UNITED STATES OF AMERICA

FOOD AND DRUG ADMINISTRATION

\+ + + + +

CENTER FOR DRUG EVALUATION AND RESEARCH

\+ + + + +

PUBLIC MEETING

\+ + + + +

TUESDAY

SEPTEMBER 23, 2003

\+ + + + +

The Meeting convened at 9:00 a.m. in the National Transportation Safety
Board Boardroom, 429 L'Enfant Plaza, S.W., Washington, D.C., Melissa
Moncavage, moderator, presiding.

[FDA PANEL MEMBERS PRESENT:]{.underline}

MS. MELISSA MONCAVAGE MPH, DDMAC, CDER

DR. KATHRYN AIKIN DDMAC, CDER

GLENN BYRD Center for Biologics

Evaluation & Research

DR. MARTINE HARTOGENSIS Center for Veterinary Medicine

DR. THOMAS ABRAMS Director, DDMAC, CDER

DR. NANCY OSTROVE FDA Office of Planning

PETER PITTS FDA Office of External Relations

DR. ROBERT TEMPLE Director, Office of Medical Policy, CDER

DANIEL TROY Director, FDA Office of Chief Counsel

DR. JANET WOODCOCK Director, Center for Drug Evaluation & Research

DEBORAH WOLF CDRH

[ALSO PRESENT:]{.underline}

DR. JOHN E. CALFEE American Enterprise

Institute

DR. JON HALLBERG University of Minnesota

DR. FRANK R. LICHTENBERG Columbia University

DR. NEAL MASIA Pfizer, Inc.

MICHAEL ROBERTS Catalina Health

Resource

ANDREW SCHIRMER McCann Erickson

DR. LISA SCHWARTZ VA Medical Center

DR. STEVEN WOLOSHIN VA Medical Center

DR. MIKE MAGEE Pfizer, Inc.

DR. DEAN G. SMITH University of Michigan

CLIFFORD THUMMA Pfizer, Inc.

DR. ALAN GOLDHAMMER Pharmaceutical

Research &

Manufacturers of

America

GAY KASSAN Parade Magazine

A-G-E-N-D-A

Ms. Melissa Moncavage, MPH - Welcome 4

[UTILIZATION AND DEMAND:]{.underline}

John E. Calfee, American Enterprise Institute 7

Jon Hallberg, MD, University of Minnesota 18

Frank R. Lichtenberg, Columbia University 31

Neal Masia, Pfizer, Inc. 42

Questions for Speakers 54

[BRIEF SUMMARY]{.underline}

Michael Roberts, RPh MBA, Catalina Health

Resource 74

Andrew Schirmer, McCann Erickson 84

Steven Woloshin, MD,MS, VA Medical Center 96

Lisa Schwartz, MD,MS, VA Medical Center 106

Questions for Speakers 112

[PATIENT/PHYSICIAN INTERACTION - GLOBAL:]{.underline}

Mike Magee, Pfizer, Inc. 138

Dean G. Smith, PhD, University of Michigan 155

Clifford Thumma, Pfizer, Inc. 163

Questions for Speakers 176

[INTERNET & COMPLIANCE]{.underline}

Alan Goldhammer, PhD, Pharm. Research & Manufacturers of America 195

Gay Kassan, Parade Magazine 207

Questions for Speakers 219

Robert Temple, MD - Closing Remarks 223

P-R-O-C-E-E-D-I-N-G-S

9:05 a.m.

MONCAVAGE: Good morning. Welcome to our second day of the FDA Public
Meeting on Consumer Directed Advertising or Promotion known as DTC.
I\'ll review the agenda and the ground rules for the meeting and go over
some of the information that you heard if you were here yesterday. For
those of you who are new, you might want to know this information.

The objectives of this meeting are to enable the agency and other
persons and organizations to present their results of research on
direct-to-consumer promotion. The agency is very interested in hearing
the results of other\'s research.

Although this is not a meeting about making policy or discussing option
about DTC, the process is to gather data. This data is very important to
us \-- will be very important to us in the future as the agency
discusses what its next steps might be with regard to direct-to-consumer
promotion policy.

First, I would like to introduce the members of the FDA panel. Starting
on the left is Dr. Kathryn Aikin, a social scientist in the Division of
Drug Marketing, Advertising, and Communications in the Center for Drug
Evaluation and Research.

Next to her is Peter Pitts, Associate Commissioner of External Affairs
at FDA. Next Dr. Robert Temple, Direct, Office of Medical Policy in
CDER. To my right is Mr. Tom Abrams, the Director of DDMAC and CDER.
Nancy Ostrove, the Director of Risk Communications, FDA\'s Office of
Planning. And Deborah Wolf, Regulatory Counsel for the Center for
Devices and Radiological Health.

We will be using the same ground rules that we used for Part 15
hearings. That is, this is an informal meeting. The rules of evidence do
not apply. No participant may interrupt the presentation of another
participant. Initially FDA panel members or members of the presenting
research panel will be allowed to question any person at the end of
their presentation.

If time permits, after the panels have completed their questioning,
others from the floor may ask questions during the remaining time.
Questions will be limited to one per person from the floor.

Public hearings under Part 15 are subject to FDA\'s Policy and
Procedures for Electronic Media Coverage of FDA\'s public administrative
proceedings. Representatives of the electronic media coverage may be
permitted subject to certain limitations; to videotape, film, or
otherwise record FDA\'s public administrative proceedings including
presentations by the participants.

This meeting will be transcribed and copies of the transcript may be
ordered at the registration desk or accessed on the Internet. An
instruction sheet is available for Internet access at the registration
desk.

We have a full day for the second day of research presentations so the
panel presenters will limit their presentations to 15 minutes and each
panel will have a question and answer session for up to 30 minutes
following.

For some housing keeping information, the restrooms are located in the
registration lobby. No food or drink is permitted in the auditorium.
Please note the exits from the room for your safety.

Okay. Let\'s get started with the first panel. We have four presenters
for this panel. Our first presenter is Dr. John E. Calfee from the
American Enterprise Institute.

DR. CALFEE: Thank you, Melissa. It\'s a pleasure to be here. I\'m hoping
I won\'t even use my entire 15 minutes.

This is a study that I conducted actually with two co-authors, Cliff
Winston who\'s at the Brookings Institution, and Randolph Stempski who
at the time was at American Enterprise Institute. I believe he is now
working in Wisconsin but I\'ve lost contact with him, but he did the
econometric work.

Our goal was simply to look at the market for the statin class of
cholesterol-reducing drugs and see whether we could detect an impact of
DTC advertising generally and the August 1997 change in FDA policy on
DTC advertising in particular. We started out by gathering some data
from IMS Health which involved considerable negotiations but eventually
we got the data that we wanted.

Let me proceed here. This will require some study that you can ignore
because the next one is what the previous slide should have looked like.
This is simply the attachments which I imagine are available online or
will be available online. So I am describing basically \-- I\'m
summarizing results of the first article that is listed there and the
other article just includes a few remarks that I published in [Health
Affairs]{.underline} earlier this year.

This is an abstract. I\'ll skip that. Then you\'ll see essentially the
problem that we encountered in our study. This is a graph of the total
number of pills this man is on on a monthly basis, again, based upon the
IMS health data. We have a big line indicating when the FDA changed its
policy towards DTC advertising.

There is no doubt that the statin market has been growing very steadily.
Almost, you could say, relentlessly throughout this entire period. Our
data started in 1995 and went through the year 2000. We wrote the paper
early in 2001. There is no obvious impact of the change in FDA policy
and DTC advertising, at least as far as this particular market is
concerned.

We got data on advertising and promotion. This graph represents the
total promotion being spent on the statin class of drugs. Actually,
those numbers are pretty big because we are looking at monthly
expenditures and so, for example, \$30 million per month is the
equivalent of \$360 million per year which is a pretty substantial
promotion budget for just one product category.

Again, to our surprise, there was not a large difference in the volume
of statin advertising until late in the year or in the middle of the
year 2000 but there are considerable gyrations and these gyrations are
more obvious in the next graph which breaks down promotional
expenditures by media.

The broken line near the top is detailing toward a position and in this
it\'s almost every other pharmaceutical market. Detailing is still the
primary mode most of the time for promoting prescription drugs and
detailing have become quite substantial before August of 1997 and
continued to be sought and substantial and most of the time, but not all
of the time, dominated the market.

The heavy purple line is television advertising and, as you would
expect, the volume of TV advertising for the statin drugs has been much
larger since August 1997 than it was before. Again, in the year 2000 it
became quite large at times.

There is another line there for print media. There is a small broken
line near the bottom for medical journal advertising. The relevant thing
here, I think, is that detailing aside there are actually considerable
gyrations in the volume of these different forms of advertising,
especially TV advertising so that if this advertising was having a
short-run effect, we figured that we probably would be able to pick it
up because there is simply a lot of variance in these particular
explanatory variable.

We didn\'t find much. We employed basic econometric techniques because
the dependent variables we were looking at which is the total number of
prescriptions and various other measures such as total sales, number of
new prescriptions, number of refills, etc.

Because there is an obvious trend in those data, we de-trended the data
as we normally do and we could not find a significant relationship
between the volume of promotion including the volume of television
advertising and the dependent variables we were looking at such as the
number of prescriptions being written or total sales.

We looked at lag measures of these variables. In other words, the
previous month\'s number of prescriptions, etc., and we are never able
to find anything. We even were not able to find any connection between
advertising at the brand level and market shares at the brand level
which was a genuine surprise for us.

We kept working, of course. I should mention that the original goal of
this effort was to, first of all, to estimate the impact of DTC
advertising on statin prescribing and then we were going to estimate the
net benefits to patients and to the health care system generally from
the uptake on statin drugs induced by the advertising because we didn\'t
find the effect of the DTC advertising. We never got to the step of
assessing the benefits of the advertising.

I will explain in a moment why we don\'t take this as evidence that the
advertising as no effect. We just think it\'s not easy to detect, at
least with the kind of data that we worked with. In fact, I should say
something about that. If you think about an ad for a statin drug, it\'s
really effective.

A Dan Reeves ad for Zocor and you think of what it might do and you can
imagine three or four different kinds of patients responding to that ad.
Patient No. 1 may be someone who sees the ad and says, \"Boy, this is
worth pursuing,\" happens to have an appointment with the doctor next
week, goes in, sees his doctor.

He talks to the doctor and the doctor says, \"Yes, I have mentioned
these drugs before and you have been rather reluctant.\" The patient
says, \"Well, I\'m convinced now.\" The doctor says, \"Wonderful.
Here\'s your prescription.\" The patient goes out and gets it filled.

The next week patient No. 2 goes in and says to the doctor, \"I saw an
ad. I\'m really worried about cholesterol.\" The doctor says, \"You have
good reason to be worried about your cholesterol. I\'ve been following
that. I think you ought to do something about it. Here is what you ought
to do.\"

He gives him some dietary recommendations, etc. He says, \"Come back in
three months and we\'ll see how you\'re doing.\" I have been through
that. He comes back in three months and there\'s been very little change
and then he gets the prescription.

Patient No. 3 is already on a statin drug. He has been rather slip sod
in maintaining the prescriptions, sees the ad, is reminded of why he had
the prescription in the first place, goes out and gets it refilled, but
he may not get it refilled for a month because that is when his
prescription runs out.

You can see the difficulty. You can have an ad that is quite effective
but the effects of the ad will be dispersed over time and working with
monthly data it could be very difficult to disentangle the effects of
the ads from anything else that is going on.

I should mention we did try to take into account other variables such as
the prices of the drugs. There isn\'t much to take into account there
because the prices were very stable. I\'ll have a graph about that at
the end.

We try to take into account what you might think of as the information
environment. That\'s not easy to do, as you can imagine. We did put in a
dummy variable for the original results from the 4F studies when it
appeared, I think, in \'95 or \'96. I\'m not sure when it was. I\'m sure
Bob Temple knows when it was. That didn\'t change our results. We still
couldn\'t find anything from advertising.

We then began to be curious about what we might be able to figure out
about this market. We went to Scot Levin and got another dataset from a
panel they maintain of physicians because we are interested in what was
going on in doctor\'s offices.

This is a graph of new high cholesterol diagnoses in this particular
dataset. I have forgotten exactly how Scott Levin codes a high
cholesterol diagnosis but I don\'t think it\'s simply a measurement. I
think it is something more than that. The doctor has to decide \-- the
doctor and patient have to decide to do something.

You can see diagnosis is increasing steadily. Again, it\'s not clear
that they have been increasing more rapidly since August 1997 than they
were before. Figure 5 is the number of visits being paid to doctors by
patients who are under treatment for high cholesterol.

Again, you can see the trend. It\'s a very strong, very vigorous trend.
Again,almost a relentless trend throughout these years. I suspect it\'s
continuing more or less the same way, although from what I\'ve read it
may have leveled off in the last six months or year.

We explored these datasets. We couldn\'t find a connection between DTC
advertising and patient visits. I don\'t know why this thing keeps on
moving forward. I don\'t think I\'m touching anything. And that didn\'t
surprise us at this point because of the lag effects that I have
discussed earlier.

We constructed a variable that we call success which is the proportion
of patients under treatment whose cholesterol is maintained below what
was then more or less a benchmark level of 200 for total cholesterol. We
found that the proportion of patients who were being successfully
treated appeared to have a positive impact on the number of new patients
who were being diagnosed and treated for cholesterol.

We interpret this as evidence of something that we strongly suspect
takes place which is a considerable amount of word of mouth discussion
of cholesterol generally and of the statin drugs.

Specifically in our suspicion, which is one reason we looked at this
relationship, is that when people take their statin drug, go back to the
doctor, see their cholesterol levels plummeting that they talk about
this. They talk to their relatives and friends and so on and this tends
to build up demand.

We then explored the relationship between advertising and this variable,
the success variable, that is, the proportion of patients who are being
successfully treated and we did find a positive relationship between
advertising and that which we interpret as, I would say, speaking as at
least a quasi-econometrician, is crude evidence that advertising
reinforces word of mouth which, in turn, reinforces the detection of
high cholesterol and the treatment of it with statin drugs.

Some conclusions about what we found. We couldn\'t find any evidence of
any adverse effects from the DTC advertising. There is no tendency, for
example, towards over-prescribing of statin drugs. There have been
several studies, most of which have appeared since then, in which people
have tracked diagnoses of cholesterol and have not found any tendency
toward over-treatment.

We certainly did not find that in the dataset that we looked at. In
fact, one of the things that struck us when we looked at the Scott Levin
dataset where you have the cholesterol readings of the patients who are
being treated by these physicians is that the point at which physicians
were intervening to treat patients seemed to be very consistent.

As I recall, they were following a guideline that says you start
treating it at roughly total cholesterol of 240 or so and then you
persist with that, at least until it\'s under 200 if not considerably
further. Essentially we found that the pattern seemed to be quite
stable.

That is, physicians were intervening at roughly the same point
throughout this time period but there is no indication that they were
just handing out prescriptions regardless of people\'s cholesterol
levels.

As I mentioned, we found no primary effect from advertising in overall
demand. We did find an intriguing relationship between advertising and
the extent to which patients were being successfully treated which, in
turn, had an impact on the extent to which patients were being treated
period.

There was no indication that DTC advertising might be bolstering the
prices of statins. This last figure in my presentation is the IMS health
dataset for deflated prices of statin drugs. It\'s a weighted market
average. Price data, as you all know, are not perfect in this market.

No one really has the exact prices that are negotiated between the
manufacturers and PBMs and managed care organizations and so on. On the
whole I think that the IMS dataset at least is a pretty good proxy. And,
as you can see, prices have been extremely stable in this market. During
this period there was the entrance of one or two drugs. I think that all
of these data was collected before Bay Call had exited from the market.

So those are the overall conclusions of our study. We were modestly
encouraged in the sense that we didn\'t see a downside from the statin
ads. We saw room for a considerable benefit from those ads. We saw a lot
of evidence that the doctors continued to play the dominate role in this
relationship.

There\'s very little indication that the patients simply get
prescriptions simply as a result of seeing an ad. There has to be
something else going on. That something else appears to be a fairly
deliberate process of patients looking at their cholesterol levels, at
their progress, etc., and then at some point initiating drug therapy.

So, Melissa, I\'m done. Thank you.

MS. MONCAVAGE: Thank you very much, Dr. Calfee.

Our next speaker is Dr. John Hallberg from the University of Minnesota.

DR. HALLBERG: Good morning. Thank you for having me. I\'m Jon Hallberg.
I\'m an Assistant Professor in the Department of Family Practice and
Community Health at the University of Minnesota in Minneapolis.

I\'m also the Medical Director for the primary care center there. I
mention those things because I think I will bring to this morning\'s
presentation a unique perspective as someone who is in the trenches.
That is, in fact, what led to this study that you will be seeing before
you.

\"I Saw This Ad Last Night\...\" is the title of the talk. DTC
advertising and the incidence of patient requests for medications. I did
this study with two of my colleagues, Karyn Baum, a General Internist in
the Department of Internal Medicine at the University, and David Powers,
a colleague of mine in the Department of Family Practice.

I think there are a couple of unique things to point out. In the twin
cities we have been incredibly HMO saturated for years. I think that
brings a unique perspective to this.

And what we wanted to do with this is to create a snapshot, if you will,
in looking at the incidents to see what is it like kind of in the day of
a life of a family physician or general internist and how these requests
are coming to us and, in fact, to sort of quantitate some of that stuff.

As background, I think what led us to this study was simply just
anecdotal around-the-table discussions and perhaps some frustrations
that we had had. We certainly felt that we are increasing amount of time
discussing DTC advertised drugs with our patients. I\'m not saying
that\'s a bad thing.

I\'ve got a slide where I will address that in a second. But it was
certainly more time consuming and at a time when we were spending 10,
15, 20 minutes with patients with multiple questions. If a request for a
drug comes up, it can take considerable time and really derail the
process.

