176:16
provided 4:13; 9:6; 18:2;
63:12;65:16;66:21;
124:18; 22412
provider 147:8,11; 211:2
providers
126:22; 13S:l;
145:12; 147:18,22;
154:19; 155:14; 241:9,16
provides 15:s; 17:25;
57:7; 65:3; 71:7; 73:25;
75:22; 217:lS
providing
142:9,11
proximal 41:lo; 199:l
Prozac 160:~ 3,4
psychiatrists
167:7
psychological
22: IS;
172: 14

Company

(zO2) 546-6666

:
-;’
f@-Y

Hearing Volume 2
June 27,200O

Food and Drug Administration
Gastrointestinal Drug Advsiory Committee
214:21; 215:20

psychosocial
231:s
public S:4,18; 8:13,1S,
il; 10:4,12,19,20; 12:12;
19:4; 131:5; 134:5;!37:*t;
7~22;.

Iradiographic
Iraise 176:16

19:22

raised 89:4; 100:5;

randomized

56:22;

1
,

;)ursue 182:25
pursued 209:5
purview 228:20
push 194:15; 220:21;
234:21; 236:7; 237:5,10;
239:17
put 82:23; 83:16; 89:17;
92:21;94:5,8; 119:9;
127:21,22; 142:14,22;
155:s; 1577; 165:12;
1665; 170~7; 202:9;
213:6; 2265; 228:17
putting 89:9; 211:9

Q
QT 145:24; 152:20; lS3:2
qualify 126:15; 167:21
Quality 15:9; 21:5; 22:13,
18; 23:1,2,8,10,18; 24:6,
23; 25:s; 27:2S; 28:7;
46:17; 7O:l; 135:9; 174:25
quantify 47125
quantitative
68:23; 219:8
quantities 63:9; 6418
Quarterly 49:2; 54:18
quick 87:16; 142:lO
quickly 143:16; 186:4
quite 8:20; 91:9; 175:7;
185:5; 208:22
quoting 754

R
race 21:13
Racelethnicity
144:23
races 144:24
Raczkowski
106:14,17;
123:22; 133:20; 138:5;
143:5; 148:14; 156:7;
157:7,12,19; 161:25;
162:1,8; 198:10,12;

~,~,9;io;~~j$&;~,~4; T*
24~12 "I';,~;~;;;-.~;;('
!cQ'~

i45:2; 13; 202:25
rash 41:19
rat 96:1,1
rate 21:16;40:7,11;
84:17; 160~24; 201:18,21;
202: 16; 203:3; 2264;
233:s
rates 22:6; 42:21; 45:17;
53:12; 54:25;70:14;
127:6; 162:3; 193:5;
194:17; 236:5; 237:13
rather 19:2; 33:25;
113:14; 133:24; 165:2S;
172:17; 173:12; 182:5;
223:lO
ratio 46:lS; 115:20,22
rational 28:20; 191:5
rationale 139:18
re-anastomosis
97:14
m-labelings
150:s;
154:20
re-prepped 36:23
re-review 9S:23
reach 69:lO
reached S2:8; 72:15;
238:22
reaction 127:17; 146:lO;
148:s
reactions 126:10,11,13;
127:5; 128:l; 131:18;
148:3
read 920; S&20; 94:23;
97:6; 140:9; 169:3,4,S,
10; 213:4; 214:18,20;
218:5,22,23,24; 221:4
readmitted 38:18,21
reaffirm 233:16,22
real 10:3; 5O:ll; 76:l;
167:21; 191:22; 198:22;
201:23; 218:10,25;
237:12
real-world 864; 88:23
reality 12:4
realize 925; 204:20
realized 133:7
realizing 9:21
- really 791; 80:4,6,14,

MiillerReporungCompany

L8,19; 82:25; 83:lO;
?8:25; 89:9,10; 9O:G;91:9
37~20;98:9,11,14,19,22;
100:21,23; 1Ol:lS; 140:4;
147:13,21; 148:4,5,16;
154:5,7,18,21; lS6:3;
166:18; 170:12,25;
178:18; 181i7; 182:20;
183:22; 188:21; 196:4;
197:lS; 198:3; 199:6;
200:19; 204:7; 208:ll;
209:1,17; 21016; 211:lO.
22;214:18;216:25;
/
217+,53 22; 22724; ,:
21~2, qis; 2199x2;‘
,:.
22010, f4f222.19; 223+$
229.115,$( 230:22; 23x:3

(202)546-6666

reams 162~20
reason 65:2;78:1,11;
79:8; 134:8; 146:17;
209:7; 227:lS; 238:24
reasonable 126: 16;
178:3; 186119; 192:20;
195:22; 206:9
reasonably 54:8; 141:2
reasoning 160:20
reasons 139:16; 189:13;
197:2; 208:2
reassess 204: 14; 205: 1;
236:4,23
reassurance
197:lO
reassured 197:12
reassuring
130:4
recall 15:22; 82:19
receive 60:7; 64:20,22;
95:24; 145:11,14; 174:4,
6; 176:3
received 13:5; 14:12;
16:6,8; 17:16,21; 38:6,
19; 84:24; 107:l; 129:7;
144:22; 150~2; 151:15;
152:12; 168:13; 170:19;
191:23; 225:8
receives 132:l
receiving S:8; 52:7,16,
20;56:12;63:11; 11O:lS;
117:2S; 201:14; 234:14
Recent 1O:lO; 18:4;
73:12; 135:s; 173:15;
175:25; 183:11,14; 213:3
20
recently 9: 16; 20: 12;
32:s;49:8;71:2,17;74:1<
78:21;94:9; 135:7; 171:2,
6; 172:24; 183:21; 191:lG
208:13; 214:4
receptor 28:17;96:17
receptors 28:18; 94:24;
95:1S, 17;96:19
recess 106:12
recessed 163: 11
rechallenge
146:ll
recognition
637; 6617
recognitions
61:14
So:1
I recognizable

Min-U-S&p@

155:24
*eflected 75:4
eflection 14:9
reflects 220:23
reflux 2S:13
reformation 203:22
refugees 174:15
regard $9; 15: 19; l&4;
57:17; 1466; 154:9
regarding 13:17; 15:24;
16:23;72:1+73:4;74:11;
76:15;?:,16;78:19;
109:2@?&43:25;
i45.j@@0;.~52:9;
155:rgiij~-:lO.,,~~~~~~~~~~
182:1S;‘l8%~2~2Oi:6,12;
"
',
-PI:::
ST&‘,
SC+..
r~~~~~~~~;s:~~~~~~~~~ &@$2~;ii$;‘2~9:15~
23gi4.y !~~&%f$@):i ,.
y9:25gg&.$
(qj;,
.,“-“^&!*,.,.3L-...
1,j&l(i; 15f:~2,~$‘~“~*+~&+. reg%&ss,,2j
1:4
154~23; 204:23; 205:3
region 43i25; 44~2
recommending
230:4;
register 6S:lS
234:17

registries 187:18
reconcile 82:22
regulate 189:14; 190:25
reconciled 33:18
regulated 4:14; 241:5
reconvene 236:3
regulation 106:l; 137:s;
139:23; 140:2; 141:13,18;
record 4:lO; 5:2,6;
223:13,24,25; 224:14;
103:4; 149:s; 1561
225:2,7; 227:23; 231:20
records S1:14; S5:7,18;
regulations
135:20,21;
103:22
138:23; 141:22; 231:22
recovered 37: 11
regulatory 226: 11
recruiting 84:22
reign 242~4
rectal 119:18,20; 12O:lO
reiterate 183:9; 241:s
rectum 98:l
relate 57: 13
recurrent 20:5; 87:24;
related 13:22; 16:14;
212:14
23:1;2S:5; 28:7; 36:l;
recurring 146:13
37:17; S8:7; 74:18,24;
redesign 65:s; 236: 15
7S:1; 85:15; 86:20;
reduce 207: 13
104:20; 108:3; 113:ll;
reducing 50:4
158:21; 177:2; 185:15;
reduction 30:21; 56:2S;
188:l; 201:s; 222:6
78:9,16; 154:7; 241:lO
relating 83:4; 103:7;
redundancy
12:15
104:7
reemphasize
220:9;
relationship
126:17;
221:zs
129:4,18,25; 130:9;
145:19; 169:ll; 170:3;
reenforce 6l:ll; 63:5,
174:1; 188:7; 199:22,23
23;64:15,21; 67:7,24;
1OO:ll; 105:9; 134:13;
relative 16:12; 8O:lS;
220:6
138:l; 233:2,6,11
reenforced 61:8
relatively 14:23; 70:6;
12S:19; 162:7; 183:15;
Reevaluation
106:16,
184:13; 203:2
20; 107:2; 10&l
relaxed l66:8
refer 117:8,14,17;
126:23; 136:13
releasable 5:19
Reference 9:5; 104: 11;
release 185:2
105:6; 140:17
released 207:3
referrals 89:6
releases 13018
referred 60~13; 67:17;
relegated 152: 2 1
70:5; 118:22; 162:ll;
relevant 35:9; 62:8;
210:24
160:6; 184:21
referring 118:2,3
relief 8:18; 29:12,13,15,
refilled 166:16
22; 31:24,24; 32:1;70:18:
refills 77:1,5; 166:14,15
93:14,17,18; 112:5,7;
161:12; 162:12
refine 53~7
remain 136:l
refining 56:2
remainder 30:3
reflect 17:11;81:16,17;

ecognize S9:21;76:10;
L25:6; 147:8; 209:10;
127:2,23; 229~17
ecognized
34:17; 43:s;
73~22;74:2,21; 175:24
recognizes 143:9
recognizing
137%
recommend 15019;
.189:s; 221:12; 236&l, 3
recommendatjon
13%
187:25; 191:25; 194:13; ._
” ..... t<:.j,,-* ,. ,.i
1 “T$;‘;;
23x9
-+*‘-.-: ‘.;. ..“-?;$&:
. ,:,“”
rec~~&ndation*
“?$&~
s ‘rj ,...>* ;“y$*CL+
I
$~;~Jr~gq$yjyj~;
:;<$%g;