But we found as we did some background checking that a lot of the
reports, in fact, were like ours, anecdotal, just sort of conversations
and letters. There didn\'t seem to be a lot of information about the
direct impact on, at least, primary care practice.

Keep in mind, I mean, as a primary care physician, as gate keepers, if
you will, I would include pediatrics and perhaps even OBGYN in that mix.
We sort of take all comers. We don\'t focus just on high cholesterol or
just high blood pressure or erectile dysfunction. I mean, it\'s anything
and everything. Questions can really be wide ranging.

I won\'t go into this much. Obviously you probably know the advantages
and disadvantages. Certainly one hope that by advertising it will
increase awareness of treatment options and perhaps lead to the
discovery of underlying disease that had heretofore been undiagnosed.
Certainly in Powers patients we hope to perhaps pick up or catch some
co-morbidities.

There is some argument that if you catch disease early enough through
advertising, getting people in the door, that we might treat conditions
or discover conditions that had otherwise not been picked up and,
frankly, it would be much worse if they were caught after the fact.

Disadvantages, of course, pressure to prescribe expensive and
potentially unnecessary drugs. I think many of my colleagues feel that
it is just simply flat-out a waste of time. This, of course, can lead to
an adversarial relationship between the provider and patient or consumer
or customer as we are shifting our language a little bit. Of course,
there is concern of elevation of drug and over-all health care costs.

So the questions that we pondered and looked at, and the main one is
simply this: How often do patients want to discuss these drugs, these
DTC advertised drugs? And how strongly do they want to get that
medication if, in fact, they are inquiring about it? When and how did
they learn these medications and are there certain predictive
demographic characteristics that indicate who is more likely to inquire
about these drugs.

Here is the snapshot if you will. Here is the little piece. All patients
checking in for appointments at three University of Minnesota affiliated
primary care clinics during a two-week period of time were given written
anonymous surveys while waiting in clinic lobbies.

We thought we would get them there and have them fill them out rather
than in the exam rooms where the physicians might have some influence on
them or make them feel uncomfortable. These were not done
simultaneously. The surveys were done over two-week periods but at three
different two-week periods of time but within a three-month overall
window. Of course, the completion of the survey was voluntary.

I think it is interesting to note that the three clinics that we chose.
If you can picture the twin cities, St. Paul is east of Minneapolis. We
chose a clinic called Bethesda. It\'s at St. Joseph\'s Hospital. It\'s a
Catholic hospital.

It\'s an inner-city situation and we have a very large Hmong population.
For those of you who may know the Hmong population, they are people from
Laos. I think we have the largest urban population in the country and
California is either first or second. At least a third to a half of the
patients at that particular clinic is Hmong.

Then on the west side of Minneapolis entering a suburb called St. Louis
Park we chose a hospital based \-- affiliated, rather, clinic. It\'s
inner-suburb, strong middle class background. In my clinic we have
approximately 26,000 patient visits a year.

I, myself, at the time the study was done was 80 percent clinic time so
I have seen patients the majority of my time. We have a diverse patient
base; professors to people in the community. You might guess a fairly
highly educated group but very diverse, too. Large Native American,
African American, and Somali populations.

So the questions that we asked specifically are these. \"Do you plan to
discuss a specific medication with your doctor at today\'s appointment?
Did you make your appointment for this purpose? Where did you learn of
this medication? How important is it that you receive it?\" Then just
gathering some demographic information.

Here are the results. 962 patients completed the survey which was about
a 60 percent response rate. Some of reasons for non completion
\--frankly, we thought the response rate would be higher given the
typical wait time as, I\'m sure many of you who go to your primary care
physicians unfortunately probably realize, there is usually a little
time there.

But the two main reasons we found were that the patients were simply
waiting for an interpreter who hadn\'t shown up yet. In one of the
clinics the room process was actually too efficient. They were whisked
away before we really had a chance to get them.

Despite that, we had a roughly 30 percent breakdown between the three
clinics. We really spread the data between the three sites. We found
that 99 then of the total patients representing 10.3 percent of those
planned to discuss with their physician the medication that they had
learned of outside of the physicians office so a significant number of
people.

It wasn\'t the reason they made the appointment but they wanted to
incorporate as part of this. My own gut reaction to this is this is now
low. I mean, I think physicians now would say it seems to be higher than
that. We found that 10.3 percent felt that way.

A third of those patients, or 3.1 of the total, specifically made their
appointments for this purpose. I was doing some analysis of my patient
records recently and 3.1 percent may not sound like a lot but if one in
30 of my patients had pneumonia or mononucleosis or conjunctivitis I
would be a little bit surprised.

I know looking at my data that this is more common than those conditions
so it certainly ranks up there among one of the more common reasons
people are now coming to see us. Of those wanting to discuss the
medication, 84 of the total, 84.8 percent could name it or knew it well
enough to describe it such as, \"That little purple pill for
heartburn,\" or, \"That little thing that is behind the home plate for
erectile dysfunction.\"

Probably not surprisingly patients learn of these medications mainly
from television. Family and friends as a cluster came in second at about
a quarter of the patients. And then magazines accounted for 15.7. Now,
there were other sources. I didn\'t include them all here but certainly
newspapers, billboards, radio ads all contributed but over half were
television and magazines.

Then with the family and friends I should note that many of the
annotations written said things like, \"My sister wants me to ask you
about this,\" or \"My mother would like we to ask you about that,\" or
something along those lines.

Interestingly, patients were split as to how strongly they felt they
actually needed these medications. Again, this doesn\'t add up to 100
percent. It didn\'t include all the sort of gradations.

Almost a quarter were very sure that they actually needed this
medication even though they were currently not on it. A little over a
third were undecided and wanted our information or input as to whether
they needed it or not.

There were a significant number that were very unsure they needed it but
those folks generally were saying, \"You know, my husband has got this
condition or my son has this condition. What do you think about that
drug they have been advertising?\" That\'s where those came in.

Fifty-three different medications were identified by name. I would have
guessed before the survey that, you know, Viagra or something like that
would have been way at the top of the list with a number of responses
but that was not the case. Prevacid was the first, then Viagra, Vioxx,
Allegra, Selexia, Zolof, and on down the line so you can do the math.
There were a lot of medications that people were asking for.

Not all, by the way, were prescription. Of this some were things like
Benadryl but a lot would be things like Allergy Med that has the
advertisement with the guy going through the wheat field on a wind
surfer or the antihistamine with the balloon in it.

More women than men completed the survey. This actually kind of reflects
just the fact that women go to their primary care physicians more often
than men do so this is almost completely what we would expect, 63.1
percent versus 36.9.

And this is quite surprising and this may reflect that Minnesota has a
very high graduation rate from high school and very highly educated
populous. The majority had more than 12 years of schooling so 60 percent
of our patients had completed more than high school.

I think this is very interesting, too. You would think that the heart of
the mid-west, the twin cities, that it would be overwhelmingly
Caucasian, English speaking, and I suppose that\'s true when you compare
this to other metropolitan areas, but three-quarters of the patients
spoke English as their primary language. We did this instead of straight
demographic information.

We were really interested in languages. We then listed and they could
check off the boxes figuring these would be the big ones, Hmong,
Spanish, Vietnamese, Somalian and Russian based on immigration
statistics in the twin cities.

Actually, other 9.1 percent was the next cluster and there were 36
different languages identified as being primary. In other words,
languages spoken at home as their first language. As you can see, Hmong
was our next cluster there, then Spanish and then on down the line.

Just to give you a little flavor of the languages, here are a few just
in alphabetical order. I think it would be a poor Minnesota study if
there weren't at least one or two people that listed Swedish as their
primary language.

Finally, we had our statistician do some aggressive analysis trying to
figure out if there were any differences based on clinic site, age,
gender, educational level, ethnicity, primary language and we found
none. Across the board it was very, very similar.

So, in conclusion, patients commonly want to discuss a wide range of DTC
advertised drugs with their primary care physicians. Occasionally
patients make appointments specifically for that purpose. \"I want to
discuss this drug with my physician today and that\'s why I made this
appointment.\" Again, that percentage, that 3.1 percent of the time is
more than I see people on an out-patient basis for things like
pneumonia, mono, conjunctivitis, and the like.

Patients learned of these medications from a variety of sources.
Television is the most common one. Patients are uncertain as to their
need for them but they want to discuss them nevertheless so this is a
time consuming and, one has to agree, educational opportunity and time
of exploration for us as providers. But it does eat away at our day and
consume time.

A significant minority will request a particular drug. Then finally,
there were no significant, predictable demographic characteristics that
would identify who might be more interested in discussing or requesting
a DTC advertised drug. I think of this in the sense that I look at my
schedule before I begin the day and so I realize that I can\'t guess
based on gender, age, ethnicity who is going to be more likely to ask me
that day about medications.

So further studies that we would like to engage in and look at would be
certainly include making a larger study, probably multi-institutional.
We don\'t have a rural aspect to this study. This is very urban. One
could say it is slightly suburban but we would like to expand it. We
have a network in Minnesota where we really could do more of a rural
approach to it to see if, in fact, the penetration is occurring there at
the same rate.

Then two follow-up points that have come up in previous conversations.
One is \-- and this has been explored, I know, in research \-- how often
do patients actually get the medications they requested or wanted and
discussed. Kind of what we call the cave-in value. How often do you sort
of go ahead and prescribe it.

Then something that is now coming up, and you may notice this yourselves
when you\'re watching some of the ads, is there is the rather rapid at
the end of the ad discussion of side effects. We are now seeing people
who say, \"I\'m on Lipitor but what about all these side effects I heard
about on the TV? You didn\'t tell me about those to begin with or the
pharmacist didn\'t tell me.\"

So now people are coming in quite alarmed by the potential side effects
which often quickly and quietly the word death will be in there. This is
raising another issue and I think we need to explore that more fully.

Here is my contact information. Thank you.

MS. MONCAVAGE: Thank you, Dr. Hallberg.

Our next speaker is Dr. Frank Lichtenberg from Columbia University.

DR. LICHTENBERG: Well, thank you and good morning. It is my impression
that the ultimate question that the Commission really wants to explore
is what the impact of direct-to-consumer advertising is on public
health. Public health is kind of multi-dimensional. That would include
longevity, quality of life, productivity, and other things.

While this is clearly a fascinating and important issue to investigate,
I think it would be extremely difficult to investigate this directly. It
would be very hard to run an experiment where we are going to sort of
change advertising and see how people\'s health reacts to that.

So instead I think that really we should think of this as kind of a
two-step process. In the first stage the question is what effect does
advertising have on the utilization of drugs in general, and
specifically of new drugs because it is true that probably the majority
of direct-to-consumer advertising on prescription drugs is on new drugs.

In fact, there\'s a lot of evidence that manufacturers of drugs reduce
their advertising of those drugs before the patent expires. When generic
entry is about to happen, firms reduce the amount of advertising so most
direct-to-consumer advertising is of relatively new drugs prior to
patent expiration.

The first question is the impact of advertising on the utilization of
drugs. The second question is what impact does the utilization of drugs,
and especially new drugs, have on public health.

Now, the impact of advertising on drug utilization has been the topic of
numerous studies. Jack Calfee told you about his study a few minutes
ago. And my reading of that literature is although Jack failed to find
much of an impact of advertising on consumption of drugs, there are some
other studies that do find an impact.

However, one of the key findings of those studies is that advertising
does effect utilization of drugs but not at the brand level so, for
example, if Pfizer advertises Lipitor, what that is likely to do is
increase sales of statins in general but not specifically of Lipitor. So
this has been found in a study by Wosinska and another one by Rosenthal
el al.

They looked at two classes of drug, proton pump inhibitors and nasal
sprays. In both cases they found that increased direct consumer
advertising increased utilization of those drugs at the therapeutic
class level but not of the specific brands advertised.

Now, my research really focuses on the second stage of this process and
what my research is about is about the impact of new drug utilization on
various aspects of public health. As I said, I think you need to think
about this part of the process as well as the first stage.

Let me suggest what the key findings of this research which I have been
engaged in for about a decade are. I find that new drugs confer a number
of important benefits including longer life, higher productivity,
reduced utilization of hospitals and other medical services, and
enhanced quality of life, especially among the elderly.

I also find that in the aggregate the benefits to society of new drugs
exceed their cost by a substantial margin. Therefore, increase in
consumption of new drugs may lead to significant improvements in public
health.

One could represent this graphically in that way, and the idea that
direct-to-consumer advertising and other public policies may indirectly
affect public health by affecting new drug utilization.

Now, let me \-- I don\'t have time to tell you about all of the studies
that I have done so I am going to focus on one recent study which looks
at the impact of new drug utilization on longevity. Now, if we look at
data for the world as a whole over the last half century, we see that
life expectancy at birth went from about 47 years at mid-century to 65
years at the end of the 20th century. So almost a 20-year increase in
life span of the entire world population over this period.

Now, what I did in this study was examine the relationship between the
launch of new drugs in different countries and the increase of longevity
country by country.

One thing that we know is that different countries experience different
rates of new drug introduction so these data which are based on data
from IMS Health show that the U.S., the U.K., Italy and Japan are among
the countries that have the largest number of new drugs introduced.
During about a 20-year period there were about 400 new drugs introduced
in each of those top five countries.

In contrast, Pakistan, Singapore, Saudi Arabia, and the other two had
among the lowest number of new drug launches so consumers in those
countries have less access to new drugs than people in the highly
developed countries.

So what I found in this study is that launches of new chemical entities
have a strong positive impact on the probability of survival. Now, it
does take time for new drug launches to have their full impact on
longevity or survival rates which is not surprising because it takes
time for new drugs to get out on the market place to defuse to the
general population.

In particular, I found that new drug launches account for a significant
fraction of the long-run increase in longevity in the world as a whole.
So remember I\'m starting out with the observation. Longevity increased
by about 20 years throughout the world over this half century period.
How much of that can be attributed to the launch of new drugs?

I estimate that, first of all, between 1986 and 2000, the period that I
can study with my data, average life expectancy increased by about two
years in this sample of countries. And my estimates implied that new
chemical entity launches account for about 40 percent of the increase in
longevity in this sample of countries.

Now, actually the easiest way of representing the key findings of this
study are in this chart. What the yellow bars represent is the total
increase in longevity starting from 1986 out to 2000. It indicates that
in the year 2000 on average people lived two years longer. Life
expectancy at birth was two years longer than it had been in 1986.

The blue bars represent the amount of that longevity increase that can
be attributed to the launch of new drugs. As you see, I estimate that
0.8 years, or about 40 percent of the total increase in longevity was
due to the launch of new drugs in these countries.

So 0.8 years of longevity increase over a 14-year period, that averages
out to be three weeks per year. My estimates indicate that longevity is
increasing on average by about three weeks per year due to the launch of
new drugs around the world.

So that is, in a sense, the longevity benefit of new drugs. But what
about the cost? How much is it costing us to achieve these longevity
increases? Well, in 1997 average per capita pharmaceutical expenditure
in the OECD countries was about \$250.

The average person spent \$250 per year on drugs. As I\'ve said, I
estimated the average annual increase in life expectancy resulting from
new drug launches is three weeks a year or .06 years per year. That
implies that pharmaceutical expenditure per person per year divided by
the increase in life years per person per year attributable to new drug
launches is about \$4,500.

In other words, in a sense, on average it cost about \$4,500 of drug
expenditures to increase your longevity by a year. That is far lower
than most estimates of the value of a life year, of the amount that
people would be willing to pay to live an extra year.

Estimates by other economists implied that in the United States
willingness to pay to live an extra year is a number like \$150,000,
much higher than my estimate of the cost of achieving longevity
increase.

So that\'s a snapshot of this study which looks at the impact of new
drugs on longevity. Now I would like in the remaining five minutes talk
about some more recent work which is looking at the impact of new drugs
on productivity. This is clearly a concern to employers.

We know that health care costs are going up. This is the most rapidly
rising part of employee compensation. So employers want to know are they
getting anything for spending all this money on health benefits and
health insurance.

Well, I think they are. First of all, we should recognize that illness
and disability impose substantial cost on society in general and
employers in particular. I hypothesize that new drugs and other medical
innovations like medical devices and surgical procedures reduce the
economic burden of illness and disability.

The evidence that I\'ve developed indicates that the benefits to
employers of new drugs in the form of reduced work loss time and greater
ability of people to work exceed the incremental cost of the new drugs.

Here is some data from the National Health Interview Survey which shows
the percent of people of working age who report that they are completely
unable to work, so 15 percent of people between the ages of 55 to 64 say
that they can\'t work at all because they are too ill or disabled. To
the extent that new medical technology including new drugs can reduce
that inability to work, that can make society more prosperous.

Now, the hypothesis that I investigate in this research is that the
introduction and use of new drugs can reduce the number of work hours
lost due to illness and disability. This can happen in two different
ways.

Suppose the number of drugs available to treat a condition goes up so
that there are new statins or new drugs for asthma and so forth,that can
have two effects. It can reduce the fraction of people who are
completely unable to work, and it can also reduce the average work days
missed by employee persons. On both counts that would increase the total
amount of hours worked by the working age population.

An example of this from the [New York Times]{.underline} a few months
ago, the FDA approved Amevive, a new drug for \-- a new biotech drug to
treat psoriasis opening what doctors say will be a new era in treating
the disease, a sometimes debilitating skin ailment.

Doctors said Amevive, as well as several other biotech drugs, could help
patients with severe psoriasis without the side effects of existing
drugs which can cause liver or kidney damage. New drugs may be better
not only that they treat the symptoms better, but they avoid the side
effects of earlier drugs.

Now, the way that I can do this research is that we can observe
different rates of new drug introduction for different diseases. Here
are two different diseases, thyroid disorders and endocrine gland
disorders which include diabetes. We see very different rates of
introduction of new drugs for these different kinds of disorders.