(21)

psychosocial

- remainde

Food and Drug Administration
Gastrohw&nal
Drug Advsiory Committee

Hearing VObme 2
June 27,200O
remained 3O:lO; 3S:22
re&aining 24:5,24; 26:2
ins 17:lS
rk 195:14
:
rkable 749 . ,,/ :. __
remarks 18:21
:::
.I
remember 130:q”‘y;

58:22;60:17; 66:3; 67:12,
14,19; 7612; 219:4
represented
30:1;40:12,
19; 58~8; 162:3
representing
103:17
represeib
.,i514;;iij:ibi

response 16:21; 47:20
66:4;70:14;81:11;96:2~
21; 112:17,18,20; 113:!
162:3; 163:7; 177:20;
178:7; 204: 10
responsibilities
180:8
responsibility
10:16;
45:s; 47:22; 48~24; 5o:ll;
55:9; 160:25; 204:2
.. 59:3; 176:7,10,14
l4:9: 47:C
reproduced
ii625
_i responsible
59:i; 141:8,13; 18$:12;
,- 224~24
;.,I responsfve l&:6 *’

16O:ll; 193:lO; 2!,?:6“ .;
remind 63:16; 123:12 “‘y.’
reminder 62:x ij”&$ i;i’; ”
l2738,9; l3l:l9,20
::‘ ‘;&
I..o,.,t-. :p&&
$‘-;‘8S’,?~~~i,~~,~~s:l;zzl
reminding 123:7 &,?j:&,
_,,.$:,,*,“.*:;$&y.$‘i
$L::
,:,,
_i
remiss 5:25 ~-ic~~$$p~%g~~
; +& ,:.., *,&!g$&&~.~&<;
+y!$$!;;j
!;.Y;; :i
%$
“- restarting 146:10,12
removed7~:21;j22:l;;
:.=‘:‘.<
e..:,y,i?.i<
j.:’,;;;ye+b;*+r ,
,i r&~a;ii;lnQj~y+~~y&
19~?~~~~~~~~~~~~~.~~~~~~.~~~~~
__*,,
,* -**T1>‘.jf-.
I &“‘z$d
restrict 182:i2 1 :‘ry”
remuneration
l&4:14
YB
i_ :;%,$::.:..;~.p>~:*~~~q,$
&&
renal 2514; 26:14,~7;‘%‘G
restricted 84:3; 124:5;
27:8;70:2;1-18:6;‘122:2
’ required 17:12; 36:20;
131:13,23; 132:3; 194:?
rep l&: 14; .$iy;:‘pp;;
43:24,2S; 74~7; 117:1,2,
238:9; 239: 13
3,4,6,7,10,14;
118:22;
169:&211:18,21;232:14
restricting
192:18
121:5,6,10; 122:24,25;
repair 42:12; 122:5;
restriction
131~6
123:3; 125:12; 126:25;
123:l
restrictive 228:9
128:4; 132:7,8,10;
repaired 97:7,12,17
resulted 17:7; 21:17;
135:20,25; 136:3,2l;
repeated 54:lS; 154:lS
74:16; 128:23; 130:2
137:6; 141:1S, 19; 142:15,
20; 147:13; 225:6; 22615,
repetitive 69:3; 104: 17;
resulting 37:23
1s
105:16
results 23:2; 29:2,19;
requirement
7S:ll;
replacement
119: 12;
31:9; 32:20; 109:24;
136:2,22; 141:21
113:6,20; 143:23; 153:2
135:24; 136:4; 181:8,14
205~7; 225~3
requirements
135:22;
138:22
resume 31:8; 106:ll
requires 137:12; 141:7;
resumed 30:25; 35:21,
163:l; 200:5,6; 223:9
23
reply 65: 14
requiring
42:lS; 199:13;
retail 60:6; 62:22; 105:l
report 10:11;86:11,24;
223:5; 225:2
retinopathy
24:lO
87:7; 89: 16; 150:3;
Research 4:15;7:11;
return 108:6; 2OS:ll
157:14; 160:1; 206:10,12;
14:4; 17:2; 47:1,19; 49:15;
231:17,18; 24O:ll
returned 30:5,11;41:11
50:8;
S2:24; S3:1,3; 5512;
reported 4:14; 5:4;
18
56:ll; 66:6; 68:19,20,23,
23:17; 24~6; 26:10,20;
returns 38:16;41:22
24,2S; 69:3; 7212; 94:19;
32:17; 35:2,4,19; 36:1,2;
reveal 71:18
101~19; 103:2,8; 104:6,
38:3;39:4,6;41:13;71:14;
revealed 38:22; 39:l
25;
139:13;
164:20,22;
94~24; 128:20; 129:12,20;
165:23; 170:s; 227:2S;
reveals 422
146:lS; 147:12,17; 158:4;
230:17;
231:12
reverse 182:22; 183:5
160:8; 163:2; 181:13
researcher 231:7,8
Review 623; 13:5,6;
reporter’s 14621
resection 42:6
17:14; 18:14; 19:3; 33:6,
reporting 16:ll; 48:22;
reserved 13:6
25; 36:7; 37~20; 40:1,22
119:3; 145:9,10; 147:6;
4414; 49: 16; 54: 17; 99:7;
residents S5:24
218:7,12; 235:21
123:22; 143:20,22; 144:
resistant 79:24
reports 1O:lo; 16:8,10,
145:17; 156:2; 181:3
15; 34~24; 36:14; 39:19;
resolve 215:ll
reviewed 9:s; 74:l; 80:
40:4,9,10,18; 41:12;
resolved 186:3; 213:5
reviews 49:2
45:21,25; 46~4; 71:16,20;
resolves 199: 17
72:17;78:12;86:16,17;
revise 63:21
resources 21:21,22
87:7; 107:l; 128:19,21,
revised 60: 14; 66: 15;
22; 129:22,23,24; 130: 12; respect 5:3,10; 39:16;
82~2
41:23; 43~14; 81~24; 89:12
144:23; 14S:ll, 14;
pevision 47:12; 210~6
*espond76:11,14;
146:23,23,25; 147:l;
revisions
60:20,21;
100:4; 113:4; 114:lS;
152:12; 188:24
H:23;64:1
lS8:24; lS9:l; 161:17;
sent 13:7; 18:s;
revisiting 159:12
162:2; 210:17
.7; 99:2; 160:13;
revolution 221:16
162:lS
responded 1 l3:4
revolve 108:23
representation
75:21;
responder 32:16; 93:15,
131:18
15; 161:20
Rhode 148:2
representative
617;
responders
108:2S;
rhythmic 96:7
118:25; 19S:lS
111:5; 114:23.24; 115:22
Richard 616; 12:17,24
Representatives
5: 1S;
responding
109:25
- 164:12,16

\

remained - sample

(22)

Mill-u-script@

road 220~14; 236:22
robs 172:17
robust 33:4; 46:9; 70:s;
71:s; 103:2
Rochester 55:22
rodents 197:21
Rodriguez 108:lO;
143:12,14; 157~3; 162:18;
235:2
:.
role 8:24; 23:12,13; 26:7,
9,16,21; 182:l; 211:18;

richest sS:9
rid 84:14;85:10
right 4:4; 29:21; 37:s;
41:20; 69:12; 85:s; 103:l;
134:l; 14O:lO; 1563;
182:13; 187:17,22;
192:ll; 193:9,13; 194:23;
210:11,21; 213:3; 22O:lS;
226:19; 227:21; 230:13;
232:13; 235:21; 2368
rigid 237~6
-..1
rigorous !78:!8

221:25.;:.~;~~~,:~~~~~~:a.

&j;r g&z& 95:3: ’ : -y

rise 7~~:~:~~~~~~,~;:_;~~~~
r&$:,5;17;9:13,1$,,J~~
,;’
$l,q, -l-gqqI$ioj,2L;+$
21,22; i2:qH;15,2?;,,
2;;
16:23,24; 18:5; 16;18;

33:15,25; 46:20,21; 47~2,
22,24; 48:1,3,12,20,25;
49:12,18; 50~15; 51:1,7;
52:15,17; 54:2; 5S:5,16;
56:6,6,17;57:ll; 58:5,
19; 59:s; 68~10; 69:8,9;
71:25; 72:2,6,10; 765,7;
79:13,19;80:14; 82:7;
57:13; 91:17,20,22;
92:14,15;98:8; 107:9,11,
r6,17,20; 108:6, lo;
109:4,7; 110:12; 120:6;
123:20,23,24; 124:3,9;
126:4; 128:12; 131:12,22;
132:lS; 133:5,6,8,1S;
134:9; 135:12; 143:10,12,
13,19,20; 144:l; 147:3;
148~18; 149:1,8,15,18,
22; 150:9; 152:9; 1 54:1S,
23; 155:18; 156:13,16;
157:3,5; 164:8; 171:13;
177:4,6,15; 178:9,13,18,
20; 179:4,6,8,14,16,18,
19; 180:4,11,12; 181:1,5,
14; 182:19,22; 183:4,8,
23; 186:17; 188:1,11,13;
189:19,23,25; 190:21;
195:1s, 16,22; 196:11,16,
17,20,24; 197:3,12;
202:12,12; 204:3,4,9,11,
22; 205:lS; 207:11,12,13;
211:13; 217:l; 221:18;
I
223: 10; 224:9; 230: 11;
231:5; 232:2; 234:9;
237~24
risk-benefit 46:lS; 92:9,
10; 106:6; 128:lO; lS7:22;
159:25; 196:7; 202:6;
203:17
risk-benefits
203:20
*isk-management
130:14
?isks 9:1l, 14; 10:5;
13:18; 47:8; 48:l; 50:4;
58:lS; 72:&S, 19,23;
>2:22; 107:8; 110: 17;
114:lS; 125:6,7,21;
130:20; 132:24; 138:l;
139:14; 140~25; 176:ll;
179:l; 191:8; 196~10;
221:2,14

Ron@$$T%3;8;
-,* ”
8’71iqms);
lp:$&k;,
171”~‘~~.~~~~~~~.~~~~~‘.
R~$&F$$:
?$&g$$‘:, : ”
room
4:21;1s~~$PF39j~
_j
:. ,.&&&L~?.CT*..
. *,
Rosemarie 76: 16 ^’‘P./S‘,
Rtise&@“~~~~~~~..
Rossiyn 6:21’
Roughly 20:2; 112:17;
128:18
round l95:9
route 91:3
routine 225:24
rudely 164:lO
rule 37:l; 141:7; 142:22;
173:12; 181:25
rule-out 38:14,18
pun 111:9,2S; 124:ll;
169:24
run-through 87:17
running lS8:3
rush 30:20
s
J3830011 32:5
safe 8:23;9:1,25; lO:l, 2,
7,14,25; 12:3; 13:2S;
16:19; 17:23;69:16;
75~23; 137:9; 173:23;
184:13; 234:17
safely 79:15; 219:19
safer 132:4
!safety 9:lO; 15:19; 16:6;
18:lS; 28:8,14; 33:7; 34:4;
46:6; 47:19,20; 48:6,21;
49:10,20; 54:20; S6:12;
S7:3,8;58:11;71:11,20;
75:12; 84~24; 86:7,14;
103:7; 107:l; 108:3,19;
126:lO; 127:12; 143:11,
13,19; 155:7; 177:13,18,
21; 189:15; 194:16;
214:13,14
sales S9:2; 60:16; 6613;
57:11,14,19; 131:7; 155:9
same 15:23; 22:l; 25:15;
13:25; 83:21; 91:3; 99:lO;
100:7; 121:8; 157:Zl;
160:19; 171:ll; 188:12;
193:17; 229:l; 23S:lO;
238:14,17; 239:ll
!sample 56:5; 63:22; 64:2,
1

II

Hearing Volume 2
June 27,200O

Fucd and Drug Administration
Gastrointestinal Drug Advsiory Committee

:

226:1,11
112:2; 113:6; 115:3;
service 228~18
sector 134:20; 135311
119:8; 120:17; 123:9;
single 46:3; 89:18; 153:s;
services 1 s5:24
Security 167:16,20
139:13; lS7:2; 180:12,13,
l60:14; 162:12,14;
session 28:10;43:11;
seeing 83:lO; 100:15;
21;
186~2;
197:23
169:21; 174:9,14; 231:6,
l63:2;-197:6; 201:19;
46:18; 209:20
13
shows
44:16;46:15;
237113
set 5:20,20;73:1;94:11;
sit 102:18; 158~9; 237:14
69:25; 70:17; 96:19;
117:5; 195:22; 201:19;
seek 229:18,20
112:24;
174:25;
228:
1;
site 153:17,19,19,20,
230:22; 235:24
seeking 174:15
239:6
25; 154:3,4; 155:20,21,
set-up 190:15,19
seem 99:5; 196 16;
21
shut 175:ll
setting 20:17; 37:13;
21O:ll
sites 131:6; 153:6,11,18;
sick
185:ll
50:11;90:11
seemed 170~10; 198:13
154:ll
_
side 11:ll; 129:5; 141:3;
settings 24: 1
seems 98:4; 104:24;
171:15,19;
182:13;

:
seven 24:5; 2612; 29114;
180:3; 182:20,24; 205:25;
210~11; 221:9;232:1;.
-24;
237:14 ‘z f&J.; >,..$ &+z;;+ 53:4; 86:23,25587:3;
95:18; i58:23;
j.. .~iJ,;aF,
“.<‘Y..
pi’ ‘~2.;.:;, “?A;,
a_~zg~.*~‘
234:6; 2358 ; ,.‘~~~~~~~;~~
128:23;15&2;‘1~6363:2; :
196I2; ;2&;25~*208;9{ $$
c.,:j ,=. ,&2*t.,.,y;r
ygy;
19e24
si&j-‘2m
1 ;ygpp;~
t&@$p~p,;,w
I’<?“k$.
;::~.~i~~~il’fjl~~~,8’;2~~:2ri.
$2.:,,>R&
,e,*.
7 :;&_*.:;/
‘seg~~ts,~~~~::~~~~~.,‘~~~
< + -~<:.-“:&< <,;.p;.Y;.
seven~~191:2a‘.“~~~~,~~,~~
p&.x~
,yg5:z24r
1
:,;.
:
,_,
‘~;~~2~~~g~~~~‘L38:12, J&17;
SIEGEL’&i; 2;201:5,,GW>,;
:; ‘<CC
b”&$ .~i P;)‘.“G‘(.
sev&i;ai
@~~g4:
ii;
.L.’
:
;:
-, .23?:3.~:~~~~~~~~,~~~~~~~~~ ‘;iei~teiii 25:7; ld3:~’
237:1;20;“238A~~ 20.‘;‘+;;
’ SC& 26,25 ;;+;;-+&q~@t
39:5; 78:14; 107:S, 25;
sig 162:22; 16331
.:--)__
; ..y : ::,-~“~~:~~:::L.~~~~::~.5~~~,
selection 48:7; 49:23;
119:7; 124:3; 128:22;
sciiies 23:17; 24:5,!4,
sigmoid 39:2,2,9, ld;
61:13; 62:3; 63:6; 64:16;
size 90:19; 1052; 139:22;
131:9; 144:15,15; lSO:5,
24; 25:22; 26~2 I ~+;,“i‘-97:s; 121:23; 122:5,25;
66116;67:1;69:13;
2262
5;
167:7;
184:23;
185:24.
scan 38:12,23; 39:s;
200:23
lOS:17; 110:20; 128:2
skeptical 15:14
severe 25:12; 80:16;
41:8;42:2;96:11; 120:13;
sigmoidoscopies
selective 28: 17
82:3,4,5,9,18;
83:13,18,
skiing 170:15
186:3
162:21
self-limiting
40:19
19;85:11,21;88:2,8;
skin l68:4
scanning 57:20
sigmoidoscopy
198:23
self-reported
22:22;
94:10,13; 98:5; 115:7,10,
skipping 198:6
scans 233:9
sign 10025; 101:8
24:16; 26:10,15
13; 144:13; 166:6; 175:15;
sleep 175:22
scenarios 2204
200:13,1S, 16,18; 213:ll;
signal 17:16; 45:16;
sell 228:13
Slide 12:23; 13:1,13,19;
schedule 12:11
214:23,24;
215:6,13,22;
71:12,20; 99:3,5; lo4:6;
selling 222:4,6
14:13; 15:18; 1620;
216:1,2,7,10,12,15;
Schoenfeld 73:12
148:
16
send 60:23; 92: 17
17:13; 18:lO; 19:8,12,24;
221:14;
235:16
school 6:24; 7:19; 8:s;
signals 47:20; 54: 15;
sensation 30:20
20:8,13,23; 21:6,2S;
severely 25:24; 88:9,16;
22:5,7; 27~21; 176~8
145:13
22:10,17; 23:5,19; 24:12,
sense 19:17,19; 22:16;
l15:16
schools 624; 171:7
significance
93:s
18; 25:1,10,18,23; 26:4,
91:9; 134:lO; X78:19;
severity 16:12; 33:17;
science 22625
significant 13:7; 17:7;
23; 27:9,15; 28:11,16,22;
208:2S; 210:2,3
35:3; 40:13; 43:16; 46:12;
27:16,24;
29:25;
30:3,8,
29:10,18,19; 30:15,18;
scientific 47:7; 49:17;
sensitivity
189:25;
71:14; 82:14; 120:14;
9,22; 31:4,5; 32:21,22;
31:1,7,12,15,23;
32:4,
55:17; 58:13; 101:17,18
190:15
128:2; 196:l
467; 69~4; 70:3; 73:11,13;
10,19,25; 33:s, 11; 34:3,
scientifically
139:5
sensory 28:19
sex 144:20
74:4,16;76:3;93:11,13,
14,20; 35:14,24; 36:6;
scientists 176:19
sent 80:9; 1SO:6; 192:5
21; 137:s; 142:ll; 161:12;
sexual 74:19,25
~7:19;39:15,25;40:3,15;
scoped 77: 12
separate 24:20; 61:16;
162:19; 180:22; 186:23;
12:17; 43:6; 44:3,6,19,
SF-36 23:7,7,10,16;
score 27: 1,2,4
150:24; 153:6,21; 189:25;
18S:lS; 225:12,13
22; 45:2,14,19; 46:S, 11,
24:16; 25:6,11,21,22;
225:19
scored 25:21; 26:3,7;
24; 47:4,21; 48:2,11,19,
significantly
20:6; 22~6;
26:2; 27:l
27:3,11
23; 49:5; 50:6,19; 51:4,
separated 104~5
23:18; 24:6,15,23; 25:22;
shaky 197:lO
15; S2:4,13,23; 53:15,23;
26:3,21;
27:3,8,11,13
Scores 23:8,9; 24:17;
sequelae 16: 15; 40: 13,
shall 236:3
55:13; 56:16; 57:lO; 58:4,
25:2S; 26124; 27:1,6,10,
20;43:18; 50~3; S1:21;
signing 102:l
shape 238:5
20; S9:4,10,23; 60:9,10,
14;89:1S
71:16; 84:19; 88:3;
signs
5921;
61:14;
63:7;
share 1625; 43:12;
18,25; 61:S, 9,19,20,23;
123:lS; 130:2; 156:21;
screen 140:25
66:17; 101:7; 118:3,7;
94:14;97:19; 176:9,13,19
62:16,17,20; 63:20,25;
157:lS; 160:8; 213:12
121:16,20; 137:22
screening 29:5
64:1,11,12,17,24,25;
shared 176:7
sequence 37:12
Sildenafii 74:13,20
scrutinized 44:7
65:7,20,23; 66:8,13,19,
sheet 22S:lS; 229~7
series SO:20; 146122;
silence 178:13
seated 168:8
23; 67:6,9,13,22; 68:3,8,
shelf 226:2
234~2
9,16,21;69:5,22;
70:16,
silent 104:3
second 14:6; 16:6; 36:18;
shopping 168:5; 169:25;
serious 16:15; 17:17;
48:3; S3:2; 55:21; 57:lS;
17,25; 71:10,23; 73:8,15,
similar 5:22; 24:4,14;
22S:4
33:19; 35:2S; 4S:21; 47:8;
109:5; 111:4; 113:19;
16,24; 74:9; 75:3,4,25;
25:19; 30:6; 31:3; 38:17;
S1:21; 69:25; 72:17;
short 95:s; 183:lS
76:s; 93:6; 106:22; 107:4,
118:5; 121:14; 122:2S;
42:19; 45:17; 51:20;
73:20; 7414; 86:lS; 97:24;
24; 108:5,9,14,21; 109:1,
shortcomings
101:19
13612; 137:2S; 151:2;
55:14; 7O:l; 109:24;
99:2,23; 103:19; 106:6;
9,12; 110:2,22; l11:3,6,
152:s; 153:13; 155:19;
111:20,24;113:20,25;
shorter 80:7
108:4,116:1,3,7; 117:13;
16,17,17; 112:2; 113:lS;
159~5; 162:l; 168:4;
137:3
shortly 57:17;80:1
118:20; 121:12; 126:9,11,
114:4,12,25; 115:6,13,
181:4; 185:14,23; 203:21;
Similarly
109:5;
112:23;
show
27~2~24;
32:20;
12,16,24; 127:3,4,18,
226:12; 23618
18; 116:4,9,24; 117:11,
114:20
44:14;70:14;96:6,16;
25; 129:12; 130:1,5,11,
16; 118:1,18,24; 120:8,
second-line
lS2:21
simple
80:2;
133:8;
180:25;
181:13;
203:l;
20; 132:5,9, lo; 137:7,19;
16; 121:2,7,14,21; 122:3,
! secondary 20:19; 35:13;
139:l; 144:6; 171:12;
206:8
13&l, 8,12; 142:ll;
9,13,21; 123:S, 11,21;
3715
217:22,25; 23612
showed 71:3; 1358;
148:3,11,12,19; 149:9;
124:1,10,2S; 125:15,25;
Secondly 64:5; NO:4
136:3; 148:3; 155:19;
lS7:lS; 172:5,16; 174:18,
simpler 80:7
126:8,14,19; 127:2,13,
secretary 4:s; 7:6; 171:7
21; 198:16; 199:12,19,25;
205:lO; 235:2
simplicity 98:16; 1OO:lZ;
24; 128:8,2S; 129:lS;
200:3,8; 201:1S, 18
showing 30:12;44:11;
section 74:23; 75:19;
215:17
130:7,13,21; 131:3,10;
162:22; 205~25
87:19; 126:5,6,6; 1406,
seriously 172:23;
132:17,22; 133:2; 134:6,
simply 42:21; 50:9; 80:9;
9; 159:23; 214~22
174:23; 223:5
16; 135:13; 137:1,14;
89:lo; 113:7; 115:ll;
shown 19:2S; 28:18;
I 138:20; 139:ll; 140:1,19
I 127:lO; 139:14; 183:3;
sections 126:2,9; 228:6
seriousness
199:24
29:19,20; 30:18; 70:9;