So what I do in my study is look at the rate of introduction of new
drugs disease by disease and examine the relationship across diseases
between the change in pharmaceutical treatment of the disease and the
change in inability to work due to the disease.

So one of the approaches I adopted was to look at the increase in the
number of drugs approved to treat the condition and ask whether that
results in a change in the fraction of people with that condition who
were unable to work according to the National Health Interview Survey.

I don\'t have time to go into all of that but what I do find is that the
increase in the stock or the cumulative number of priority review drugs
reduces the probability of being unable to work by 21 percent. In other
words, 21 percent fewer people would be unable to work in 1996 as a
result of the new drugs that have been introduced since 1983.

In fact, since in general, that implies that new drugs reduce the
probability of someone being completely unable to work by about 1.4
percentage points. That is, without the new drugs the probability of
being unable to work would be almost eight percent.

Instead it\'s about 6.5 percent due to the introduction of new drugs
over a 15-year period. If we assume that the average value of being able
to work is equal to the average compensation per employee, then the
value of that is about \$500 a year.

I see I am out of time. There\'s my summary. Thank you.

MS. MONCAVAGE: Thank you very much.

Our last speaker for this panel is Dr. Neal Masia, of Pfizer, Inc.

DR. MASIA: Good morning. I always have to lower the microphone. I want
to thank the FDA for having me here to present these data. In my 15
minutes I want to make four fundamental \-- what I think are fairly
fundamental points using what I hope will be fairly straightforward data
that we have assembled.

Two or three of these points you have heard in some detail over the last
day and so I\'m going to go through them kind of quickly. One of my
points was sort of just recently expounded in a lot of detail by
Professor Lichtenberg.

The four points that I want to focus on are, first, that while spending
on DTC and marketing in general is fairly significant, but contrary to
what you hear and what some of the reports are out there that you will
say, that spending is fairly small relative to some other spending that
we do including, most importantly, investment that we do on research and
development.

Second, DTC works by increasing treatment rates. I mean, that\'s what
you\'ve heard in the last day or so. That, of course, leads to increased
spending potentially but as one of the drivers of increased spending,
DTC is actually relatively small, relatively minor compared to other
things that are driving up spending.

The third point I want to make, and this is sort of the meat of what I
want to try to say, is that to the extent that the spending is increased
by DTC, it\'s not because DTC is doing something to price. There really
is no clear connection at all between what happens to the price of
advertised drugs in comparison to what happens to the price of
unadvertised drugs.

Then, finally, my last point is going to be that to the extent that DTC
does incur increased use by encouraging us of newer products following
what Professor Lichtenberg has just said, that is largely going to be
beneficial to society and may come with offsetting benefits to both cost
and to quality of life.

So my first slide, again, addresses the first point that I want to make.
This is a summary of a GAO report from about six months ago that just
compared the size of our investment in R&D compared to other types of
spending that we do on marketing and promotion. What you see is the big
bar on the left is the industry\'s spending on R&D which is a bit over
\$30 billion according to PhRMA last year.

Then you see the various types of spending on marketing off to the right
there and DTC is sort of in the middle at about \$2.7 billion. DTC
spending is roughly 10 percent in comparison to, say, our R&D
investments so \$2.7 billion is a fairly large amount of money but in
contrast to R&D it\'s fairly small.

And the second point on the share of our spending that we do on
marketing is that has actually been fairly constant over time. There
hasn\'t been an increase focus on marketing. What has happened is that
revenues have gone up and so total marketing dollars have gone up in
proportion to that. But as share of our total spending on various
activities, marketing in total is roughly about 15 percent and has been
for the last five or six years.

If you look at DTC \-- I don\'t know why I keep forwarding the slides.
Sorry about that. If you look at DTC which is the blue part of the
screen that you see there, you see DTC has increased since 1997 about
1.5 percent of total revenues six years ago, about two percent of
revenues today. Again, possibly in disproportion to the amount of
attention that it generates.

Now, next slide is a summary of some work done by Rosenthal and others.
This is a report put out by Kaiser just a couple of months ago that
looks at the overall impact of DTC. I think you saw one of the
co-authors of this study present yesterday.

One of the interesting things here is that using the elasticity
estimates the authors were able to look at the data of the spending
increase from 1999 to 2000 and just looked at how much of that spending
increase was probably driven by DTC spending in particular, again, on
the theory that DTC encourages utilization, that causes an increase in
spending. What their estimates imply is that roughly 12 percent of that
increase from \'99 to 2000 could be accounted for by DTC.

Almost 90 percent accounted by other things including new product
introductions, more aggressive treatment, potentially price changes and
other factors. About 10 to 12 percent driven by DTC increased use driven
by DTC. So, again, it is an important driver. It\'s probably not the
main driver.

Now, here is where we get into sort of a little bit \-- it\'s probably
worth me describing the data that I\'ve got here. What we\'ve done is
looked at what I have considered to be major products, major commercial
products in 2002 defined as sort of products with more than \$250
million a year in sales in 2002.

We excluded from this drugs for which there is a generic available or
drugs that went off patent because up until very recently, very little
advertising was done for those kinds of drugs. But over all, that gives
you a sample of about 33, or exactly 33 products with over \$250 million
a year in sales that also had some DTC advertising.

The first question is really can you market your way to success. In
other words, does \-- can you run DTC ads and if you do run those DTC
ads, are you guaranteed sales. The answer to that is no. What you see
here is just a scatter plot showing you the various data points.

On the Y axis there you have the total increase in sales on a
prescription basis from 2001 to 2002. Then along the X axis there you
just see the amount of spending on DTC for each product and each dot
represents a product. You see there are some products that actually had
a fall-off in sales despite failure significant DTC campaigns. You had
some products that had a fairly significant increase in sales despite a
relatively small amount of spending.

If there was a strong correlation between these two if you were
guaranteed success, you would see something that looked more like a 45
degree line there and instead you see, you know, a slightly negative
correlation between the two things.

Now, this is not to say that advertising doesn\'t work but this is to
say that advertising doesn\'t always work and it doesn\'t guarantee
increased product sales.

Now, the real sort of question \-- one of the questions I get a lot is
sort of what is the link between prices and DTC because there is a sense
that, you know, only the most expensive products are advertised and so
the rest of these slides get at this question in a direct way, again
using the same data.

Here what we\'ve done is looked at products with more than \$250 million
a year in sales again, but either they were advertised or they were not
advertised directly to consumers. It turns out that there are 76
products that fall into my greater than \$250 million a year category,
33 of which had advertising, 43 of which did not have any direct
consumer advertising which is perhaps somewhat of a surprise.

Now, if you look at the mean price of those drugs, this is the estimated
retail price according to Scott Levin, what you see is that the ones
with advertising actually had on average a slightly lower price, that\'s
the blue bars, than the ones with no advertising.

In other words, unadvertised products on average are a bit more
expensive than the advertised products. If you look at the mediums, you
see that they are much more similar and, in fact, the advertised
products slightly higher on the medium basis.

The point of this slide is not to sort of tell you how prices determine.
What it is to do is show you there is no clear relationship, no
predictable difference for products that are advertised and products
that are not advertised. There is not a clear connection. That is not a
key determining variable.

Now, if you look \-- it is also interesting to look within the category
of advertised products. It\'s interesting to look again at sort of how
much advertised \-- how the level of advertising varies and is connected
potentially to prices. That\'s what you see on this scatter plot.

Again, this is the 33 products that do have significant advertising and
\$250 million a year in sales or more. Again, what you see is that the
level of advertising, which is what you see along the X axis, really
shows no correlation \-- no strong correlation at all between the price
of the advertised drug and the amount of advertising that is done.
Within the advertised category, again, no strong connection.

Now, if instead of looking at levels, another way to go would be to look
at price increases. There is a school of thought that says perhaps the
price increases are \-- that price increases somehow finance these DTC
campaigns. Despite the fact that DTC is only two percent of total
revenues, there\'s a sense that\'s what\'s going on.

So what we did was, again, looked at the two types of big selling drugs,
those with advertising and those without. What you see if you look at
the right hand side of the graph, again, the blue bar is products that
had advertising, the 33 products that did have advertising in 2002, and
the other is the products that did not have advertising. What you see is
the price increases are very similar. No distinguishable differences
between the two. And for 2000, 2001 it was much the same story. No real
difference.

Once again here on the next graph, the next slide, I looked at within
the category of advertised drugs what happens to prices over time and
compare that to the level of advertising. Again, you see no clear
correlation at all. Some negative sort of tilt to that graph but I
wouldn\'t make a claim there. What I would say is that it doesn\'t seem
to be any relationship between prices and DTC.

So, again, my point there is fairly clear which is to reiterate, and to
perhaps beat a dead horse, there doesn\'t seem to be a connection there.
Now, my last point is really to focus on the spending increase.

I\'m not here to say that DTC does not drive up to some extent use and
diagnosis rates, and I think it\'s important, as the previous panelists
have discussed, to really look under the hood there and understand what
does that utilization increase really mean.

This slide summarizes another part of Professor Lichtenberg\'s large
body of research on this topic. The way that DTC works, the only way
that it can really work is by getting a person in to see the doctor.
They have to participate in their own health care.

To the extent that this is increasing utilization, it\'s by getting a
person to show up and getting a prescription. To the extent that is
focused on newer products, Professor Lichtenberg\'s work says that newer
products tend to pay off. The use of those newer products tend to be a
very good investment.

This study in particular looked at the economic impact, the specific
dollars and sense impact of using newer products versus older products.
What he found was roughly a seven to one ratio of benefits to cost of
using the same patient with the same diagnosis and so forth getting
prescribed newer treatment. That new treatment tends to cost something.

If you look at a 10-year age difference between the drugs, he finds that
the cost of roughly \$18 different so a fairly significant difference.
That \$18 investment, according to Professor Lichtenberg\'s findings,
saves you significantly in other health care areas, in particular in
hospitalizations, to a lesser extent office visits and home health.

The \$18 investment actually gets you \$129 in savings in other parts of
the health care system. So if your goal \-- if you have sort of a
longer-term look at spending, then yes, it\'s true that the ads work by
getting you to the doctor. That cost money. Going to the doctor cost
money.

You may get a new prescription. That also cost money but what this data
says is that those are investments that are going to pay off in the form
of reduced spending elsewhere in the form of improved mortality rates
and improved quality of life and so forth.

I think I will conclude there. In summary, again, I will reiterate my
four points which is that our investment in R&D is significantly larger
than our investment in marketing and promotional spending. That DTC does
increase utilization but it\'s a fairly small contributor to that total
increase.

That the use of DTC advertising does not guarantee market success but
that to the extent that it does work, it doesn\'t work by changing our
prices. Finally, that to the extent that we are causing the utilization
of newer medicines with this advertising, that is likely a very strong
and good investment for public health. Thank you.

MS. MONCAVAGE: Thank you very much.

Now I would like to give the FDA panelists and the presenters an
opportunity to ask questions.

MR. PITTS: Thank you, gentlemen. Dr. Masia, I have a couple of questions
for you. My first is you refer to the Kaiser study and their finding
that DTC advertising raises health care utilization costs by 12 percent.
You weren\'t clear in your presentation but that is what you meant,
right? It doesn\'t raise the price of pharmaceuticals by 12 percent. It
raises the cost of health care utilization by 12 percent.

DR. MASIA: Actually, that\'s not quite what I meant to say. The 12
percent number was actually \-- if you look at the overall increase in
spending from 1999 to 2000 on drugs, 12 percent of that increase is
accounted for by DTC according to their study so it doesn\'t cause
spending to go up 12 percent. It is 12 percent of whatever the spending
increase was.

MR. PITTS: I just wanted to be clear on that. Also, you mentioned that
higher expenses in advertising does not necessarily result in higher
sales and that some lower advertised brands cost more and some higher
advertised brands cost less, those within the same class of drugs.

DR. MASIA: That is likely true within the same class of drugs, although
I would have to look at the data again. That was in an overall sense but
within the classes of drugs, I\'m sure that would also be the case.

MR. PITTS: So within a given class of drugs there is no correlation
between the amount of money spent in advertising and the cost of the
drug?

DR. MASIA: I would have to look class by class. I haven\'t examined it
in a class-by-class basis but I am sure it would vary by class.

MR. PITTS: I found that is a very interesting way to look at it but then
you look at it that sodas cost less than cars but they spend more on
advertising. That\'s why I\'m asking the apples to apples question.

DR. MASIA: If you look at it again on a quantity change basis, which I
didn\'t show you that slide, but if you look at on a change in quantity
basis which gets you more to the apples to apples, you find very similar
results.

MR. PITTS: Thank you.

DR. AIKIN: This is also a question for Dr. Masia. In each of your slides
where you show a negative correlation between advertising and price and
advertising and market success, you have excluded HIV drugs. I was
curious why you did that and whether when you included HIV drugs back in
the calculation, is it still a negative correlation?

DR. MASIA: Sure. It doesn\'t change the results at all to include the
HIV drugs and the only reason they were excluded was that the \-- well,
I think there were only three of them that actually wind up in the
analysis.

I excluded them because the prices and the pricing structure of those
drugs were fairly different and so in order to keep the comparisons
consistent, especially given the growth of those drugs, the rapid growth
in the time period, it seemed intuitively better to leave them out. If
you include them it has no impact whatsoever on any of the findings.

DR. AIKIN: And if I could just ask a follow-up question. Given all of
these negative correlations, if I were a pharmaceutical company this
would seem to be awfully optimistic to continue to advertise at such
high levels given that you have negative correlations between
advertising and price and market share.

DR. MASIA: Well, if you look at it on a price basis, what I would say is
a lot of different things go into the pricing equation so it would be
sort of unfair to characterize this as the one determinant of what is
going to happen to your price.

I do think that there are a lot of other factors there. The overall
sense, though, is that there is clearly a good business proposition for
us to do this advertising. In other words, it does often work. On
average I think it does work. The slides with negative correlation are
all sort of within the advertised categories.

That doesn\'t really get at the question of does advertising work at
all. I think the studies by Wosinska and others that sort of point to
these class effects, I take those studies for what they find which is
that if you increase those class sales, the benefits accrue to you sort
of in proportion to your market share.

I think there is a good business proposition to getting people in and
getting them diagnosed and treated and, of course, it\'s great for
patients to do that as well but it\'s not the only determining factor. I
think there are a lot of things that go on to determine that sort of
quantity growth path.

DR. TEMPLE: Dr. Calfee, the lipid lowering study is a little depressing
in some ways because it doesn\'t seem to have had an impact and there
was a fairly large amount of promotion, but it\'s a setting in which
there was already a lot going on that might have triggered growth all by
itself.

The NIH has a program. Probably a new study showing survival benefits
came out every year during that period and it\'s hard to avoid that so
you would have to be living somewhere very strange not to know that this
was important, at least as far as the physicians go.

It\'s still a little surprising to me that you didn\'t get more people
in to get their cholesterol measured but, anyway. Have you looked at
other settings in which there wasn\'t so much background stimulation to
growth?

DR. CALFEE: We\'d like to do that. We were \-- I mean, when we started
this study we expected to find exactly the opposite of what we ended up
finding. As soon as we saw that very first graph showing such a steady
increase, we knew it was going to be difficult to find anything.

I ended up not as depressed after thinking about it as the econometric
results were rolling in partly because of what I mentioned earlier about
how difficult it would be to disentangle the effects of these ads
anyway.

I think that is one reason why people are getting mixed results, at
least on the statin market, and why they are getting this strange
situation in which you are getting a class effect without a brand effect
which, speaking as someone who has done a lot of research on
advertising, generally that\'s a pretty unusual result.

I think if there is any market where you would find that, it would be
this market because I think that most patients if they go and talk to
the doctor about Zocor, it wouldn\'t take very \-- it would not be very
difficult for the doctor to say, \"Let me tell you about Lipitor. Let me
tell you about Crestar or whatever.\" None of those things are
surprising.

I think that what has yet to be learned is the reinforcing effects of
these ads on refills, etc., and those may be really, really important.
We also don\'t know how many people there are for whom a DTC ad actually
helps overcome resistance to prescription.

I mean, I think most people talk about situations in which a patient
wants a prescription. The doctor doesn\'t want to give it to them. My
internist tells me that as a general rule his patients don\'t like to
take drugs and he has to persuade them to take one if they are going to
take one at all.

I think that in some cases what we are seeing with the statin ads is
that it\'s overcoming some of that resistance before the doctor actually
encounters it. That doesn\'t answer all of your questions.

DR. TEMPLE: There\'s still no inflection of the curve when DTC starts.

DR. CALFEE: That\'s right. That\'s right. Of course, there was a steady
succession of studies which were going to the doctors rather than to the
patients. There are other markets, you know, in which the situation
would be much more promising where you might be able to find the
immediate effects where you don\'t have to go through these other
things. But it\'s not an easy market to examine generally.

DR. TEMPLE: Then I also had a question for Dr. Lichtenberg. Looking at
sort of mass data on survival and new drug intervention and new drug
discoveries in marketing may be your only choice, but it\'s sort of
unsatisfying because you don\'t quite know what\'s driving it.

Do you have any sense from what you do or what other people have done
about which components of the overall introduction of new drugs are
responsible for this? I mean, just not to state the obvious, in any
given year a very tiny fraction of new drugs have an impact on survival
or have been studied for that. That would be a very unusual thing once
you leave AIDS and cancer.

I looked actually at the 2002 and except for AIDS, cancer, and I guess
you could argue antibiotics; none of the drugs in their initial
appearance had any effect on outcome because that\'s usually studied
after marketing, not before. So what\'s driving this thing that you see?
But maybe you don\'t study that so that would be an okay answer, too. I
just wondered if you knew.

DR. LICHTENBERG: I\'d be surprised if cardiovascular drugs did not also
have significant longevity benefits and there has been work by David
Cutler and co-authors at Harvard about that.

DR. TEMPLE: Overwhelmingly.

DR. LICHTENBERG: Right.