1;

3,8,10,18; 65:9; 90:19;
104:14
samples 27:6
San 620; 7:24
Sandy 169:14,1S
sat 170~24
satisfactorily
162:15 .’
satisfactory
207:6;

j ,l.-2:,
215:3
^.,.:.:r.,
saw 42~24; 90:24; 94:21;
202:18, 19 .,): .i’;, ;-.:‘;.
say,ng &iJi; &$g; “‘;-;-

it++; ‘;:;::.I

Miller Reporting

Company

(202) 546-6666

Mb-U-S&p-

(23)

samples - Slid{

Food and Drug Admhistratbn

Heariflg Volume 2

Gastr0~t~tlnalDrugMvsioryCo~~ee

Ju&e 27,200O

SLtudy 15:9; 21:19; 22:1,
stickers 63:12,18;64:2;
$1ponsored 219:20
2 1; 23:23,24,24; 24:9,19,
61
59
$1ponsors 130:24; 131:5;
2 1; 25:2,4,16; 26:6,25;
Si
tifle
226:25
35:2;
236:12
1’
217~8;29:2,20,21,24,25;
S’ till84:11;95:19;
136:1,
164:14
$1ponsorship
,0:7,8; 31:18,19,25;
3
7.; 149:6,7; 155:5; 167:19;
16~11;
s pontaneous
3,2:5,6,8,14,20; 35:9,22;
&,~:4,7,11,18,23;
153:4,
72:6.21:
174:ll:
187:6;
1’
3’6:3; 37:21; 40:16,18;
510:18; 52:6,6,7,14,24;
lo, 15,23; 154:6,10,13,
1’91:zj
4 5:20; 48~22; 78:12; 87:6,
5i3:6,16,17,17; 54:21,22;
25; 155:11,17; 156:6,9,
s tipulate 203:lO
7 ; 96~7; 113:6,10,21;
5,5:4,17,21; 56:3,9,12,
l&24; 16O+,l6
f :‘i”:
spasmolytic 157~17
1 19:3
I tomach 138:15; 221:9
1.4,22,23; 571, lri, 16,
slides 54:19; lg7
!
ipeak7:1;66:21;86:15;
ll,l:13;
S pontaneously
S tone 186~8 .i
1+,21,23,24,24;
5813;
slight 89:3; 112:20
* ‘;
[36:6;‘172:5; 210:19
g ? 1 13:15; 114:7
.’ ,.;‘ ,.
Stool 19:17,19; 31:‘2,‘8;’ .’ 7~17; ii {$7*;7,‘1 f; ‘.
slightly lfj@l+; lij:iijt”
qiediei ‘&:i)~U~,~3:15;, .:
r3:ip;84:8,2,!;~~~~;
153:20; 154:4* 18g.i32;5
g4..2;;&39;:;.
Y&pj+j : s potty 136123 .:;.i ,.::S+;3 622; 37:14; 81:16,18;
‘.,;*5;$&y&$
‘,
;
m3;
ili%:$9,4.(lfx.
;*
wy+
P@&&$
pa:’
.:-,,:,
_“.
>*,;::l;-i,
i
$
8
228:2 I ,1:,+:
sr;,, ;~i
.+ j,,+
&&&?5
.>s&.-g
I Y,
66:.12,25; .;,z;;z
2
i s~c;:.l’yy fmp@i~?;1’~
$~~~~;1~~.22,‘;~~~.~~~~~speakers
:
s
.~~~.“.
.-;;ill~.~““T;~~;i’-~,~,.~
+‘ ~~~~.“~~~~.~~~~~:~~~~~~~~;~
1._5;,;156:2;I$3;??;+8;:,:~
‘..Z’: / .~:..&I
:?q&.&$
‘ii
slqugh!ng
~~~2~~~~~~$3$.
; I.&$@‘f$0:9,23;‘152:6,
sp&qdri(r‘67:5; 219:23;.-::: ; 6
1
.ksl-%&:.<.
;.,*".,
.:+ _ -.- ': i i:, *>i.;; 'I;d&
2
6 s,3435j: gj3$‘~(); Y,”-‘;:;,
sl~~..-,,nv
~66;:23
;s~:syy;i~~g+$$,.
: 8
yl<“‘,..,
,.p%“‘.,*.*’
“.“‘L ~~~~~~~~~~~~~~~~~~~-~~~~~~,
: .*a$.y I( :.y;; .q;,
S
: ]J,-& j~3~2’~~@--&~~-&
1
small !1:18; !4:,?3; 3712; ppeeks 22222
37:23; 179:23
1
56~7; 70:6;‘877:5; 12@4;‘
Sitamped 5: 17
1.65:24; 170:8,13,14,18;
3p’i&it
4’8%; 126:23;
S topped 30:4,11,25;
121:24; 122:17;23; 162:f;
I.82:3,8; 204:15; 205:6;
Eitan 18:17; 58:23
142:4; 191:7; 19624;
3 1:6; 38:lO; 41:8;-199:18
179:6; 180:15,16; 181:12;
!23:20; 224~5; 233:7;
2
207:17; 216:23; 226:6
Sitand 99:5; 134:15
41:24
S topping
204:18; 206~2; 215:7
;!34:16; 235:19; 236:14
specialists 50:25;
5standard 68:20; 73:l;
S;tore 169:25
smaller 51:9
d;tudying 188~8; 23O:ll;
234:21
7‘4:25; 93:3; 162:9;
smart 215:15
;!38:12
S
#tares
145:lO
specialized 138~17
2!26:14,23; 227:9,16;
smoke 17918; 181:1,2
!stuff 185:21; 187:13;
Sstories 208:24; 232:5
2!30:23
specialty 193:6; 217:17;
I!11:9; 216:22; 227:7;
1
smokers 90:2,3; 179:5
218:6,8; 234:20; 238:2
§itraightforward
50~4
227:4,
sdandardiration
r!41:17
1
smoking 90~7; 179:23;
2!l
species 96:3,10
SItraining 81:17; 213:18
!subgroup 81:5,12;
180:1,11,12,20; 188:l
226:16,
Sbtandardited
species-related
197:23
SRrategies 154:21;
ILO9:18,24; 112:3
smooth 95:18
!
1;
228:4
2
196:15
specific 11:8,10,23;
subgroups 81:10,10;
!
sobering 190:2,4
s;tandards 221:24; 223:7
14:16; 17:lO; 32:ll;
SRrategy 69:8; 78:15;
137:ll
;
19:20; 58~6; 59:11; 60:1,5,
Sstandpoint 217:2
2131:5
subject 44:24
!
7; 61:6; 62:13; 76:6; 103:7; s;tapled 135:5
Sstraws 195:24
iubjective 70: 13;
!
110:20; 114:21; 121:16,
Aal 11:7
sstart 62; 49:23; 88:6,18;
75:16
S;trengthen
214:25; 215:24; 216:7
22;
122:4;
127:4;
128:6,7;
societies 217:17; 218:7,
1:63:8; 201:22
sitress 119:19; 120:2;
132~12; 133:14; 134:1;
!;ubjects 34:8,10; 40:6,
9,9,11
:starting 36:9;91:17;
172:ll; 175:22
135:10,20; 137:6; 139:12,
LO;44:16,18
society 10:23; 175:ll
I170:11,17
S;trictly 85:22
19.25; 140~22; 144:6,7,
4submitted 4:12
‘.state 6:23; 101:6,1G;
softeners 165:12
12; 146:25; 148:23;
5stricture 39:3; 202:9;
4submitting 4:20
;!32:6; 233:6
soiling 174:13
152:16; 177:13,16;
2!13:13
!submucosa 94:24
182:22; 189:7; 194:9;
!stated 17:17;75:13;
solely 173:13
sitrikes 98: 11
,suboptimally
191:24
195:13;
209:ll;
215:2;
108:15;
109:14
1
solid 36:21
sstrong 30:12; 48:4
tsubsequent 36:lO;
218:12; 224~4; 225:7;
!
statement
4:7;
5:
14;
solution 11:5; 91:20;
s;tronger 213:2,7
14: 13; 86: 17; 97:3;
232:9; 23616
22112;239:12
211:14; 225:10,23; 226:8
5;trongly 159:7; 223:4
133:23; 151:9; 159:16
specifically
72:12; 75:5;
!statements 4:6,19; 8:lO;
solutions 226:10,11
I;truck 178:2,16; 188:17 I !Subsequently
108:7
‘>:23; 214:6
80:13; 107:7; 108:8;
solve lo:13
115:8; 118:10,19; 135:10;
;tructural
173:14
!
subset
53:3
,states 14:21,22; 24~25;
solved 10:9,9,10
141:17; 155:14; 164:8;
dstruggle 169:22
substances
140:25
29:l; 53:2; 69:2; 70:24;
201:s; 209:7
somebody 94:16; 159:l;
72:25;75:5; 108:19;
!;tudied 5O:ll; 190% 11;
substantial
32:18,21;
,‘131:12
213:5; 229:lO
specificity
96:17; 190:1,
192:24
X&5:14;
147:6,17;
16,22
someone 202:8; 240: 11
statistical 65:9
!studies 19:25; 27:23;
specifics 140:2
sometime 218:14
28~24;29:20; 30:22;
substantially
32:15,16;
statistically
93:lO
specify 133:6; 159~22
31:17,17; 44:13; 47:2S;
sometimes 11:4,5; 80:4,
75:16
statistician
112:8
18:22; 50:8,14,20; 51:7,
10; 128:9
spectrum 17:17; 51:19;
substantive
16:22
status 22:15,22,22; 37:?i
B,ll; 54:20,24; 55:11,14 t substitute 221:8
88:13; 99:4; 103:13
somewhat 37:3; 40:25;
statutory 8~24
25; 56:13,18; 57:12,12;
79:24; 173:19,21; 183:9,
speed 143:16
subtypes 109:16
stenosis 42:3,11
58:8; 83:8; 94:18; 95:23;
10; 196:19
spicy 175:16
,
succeed 217:18
96:4,16; 103:3; 108:11,
step 60~22; 211:8;
somewhere 223: 11;
spike 197:6
success 11:22; 2O:ll
11;
109:19;
112:l;
115:7,
217:14;
233:18;
235:3;
225:7
splenic 41:lO; 119:21;
12; 124:8; 143:12,13,19,
236125; 238:21
successful
197:4
11:17; 58:3; 65:6
162:24
20; 144:14; 145:3; 1462;
stepping 8:16
successfully
36:24; 52:l
er 207:7
sponsor 14:lO; 109:19;
149:22; 154:15,17;
steps 12612; 133:6;
suffer
14:25;
15:ll;
.i 84:22; 91:lO; 94:lO;
155:18; 160:2; 164:21;
114:24; 124:7; 129:2;
148~18; 149:15; 241:8,18
47:17; 58:16; 71:9; 172:9;
133:12,13,15; 14624;
165:23; 182:25; 183:1,2,
130:17,18; 131:8; 132:20;
174:19; 176:17; 182:19;
stercal122:18;
199:19
147:l; 192:6; 198:5,14;
2; 188:1,3; 189:18,21;
134:25; 135:17; 136:15,
208:24
Steve 7~4; 2164
201:ll; 215:2; 216:22;
197:18,18,21; 203:3;
16; 137:4,17; 158:19,22;
suffered 169:18; 183:3;
218:ll
stewardship
14:lO; 47:( 5 206:l; 207:19,20; 225~4,
159:4,5; 178:2; 207:20;
184:24
5; 230~25; 232:17,19;
208:2; 216:25
sorts 110~11; 124:15
sticker 10424; 105:1,2;
sufferer
209:3
I
I 233:2,3; 23412: 23613
124:14
sponsor’s
12:9
sought 54~4
;ounds 23O:l
iource 15:13; 68:6,22
iources 34~4; 55:9
space 139:25
;p&g
120:25
;pans’148:;1’ 1. _ :.‘ :I:,-:,
rpares 182:13’‘,?i’...‘.” .<:

141:4,20; 142:9; 143:17;
14422; 145:7,16; 146:5,

slides - sufferer

(24)

~!~n-~-~crit~t~

Miller Remwtimz Com~af~

(2Oi) 546-6666

Food and Drug Administration
1 Gastrointestinal Drug Advsiwy
-2

sufferers 20:3; 21:11,13
suffering 15:l; 70:3;
76:1,2; l?4:24; 175:4;
209~2; 238:5
. sum~ie~t ~9~lb~ ~~707117;
157:4
1 .I;
sufficienily
231112
suggest 53:25;54:1$
154:17; 161:4,7; 183:13;“”
209:20; 214:9; 223:1$20;
_,“.,,
224:5
. r :,,.&;,. .:.” ‘.’

,’

10217; 2i2:2; 23
23923
: I
suggestive
53:20 1
suitable 161:23
suited 174:3
summarize 27:16; 54:19;
56:11;94:4; 108:13;
116:7; 15610
summarized
117:9;
124:2; 129:ll; 130:9
summarizing
122:lO
summary 17:14; 26:24;
27:1,2,4,6,13;69:21;
76:1,22; 116~10; 120:9;
143:24; 154:14; 1568;
162:14
summer 5610
sun 140:24,2S
superficial
120:23,24
superintendent
17~7
superior 32:3
supplement
134:13;
221:7
supplemental
51:25;
Go:16;67:11
supplemented
51:13;
103:21
supplements
2O:lO
supplied 134:25
supply 226:3
support 5:8; 69:12; 70:7;
176:17; 186:13; 212:17
supporting
242~3
supportive
38:6; 173:24
supposed 102:11,14;
135:ll
suppression
161:2
SURAWICZ 6:14,14;
77:6,7; 93:25; 97:22;
199:15,16; 214:20; 2159,
11; 217:10;230:14,19;
24214
sure 43:lO; 80:5; 91:6;
92:15;94:11; 95:1;%:16;
99:3; 100:2,3; 103:9;
121:1; 161:11; 180:2;

Miller Reportiug

Committee
,-

-

-

Hearing Volume 2
June 27,200O

t, Iought 77:14; 78:3;
zrminated 36:21
.81:12; 188:14; 189:24;
168:3; 205:lO; 216:25;
srminating 114:17
198:25; 199:8; 203:4;
17:2; 239:8
2
!05:24; 206: 11; 208: 17;
erminology 215:2
houghtful102:19
tl
!11:21; 214:8; 219:12;
erms 27:13; 40:25;
t’able 5:21; 182:17;
!20:22; 221:6,17; 223:23;
tl housands 87:9
‘l:ll;82:18,24;85:10,
2!27:14; 231:25
126:17; 228:14,16;
1;
86:14;
95:10,13;
tl hreatening 74:15;
t ablets 167:12
~29~11;23414; 237:3
02:l; 103:19; 104:20;
123:15; 132:ll
t abular 111:19
05:24; 109:24; 111:8;
Burgeon 7:24; 198:20
hr& 1323; 15:19;21:1;
tl
t ailored 17:10;47:15;
12:6,13; 113:25; 123:24;
surgery 37:4,4,8; 39:9;
9:6; 33:9; 42:22; 47:7;
2
4io:3
263; 135:6; 136:22;
12:7,15; l17:6,7,10;
4,8:5; 50:21; 53:6,12;
44:19,20; 156:ll; 175:5;
i ralarico 6:2,4,4; 242:2
118:23; 121:6,10; 122:15,
516:23;61:3; 72:3; 77:25;
83:8; 187:24; 194:16;
t alk 10:22f20:14;~idl:15,
22; i23:ftj; 129:14; .’
‘8:8;+4:~,4,13,16;86:1,
7
.96:8; 2Ol:lO; 204:21;
2u; 102:2!; 107:7; 1,21:9;
13o:li; 156~23; 175:j;
!05:17;
206..‘2@$8;
i
$7:
:..l~!;,~4~:~~~,!a:3.7* 23;
199:14, .@;‘2(jOi22;” :xy-,
1:24:?2,12; i25:1Cj$7.9;
0;3; 93;2122; 116: 14;
!13:2;224~:24;
2268;
::$$t
i
,3ij;l8;;~34;f~;l35{1~
216:2J,,:,~~~~~~~~~~~~~~~~~1
!34:i7.~3$~&23fji3~$
wi5>p;
\pj;2;
3~~~~~is~~~~~~~~~~~~
2’
1.
1‘ F..s>ys,.,!;;y~ Le.‘:+.*?(z1 ~~~~~#i?&~ ‘Y53:6,11,
I143.f8; 1$8$‘i66:23;“:’
.1!09:20; 2fi:15;21’2~2$?~;
errible ‘23632% 238:5 “:“. 1
I3:2f;~~~44Ir;:!2:4;
“’
err iti&9~~j2*:~i,”
: $f*S.: 1 1; t-56:7; Bc,$O; 159:2;
!31:7;
23pil’o;
240‘:‘?7
:
;
181:23; iti
-’
1.GG:‘il;‘~“Ip:8,~3; 171:4,
e& 57:15; 6$4, i?; 69’:;;
1:alked 139i23; 211:il; ’ *.
2~4;177:8;,184:23; 193124;
surprise 218:lO; 220:16
r132~2
.50:19; 211:21; 223:2l;
I .98:6;‘212:13,19,24;
surveillance
14:5; 55:6;
!26:17; 231:5
2!13:17,21; 235:17,22
;:alking 11:14,23; 100:21;
144:4; 145:8; 188:2,15
esting 44~7; 48~13;
I101:15; 102:9; 105:25;
t hree-month 205:4
Survey 21:20; 148:2,3;
;7:18;68:11; 150:7;
1108:l; 138~25; 169:24;
t hree-wave 65:15
173:15; 227:5; 23S:4
151:16,21; 152:2
182:23; 189:23; 199:12,
t hresholds 133:16
surveys 67:2
ests 22:25; 45:7,24;
14; 207:lO; 212:22; 213:3;
t hrilled 212:3
suspect 44: 1
~10:20;
118:8,9,15,16;
216:ll
128:5; 158:10,14; 166:25;
hrombosis 90:9
t
suspected 119:9
ralley 21:7
L67:6; 173:6,12; 174:6;
hrombotic 9O:lO;
t
suspicious 77:12;
1tangible 71:8; 133:13
L87:6
1179:20,24,25; 180:1,14
187:19
target
48:14;
54:3,8;
i
textbook 119:25
sutured 42:lO
t hrombus 180:19
108:24; 109:11,13;
:hankful172:15
sutures 42:7,9
t.hroughout 30:3,10,24;
115:19; 132:12
:11:5
rhanks 93:l; 163:9
symptom 59:14; 65:11,
1targeted 48:4; 76:5;
:he-counter
169:20
11; 106:25; 108:17;
:hrowing 229:ll
1
I35:22
158:12; 173:6; 174:9
:hemes
107:5
:humb-printing
41:9;
1
1targeting 154:22
symptom-based
l9:14
119:24
:heoretically
10:2
1teach 5:7; 6:23
symptomatic
8: 18;
rhus 9:25; 28:19; 30:21;
therapeutic 13:5; 30:22;
1teaching 102:15
12:12; 98:8; 107:20;
123:9; 138:6; 157:l
‘a

62:9
ream
6:9;
49:3
1
112:21; 161:4; 173:22
-herapeutics
6:20;
~~3~p:om~tWw
t cams 218:2
t’imes 15:15;39:5;44:11,
;9:15
t ear 225:16
15; 110:25; 167:12;
symptoms 20:3,5,12,
herapies 13:s
t ear-off 229:6
1.69:22,24
21; 30:5,11,25; 31:6;
herapy 35:17; 36:17;
t ears 170:25
)2:14; 48:8; §0:2; 59:21;
iming 41:l; 83:25;
t
i8:20; 39:7; 4 1:4,8,20;
;1:14; 63:7; 65:12; 66:17;
.58:20;
159:5
I
t,ease 149:11,13
l2:14; 43:21,23; 56:24;
7O:lO; 73:22; 87:24;
t iny 218:23
;9:13,16; 70:23; 77:19;
t:echniques 57:20;
110:9; 115:4; 118:3,7;
117:21,22; 119:12;
1139:24; 175:23
t ired 172:4
L21:16; 123:lO; 157:2;
121:13; 128:6,13; 135:24;
33:13
1:eleconferences
I:issue 96:17
t&6,11;
172:13; 174:lO;
L36:4; 174:22; 181:8,14;
:elephone
231:17
I
1:itle 141:24,24
175:10,12,14; 205:11;
185:24; 204:14,16;
telling
235:7
1
1:itration 78:ll
212:14
219~24
1tells 186:23; 207:4
1today 6:2; 10:20; 11:25;
syndrome 8:19; 13:4;
thereafter 54: 18
12:8,X4; 13:14; 14:14;
15:12; 28:l; 29:15; 31:22;
1temporal l45:19; 146:6;
/
therefore 15:l; 50:3;
16:23; 17:6; 33:9; 34:2;
35:9; 63:5; 64:23; 65:19;
199:22
j4:1;94:15; 115:9,1S;
13:lo; 45:12,22; 4712;
69:24; 106:24; 108:16;
itemporary
38:23; 122:6,
if 133:11; 143:9; 203:25
50:1;69:21;71:24;76:11,
110:4,6,15; 123:13;
24; 204:16; 221:12
thickening 41:9; 119:21;
13;81:2; 101:23; 111:24;
128:16; 132:14; 144:14;
ten 77:21; 137:ll;
120:14
135:15; 143:18; 149:17;
149:10; 156:19; 157:24;
139:21; 143:8; 158:3;
thinking 11:14;78:10;
158:25; 172:5,5; 201:21;
164:5,7; 166:25; 167:17;
169:19; 204:14; 220:14;
183:ll; 185:12; 186:1l,
207:15; 220:23; 221:15;
168:21,24; 169:18; 190:9,
224:l; 234:13
25; 204:13; 238:21
227:5,18; 232~2; 236:19;
20; 212:12,18; 219:23
tend 136:9; 188:lO
242:l
third 14:9; 1614; 20:20;
system 16:ll; 51:23;
tenderness
38:12
48:12; 57:24; 121:20;
today’s 13:18; 33:12,24
82:20; 119:3; 145:9, lo,
tends 93:2
122:17; 123:l; 138:9;
164:7
10; 147:7; 155:25; 218:8
151:3,4, lo; 153:14
Tennessee 55:18;
together 12:2; 105:15;
systematic 49:l; 54:17
164:17
third-party
68:19,24
127:20;215:16;218:11
systematically