DR. TEMPLE: It\'s not clear the new ones in any given year are better
than the old ones. They absolutely do have major effects. There is no
question about that.

DR. LICHTENBERG: So, no. I mean, my research is very macro. It is trying
to get at the overall question about the impact of new drugs in general
and I don\'t do case studies. I don\'t do clinical trials of specific
drugs but there does seem to be debate about the value of innovation in
general so that is kind of what my research tries to address.

I\'m also looking, I think, at some outcomes that are not typically
addressed in clinical trials such as work loss and hospitalization and
things of that nature.

Now, I do distinguish in some of my studies between priority review and
standard review drugs.

In some cases I find that it really is only priority review drugs that
are confirming these benefits so that the standard review drugs \-- I
don\'t see sort of a great deal of additional value in standard review
drugs.

DR. TEMPLE: Just an observation about that. Most new anti-hypertensives
come out as standard review drugs but I don\'t know whether it\'s being
good people or trying to find a niche in the market place.

There is a huge number of outcome studies done by people who make one
kind of anti-hypertensive drug or another, ace inhibitors, A2 blockers,
beta blockers, which is responsible in very strong measure for the
observation that cardiovascular disease is going down. I have always
found that interesting. Most of that is after marketing work.

One last question for Dr. Hallberg. I understand you observed, and
others have said this here, too, that physicians are sort of bothered by
having to spend time at doing all this. I wondered if you\'ve also \--
you talk mostly to patients, I know, but I wonder if you have
observations about whether they thought that at least some of these
appearances and requests were very worthwhile because the people had
some disease that really needed to be treated and now they had an
opportunity to see them. There must be some balance there.

DR. HALLBERG: Absolutely. I mean, I think anything that gets a patient
in the door is certainly welcome. Drugs in the statin class, for
example. I think one of the things I was observing is that is such an
overwhelmingly positive category of drug that it seems like \-- the [New
England Journal]{.underline} had that article that showed this
incredible benefit to that.

I think the harder thing is when it\'s more the lifestyle enhancing
medications to be honest. I mean, you probably recall the campaign a
while ago for Sporonax. It showed a healthy toenail on the side of
buses. I can\'t believe how many people came in to ask me about that.
The toenail actually looked healthy. It wasn\'t a really bad thick
onychomycodic fungal nail. It was an attractive looking big toe.

Really we spent a lot of time talking about that. Perhaps we could
redefine what our levels of frustration are. If someone is asking about
Viagra, I know my urology colleagues find that is the first point which,
you know, they make sure they get their glucose checked and they get
their cholesterol checked. That is actually a very beneficial encounter.

MS. WOLF: I wanted to ask Dr. Hallberg also, you said that when patients
come in and talk about the drugs the word death sometimes comes up. I\'m
just curious what kinds of risks you get the sense that patients are
willing to take and sort of how much information they think \-- the
kinds of questions they ask you based on the information that they see
presented in ads.

DR. HALLBERG: It\'s a hard question to answer. I think that, again, it
depends on the nature of the drug. If you talk to a patient about the
fact that their total cholesterol is 260 and that they are hypertensive
and diabetic and that their risk of mortality actually is quite high, we
calculate their 10-year risk and its 20 percent and then you calculate
that against the risk of really catastrophic adverse drug reaction, you
have to put that in perspective and it takes time.

I mean, to do it right it is a difficult thing. It\'s harder when it\'s
a drug for hair loss or something else. In fact, that\'s one of the
arguments we often will say is, \"Do you realize that with this toenail
medication we should really be monitoring your liver function tests?\"

They think that the risk really outweighs the benefit in this case.
\"Why don\'t you try this topical or frankly don\'t worry about it?\" It
really depends on the class of drug that we\'re talking about and the
risk associated with the underlying disease.

DR. HARTOGENSIS: Hi. This question is for Dr. Masia. Does your analysis
of top selling products include animal health drugs and, if not, do you
have a feeling of the impact of DTC on vet med products?

DR. MASIA: Unfortunately, it doesn\'t include any of the animal health
products. I would say I would have to look at it. It\'s something that
could be examined and perhaps we will go back and examine it if that
would be of interest.

DR. HARTOGENSIS: Okay.

DR. OSTROVE: Just a quick question for Dr. Hallberg. You say that
patients learn of the medications mainly from television, magazine. I
mean, you have the percentages. Did you make a distinction in asking
them whether they learned from ads versus programming?

DR. HALLBERG: No, we didn\'t. May I ask a point of clarification? By
programming you mean like \-- what do you mean by that?

DR. OSTROVE: Well, new shows, for instance.

DR. HALLBERG: Oh, I see.

DR. OSTROVE: Articles and magazines. There\'s an awful lot of the media
that\'s not just advertising but it does talk about drugs.

DR. HALLBERG: We didn\'t further define that.

DR. OSTROVE: Thanks.

MR. PITTS: Dr. Hallberg, two more questions. One is kind of a follow-up
to Nancy\'s point, which is, were those your three prompts on the
questionnaire: television, family, and friends?

DR. HALLBERG: No. I\'ve got a copy of the survey with me. There are
about seven prompts.

MR. PITTS: That\'s unusual. Yesterday we heard a couple of presentations
that showed the Internet being doubled digits now. I would expect an
educated audience would show up more significantly.

DR. HALLBERG: That was a really small percentage. It was in the single
digits and very low.

MR. PITTS: I also wanted to pick up on Dr. Temple\'s comment in terms of
time spent. As the non-doctor on the panel, let me assure you that as
frustrating as it is for doctors who spend a lot of time with patients,
it\'s twice as frustrating for patients who spend a lot of time with
doctors.

DR. HALLBERG: Understood.

MR. PITTS: My question is back in terms of pressure to prescribe versus
pressure to get to the next patient. What is the gist there?

DR. HALLBERG: You know, I think I\'m in a unique perspective. I had been
in private practice for five years and I will tell you that in private
practice when a typical family physician is seeing 10 to 15 people per
half days, 20, 30, 40 people a day, there is an intense productivity
pressure there.

Anecdotally from my colleagues in the community, they often will write
the prescription just to get them out the door because they don\'t have
the time to argue about it. I think I\'m in a very academic institution
and we assume they look at things.

Many of my colleagues are very involved with evidence-based medicine
projects and, to the detriment of the patients, will start talking
statistics and looking at the pros and cons and overwhelming them with
numbers.

It\'s a very different perspective where I\'m at, I think, now. I think
it would be very fair to say that productivity in primary care
specialties, the emphasis there is so high that you simply don\'t have
time to discuss stuff much. I can\'t extrapolate and say that,
therefore, those physicians will always just give what the patient
wants.

Let me point out, I think that in my case, and certainly in Minnesota,
patients may come to us with the request for a particular drug but their
health plan probably doesn\'t cover it or may not cover it so a lot of
times it\'s really health plan drive. Then we\'ll spend a fair amount of
time going through kind of prior authorization process which I will tell
you is a real hassle.

You have a 1-800 number and call a pharmacy some place and then are on
the line and go through seven or eight different questions to allow a
particular drug to be prescribed. Usually two or three others have to
have been tried before they will grant authorization for that. That
actually is a very time consuming process.

MR. PITTS: I guess where I\'m going to is I\'ve stipulated a lot of time
consuming things on doctor\'s plates and on the plates of practices. In
a perfect world do you feel that patients coming to visit their doctor
because of information received outside of the doctor\'s office is a
good thing?

DR. HALLBERG: The information is a good thing.

DR. AIKIN: Yet another question for Dr. Hallberg. You talked about 35
percent of your patients being undecided and 14 percent being unsure
whether they need the medication. I was wondering if you could explain a
little bit more about the range of that scale because it seems to me
that undecided and unsure may be very close to one another.

DR. HALLBERG: Yes. I actually excluded those. There actually is a
slightly unsure category in there so we could actually expand that a
little bit further. A big chunk of the patients were curious about a
drug, had heard about it, wanted to know more about it.

I think that question really is getting at how many of the people coming
in the door know for a fact that they want a particular medication. We
were surprised by how many people were just curious and would actually
take the time and an appointment to want to inquire about a drug that
they had heard about.

DR. AIKIN: So you are really trying to just distinguish people who were
wanting and were sure they wanted a medication from those who weren\'t
sure?

DR. HALLBERG: Exactly. Just to be clearer.

DR. AIKIN: Okay. Thank you.

MS. MONCAVAGE: If there are no more questions, we\'ll take questions
from the audience. Oh, I\'m sorry.

DR. LICHTENBERG: After a thought about Dr. Temple\'s question about
survival, and perhaps when you look at clinical trials data, you found
that there were not significant survival differences for many categories
of drugs.

However, I would point out that is based on clinical trials data which
is based on a relatively small sample of people. Maybe 1,000 people. I
don\'t know the average size of a clinical trial. I\'m looking at data
for the entire population of all of these countries so I look at data
for every death in the United States, two million deaths per year.

There is a lot more statistical power when we are looking at an
extremely large sample. Admittedly, clinical trials have tremendous
advantages but sample size is not one of them. Even though it might not
be evident in a clinical trial, it could show up in population data.

DR. TEMPLE: It would probably help to look at the specific kinds of
death that are modified. I mean, everybody knows the stroke rate in the
U.S. is coming down and that\'s got to be due to blood pressure drugs
and maybe lipid drugs and, I don\'t know, maybe something else, aspirin
and things like that.

A lot of these wouldn\'t be too mysterious, I think, if one looked at
them. What would be interesting is after you take care of all those,
there are fewer of something else. That would be very interesting.

DR. MASIA: Okay. If you have a question and you\'re in the audience,
please step up to the mike. Would you please identify yourself also.

AUDIENCE MEMBER: (Off microphone.)

DR. HALLBERG: My sense is no because it kind of reminds me of those
credit card ads where the financial details at the end are read so fast
that it\'s just a blur of information. I\'m guessing that it\'s required
to be on there but it\'s so fast that patients really need that sort of
clarification. They are turning to their physicians to sort of ask more
about it. Let\'s face the facts. I mean, I don\'t think that we do a
very good job of discussing potential side effects of medications.

Pharmacies by in large are getting better about that handing out
print-offs and we are also doing a better job of that now in the clinic
setting. I think it\'s creating some anxiety and I don\'t have any
numbers on it yet. It\'s a future study perhaps but that\'s only kind of
a gut level feeling.

MS. MINTZES: (Off microphone.)

(Whereupon, at 10:33 a.m. off the record until 10:34 a.m.)

MS. MONCAVAGE: If there are no more questions, it looks like we are
ending this session a little bit early. Why don\'t \-- let\'s see. It\'s
about \-- should we go ahead and reconvene in about 15 minutes? Let\'s
say at 10 to 11:00. I would like to thank the panelists for presenting
and for the questions and why don\'t we acknowledge them for this.

(Whereupon, at 10:34 a.m. off the record until 11:04 a.m.)

MS. MONCAVAGE: I would first like to make a couple of announcements
regarding what is available. One, just in case you were going to
inquire, we don\'t have any handouts of the presentations available for
you at the meeting. However, the presentations will be available on our
Center for Drug Evaluation Research website within two weeks.

Additionally, the transcripts will be available within six weeks. If you
are interested in ordering a transcript, it\'s on the back of your
program for today. That information is there so you don\'t need to ask
anybody about that.

I would like to introduce a couple more panel members who joined us. 
First is Mr. Glenn Byrd who is with the Center for Biologics Evaluation
and Research and Dr. Martine Hartogensis from the Center for Veterinary
Medicine.

The second panel will also have four presenters. Our first presenter is
Mr. Michael Roberts from the Catalina Health Resource.

MR. ROBERTS: Good morning and thank you for the opportunity to speak
with you today. We would like to talk about some alternatives to the
brief summary. A little bit about our company. We provide useful
information to pharmacy patients. We are an extension.

Our newsletter we call it is an extension of the patient and pharmacist
communication. We assist retail pharmacies nationwide by provide each
patient with a customized educational newsletter. Currently we provide
these services to over 15,000 pharmacies nationwide and it prints with
every prescription.

The newsletter contains information about the proper use of the drug
dispensed to the patient including the name of the drug, indications for
use, drug interaction precautions, adverse reactions, and possibly side
effects. This particular section of the newsletter is intended to
satisfy the useful patient information criteria of Public Law No. 104
through 180 and the action plan for the provision of useful prescription
medicine information.

The bulk of our newsletter, what the Catalina Health Resource newsletter
may also contain would be public service announcements and health
messages from various public service organizations such as the FDA,
additional educational information for consumers, compliance and
adherence advice, health information related to the prescribing
medication or the condition the medication treats, and information and
advertising for health related products including over the counter and
prescription drugs, foods, dietary supplements, and health and beauty
aids.

The brief summary that accompanies print advertising, the manufacturer
reprints most of the drugs full labeling for health care professionals
to satisfy the brief summary requirements. Typically it include all
contra-indications, all warnings, all precautions including
carcinogenesis, mutagenesis, and impairment of fertility, pregnancy,
nursing, pediatric, and geriatric use, table reporting all adverse
events observed in clinical trials and overdosage.

Consumers don\'t read the brief summary and they don\'t understand it if
they actually do read it. There is no real dispute or disagreement the
brief summary needs to be fixed. Over 70 percent of consumers surveyed
in 2002 read little or none of the brief summary.

Fewer people are reading the brief summary now than they did three years
ago. Over 50 percent of the respondents report the brief summary is
somewhat hard or very hard to understand. I think the source of that
survey is well known.

Interestingly enough, January 11th issue of the 2003 [TV
Guide]{.underline} there were ads for the following, among others; an
over-the-counter drug, a weight loss supplement, a food product, a
multi-vitamin with lycopene to reduce the risk of heart disease, and a
prescription drug.

Although the Rx drug is the only product with two intervening steps
before a consumer can obtain the product, it is the Rx drug that has a
one-page ad and three pages of brief summary. It kind of looks something
like that for those of you that have the eye chart.

The fundamental questions are what are we trying to communicate and what
is the best way to communicate that message. The current brief summary
approach of providing all or nearly all of the risk information
associated with the drug does not work.

As an alternative we should consider a staged approach to providing risk
information that considers where the consumer is in the process of
learning about a prescription drug. We should consider an approach that
emphasizes making high quality information easily accessible to the
interested consumer.

What are some of the alternatives to the brief summary? The FDA approved
patient labeling model, the adequate provision model based upon the
FDA\'s August 1999 guidance for industry consumer directed broadcast
advertisements, the Rx facts model, that I will speak to a little bit
further into the presentation, and the useful, written information model
that accompanies dispensed prescription drugs following the requirements
of Public Law No. 104 through 180.

Under the FDA approved patient labeling model the FDA proposed that the
FDA patient labeling could be used in lieu of the current brief summary.
The draft guidance gave examples of FDA approved patient labeling that
would satisfy the brief summary requirement.

Definitely a step in the right direction but there are some problems
that still remain. The patient labeling is a huge improvement over the
typical brief summary because it is written with the consumer and not
the health care professional as the intended audience. With its emphasis
on clean, bold type, clear organization and readability, it\'s excellent
when viewed on a website, downloaded, or printed for a brochure.

But the FDA approved patient labeling is still very long, typically four
or more 8 1/2 by 11 pages. The FDA approved patient labeling is still
very complex and, consequently, legibility and readability are lost once
the information is crammed into a single page print advertisement.

The FDA approved patient labeling fails the standard readability test.
We have conducted readability analyses of the FDA approved patient
labeling for the seven drugs identified in the FDA\'s draft guidance.

We used three standard readability measures, Flesch-Kincaid grade level
which is simply part of standard Microsoft word processing program,
SMOG, simple measure of gobbledygook, readability index commonly used by
the U.S. Government to measure readability, and the Fry Readability
Graph. The measures are based upon words per sentence and syllables per
word. All seven examples from the draft guidance scored at above the
10th grade level on the SMOG test.

All seven examples scored to at least the 8th grade level or higher on
the Flesch-Kincaid grade level. All but one example scored to at least
the 10th grade level or higher on the Fry Readability Graph. Even the
FDA approved patient labeling is written at a high school or collegiate
reading level.

Here is a composite of the seven drugs and the average is at the bottom
averaging out at near 9th grade level on Flesch-Kincaid, 11th grade
level at SMOG, and just about 11th grade level at the Fry Readability.

Another alternative I want to speak to is the adequate provision model.
We suggest that we apply the FDA\'s guidance for industry, consumer
directed broadcast advertisements to print advertising.

Under this model the advertisement must, among other things, present a
fair balance between information about effectiveness and information
about risk, include a major statement conveying all of the product\'s
most important risk information in consumer friendly language, and
describe the adequate provision the sponsor has made for the
dissemination of the drug\'s packaged labeling.

What are some advantages to this approach? The approach more closely
mimics how consumers actually gather health information. It\'s a dynamic
process and consumers often obtain health information, not in a lump but
from a variety of sources in a variety of ways.

National survey on Americans as health care consumers, an update on the
role of quality information conducted by the Kaiser Family Foundation,
and the Agency for Health Care Research and Quality indicates that
Consumers seek out health information from family and friends, health
care professionals, the Government websites, health plans, and other
sources.

This approach mimics that applicable to other consumer products by
recognizing that a single advertisement does not have to contain every
single bit of information that may or may not be relevant to the
consumer. The approach emphasizes importance over completeness. The
major statement communicates the most significant risk information and
completeness is addressed through adequate provision for more
information.

We would like to present the Rx facts alternative. We have prepared, and
I will show you momentarily, an example of a suggested format for an Rx
facts box for the drug metforman and atenolol. This approach brings
prescription drugs in line with other consumer products that have
standardized fact panels, foods, supplements for OTC drugs. The facts
format itself has been subject to extensive testing and consensus
decision making.

The fact panels convey easy to read information to consumers in a
consistent and familiar format. The samples do not purport to include
everything the consumer needs to know before taking these drugs. These
are brigaded formats and so should include an adequate provision
component for the consumer who is interested in learning more.