569;
tense
238:19
thoroughly
226:17
told
137:23; 167:5,18,
204:15
tension 227:l; 237:2;
though 84:9; 90:9; 182:9 ; 22; 168:18; 171:18;
systems 63:16; 173:4;
193:15; 222:12; 230:6;
238:8
186:12; 193:4; 196:6;
188:15; 194:15; 225:22,
I 240:15
1 223:ll; 224:14
I term 184:22
22

Company

T

(202) 546-6666

Min-U-Script@

(25)

sufferers - to1

Food and Drug Administration
Gastrointestinal Drug Advsiory Committee

Hearing Volume 2
Julie 27,200O
treated 14:24; 34:23;

tolerate 129:lO
tolE32: 11; 174:24

tomographic
57:20 .-- ::“I 1.
tone %:8; 139~4; !73$ ..:,:
took 1ll:ll;
‘$V$~~~-j;
185:20; 192:14 . . i, I.--.+&i,
d..
\,l’;*.
tool 9:18; 72:11;95:$
j.
132:lS; 133:5; ?+?j..i .,;,j;

39:ll; 44:10,16,24; 85:2;
119:16; 167:3; 176:4,4;
178:lO
treating 70:13; 140:14;
173:24; 190:3; 220:20
treatment Ji:$; 13:2,12;
14:22; 15:2,17; 18:8; 20:9,
11; 29:6,8;9; 3432,‘d,4,9,
10, l&24,24; 31:4,5,21;
32:7; 35:23; 36: 12,24;
37:22; 38.;3; 9; 39:13; 41:4;
469; 51:2; 58:16;73:18:
‘.I ., *.-;,..*p+

q::p; 82:i2,14,15;
$&il;-li;“9$$1&.23;-~~

116:17,21,22; 117:3; :.t‘:
118:20: 121:4; i22:j; “‘“*
123:3; i29:22.
totaled 150125; 151:3

totality 71:6
toward 18:6; 132:12;
208:22; 229: 13; 239: 11
towards 85:23; 238:23;
239:lO
toxic 121:25; 123%
160~10; 206:s; 213:13

3; 148:l; 197:7;
198:15
toxin 95:22
tracer 24:21
track 68:5,22; 103:4;
193:4
tracking 48: 15
tract 94:25; 116:2,3,8
trade 50:17
traditional 22:20; 173:5
Traditionally
9:s; 233:19
training 60:16; 67:11,15,
16
transaminase
150:7,11,
13,16; 151:7,13,16,21,
25; 152:2
transaminases
118:lO
transferase
186:18,19,
25; 187:ll
transferases
185:9;
186:1,3,10; 187:lS
transient 40:12,19;
43:lS; 51:20;71:15,18;
103:14
late 133:9
jating 217:24
i
,‘kural 122:l; 123:3
‘transverse
37:6,25;
41:9; 42:3,6,9; 43:22;
122:19
travel 169:16
treat 132:5,9; 16%
174:s; 220:5; 231:lO

tolerate - using

r.Qs:;is; rop~;lp~;

1!5i14;,i~~~~?;‘128:15;:j;
l32:8; 138:$;156:25;’
.-’
157:i, i; 23; 160:3,4;
161:5,13,15,21,21;
172:14; 174:2,3; 176:3;
190:19; 209:2; 212:7,11;
229:18,2i
treatments 49:9; 93:7;
114:lS; 132:5; 232:7
tree 178:6
tremendous
22O:ll
trended 69:4
trial 36:20; 44:s; 56: 19;
58:9; 112:4,16; 113:8,11;
12g:17; 159:23; 161:22;
n66:6; 171:14; 194:24;
205:3,4,5; 238~6
trials 16:10;42:20; 50:10,
13,16,17; 56:4;71:22;
80:25;86:16;87:2;90:15;
110~24; 112:13,13; 129:7,
8; 144:4,9; 145:6; 159:9,
24; 166:ll; 187:17;
202:19; 207~6
Triangle 66:6
tricyclics
160:7
tried 88:ll; 105:12;
167:7; 169:19; 170:20
trigger 137:15
triggering
137:25; 138:9,
18
trimebutine
31:20; 32:2;
93:22
trivial 27: 18
trivialize 15:15; 73:2
trivialized
172:13
trouble 81:23
troublesome
200:16
troubling 73:21
true 115:21
truly 81:9; 171:8
truthful 9:23
try 11:20;42:18;79:6;
82:22; 84:22; 143:15;
I 149:13; 157:13; 174:s;
175:20; 177:l; 183:4;
184:12; 203:3; 227:15;
232:lo; 234:21; 240:5;
241:23
trying 75:lO; 78:2S;
I 80:18; 96:13;99:19;

(26)

16; 240:5;241:4
,03:13
Jp-side 232:8
unanimous 13:9
Jpdate 13~7; 18:14;
mcaring 102:22
28:15;31:13
tncertain 1%:8
updated 14:3; 60:15;
mclear 129:19
%:20;67:7;177:21
mcontrolled
232:19
,
upon 5:13; 29:2;64:14;
mder 9:l; 57:1,23;
51:3;82:13; 105:lO;
.16:11; 120:9; 140:14,16;
118:14,17; 14(i:lO,ll;
.43:1; 17o:lo; 194:7;
147:15
!03:12; 221:8; 228110
uPs~?.~$l::~~ :
rnder-reporting
147:7,
upt&e 233:~ .:“.?‘:~::,:

!4; 148~24; 162:19;
. a,...:“-‘..,5.;,;,;;.‘?
‘., ?Y;*
!40-12
::
:,;;.,
.;,~~~‘,~~,;~~I:,~::,~
Upwar&,,,2&1T;
21:17
__
..~..,~.~,.~~~..,?~~~~~~..~
( i..,i..
~~~~~~~~~~~~~~~.~;~!~.
&r&u?
2,l.il!ZI’“‘“?f
irid~~~i~~di^~~~~~~~;~~~~ ~~~~~~~~~~~~~~~~~~ ti.4
53:10, i3r$dz1g:23; :s;j;G.;; I;i21e”ilin~~~~~~~~~~“~~~~ 19, ~f,2~~f@$$161~13;
~74:12~~i~:15;il”.*“,.~“~.,. .,. _
;idh&;d
i-;g~s/&‘;*
55:14; 56:l; 65:2,5,6;&‘,;-<<&~
&s:;i >“.
Uf& z.&;ls , w$,;+;;:;.+g;>
>.:-.
21;77:18;80:25; 84:5,7,
146:13,17; 152i17; 154:1
13,24; 86:6; 90:3,24;
u+e 12635;2.14:12
mderstandable
138:2S
93:16,21; 95:25;97:1;
usages-211:25c” ‘^.
Jnderstands
lo:5
102:7; 108:11,23; 109:18;
USC 4: 17; 6:lO
understood 7~19;
111:2S; 112:22; 115:7;
use 9:l; 10:1,4,7,15;
139:2,10; 187:5
116:14; 119:13; 124:19;
11:l; 12:3; 13:25; 1619;
12S:3; 127:16; 141:9;
mdertake 234:s
17:24; 18:9; 35:10,11;
143:20,21; 15O:l; 153:7;
mdertaken 207:12
18:6,9;49:7;51:5,9,11;
154:17; 15614; 158:21;
mderwent 129:14;
j2:22; 55: lO,l7; 56:24;
159:1; 164:25; 165:21;
.30:11
j8:15;6O:I3;61:10,25;
167:12; 170:3; 17737;
mfortunate
11:16
52:8,18,21;63:2;65:1,
185:2; 186:20; l%:l;
22;66:1;67:1,17;69:16;
rnfortunately
102:12;
197:2,15; 200:17; 201:l;
72:12,20;75:6,18,20,24;
.72:21; 219:3
217:14; 218:18; 227:1,12
63:25;88:1?;92:19;93:2;
mheard
188~20
two-thirds 20:3
101:14; 104:7,17; 105:lS;
uniform 142:12
tying 237:13
110:21; 1ll:l; 126:ll;
Aformity
136:17
type 19:22; 23:21; 24:9;
127:22; 131:15; 132:4;
64:12; 79124; 82:lO; 90:9;
Jnindicated 189:13
134~8; 136:5,8,11; 137:9;
116:10,11; 131:13;
unique 47:16; 48:9; 52:2
138:3,3; 139:23,24;
134:17,19; 135:14,16,18;
140:21,23;144:21;145:1,
lnit 131:24; 136:5,8,11,
136:12; 137:lO; 139:21;
18; 146:19,20,21;154:7;
24; 195:7
158:13,15; 174:16;
165:1,14;188:2;193:14;
Jnit-of-use 125:24
222~24; 234~18
194:3,7;203:11;211:4;
Jnited 6:19; 29:l; 52:25;
types %:18;98:10,15;
215:2;217:23;223:13;
;;;$,
16; 69:l; 150:23;
131:lS; 135:lO; 194:17;
232:10;234:17;235:10;
218:23
238:25
University 6:14,17; 7:4,
used 8:18; 10:4; 11:13;
typical 119:1,24
?,24;8:1;43:2;45:11;
21:21;31:21;52:1;72:24;
jj:19; 184:19; 192:25
73:18;93:5,7;99:7;106:5;
unknown 113:ll
108:12;110:4,6,8,25;
unless 203:14; 206:s;
114:22;125:5,23;127:14,
209:14; 216:7; 231:2;
25;128:9,15;130:14,16;
u 8:7
238:l
132:12;133:5,16;137:11;
U.K55:8
144:22;148:15;153:6;
unlikely 186:23
U.S 11:13;21:15,19;
155:13;157:23;191:21;
unnecessary
175:3
23:lS; 25:20; 27:5,12;
196:2;197:5;203:12;
unpleasant 30:20
99:14
207:13;220:7,8;223:24;
UCLA15:8;18:12;19:11;
unreasonable
73:l
226:23;240:19,21
2S:8
unusual 202:25
useful 103:6; 134:10,22;
Ukraine 98:14
up 41:1; 54:16,23; 76:22;
145:13;154:15,22;
ulcer 37:24; 42:lO;
79:18;92:12,18;95:24;
195:12;224:11;233:25;
122:19; 160:22; 161:s;
10&l; 103:23,24; 109:17
234:s
117:4,6; 119:22; 120:23;
199:20
user 139:2
135:s; 14O:lO; 142:14;
ulcerated 120:19
users 50:22,24; 53:11,
143:23; 159:4,11; 165:22
ulceration 41:23; 42:s;
13; 54:21; 56:s; 144:18;
169:23; 170:2; 178:15;
122:20
151:14; 193:12
184:2; 198:21; 201:22;
ulcers 41:19; 162:5,6
uses
10:4; 190:25; 191:3
214:22; 215:7; 216:4;
ultimate 97:21; 132:18;
using 21:4; 23:7; 25:6;
219:2,13; 220:16,X?
133:21
39:5;53:8;55:2;57:19;
22l:lS; 222:5; 223:10;
- -- -ultimately 73:l; 195:19
68:23;71:2;79:23;103:5,
224:1,24; 230:8,20,21,
24; 128:7; 129:21; i46:22;
23;235:24;236:24;237:7
unacceptable
194:lS;

170:2,3; 188:s; 202:16;
209:4; 214:3; 240:8
turn l&23; 28:2; 33:6;
46:19; l15:25; 126:l;
133:17; 143:!5; 235:8
Turning 118:19; 121:3
twelve 204:24
twenty 192:9
twice 171:4; 187: 11
two 6:24; 14:14; 21:14;
22~23; 23:22; 24~24; 261;
28~23; 29:19; 31:16,21;
34~4; 36:9;‘37:16; 38;JO, :<
15,16; 39:il;‘&k2??@5;“
25; 46~1; 4925; 52:19; “?f

U

Min-U-Script@

Mi&r

Reportif@ Con

my

(202)

546-6666

Hearing VOhme 2
June 27,200O

and Drug Awtration
8. GastrointeMnal
Drug Advsiory Committee
Fad

“,

150:12,12; 153:s; 198:2;
234:3; 239:4,13
usual 4:4; 41:17
usually 32:13; 101:6;

validated 149:7; 156: 1
Vanderbilt 55:19
varied 153:20
variety 54:5; 104:7;
134:lo; 187:3; 193:2C
19615; 208:2; 230:10;
232:lB
various 41:l; 46:4;
93:13; 108:6; 124:9;
207:15,15
, vary 150~17; 155:20
varying 120:14
vascular 94:22; 95:2,3
vasospasm
%:3; 233:1
vast 77~22; 192:3
vehicle 66:20
vehicles 6015; 61:17;
67:lO; 100:13; 105:15
ventricular
152:12
version 65:22
versus 37:2; 80:17;
8l:lB; 83:19; 85:12; 87:9;
154:4; 161:3; 206:18;
210:15; 223:21
vessel 95: 13
vessels 94:20,25
veteran 223:3
veterans 224~22
Viagra 75:6; 144:20,21
Vice 6:22; 58:24
Victor 106:14
view 30~12; 54:13; 62:22;
92:3,24; 189:ll; 202:10,
11; 215:4; 216:24
views 74:13; 199:3
virtually 31:9,18
virtue 145:2
visit 168~4; 170:20
visits 21:21; 53:22;
219:6,10
visuals 217:23