These samples are intended to stimulate discussion on alternative
formats for the brief summary given that consumers would see this
information at the very beginning of their journey from an ad to a
dispensed prescription drug. We believe that readability and consistency
are higher priorities at that time than providing every side effect,
contraindication, and warning.

This is an example of what this information may look like and we have
completed components such as the active ingredients, usages, warnings,
using the product, directions, other information, and adequate
provision. We\'ve got some actual hard copy samples that we will submit
along to the agency.

The useful patient information model, also a good alternative to the
brief summary. Useful written information must accompany all new
prescription drugs dispensed pursuant to Public Law No. 104 through 180
acknowledging at this point the consumer is a lot further down the
decision path and at this point is actually getting a prescription drug.

Kelly and Health Resource is working with a coalition of stakeholders to
devise a standard format that is scientifically accurate, nonpromotional
in tone and content, sufficiently specific and comprehensive as to
adequate inform consumers about the use of the product and in an
understandable and legible format that is readily comprehensible and not
confusing to consumers.

In conclusion, we believe there is a need for a new paradigm,that the
focus should not be on each individual communication but on what is
needed at the different stages in a consumer\'s journal from seeing an
advertisement to obtaining a prescription drug.

Consumers do not understand and do not need to understand the fine
distinctions between labeling and advertising or broadcast versus print
or brief summary versus full product labeling versus useful written
information versus adequate provision versus FDA approved patient
labeling. One format will not be appropriate in all instances.

For instance, the accompanying information for a magazine advertisement
need not be the same as in-pharmacy communications. It is time to look
at these different vehicles as part of the greater whole. The goal
should be to make quality information in a variety of formats, media and
locations easily available to consumers.

We are seeking the FDA to broaden its guidance to allow industry to
develop these alternatives and then submit the results and the data back
to the organization and find that these different alternatives are
useful for consumers. Thank you.

MS. MONCAVAGE: Thank you very much. Our next speaker will be Mr. Andrew
Schirmer with McCann Erickson.

MR. SCHIRMER: Good morning. As the sole representative of the
advertising community, I\'m going to speak today from the point of view
of those people who create the ads that we have been discussing the last
couple days. It is not only important to us to communicate clearly with
consumers. It\'s what our clients pay us to do. It is very important for
our livelihood and we are pleased to be a part of the discussion today.

If you work for an advertising agency, you are never not doing research.
We are constantly talking to our patient consumers to find out how they
think, how they behave, and what they are doing in regards to their own
health care.

What we decided to do for today is focus on two issues of the questions
asked, the comparative claims in terms of comparative advertising of DTC
or OTC products, as well as the discussion of fair balance. What we
usually do with consumer research is we go out and we talk to consumers
where, in this case, we give them statements and ask them to react.

Now, the first topic we want to talk about is comparative advertising.
In terms of the health care discussion, there are some questions as to
whether it is appropriate, how much information is needed with it.

What we need to do as consumer communicators is understand that it is
within context of the history of advertising and communications of which
comparative advertising has played a role for probably hundreds of
years.

It creates the context for people to make brand or product or even
category decisions by virtue of what else is in the consideration set
for them. Consumers are able to make more informed decisions or choices
based on their product purchases in the rest of the world based on what
they know of every product vis-à-vis the other competitive products.

Now, because of technical issues I wasn\'t able to show a reel today but
what it was intended to do was take us all back to the advertising that
we remember from the old black and white days through current times in
which we can all remember Jif going head to head with Skippy and Hunts
and Heinz, which is thicker, and rolls of paper towels rolling out and
one stops before the other. And cars and leasing deals and telephones
with long distance services clicking away, which is the better value.

It\'s part of the advertising nomenclature that\'s been going on forever
and people are able to discern that there is one point of view here
showing two products and the one point of view is coming from the brand
that hopes to tell you a story about their product so they\'re used to
it.

When we talk in marketing or advertising terms about the cola wars or
the long distance service wars, it shows that it has permeated our
vocabulary in terms of marketing and sometimes even lay consumer
discussions. It\'s also an important part of the consumer decision
making process.

Now, we acknowledge that there are significant shifts once we start
talking about DTC, once we start talking about health care in general.
In terms of the kinds of comparisons that we would be able to use, these
need to be based on labeling, prescription data, perhaps doctor referred
based on raw script data, and head-to-head trials.

In other words, the old Hunts and Heinz pull the can up or the bottle
and see which bleeds down faster is not a part of the discussion in our
minds. What we need to talk about is what are you legally able to say
vis-à-vis the comparative or competitive products.

Understanding also that there is serious health issues surrounding most
health care categories and certainly in the Rx category we need to be
responsible. But at the end of the day the consumer is not the final
decision maker and we need to continue to emphasize that point in these
discussions.

We do hope that the consumer education is able to affect the consumer
doctor dialogue which will drive the final doctor decision. In other
words, we still have that leap that we\'re making there and we think the
consumer is getting more information in order to have richer discussions
with their physician.

Now, in order to prove our point of view, we did some proprietary
research. What we did is used Harris Interactive and we were very
focused on the two questions that we talked about earlier. We took a
sample and we made sure that sample reflected the adult population at
large.

We did a couple surveys with a little over a thousand on each one. The
way the surveys were done was we would put a statement out and we would
ask the participant to agree or disagree with that statement to try to
get kind of as clean a read as we could.

The respondents suffer from a number of conditions, some more than one,
some none at all because we did want to reflect the national population.
We also asked the question of how they were treating, whether with an Rx
solution, an OTC solution, both or nothing at all.

One of the interesting points coming out of this which is no surprise to
those of us who have worked in a number of these categories is consumers
are looking at OTC and Rx in some cases, if not interchangeably, options
for the same indication; specifically, allergy, acid reflux, and
migraine. A great number of patients are using both OTC and Rx.

Now, in confirmation actually of Michael\'s presentation, one of the
things we are seeing is that people do feel that they are getting
information when they are getting either an Rx or an OTC product.

I often read the usage and side effect information that is provided with
my prescription medicine, or I read the back of the package of my OTC
medicines and 92 percent agreed with these statements. It\'s an
important point to make because as was the point made earlier, the
advertising is not the only place people are getting their health care
product information.

Remarkably, almost all of the people agreed with the statement,
\"Understanding the differences between medications helps me make better
health care choices.\" This is not something that has them uncomfortable
in any way. I say remarkable simply because it was almost 100 percent.
We had figured that a majority would feel comfortable with the
discussion.

Also interesting, 98 percent agreed that medicines can be different
without being better. Therefore, simply by doing comparative
advertising, it does not absolutely connote superiority. The consumers
are still reserving the right to make their own decision.

So some findings from the research with some conclusions or assumptions
we\'re making connected with that. Comparisons of medications help
consumers because we think better informed consumers are making better
decisions and they are welcoming the discussion of comparative
advertising. Comparison does not necessarily connote superiority. They
are able to understand differences between products and that leads them
to their own conclusions. But, most importantly, they are getting
information from other sources. As they are reporting to us, when they
are actually receiving the products they are getting a lot of
information about the product\'s benefits as well as any side effects or
issues.

The second subject was fair balance and, once again, posing statements,
asking the responders to say whether they agreed or disagreed. In terms
of fair balance over the years, we have seen while there has been a
quantum change in TV because the regulation change in \'97, we\'ve seen
more of a slow evolution over the years in terms of print and that fair
balance type sizes creeped up over the years.

Remarkably the type designers of the world have seen more input from
certain quarters then they ever thought they would get in terms of
whether something could be justified or flushed left or right.

But the bottom line was, how do we get the fair balance to be truly
balanced with the claim information and we have all gone along with
that. The important thing to note here is also there are other places
for information. As I think was mentioned earlier, on line is a place
where people are going, especially when they receive a new product from
their doctor or whether they hear about a new product.

In terms of some data that exist through the FDA study, we do know that
the percentage of people who are recalling seeing fair balance
information is comparable to the percentage of patients that are
recalling the benefit information. In terms of is it balanced, we do
believe that survey shows it clearly is.

We also know that we have seen advertisers get better at developing
language to these side effects because we know it\'s a more complex
discussion often times than the benefits, so how do we make the language
more understandable to the consumer?

In terms of the results here, we saw a little over 90 percent agreeing
with the statement, \"Most of the time I read the usage information
about the prescription medicines I take.\" 95 percent agreed with the
statement, \"I can understand the product information which is provided
with my prescription medicines.\"

Once again, connecting to the earlier point that they are getting the
information in the entire transfer of the product to their medicine
cabinet versus simply an ad. Importantly, 91 percent agreed with the
statement, \"I believe the side effect information that is provided in
advertising for prescription medicines is helpful.

We have seen that in other research as well. It\'s not just they have to
do it. It helps me make my decision and it\'s the credible and right
thing for the pharmaceutical manufacturer to do.

Eighty-nine percent agreed with this statement, \"I believe the side
effect information that is provided in advertising for prescription
medicine helps me better understand the pros and cons of that
prescription medicine.\" It\'s obviously something that they have grown
not only accustomed to but they expect and, importantly, they understand
it.

Now, in terms of where we\'re going, we are making strides. I think
it\'s remarkable and you would probably have a very different number if
you went out and asked people, perhaps people that didn\'t watch ER 10
years ago, what a placebo was versus 87 percent today that know what
that means.

Yet, of course, even more know what a sugar pill is. Then you look to
dyspepsia and indigestion and perhaps a more colloquial term for that,
and you would see much more of a disparity so we think that points to
the opportunity to continue to clarify.

So in terms of fair balance, we are seeing a majority of consumers are
reading and comprehending the fair balance and safety information. They
are aware of the side effect and other safety issues as reported to us.
They feel it\'s important and helpful because they are involved in their
health care management.

They are no longer just relying on others to make decisions for them.
They want to be a part of the dialogue and they believe both positive
and negative information is helping them with this decision. Simple
language is understood by a larger percentage of consumer patient
population and we should continue on that path.

Overall from our research, probably with a halo effect of our own
personal experience on the side of the people that are making the ads is
for the consumers understanding the difference between medications is
helping them to make better health care choices.

We think that goes all the way through the choice to actually go have a
conversation with the doctor all the way through to having a discussion
about what product they might most appropriately be on.

They are getting the information from many other sources other than
advertising while they understand the information in advertising, and
the comparisons between Rx and OTC products are useful because many
patients are putting them both in the same consideration set so
understanding the differences is helping them with that decision and
those discussions.

The current fair balance disclosure is effective and informative but
could benefit from additional clarity and simplicity. Just to stress, we
don\'t think that the appropriate move is more, just better.

The other probably closing note is just the notion that as a society as
we have all gotten better at making health care choices and decisions,
we are becoming more savvy, we are becoming more aware, and we do want
to have richer discussions with our health care providers. In doing
anything, we need to make sure we are always respecting our patient
consumer, David Oglvy, the old grandfather of advertising, once said to
a bunch of close-minded clients who don\'t exist today that, \"The
consumer is not an idiot. She\'s your wife.\" You could easily say your
husband or you or me. The reality is regardless of what we\'re talking
about, let\'s treat our consumers with respect because that\'s what they
demand. Thank you.

MS. MONCAVAGE: Thank you very much, Mr. Schirmer.

The third panelist is going to be Dr. Steven Woloshin. He\'s with the
Veteran\'s Administration Medical Center and also with Dartmouth Medical
School.

DR. WOLOSHIN: Thank you very much. I just want to acknowledge the work
that I\'m going to present is done with Lisa Schwartz who is here and is
actually the next panelist, and Gil Welch who is back in Vermont. We
also would like to acknowledge technical support from Kit Aikin. Lisa
and I were also supported by a grant from the Robert Wood Johnson
Foundation.

A few years ago we got interested in direct to consumer drug ads and we
really were curious about what kind of information is in the ads. We
decided to take a systematic look. We did a content analysis of the body
of direct-to-consumer ads, the front page of the ads in popular
magazines which was published in 2001. What we found was that with
regard to harm information almost all the ads explicitly noted side
effects. Half the time there was some attempt made to quantify their
frequency.

In contrast information about benefit really existed typically in the
form of vague qualitative statements like \"Zyrtec works.\" Only 13
percent presented any data on benefit. Let me make an assertion. I think
that there should be benefit data in direct-to-consumer ads and there
are a few reasons. To help consumers understand how much benefit their
drug might provide and to put qualms into context people need this sort
of data.

Another reason which isn\'t on the slide but which has come up in a
number of the discussions in the past two days is that part of the
purpose of the ads is to promote discussion at the time of doctor
visits. Having data in the ads would also help facilitate that
discussion.

The objectives of the study I\'m going to present now are to see if
consumers want benefit information in the ads and then to find out if
they find our proposed method of providing such information which we
call the prescription drug benefit box understandable and valuable.

Here is a sneak preview of the box. I just want to say a couple of
things about it right now. I\'ll talk about it some more in a bit. It\'s
just simply a standardized format for presenting benefit data.

It\'s modeled on the nutrition facts box which everyone is familiar with
in the back of cereal boxes. It\'s designed to show drug efficacy by
presenting the chance of clinical outcomes for people who take the drug
and for people who are in the control group.

Let me give you a brief study overview. There are really two parts.
First we asked people what information should be in drug ads. Then we
showed them some ads with and without the benefit box to learn about
comprehension and the reaction to the box.

We talk about which drug ads were studied. We wanted to find three
current drug ads that met the following criteria. The drug was for a
common medical condition. The main part of the ad clearly specified the
purpose of the drug.

We went to Dan and Witz, the local general store in Vermont, and we
easily found three ads that met this criteria, pravastatin which is a
cholesterol lowering agent to reduce second heart attacks, clopridogrel
which is an anti-platelet drug to reduce second heart attacks and
strokes, and rofecoxib which is a COX-2 inhibitor to reduce arthritis
pain.

To avoid preconceived notions about efficacy from people familiar with
these drugs, we performed a modified pig latin transformation and the
algorithm is available after the talk. Prevastat became avastat,
clopridagrel became pridclo, and rofecoxib became ofecox.

Here is the study design. The first question that we asked, we asked
people what data did they desire in the ads, data about benefit, data
about side effects, both, or neither. Then the respondents went through
a training task to familiarize them with the three elements of interest
in our study, the ad itself which we are all familiar with these.

The ads are the actual ads but they were modified only in that the name
was changed to the pig latin form and any identifying information of the
drug company so Merck became Erckmay for example. Then the brief summary
which you are all familiar with this. Again, this is exactly as it
appears except that the name has been changed.

Then finally the benefit box. This is the box where it appears on the
brief summary. Let me just point out that the data in the benefit box
comes from the published versions of the main randomized file cited in
the FDA drug approval process.

We conducted at-home interviews. We had trained field interviewers from
the Center for Survey Research at the University of Massachusetts in
Boston and they conducted 203 in-person interviews. Interviewers were
randomly assigned to city blocks in several towns in the greater Boston
area. They interviewed up to four English-speaking adults per block. The
participants were paid \$20 per interview.

I\'ll show you the characteristics of the sample, as I said, 203
participants. The mean age was 52 years, the range was from 30 to 91, 29
percent were 65 years old and older, 65 percent were female, 90 percent
were White. It was a broad range of educational attainment. Fifteen
percent had less than high school, 39 percent were high school
graduates. There was also a broad range of income as you can see.

Here are the tasks that the respondents were asked to go through. They
read the first ad with its standard brief summary. Then after a little
while they were given the ad with the benefit box. Then we assessed
comprehension.

They were shown the second ad with its brief summary and we repeated the
process, assessed comprehension. This time we also asked for some
reactions to the box. Was it easy or hard to use, did they trust
information, did they find the information valuable.

Then finally there was a third task where we assessed the impact of the
box on perceived efficacy of the drug. Lisa is going to talk about that
in her presentation. At this point we also asked them whether they
preferred the ads with the box or with the standard brief summary.

The results. The first question we asked them, this was before they saw
anything, before they saw a brief summary or a drug box, we said, \"What
data should be required in drug advertisements to the public.\"

About two percent said side effect data only. That same amount said
benefit data only. Four percent said neither. From comments on the
surveys these are people who had said, \"I hate drug ads. I don\'t want
them at all.\" Fully 92 percent of people said they wanted data on
benefits and side effects.

Here is the comprehension task. We showed them the box and we asked them
to extract specific pieces of information from the box to show at least
some minimal level of comprehension. This box is for the drug Ofecox and
it says, \"In a study people with arthritis either took Ofecox or
ibuprofen.

Here are the percents of people who said the following after six weeks.
Among people given ibuprofen, nine percent said they had an excellent
effect, 43 percent said they had a good effect, 48 percent said they had
a fair, poor, or no effect. Among the people given the drug Ofecox nine
percent had an excellent, 50 percent a good effect, and 41 percent fair,
poor, or no effect.\"

Then we asked them the question, \"What percent of people given Ofecox
said it had an excellent effect on their arthritis?\" We were looking
for the response nine percent and 95 percent of respondents answered
correctly.

Another comprehension task with Avastat. \"What percent of people given
Avastat had a heart attack?\" If you look down the column, you see that
eight percent of the people given the sugar pill had a heart attack at
five years and six percent of those given Avastat. This is the answer we
were looking for and 97 percent of the respondents answered correctly.

Let me ask about reactions to the box. We asked how easy or hard is the
box to understand and the responses were on a 10 point scale \-- 11
point scale from extremely hard to extremely easy. The average response
was nine so people found the box extremely easy to use and understand.

Then we asked, \"If you are reading an ad, how much attention would you
pay to the information in the box?\" Seventy-five said they would pay a
lot of attention, 16 percent said some attention, and only eight percent
said they would pay little or none at all.

The next question was, \"How much do you trust the information in the
benefit box compared to the first page of the ad?\" Sixty-seven percent
said they would trust the information in the benefit box more than the
first page of the ad. Twenty-seven percent said they would trust them
equally and six percent said they would trust the information box last.

Then we asked for a direct preference for the ads with or without the
benefits box. About two percent of people said they would prefer the ad
without the box either strongly or slightly. Five percent said they had
no preference, they were indifferent. Ninety-five percent of people said
they preferred the ad with the box, 78 percent of them strongly.

Next we asked, \"How important is it that information in the benefit box
be included in the drug ad?\" We got the same pattern of answers. A few
people said it was not important or just a little important. Some people
were \-- about 20 percent said it was important and over 70 percent said
it was very important.

We acknowledged some limitations to the study. First, it may not be
representative because this is a convenient sample of advertisements and
it\'s a convenient sample of respondents so it\'s possible that with
different ads or with different respondents results might vary. However,
these are pretty extreme results.

We wanted to point out that we were extremely pleased to see that even
among the subjects with low education attainment, they still valued the
box and said they understood it.

The next possible limitation is social desirability. Whenever you do
face-to-face interviews, you may promote favorable responses because the
interviewee wants to please the interviewer.

But while this is possible, I should point out that the very first
question we asked about the preference for what kind of data should be
in the ad was asked before the subjects had any idea what the study was
about before they saw any of the materials. That strong response
predated any exposure to anything that might have hinted to what we were
getting at.

Then the last issue is that this is, of course, a simulation. We don\'t
know whether people would really pay attention to a value or like the
box in real life.

So in conclusion, most people interviewed said they would require
benefit data to be included in drug ads. Almost all found the benefit
box easy to understand and demonstrated basic comprehension of the
quantitative benefit data.

Finally, people valued the content of the benefit box and preferred that
it be an integral part of direct-to-consumer ads. Thanks.

MS. MONCAVAGE: Thank you very much, Dr. Woloshin.

Dr. Lisa Schwartz will be our last speaker on this panel. She is also
from the Veteran\'s Administration Medical Center and Dartmouth Medical
School.

DR. SCHWARTZ: Thank you very much for having us here today. I\'m going
to tell you some more about the benefit box, specifically about its
effect on the public\'s perception of drug efficacy.

In the last presentation we pointed out that data about drug efficacy is
typically absent in drug ads. We suspected that the lack of benefit data
in drug ads may leave the public to overestimate drug benefit.

In support of this, in another survey one quarter of Americans believe
that only extremely effective drugs can be advertised to the public. In
another study, physicians report that exaggerated perceptions of benefit
as the most significant problem that DTC ads create for them.

The objective of our study was to learn how a drug benefit box, that is,
date on prescription drug efficacy in the brief summary of
direct-to-consumer drug ads affects the public\'s perception of drug
efficacy.

Just to remind you, this is the drug box that you just saw which
summarizes the benefit of the drug for the advertised indication using
data from studies in the FDA approval process and presents the chance of
various clinical outcomes for drug and control group. This is the box
that you saw before which I want to go over a little bit more.

This is the patient\'s rating of the medication on their arthritis
symptoms and among those given ibuprofen nine percent said it had an
excellent effect, and among those given Ofecox that nine percent said it
had an excellent effect. Then there\'s the proportion saying that it had
a good effect or a fair, poor, or no effect. These are the same 203
people that you just heard about with an average age of 52.

But here is a little bit more description of the participants. About
half had paid attention to any advertisement for a prescription drug in
the past three months and many people were currently taking medications
to prevent heart attack or stroke or to treat any arthritis or joint
paint. The reason we were interested in this is that these are the
categories of medicines that we were asking people to evaluate as we
were showing them.

Well, I\'m going to talk about the study design elements that are
relevant to this particular question. As Steve said before, we asked
people to read the first ad and the brief summary. Then we also asked
them to rate the efficacy of the drug. We are going to call that the
efficacy before.

Then we added the benefit box to the brief summary and then we asked
them again to rate the efficacy of the drug now looking at the benefit
box. We then showed them a second ad with a brief summary and we
repeated the same procedure. Finally we showed them a third ad with a
brief summary but this time what we did was we randomized the
participants into one of two groups.

Half of them were randomized to the control group where they just saw
the standard brief summary, and the other half of the participants were
randomized to get the brief summary which included the benefit box.

Then each group rated the efficacy of the drug as they saw it in the
form of the advertisement that they had. So here is our first result. We
asked people how effective is Avastat in preventing heart attacks for
people with high cholesterol.

When people were reading the ad before they had seen the benefit box, 51
percent rated Avastat as being extremely or very effective in preventing
heart attacks for people with high cholesterol. Here is the proportion
who rated it somewhat effective and little or not effective.

After reading the ad people rated the drugs as being less effective.
After the box, 26 percent rated it as being extremely or very effective.
Here is the proportion who rated it somewhat. Here is the proportion who
rated it little or not effective.

Here is our second ad for Ofecox. How effective is Ofecox in treating
arthritis symptoms? When reading the ad before they saw the benefit box,
65 percent of people thought it was extremely or very effective. Again,
after seeing the benefit box, perceptions of efficacy shifted
substantially and 27 percent of people thought that it was extremely or
very effective.

We then asked this question. \"How effective is Ofecox compared to
ibuprofen in treating arthritis symptoms?\" What we were interested in
is how people thought Ofecox compared to the alternative ibuprofen which
is the comparison that you saw in the benefit box before. That was what
in this study Ofecox was tested against.

When reading the ad without the benefit box, 70 percent of people
believed that Ofecox was more effective than ibuprofen. After seeing the
benefit box there was a very substantial shift and 38 percent of people
now thought it was more effective but there was a very large shift to
the same category which is really what you see in the benefit box which
compares Ofecox and ibuprofen.

Here is our third ad which is the randomized comparison which was
Pridclo. We asked, \"How effective is Pridclo in preventing heart attack
or stroke for people who have already had one?\" So among the people who
were randomized to the ad without the benefit box 59 percent believed it
to be extremely or very effective so just reading the ad in the standard
brief summary.

Among the group of people who saw the Pridclo ad with the modified brief
summary, 23 percent thought it was extremely or very effective. Then we
asked the question, because the data in the benefit box for Pridclo
actually compares Pridclo to aspirin, \"How effective is Pridclo
compared to aspirin in preventing heart attack or stroke for people who
have already had one.\"

So people who didn\'t get the benefit box, 60 percent thought it was
more effective and people who got the ad with the benefit box, 32
percent thought it was more effective and there is a much bigger
category of people who thought it was the same.

The data in the box actually shows that there are three outcomes. One is
having a second heart attack or stroke. In the aspirin group it\'s six
percent and in the Pridclo group it\'s five percent, but the other two
outcomes, dying from a heart attack or stroke or dying for any reason,
are identical in the two groups so this is a pretty fair evaluation of
the data.

It has limitations. It may not be representative which Steve already
mentioned. And it\'s a simulation and we don\'t know what effect this
will have in reality.

So our conclusion are that quantitative data about drug efficacy
presented and the prescription drug benefit box reduced the perceived
efficacy of the advertised drug and it helped people to more accurately
gauge the benefit of the drug compared to an alternative. Thank you.

MS. MONCAVAGE: Thank you very much. We would like the FDA panel to pose
questions or the speakers to pose questions.

MR. PITTS: Mr. Schirmer, couple of questions. Thank you for your result.
It reminded me of my studying of Soviet election results. Is there room
for improvement? It was a little vague to me. Obviously the data you
were referring to was specifically not geared towards brief summary
information advertisements. Correct?

MR. SCHIRMER: Right. Fair balance versus brief summary.

MR. PITTS: So if the information \-- so is your point that the
information on actual purchased products is so terrific that the
information provided in ads can be reduced?

MR. SCHIRMER: No, not necessarily. The conclusion is it\'s all additive
and there is no single source in which patients are getting all their
information. Many report that they are reading the back of OTCs and they
are reading the material that comes with their Rx. Now, that\'s asked if
they read it.

Some say, \"I don\'t read it at all.\" The other group says, \"I do read
it.\" We didn\'t dig into comprehension but what we did discern is that
people felt that information that they did glean was helpful in their
own self management of how they took medication and how they talked to
their doctor.

MR. PITTS: Do you have an opinion about whether or not print brief
summaries should be changed?

MR. SCHIRMER: Our feeling is that they can only be clarified and
simplified but in an effort to give more information if it becomes more
verbiage, we don\'t think that is the answer because, as was mentioned
earlier today, that block of copy at the bottom of a Mastercard or a
leasing ad where you see all that small type and on the radio it\'s just
a lot of chatter, people have just blanked that out so it\'s 60 seconds
with 20 just kind of omitted. We think if you add to it, it actually
will start to disappear.

MR. PITTS: On a different topic, you raise the issue of comparative
advertising. I know that the Better Business Bureau does a lot of
complaint resolution in this respect for OTC medications and said the
overwhelming amount of their complaints is comparative claims. Do you
think this is something that given their druthers that
direct-to-consumer advertising would move towards?

MR. SCHIRMER: In terms of more FTC regulation of truth in advertising
versus \--

MR. PITTS: Whether they would chose to take more of a comparative
approach.

MR. SCHIRMER: As a trend?

MR. PITTS: Um-hum.

MR. SCHIRMER: Well, I think there is the potential of that but at the
end of the day, there will be no claims made vis-à-vis another product
that hasn\'t been vetted out by the same organization that that\'s the
current advertising that may not be comparing to anything else other
than placebo.

MR. PITTS: Earlier presentations yesterday, and I guess a little bit
this morning as well, pointed out that generally speaking
direct-to-consumer advertising doesn\'t necessarily improve market share
so much as it increases the size of the pie overall.

MR. SCHIRMER: Well, the only thing I would challenge that is I think
that chart answers the question does DTC work for every brand? The
answer is no, it works for some very well. It doesn\'t work for others
and you need to know the difference.

MR. PITTS: Thank you.

DR. TEMPLE: A lot of interesting material here. Mr. Roberts, one
question I had was about how difficult the brief summaries are. Does
anybody pay attention to the different parts of it? For example, the
whole thing might have a score of nine but there might be a short punchy
part at the beginning that only had a score of six. Is that kind of
thing thought about when one looks at documents?

I mean, it seems at least potentially remedy. Some things in one of
these are going to be fairly hard to explain. They are going to have
medical terms or some alternative to it but there might be other parts
that are shorter, punchier, and easier. I wondered if you considered
that.

MR. ROBERTS: We haven\'t done primary research on specific components of
the brief summary. It would be hard to dispute that consumers want
benefits and risk information and have often pointed out that is the
type of information that they are seeking from their advertisements and
knowledge is to include brief summary in that component so I\'m sure
that there are elements that are significant as long as they are
presented in a fashion that is readable and understandable to the
consumer.

DR. TEMPLE: Would that solve \-- would that solve the problem, for
example, if overall the part of, oh, I don\'t know, a patient package
insert or something like that, if overall it had a score of nine but
there were parts of it that were easier to read, would people be
discouraged because the whole thing is hard or would they read the parts
they can follow? Does anybody have any sense of that kind of thing? One
possible remedy is to have both the hard part and an easy part in a
document and question I\'m having is whether that would help.

MR. ROBERTS: Yeah. Again, I can\'t speak to primary research. I can
certainly opine that depending on medical terminology is often obviously
predominant in a lot of these communications and consumers don\'t
understand what tardive dyskinesia is and often terms such as tardive
dyskinesia need to be interpreted appropriately if they are going to
result in print media.

DR. TEMPLE: Right. Take a paragraph or so. A very scary paragraph.

MR. ROBERTS: Absolutely.

DR. TEMPLE: This is for Andrew Schirmer. I understand that people want
to know what the differences between drugs are and what the comparisons
are. One could say that after knowing that a drug works, there is
nothing more important than that. But it\'s very hard to do because it
is easy to emphasize the things that were good and ignore the things
that are not as good.

Do you get any sense that what consumers want is a complete description
of all the possible differences? Do they worry about whether someone is
over emphasizing one thing and forgetting about another thing? You did
point out that they realize that differences don\'t necessarily
represent advantages so that seems they are fairly canny about this.

MR. ROBERTS: Well, I think there are a couple of general rules. One of
the things is people always tell you they want a lot more information
than they really do want in reality. The other thing is that patients
want to be just a little bit smarter when they go talk to that
incredibly intelligent, well-schooled, knows a lot more than me
professional physician. It\'s an intimidating experience.

If I have my cards lined up that I happen to know a little bit about
this and this is a little bit different, I can have a little bit more of
an intelligent dialogue and I\'m not nearly as intimated as if I go in
and I say, \"I don\'t know much about this. I guess you make the call.\"

DR. TEMPLE: Okay. But they would feel stupid if they thought there was a
major advantage and the doctor says, \"Oh, yes, but don\'t forget it
also kills you.\" They probably wouldn\'t like that.

MR. SCHIRMER: I don\'t think they would like their doctor either, but I
think, once again, you\'re bringing up the point that it is all about
that doctor discussion and it\'s all about getting the patient not
necessarily on a level playing field with the doctor, but a little more
comfortable to have a dialogue about something they don\'t know as much
as the person they are speaking with does.

DR. TEMPLE: Finally, let me ask Dr. Schwartz and Woloshin something. You
raise a very interesting problem, especially when it comes to
symptomatic treatments which you probably have noted are usually not \--
the effectiveness data is usually not represented in the clinical trial
section of labeling.

With antidepressants, let\'s say, we were better on the HAM-D but they
don\'t give scores. The reason for that historically is it\'s too study
dependent, it\'s manipulable, it depends on the population you pick. The
belief is it doesn\'t give you a true picture of the drug. Of course,
that means there is no picture of the drug.

I was interested by your examples. The analgesic or the
anti-inflammatory drug, those results strike me as basically meaningless
because there is no placebo in there to tell you whether either of the
drugs did anything in that study, which they might not have.

The small differences between them, unless this was a very immense study
or obviously non-significant, so the right conclusion is you can\'t tell
if there is any difference, and yet many people even though they were
less impressed after reading the ad than before still thought that one
drug was better than the other based on that study which isn\'t quite
right.

So if one were going to present those kinds of data, how would one do it
in a way that would convey all of that and, in addition, would make sure
that they present the best study out of ten and large numbers other
complaints.

We deal with this all the time in advertising to physicians because they
do get the benefit results. A very large fraction of those raise
problems with us because it is selective, not surprising. You pick the
good study to show.

DR. SCHWARTZ: There were a couple of things. One, I think you are just
raising the question with the quality of life outcomes a lot of times
there are scores and we actually went to the

\-- the reason we got to that particular trial was in the FDA approval
document there was only one \-- in osteoarthritis there was only one
long-term randomized trial which was six months.

We went to that and found that it had been published in the [Archives of
Internal Medicine]{.underline} and still there wasn\'t data that we
could really understand how you communicate so we asked the investigator
to give us the data broken down into the categories that you saw. One
issue is about can you get outcome measures that people will be able to
understand.

Two of the studies \-- and the other issue raised was about whether
there really is a difference and you\'re right. There\'s no statistical
difference but there is a little bit of a shift in the percentages.

In the Ofecox the reason why people need that is a little bit more
people had no effect and had a good effect. There\'s no difference in
the excellent effect. So you can sort of understand people are
struggling with that. The issue is how do you tell people about whether
this is due to chance or not. There are differences and we have to start
to figure out how to say this is a real difference.

We\'ve been doing some testing where we say this may be a fluke so that
you would have sort of a graying of results that were different and you
would explain to people, \"Oh, there\'s differences. This may be a
fluke.\" Or otherwise you say, \"These are real differences and we\'re
confident that these really happened.\"

DR. TEMPLE: Those are murderously difficult things to explain to a
sophisticated audience.

DR. SCHWARTZ: Well, but I think you can. I mean, we\'ve been doing some
cognitive \-- I mean, I think it\'s challenging to get those ideas
across but we think you can but I think it requires a lot of work to
find the right words to say that.

DR. TEMPLE: Okay. I guess the other impression I had was they got it
wrong on the lipid lowering drug. That was really an important effect
and they all thought it wasn\'t worth much. That is not so gratifying
either.

DR. WOLOSHIN: That\'s right because for us that drug\'s a winner but I
think part of the problem is people just don\'t used to seeing data so a
difference of eight percent versus six percent seems little so there is
an educational process that will have to occur.

DR. SCHWARTZ: And helping people to know which outcomes really matter.
Something that shows an all-cause mortality difference, that\'s the best
we have in medicine. There is clearly education.

DR. TEMPLE: That one is particularly interesting because, as you know,
people are criticized for presenting the present reduction in heart
attacks. Forty percent reduction, that sounds really big or 25 percent
sounds really big. But then when you show it\'s only eight percent
versus six percent, it doesn\'t look that big so there is a certain
movement to make sure that people give absolute rates.

Here the absolute rate was given and they were suitably unimpressed
which is just what people think would happen if you get the absolute
rates. I\'m impressed that these are hard things to communicate to
anybody.

DR. SCHWARTZ: But it may be over time that we can do a better job
communicating these. There is a teaching process because people haven\'t
seen this data and so the way to help people is to keep doing more of it
to realize where that ranks on the scales of things that medicine can
and can\'t do.

DR. WOLOSHIN: When you guys adopt our benefit box, you can imagine the
ruling out process would include some sort of educational component.

MS. WOLF: I just wanted to clarify, for the studies that you all did,
the ads that you showed them before you showed the box, was the benefit
data in the ad at all?

DR. WOLOSHIN: No. None of those ads included any benefit data.

MS. WOLF: So there\'s no comparison between the data appearing in the
face of the ad and the box format?

DR. WOLOSHIN: The only data that the respondents saw was in the box
which appeared in the brief summary.

DR. SCHWARTZ: We just selected \-- I mean, most ads don\'t have any
data. There are a couple that do have data about benefit but these
don\'t so what were people\'s impressions from the words and there are
no numbers there.