Miller Retxwting

1 14:22; 217:17; 218:lS;
I 220:2,6; 233~25; 237~7;
2:38: 13; 239: 1; 240: 17
vweak 180:20
Yueb 2196; 220116;
t40:14
Neb-based 98: 17
Hebsite 60: 14; 64: 19;
;5:17,25; 66:2
websites 219:16,16;
120125
Meek 30:2,9,23; 31:4;
)g:5; 41:22; 84:l; 161:13,
@ini i&:18’
.” ,,~~~~,,‘.~,.15; J65:lo; 168:25; JO
s,j: : . :_,pP
5s. .. .d>
“‘?i;
-+“.\,,’i ‘_,;._.:&.,:;,~;);q;y;1;:” :. 175:2O;~~~~ii~B~~~s:F1I‘:
213;II_ c$$,;-:;;;:j; S:;Z:,;;~;
.~~~~~~~W
“‘”
,‘,e;~:--,:.
:- “‘,3 _,,: ,_j ,~r. -,.,,- /,‘, 1Weekly 31:24; 32:l
I
_,,
:.
,we&
29:6,24; 32:7,14;
Nait 1j8:20; Y79:22
3e;:16;39:11;41:16,24;
waited 171:l
42!:15;43:23; 45:9; 61:3;
77‘:18,25;86:1;93:13,17,
waiting 170:22
1Ei; 144:15; 159:1,2,2,11
waiver 4:19
24I; 1w):2,3; 161:20;
1,-r&11; 184:4; 185:24;
waivers 4:17
walk 40:24
1t)6:18; 193:24; 204:14,
wall 37:6; 42:8,10
21f; 205:l; 212:25; 213:21
2114:6; 235:17
wants 208:14; 228:13;
2:34:4
W eigh 9:lO
w lam 75:7; 92:20; 168:12 ; w #eight 124:15
1169:2
\IIIEISS 203: 15; 206:23;
rarned 9O:ll
2:29:13; 234~24
rarning 17:18,20;
w lelconw 8:9; 11:24;
2:12,16,20,21; 74:8,13 ‘I 1:2:25; 102:16; 164:2;
5; 75:1,6,12; 126:6,15,
1169:13
I; 127:7,16; 129:16;
wrell-accepted 70:12
31121; 152:19; 160:9;
n rell-being 22: 16
66:s; 170:6; 181:9;
9:s
Hrelkontrolled
97:20; 198:3,4; 208:5,
tell-spoken
12:7
4,16,22; 209:6,9,14;
z fellcome 5:15; 8:15,16;
10:7,19
12:9,18,19; 13:21; 16:9,
farnings 73:4; 74:ll;
2 2; 18:20; 33:12,18,22;
‘5:16; 105:7; 126:9,20,
34:1;47:1; 57:l; 58:25;
~3;127:6,14; 128:3;
5,9:9;60:16,19;61:18;
52:16; 197:17; 207:17;
0;2:12; 66:3,10,11,22;
!OB:l, 19,20; 214:18;
c;7:5,11; 71:24; 75:13,15;
!19:17
7‘6:13; 111:23; 123:24;
warranted 17:20; 68:7
I.26:3; 169:16; 220:18;
warrants 92:lO
;!30:6; 241:22
uars 223:3; 224:23
\Nellcome’s 18:3,15
Nashington G:l5;76:1: 8
1llVells 23:7
JVatch 231:16; 24O:ll
1A/ELTON 7:23,23; 93:25
mater 233:4
‘34:2;95:5,7;96:15;97:1,
watery 212:20
15; 162:16,17; 179:24;
182:14; 184:2,9,16;
way 22:12; 26:25; 32:12 I;
188:17; 194:l; 198:18,1s
49:21;80:11;91:17;
1s:lo; 200:4; 204:6;
103:25; 105:3; 120:2;
205:8,9,14; 206:20;
141:25; 158:lS; 160:17,
216:9,14,19; 232:21,22.
20; 1629; 167:l; 179:15 1;
180:20; 182:24,24; 183 :6; 240:23; 241:2
18.&11; 196:5; 204:12;
Whereas 104:l; 159:lS
210:5; 213:7; 214:ll;
Whereupon
163:lO;
215:12,15; 217:7; 220:; !;
242:7
222~7; 226~8; 228~5;
whey 158:15
229:21; 230:13; 231:9, I19;
white 41:6; 139:24
232:5,12,16; 233:lo;
Whitehead 24:19
239:13,24; 241:25
whole 80:3,6; 89:l;
ways 50:4; 57:3; 86:6;
145:24; 177~24; 178:3,4
92:s; 98: 15,20,22,24;

vitality 23:13; 26:8,16,21
vitro 57:15
I
vivo 96: 1
vocal
104:2
I
‘oice 23:4
folume 36:21
rolun&
131:ik; 132:6,
.g; 13614; 145: 11; 147:7;
!27:6
vomiting 41:6; 121:18
rote 2@?:14,23,25;
r&16 _, .-I &~;;,;;.T,,

Company

(202) 544-6666 Min-U-Scrip&B

20 2:23,24; 214:19;
23 1:lO; 232:18
196:lO
WI loleheartediy
WI hose 5:12;8:19; 59:14;
1c,8:17; 123:14; 187:19
wiide 51:24; 135:6; 148:23
W’ idely 191:20; 197:5
W ider 11:13; 193:14
W idth 5:22
ild HO:9
rilliam 76:16
_.,

rithdraw 82:14
z-z
riihdrawal !07:1$;
24:6; 132:20,20; 205:12 I
rithdrew 35:12
rithholding
142:s
#ithin 21:16; 28:19,25;
~13; 38:6; 42:lO; 45~22;
9~4; 52:24; 53:16; 55:25;
,6:5; 61:3; 73:4; 77:18,23
14;136:20; 173:22;
83:14; 186:18,20;
89:16; 206:15; 212:25;
!15:12; 228:20; 238:13
without 35:16,19;40:12,
.3; 43:lB; 45:4; 73:lo;
~07:18; 109:4,8; 114:15;
L27:ll; 139:16; 140:25;
j6:14,17; 167:20,25;
68:7; 171:s; 1%:23;
03:10; 212:22; 236:16;
38:13; 241:12
J&e 4:18;7:8,8;77:15,
6;78:1; 89:2,3,25; 90:s’
2; 91:6; 94:1; 100:6;
19:14; 157:11,12;
78:25; 179:1,9,14;
80:3; 181:21; 182:4;
91:11,15; 192:1,11;
95:25; 196:l; 197:16;
.98:8; 208:6,8; 211: 17;
!13:24; 219:15; 232:3;
!39:3,19,20,24
Noman 97:25; 185:4,2?
186:16
woman’s 15:l
women 8:i9; 13:3; 14:2:5;
15:s; 20:3; 47:16; 55:20;
58:16; 59:14;71:8; 87:2( 1;
106~24; 108:17; 109:14,
16,20; llo:s,6,20,25;
111:lo; 112:16,18; 113 :3,
12; 114:s; 115:4,7,9,1? 5;
136:7; 144:21; 173:16;
212:8,11
Women’s 7:lB; 171:5
wonder 78:25; 104:25;
198:14; 204:12; 21425
229:5
wondered 193:3
wonderful 223:12

rendering 161:9
iloodcock 75:5
ford 95:15
rording 85:9,12; 136:16
fords 41:25; 42:25;
,3:24,25;84:15; 107:16;
09~22; 113:12; 157:23;
59:lo; 174:7; 212:4,22;
!13:21
work 11:22,25; 12:2;
!2:4,7; 27:21; 63:15;
18~2, i9;ib5:15; 167:8,
r;m~~;s:$l69:22;
17o:lq;,~,~~~,4211:2;
11;:1$,.17,?9; 225:21;
I@‘~; 2~@‘2,3~r~,4;
141’;4,*23?;;~;f !,:I, i
No&& 217:19; 224:23;
24i:13, 13-“%’ ,

’working 8:17; 47:14;

106~3; 12613; lfi4;
1%:25; 228:15,16,25;
235:lO; 239:7; 24l:ll
Drks 79:l; 228:16,24
orkup 240~23
orld 10:3; 5O:ll;
u:21; 192:4
orld-recognized
43:9
orldwide 46:25
orried 19619; 199:17;
)6:3
‘orry 210~8
lorrying 168:7
rorse 23:lB; 24~6; 25:22
6:3,7,14,20; 27:3,11;
215; 170:3; 230:9
rorsen 221:lO
worsening 13722
rorst 165:2S, 25
forth 38:20; 196:ll
/rite 232:4
writing SO:10
written 4:20; 134:10,12,
!2; 138:23,24; 208:lo;
!17:22
wrong 96122; 121:lS;
174:8; 205:lO; 212:17;
115~23

X
X 29:23; 89:16; 205:l;
219:9
x-ray 38:22
--

Y
Y 29:21
year 11:lB; 54:lB; 55:1
73:11,14;99:15; 106:25
143~8; 144:16; 145:15;
153:8,8; 16O:lB; 167:15
i 17: 170:14: 171:2; 174:I
1 ;$j;;; 207;5,8; 2iS:i;

(27) usud - Ye

Food and Drug Administration
Gastrointestinal Drug Advsbry Committee

Hearing Volume 2
Ju;j, 27,ZOOO
236:2,3,21; 237:18;
23&22; 239% 241:15
s 21:7; 23:6; 54:23;
,95:16,25; 11719,
): 128:18; 136:3;

Zantac 160:21,25
zero 203:7

I

=-svww2 -

7~rc-l t&j)

~rrin-v-scripti

Miller Reporting

Company

(202) 546-6666