MS. WOLF: I was asking in terms of because when we look at ads the
question of whether if the data are in the ad what difference that makes
to a consumer.

DR. SCHWARTZ: Right. We were specifically answering the question about
including it in the brief summary but not altering the ads in other
ways. We have the idea of wanting to test it in the ad itself.

MS. MONCAVAGE: Tom.

DR. ABRAMS: This is for Mr. Michaels \-- Mr. Roberts rather. There are
difficulties trying to choose what risk and warnings to put on product
labeling. You can\'t give them all. When you designed and looked at the
prescription facts alternative, did you have criteria that you used and
can you describe that?

MR. ROBERTS: What we have typically done in our past in whether
providing useful information is the criteria that is normally developed
are the most relevant side effects that typically get down to a three
percent versus placebo typically is what they are looking at in the PI.
We try to apply criteria such as that in terms of producing the most
relevant information to the consumer.

DR. ABRAMS: Okay. As was alluded to before, some of these medical
warnings are difficult to explain in a couple of words. Your format is
very concise. Do you think at the warnings and comprehension of the
warnings? Do you translate the warnings that are more difficult?

MR. ROBERTS: We would routinely translate warnings when we are
developing materials. We believe that is an important part of
communicating consumer friendly information. Again, I do think there is
a relevant point that it also depends upon where the patient is along
the continuing of dispensing.

Whereas it\'s always important that the information is consumer
friendly, the information typically is going to be more robust after the
prescription is dispensed and they receive that information versus much
further up the trial when they might be looking at an ad.

DR. ABRAMS: And did you do any testing to see what the consumer actually
took away from this format?

MR. ROBERTS: At this point we have not specifically tested the drug
facts model. We are relying upon the previous research of the facts
model in terms of consumer acceptance.

DR. ABRAMS: Okay. And one final question. You mentioned it depends where
the consumer is on the selection or the prescribing process. How can you
determine what information is needed for the consumer? Did you get their
feedback?

MR. ROBERTS: At this point we have not tested that very specific
question of what information is sought at what particular point in time.

DR. ABRAMS: It might be interesting to do that.

MS. MONCAVAGE: Nancy.

DR. OSTROVE: Also for Mr. Roberts. Not getting into the issue of the
fact that so many medical names and conditions are multi-syllabic so
that they impact on standard readability formulas and there aren\'t any
really good standard readability formulas for health information.

Did you test your own information that you include as the patient
information for the useful piece when people get their prescriptions?
Did you do testing on your own?

MR. ROBERTS: We don\'t have primary research on that. We do have
readability primary research but not specific to \-- it\'s more
readability of the content in its entirety as opposed to applicability
of specific types of sections and whether or not the sections were
readable or not.

DR. OSTROVE: I guess I\'m probably not being very articulate in trying
to get out what I\'m asking. You say you have \-- did you use the
readability formulas on your own information?

MR. ROBERTS: Not in the Rx facts model as of yet.

DR. OSTROVE: I\'m not talking about the Rx facts model. I\'m talking
about the patient information that you are currently using in your
newsletters.

MR. ROBERTS: We have done some readability on that and it will typically
\-- we will seek to drive it lower down the grade scale.

DR. OSTROVE: And how successful have you been in getting that down to a
fifth or sixth grade level?

MR. ROBERTS: I would be happy to \-- I can\'t speak to all of the
individual drug monographs that have been produced over time. I would be
more than happy to submit information. I can check and see what we have
in terms of all available data for all individual drug monographs
because it is a continual pursuit if we are updating monographs
routinely.

DR. OSTROVE: Okay. Great. Thanks.

DR. AIKIN: This is also a question for Mr. Roberts. You advocate an
adequate provision model for the brief summary to make it more concise
and more understandable. Given that print ads are often part of the
adequate provision for broadcast, what sort of components do you
envision as being part of the adequate provision for a print ad?

MR. ROBERTS: I think I spoke to in there the elements of the broadcast
media that we feel are absolutely still applicable to print in terms of
\--

DR. AIKIN: So that would be the Internet, the 800 number in the
document?

MR. ROBERTS: Yeah. It could be an 800 number, it could be facts,
multiple vehicles to get supplemental information to the consumer.

DR. AIKIN: And how would you get information to a consumer that doesn\'t
have access, for instance, to the Internet, or doesn\'t want to go to
their doctor or call?

MR. ROBERTS: The facts would be the last one assuming they didn\'t want
to call. I think we\'ve done everything else.

DR. AIKIN: So you would just not have printed information in any other
format?

MR. ROBERTS: Talk to your doctor or pharmacist would be part of your
typical adequate provision so yet that is another mechanism where they
may have access to additional information in those sites. That might be
a little particular to what we do because our product is, in fact, in
pharmacy.

DR. AIKIN: I guess my concern is for people who don\'t want to go so far
as to talking with their doctor and aren\'t comfortable using the
Internet how would they be able to get the information?

MR. ROBERTS: It would seem the population is probably not also
susceptible to DTC advertising.

DR. AIKIN: Well, maybe, maybe not. It\'s hard to say.

DR. ABRAMS: This is for Dr. Schwartz. You talked about box efficacy
information. Any thought given to if this is placed into advertisements
providing context to the consumer that study designs may affect the
different efficacy rates and you can\'t just take one from one study and
compare it to another drug that might be advertised in another
advertisement?

DR. SCHWARTZ: The question is also when there is multiple stories. We
picked two examples with the Pridclo study where there is only one large
randomized trial.

I mean, there\'s an issue about when there are multiple studies and
whether you\'ll have to have a meta-analysis or whether there is some
way to summarize across studies for the day that you present in the box.
The question about comparing across studies, we understand it\'s an
issue. I don\'t think we\'ve gotten to the answer yet on that.

DR. WOLOSHIN: That\'s an important issue. I mean, you look at the
placebo rates in different studies and they differ. Clearly the
selection in the study populations differ. It is an important issue.

DR. SCHWARTZ: Although sometimes you can really see, though, if you look
at, let\'s say, the secondary prevention trials for statins you see the
rates are so much higher than the primary prevention trials. You do get
some information.

I mean, there is variability across trials but I think that a lot of it
is about what the indication is for. I mean, people still can learn
something from the base rates and the randomized trials for one
particular drug about how often that happens.

MR. BYRD: This question is for Drs. Woloshin and Schwartz. Do you have
any data or can you extrapolate your benefit, the perception of benefit
that consumers have with the presentation of safety or risk information?

DR. WOLOSHIN: In this study we focus only on benefit but our dream is to
have a prescription facts box which has both benefit and harm
information together because it seems to us that to interpret either
harm or benefit you need the other. We think that is really important.
We haven\'t done that.

DR. SCHWARTZ: And we like to clump them to have a limited list of
life-threatening harms and then have common and bothersome harms and
that\'s in our current draft of the table which is on our list of things
we want to do but we haven\'t studied it yet.

MR. BYRD: Any idea as to whether you might \-- it\'s obviously a guess
but do you anticipate similar results in terms of the increased
perception of benefit? Just curious.

DR. WOLOSHIN: I think it\'s really hard to say. I think people are
really unfamiliar with some numbers because for various reasons people
avoid presenting them because it creates a vicious cycle. I think it\'s
pretty hard to predict.

DR. SCHWARTZ: But I think some things may actually from the risk
perspective when you see the side effects and how often they occur in
the placebo group and you can see how much the risk is elevated in the
drug group compared to the placebo group, I think sometimes that gives
you a lot of information.

It gives you both the sense of how often this particular thing happens
in general and how big the increase is. I think \-- I mean, in our sort
of cognitive interview testing, I think people really like to see that.

MS. MONCAVAGE: If there are no further questions from the panels, we are
open to questions on the floor. Let us know who you are.

MS. DAY: Ruth Day, Duke University. Those very, very high scores, Mr.
Schirmer, that you have throughout all are spectacular. I have two
things to ask about. One is the extent to which they are so high could
they be due in part to the nature of the scale that you are using, agree
or disagree without any confidence ratings. You know, very confident,
you know, unsure, and so on, on the one hand.

On the other hand, when you have the 95 percent of people saying they
understand the side effects, that\'s what we would call medi-cognition.
Cognition is what people know and medi-cognition is how they know or
what they think they know about their own knowledge. We have a lot of
studies that show that people think they know more than they do. I think
your data are very interesting but I don\'t think they speak to fair
balance.

MR. SCHIRMER: I would have to agree with everything except for, I think,
the last three words. I also concur that many think they know more than
they really do know. I think the reality is and the case I was trying to
make is all of the information helped people make a decision with their
physician.

All information that helps people become a little bit more in tune with
the realities of medical therapeutic choices helps in that discussion.
If you ask someone on the street did they read important information
about their medication, you will have more people answer yes than no
which I think gets to your initial point.

But our point of view, and we could go back and run the data again
during the confidence and finding out most likely, somewhat likely, and
have a range. We wanted to keep it rather clean and simple for this
discussion, but we also think that while you have that variance in terms
of what people say and in terms of what they really do, it also points
to intent and that is very important in terms of what people are
intending to get from these communications.

In terms of fair balance, I would gamble that the same variance that you
describe as far as people responding to side effect and risk
information, you could extrapolate out of the benefit information as
well which is why I think the discussion about some of the data that we
saw here is so interesting because I think it\'s as difficult for people
to discern just how much better this is than that based on data that is
sometimes difficult for doctors to understand.

MS. MONCAVAGE: Yes. You might want to come down and use the mike at the
table also.

MR. MONK: I\'m Bob Monk from the New Mexico AIDS Infonet and I have a
question for Dr. Schwartz and Woloshin. I think your benefits box is
already getting pretty big with the explanation of statistics and how
important some of these changes and certain clinical indicators might
be.

One of the things that also comes to mind is that for many of the AIDS
medications recently, clinical benefit is one aspect in terms of some of
the surrogate markers like reductions of viral load or increases of CD-4
counts, but some of the major benefits are in terms of pill count,
dosing frequency, food requirements, and have you considered those and
how those might be incorporated into a benefits box?

DR. WOLOSHIN: We haven\'t thought about that but what comes to mind is
the idea of the box is to provide consumers with relevant information
that will help them make decisions. Sometimes there is mortality
information.

Sometimes there is quality of life information. Some things like pill
counts or the other things you mentioned are highly relevant and so I
would imagine that is the sort of thing that you might want to get into
the benefit box.

MS. MONCAVAGE: I think we have time for one more question.

MS. DONOHUE: Just to follow up on that and to add to the size of the box
making it no longer useful. A lot of the drugs that are advertised to
consumers sell themselves not on being more effective than
over-the-counter medications or currently maybe generic prescription
medications but on being more user friendly in terms of side effects and
titration and so forth. SSRIs are no more effective than TCAs but an
overdose is not going to kill you.

I think it would be really important to include both the benefit and the
risk information in the box and for that you would need not just a
comparison with the product and placebo but the placebo, the product,
and the sort of competitor or the alternative which obviously there are
a lot of issues involved in that.

DR. ABRAMS: Can you please identify yourself for the transcript?

MS. DONOHUE: I\'m sorry. Julie Donohue from Harvard Medical School.

DR. ABRAMS: Thank you.

DR. SCHWARTZ: I think we agree that should be there. Ideally you would
have the placebo and the two drugs that are being compared. I think we
were just trying to isolate the effect of benefit information because
that\'s a glaring omission currently in ads.

But I think eventually it would be great to replace the whole brief
summary with the box. The top part might be the warnings and the
qualitative stuff and the bottom part would be the data. Maybe there are
three columns of data, you know, placebo, drug, and comparison.

MS. MONCAVAGE: Thank you all very much. Let\'s give an applause for our
panelists here. I just want to say we will have a lunch break now until
1:45. You can buy your lunches upstairs in the kind of food court, mall
area. After lunch we\'ll have two more panels plus some closing comments
from Dr. Temple.

(Whereupon, at 12:26 p.m. off the record until 1:44 p.m.)

A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

1:44 p.m.

MS. MONCAVAGE: Just one question for the two people who asked questions
of the first panel this morning. For some reason your questions were not
recorded and if you could, please write down your question and give them
to Rose Cunningham. She\'ll make sure that the transcriber gets that so
that your question is included in our final transcript. I would really
appreciate that. Thanks.

This afternoon we have \--

DR. TEMPLE: If you can\'t remember your question, it\'s just terrible.

MS. MONCAVAGE: Probably Dr. Temple does. We have two more panels this
afternoon. We\'ll have one short break in between and then we\'ll have a
wrap-up by Dr. Temple and then thank you all and see you on your way.

I would also like to introduce another member of the FDA panel who
joined us for part of this afternoon, Mr. Daniel Troy, who was the Chief
Counsel of the Food and Drug Administration.

Our first panel\'s ready. Our first speaker is Dr. Mike Magee from
Pfizer.

DR. MAGEE: Well, thank you very much for providing me the opportunity to
speak with you this afternoon. I appreciate it very much. By way of
introduction, I am a physician who has been working in the area of
social science research for the past 20 years especially focused on the
patient/physician relationship and its evolution during this period of
time in response to the health consumer movement, to Internet, and to
the aging demographics.

I have been charting its progress toward empowerment and away from
paternalism so I\'m pleased to share some of that research with you and
specifically reference it against its interface with direct-to-consumer
advertising and the reason why I believe that direct-to-consumer
advertising has been helpful and progressive.

During the next 15 minutes some of the information \-- most of the
information I\'ll share with you is from a recently completed world wide
study in four countries or six countries on four continents which was
presented at the World Medical Association meeting in Helsinki last
week.

What this study did was to confirm prior studies in the United States
demonstrating that this important societal relationship has standing in
all of the countries that we studied but in addition is evolving in the
same manner, albeit maybe not at the same speed as it has in the United
States over the past two decades.

Today\'s patients are more partners than they have been ever before.
They have gotten there with the support of their physicians. In fact, 90
percent of U.S. physicians say today that the best patient is an
educated patient.

The move has been in a few short decades away from a paternalistic
approach where doctors said and patient did toward a current approach
that is most often a mutual partnership and an attempt to move toward
50/50 partnering and decision making, shared data, and individualization
of care.

This approach is both scientifically enabled but also heavily humanistic
in its qualities. Doctors and patients nationwide in the US say that
this relationship is three things. It\'s compassion, it\'s
understanding, and it\'s partnership.

It\'s enabled by science. It\'s enabled by technology. It expects level
of competency. But at its core from a social science standpoint, it is
what other important enduring relationships are in American society
whether they be successful marriages or long-term friendships. It\'s
deeply emotional and it has a high expectation for both service and for
confidence and trust.

The patients and the physicians over the past 20 years have moved away
from authoritarian approaches to more joint decision making. Our
research shows that patients are increasingly empowered in these
relationships. The thing that is consummating these relationships are
patient education that is coming from a wide variety of sources.

Today we not only expect that the physicians will be partners but if you
ask them to peer several years into the future, what they say is that
they are moving toward mutual partnerships.

Not only are they moving toward the expectation of a physician as a team
leader, but they are expecting that these teams will not only be the
clinical continuums which have been traditional in American medicine but
that they will be paralleled by educational continuums. They are not
expecting the physicians to do all of this education face to face. They
understand the physicians are tightly constrained these days.

What they are expecting is that the physician will oversee the team of
health professionals, that the physician will not only have selected and
coordinated the team, but also that the physician will provide some
assurance that the information is up to date and accurate that is
provided to the educational team.

The physicians in all of the six countries that we studied were the lead
source of information. When you chart it against all possible sources of
health information in every country that we studied, the physicians were
cited by the citizen as the lead source of information. But more than
this, the physicians were also in all countries that we studied the most
trusted source of information.

Beyond that the physicians were also the source most likely to lead to
behavioral change on the part of the physician. Whether we\'re talking
about Japan, South Africa, the U.S., U.K., Canada, or Germany, in all
places the physicians were the lead source, most trusted, and most
likely to lead to behavior change.

When we look at the question of what does this business of patient
empowerment really mean and, again, looking at all six countries
including the U.S. and asking the patients to reflect on where they are
today compared to 10 years ago, a large majority will tell you that they
ask more questions, that they make more choices, that they are beginning
to understand benefit and risk type of decision making. They take better
care of their own health than 10 years ago.

When you ask them how important is this relationship compared to other
relationships in society, in all six countries studied the
patient/physician relationship was second in importance only to the
family relationships. More important than spiritual relationships. More
important than financial relationships. More important than co-worker
relationships.

So it\'s standing in all these societies where we\'ve studied. It is
extremely fundamental to the society and I\'ll mention in a few minutes
why I think that\'s the case. Certainly part of it is the emotional
nature of it, the fact that it is compassion and understanding and
partnership, and the fact that it is enabled by science and technology,
but I believe there\'s more to it than that.

Now, in terms of information, this is the key lever that actually has
transformed these relationships in such a short period of time. Eighty
percent of adults in the U.S. that we studied feel that there is a need
to be more active in managing their own health care today. About half of
them actively seek out information whether before or after visits with
their physicians.

More than half of them say that when they encounter an illness, they
need more information than they currently have. About 100 million
consumers go on line these days. About 65 percent of them are looking at
health care information.

When we look at the sources of information that are turned to often, you
can see that advertising, according to consumers in the United States,
as an important source in their opinion of the information.

Now, it\'s important to realize as well that these ads have as an action
step most of the time a direction to either see a doctor that they\'ve
never seen before, or to discuss an issue with the well-established
doctor that they have in a relationship.

So if you look back on the information on source, trust, and
actionability, we need to think about these ads not only for the
informational content that they possess primarily, but also for the fact
that they haven\'t been quite successful in directing patients to see
doctors earlier than they otherwise would.

Studies will show in the general population that 10 to 15 percent of new
visits to doctors have been as a result of these ads. And for at-risk
minority populations the number is even higher. So it\'s important then
to realize that this is one of the benefits of these ads.

That is, getting somebody off the couch to see a doctor sooner than they
would which for me from, again, a social science standpoint emphasizing
prevention over intervention the critical first step is get them off the
couch to see a doctor.

Now, what then are some of the positive effects? Well, certainly one of
the things that I\'ve looked at over the past 20 years is the fact that
if you go back to when I began in 1978 coming out of surgery residency,
University of North Carolina, interested in consumer activism, one of
the things that was clear is patients had no command of the language.

Not only was there no command of the language, there was very little
understanding of basic function and disfunction physiology and
pathophysiology. What does a normal heart do? What can mess up a normal
heart? What is the relationship between risk factors and so forth?

The starting point when I came out in \'78 is the general population had
very little understanding of the language, very little understanding of
basic function and dysfunction, and in addition to that, there was a
tendency to not understand that.

To get to prevention you have to actually engage in the health care
system early rather than late. In a few short decades through a variety
of strategies including direct to consumer advertising, where have we
come to? Well, the general public has some mastery of medical lexicon at
this point. They have basic understanding of basic organ function and
disease and how those things play off each other.

They understand the notion of risk factors. And they get smart really
quickly and they are becoming empowered and they understand
responsibility for health care as a primary individual responsibility.
When they come in to see a doctor\'s office in this more empowered and
competent state, what they generally do is ask questions.

What these questions tend to do to a doc like myself, who practiced in a
rural environment and had a busy office, is they tend to cause us to
stop in our tracks and to actually engage with the other person as a
human being, to recognize who is asking this question and why, within
what context, do I remember what their family is like, their social and
economic situation.

This engagement while it may be \-- it may have a sense of adding work
or making a little bit more difficult, in fact, is very central to being
a successful doctor.

That is, you have to engage a patient within the context of individual,
family, community, and society. A patient who is empowered and confident
forces you to do that because they are coming to you and in your face
saying, \"What do you think about this?\"

As a result, you can\'t do things as wrote as you normally would. You
have to stop and you have to engage. In training of medical students
that\'s one of the central things we try to get people to do as doctors
and nurses and health professionals is engage.

In terms of this new language issue, there is a lot to that. Not to
dwell on it but impeded in a lot of these ads are public health messages
as well as language that is gradually being taken in by patients and
being understood and becoming part of their normal lexicon.

They were also beginning to understand health disorders as well as
beginning to understand even if they are low literacy and even if they
have learning disabilities they are beginning to absorb graphics and
beginning to absorb basic low literacy approaches to educating them.

Even for a patient with very low literacy, they are more likely today to
understand that depression has a chemical basis than they were prior to
these ads. They are more likely to not blame themselves for feeling
depressed but understand that may be something that could be addressed.

So it\'s important to understand that these ads do attempt when they are
done well to cut across cultural and literacy barriers and a variety of
other barriers that have prevented us from really making gains in
prevention and kept this locked into a high cost interventional type of
health care system.

In terms of providing a new understanding of disease and causality, one
of the things I want to just emphasize is this notion that
destigmatizing disease. It is very difficult for patients to really get
over kind of that barrier of not having confidence, especially if it\'s
something personal and certainly when you get into depression, erectile
dysfunction, and diseases like this, it is easy to understand that those
things are hard to talk about.

The thing I want you to appreciate as well is even talking about your
heart or even admitting that there might be something that isn\'t just
right about you and coming to grips with that and seeing somebody and
putting yourself at risk for having that discovered and having to deal
with it, that\'s a big barrier to overcome.

Even for the everyday preventive type of visit, especially for men, I
think, it\'s very difficult to get off that couch. The constant
relentless push, \"Go see your doctor. Talk to your doctor,\" does
serve, I think, a purpose and has had a benefit. We are at least a
little bit closer to prevention today than we might have been five years
ago.

When these patients come in and they are triggered by an ad to come in
whether it be to ask about a disease or ask about a product, it is
important to realize that they don\'t simply get the product. Here 48
percent actually got a treatment that they asked for, but also 39
percent had behavioral lifestyle changes.

There was more going on and certainly an empowered patient and a
responsible doctor are negotiating with each other. This partnership is
about give and take and it would be rather simplistic to think that a
patient could come in and say, \"I want this,\" and the doctor without
thinking about it says, \"I\'ll do it,\" just to get them out of here.
That has not been my experience either as a caregiver or a medical
school administrator or teacher or somebody who has studied this thing
for a long period of time. These relationships are much more
multi-faceted and complex than that. Basically for doctors it\'s a good
thing to have a patient questioning you.

The other thing that I think is important to realize is that one of the
big problems we have in society from a preventive standpoint is that in
the major diseases that cause chronic disease, we diagnose them too late
and we have problems with compliance. Frankly, the numbers of untreated
and undiagnosed in every category swamp the numbers of diagnosed and
treated.

Regardless of how well we do in moving patients to a doctor\'s office
and getting them diagnosed, we still have got a long ways to go in
hypertension, diabetes, hyper-lipidemia, and every chronic disease there
is. Anything strategy that actually moves the dial back from 65 to 35 or
40 for early diagnosis and then, in addition, encourages compliance, I
think, is worthwhile.

It\'s not realized that one of the side benefits of DTC is that if you
are on a drug and you happen to hear the name of that drug in the ad, it
does remind you to take the pill that day so there is this triggering
mechanism where if you are walking by the TV and we hear the word of
your product and you say, \"Oh, I didn\'t take that today.\" There are
certain side benefits in terms of compliance and reminders that spin off
of these advertisements as well.

Now, if we are successful in getting somebody to go to the doctor who
has not been to the doctor before, one in four or 25 percent of them do
have a new diagnosis that occurs during that visit. It may be something
totally different for what they came in for and these are not trivial
diagnoses. These are serious things that are picked up. Why are they
picked up?

Because the simple history of physical examination and some simple blood
work is what gives you these diagnoses of most chronic diseases and
co-morbid conditions as well. If somebody comes in for erectile
dysfunction and they have a simple history of physical and blood test,
they are going to pick up the side diseases, the co-morbid conditions
that actually cause the erectile dysfunction.

If you have a million people who come in with erectile dysfunction,
statistically about 30,000 of them will have untreated diabetes. About
50,000 will have untreated heart disease. About 140,000 will have
untreated hypertension.

Again, from a preventive oriented physician\'s point of view, getting
them in the door is a big, big first step. The DTC prepares patients, I
think, to be more informed and more competent. This leads to
individualization of care.

Lastly, let me say this about this patient/physician relationship. We
tend to think that what it delivers is nuts and bolts health care and it
does that pretty well a couple of hundred thousand times a day,
grassroots in the communities.

People come in with their fears and worries. They have evaluation. They
have a history, a physical. They have some blood work. You get
diagnosis. You agree on treatment. I think that the relationship
delivers that quite well. Not perfect but quite well.

It delivers through more things to society that are often ignored. The
second thing it delivers is that a process is daily fears and worries
for a populous. In so doing, it vents those fears and keeps them from
accumulating. We understand today the effect of fear on a population and
how it can interfere with productivity and general good health.

Secondly, in individualizing the care it tends to relink the individual
to their family context and community context so it gently reinforces
these very important linkages between an individual, a family, and a
community.

Lastly, it provides enough hope and confidence long term that people are
actually considering investing long term into the future. Part of the
reason that this relationship scores so well in all of the countries we
studied is certainly that it\'s emotional, it\'s compassionate, it\'s
understanding in its partnership. It\'s about the future and it\'s about
productivity.

In addition, to be able to process fears and worries, to be able to
reinforce family connections, and to be able to point someone toward a
hopeful future where they have investment is a very important series of
contributions. Again, I think if DTC can move more people into this
infrastructure and support network, it is a real benefit.

In summary then, helping patients proactively engage with their
physicians is an important contribution of this type of advertising
ensuring that the patients are informed and empowered, confident,
understand the lexicon, are willing to actually engage as partners for
themselves and for their families, keeping the patients engaged over a
period of time, sustaining the treatments that are put in place to keep
them in control of their disease rather than have the diseases control
them.

And expanding both communication between doctors and patients which
really consummates this relationship and individualizing the care so
that we doctors don\'t become robotic in our approach to patients. All
of these, I think, are important contributions worthy of consideration
when thinking about the pros and cons of DTC. Thank you very much.

MS. MONCAVAGE: Thank you, Dr. Magee.

Our next speaker, Mr. Dean Smith from the University of Michigan. Excuse
me. That\'s Dr. Dean Smith.

DR. SMITH: Good afternoon. Thank you for permitting me to speak here
today. It\'s actually just Dean. The only person required to call me Dr.
Smith is my younger brother.

Today I\'m going to be presenting research based on New Zealand and I
wish to acknowledge my colleagues, Lynne Eagle and others at Massey
University. Direct-to-consumer advertising is as controversial here as
we are experiencing in the discussion today but also in New Zealand,
which is the only other country that permits direct-to-consumer
advertising, it\'s technically been permitted in New Zealand since 1981
but has only become commonplace following changes in the United States
in 1997. Many of the ads that are seen in New Zealand are derivative of
efforts and programs that happen in the United States.

In New Zealand there is a slightly more fevered pitch about
direct-to-consumer advertising and this past year I\'ve seen Government
hearings pushing bands on direct-to-consumer advertising.

What I\'m going to be presenting today are results of research based on
questionnaires sent to physicians, nurses, pharmacists, as well as
consumers. The work was funded by the business school at Massey
University.

We wish to acknowledge that many of the questions were blindly stolen.
Others were by permission from Dr. Aikin and Slaughter who you heard
from yesterday who received at least some permission from but I guess
we\'ll be sued in New Zealand court.

Our response rates from our four surveys were roughly 30 percent. They
were all mailed and there was no financial renumeration associated with
responding to the survey.

I\'m going to present ad results from discussions with both consumers
and providers and I\'ll hope to keep at least some continuity here.
Seventy-three percent of the consumers that responded to the surveys in
New Zealand reported seeing direct-to-consumer advertising.

This we had originally compared with some survey in the United States
suggesting that it was closer to 85 percent here, although yesterday we
heard two different presentations giving 76 and 77 percent as consumer
response rates which might mean that the New Zealanders aren\'t that far
off from those of us here.

We asked them among the questions whether it caused them to see a doctor
because of a medical condition. We asked them both about existing
conditions and conditions not previously discussed among our consumers
and those with chronic conditions.

What we found were numbers similar to that found in the United States,
although a common theme here will be numbers that are similar but
slightly dampened in their effects. Consumers come to the physicians
because of illnesses seen or not seen before and consumers with chronic
illnesses were more likely to go see their physician because of ads.

We asked a number of questions that had persons give us responses in
terms of percentages and we bracketed them for this presentation in
terms of less than 25 percent, 25 to 50, 50 to 75, and 75 or above
because one of the things I want to highlight here is the range of
expressions that we got from persons. Not just it was eight percent or
nine percent but the range on almost all the questions we had.

We asked patients who have asked their doctors about a medication as the
result of advertising. General practitioners estimated that a very small
percentage of their patients, few than 10 percent, had asked them about
anything that came from media.

Similarly, low percentages from the Internet but when patients did come
and ask their physicians about drugs and about conditions related to
advertising, it was usually through a regular appointment rather than a
special appointment for this purpose.

We asked physicians what pressure they felt because of patients and
asking about products. We asked them about a number of specific
products. The product that yielded the highest pressure among physicians
to respond to them were weight loss drugs.

Part of this reason for this being the highest pressure is that there
have recently been weight loss medications approved for sale in New
Zealand but they are currently not approved for reimbursement. This is a
country with nationalized health care but also as a national formulary
which doesn\'t include all medications.

We found that many physicians felt some pressure or a little pressure.
It was interesting in a national commentary on this, one person
suggested that appropriate public policy would be a sort of mistraining
on the part of physicians.

We asked about the frequency of the actions taken when patients did come
and ask about advertised medications. The results were similar as those
found in the United States. The most likely recommendation that
physicians gave to patients when they came in asking about weight loss
reduction medications were changing their lifestyle but they were
frequently given medications or given other prescriptions. Very little
recommendations, though, for over-the-counter medications although they
are plentiful.

The perceptions of patients\' reactions to recommendations as to both
pharmacists and general practitioners were that by in large patients
responded appropriately to the physician\'s medication. They agreed with
it. There were very few patients of them challenging it. There were
other follow-up questions not presented here about whether you would
change doctors because of this and the percentages were very low in the
single digit percentages.

We asked a series of questions of both general practitioners,
pharmacists, and practice nurses on the burdens and effects of
direct-to-consumer advertising. The first was the question, \"Does
advertising place an unnecessary burden on your medical practice with a
zero to five scale where three was neutral.\" And the medium response
was three. They were neutral to this and did not place unnecessary
burden on the practice.

They did think that advertising provided patients with information that
they have the right to know, although the difference from neutral is
minimal here. They were in disagreement that ads provide medical
information that professionals would not give, although the numbers here
aren\'t zero. Again, there is quite a range of responses so there were
quite a number of consumers that did agree with this response.

There was widespread agreement that ads make patients aware of new
medications. There was also a response that ads did not give enough
information about either the positive or negative benefits.

There was a stronger feeling that not enough was given about the
negative benefits but consistent with some of the earlier discussion we
had today about giving positive benefits there was a feeling there was
some lacking there, too.

There was an expression from GPs, pharmacists, and consumers that
advertising creates needs in patients that are not justified. The only
group not agreeing with this in a significant manner were practice
nurses.

There was widespread agreement among the providers that advertising
gives an opportunity to discuss options in managing a condition and
options that go beyond just giving the drug that the patient asked for.

This slide is somewhat out of order but we asked patients that consulted
the doctor regarding advertised medications whether it was the first
consultation about it, whether requested medications were prescribed,
and whether other medications were prescribed instead.

Again, our results here were very similar to those found in U.S. based
surveys but slightly lower across the board. That is, lower first
consultations, slightly lower percentages of them getting the medication
asked for, or getting other medications they asked for.

We also asked providers whether they thought that advertising\'s first
consultations on symptoms that might go untreated and, again, there was
widespread agreement that this is the case.

We asked the patient\'s perception of advertising influence on their
current medication, a point that has been discussed a couple of times
today. We asked them both whether seeing an ad would make them more
likely to refill a prescription or take a medication more regularly. The
responses of this happening more often were 15 percent more often to
refill a prescription and 18 percent more often to take one regularly
both of which are positive benefits of DTC.

Virtually no responses that ads would make them take something less
often so perhaps they are not hearing the side effect issues. But the
majority of the responses, over 80 percent, were that DTC would not have
an effect on this.

We had a rather long questionnaire, several suggesting plus or minuses.
The questionnaires to all the groups were some 11 pages which may expand
our 20 percent response rate. We have yet to do a series of
multi-variate analyses to control for all of the individual type of
attributes that might affect their responses. But these are ongoing and
details of all these reports are going to be provided on the Massey
University website.

I\'ll end with one final comment. Dr. Temple suggested yesterday that
perhaps more research should go on that is comparative perhaps comparing
New Zealand to Australia. If there\'s funding here, I already have my
bags packed and the hotel picked out. It\'s one near a beach. Thank you.

MS. MONCAVAGE: Thank you very much.

Our last speaker for this panel, Mr. Cliff Thumma from Pfizer.

MR. THUMMA: Good afternoon. I would, again, like to thank you for the
opportunity to be here. I would like to talk to you today about some
research that Pfizer conducted in 2001. It was actually made public
through the website of the vender who conducted it in the beginning of
2002 which addressed the important issue and then actually the not
terribly well studied issue of the impact of DTC on the doctor/patient
relationship.

Since then there have been a number of studies including the FDA\'s own
work that have come out. I want to talk a little bit about how my
results ultimately compare to some of those things. There\'s nothing I
like more than presenting Dr. Aikin\'s results to her.

I would like to talk a little bit about the way we think about getting
someone successfully treated. Essentially an overly simplistic way to
look at this, which I hesitate to present to health care professionals,
is that it\'s really a three-phase process.

We need people who are motivated to become more informed to seek a
diagnosis. We critically need engagement with a health care
professional. Finally, we need commitment to therapy. Once a therapy has
been arrived at, it does no one any good if they don\'t stay on it.

Fundamentally, what I\'m talking about today is the middle box but I
sort of hate to start in the middle of the story so I would like to make
a few points about what I think we have seen in the literature and a lot
of what we have seen here today and yesterday on the opportunity to use
advertising to motivate patients.

I think we have seen patients consistently report and consistently agree
that this stuff is providing them with information they find useful. We
continue to see an amazing amount of convergence on the fact that it is
motivating people to look for additional health information, websites,
other ads, other places like that.

We are also seeing that patients are being motivated to speak to their
physicians by this type of information and ultimately we are seeing a
number of pieces of research that suggest that they are, in fact, being
diagnosed for new and important conditions.

The other thing that I think has been a theme today and yesterday is
more and more we are also beginning to understand the importance of
information being accessible to patients and delivered to patients in a
way that they can understand.

In the Pfizer marketing organization it is our policy now that we are
striving to write everything that we deliver to patients at the 6th
grade level. Those of you who do communication for a living realize how
hard that can be with some of the concepts and some of the things that
we want to communicate. Again, it is critically important to make sure
that people understand what we\'re telling them.

Now onto more of my study and the subject of engagement. One of the
things that we had seen for years is when you ask patients how this all
is going, they consistently report. \"It\'s going pretty well. I\'m
really interested in going to my doctor and finding out what is right
for me.\" That interaction typically whether you\'re looking at the 1999
FDA study or some of the other things, it seemed to go fine. The
questions were well received. The questions were answered and we moved
on.

At the time, though, there was a significant interest in understanding
what the physician\'s perspective was on all of this. What we did is we
engage the firm of Market Measures, now Market Measures Cozant, which is
a marketing research agency that is fairly well regarded and widely
used. We set about to understand the impact of DTC advertising on
doctor/patient interactions in two specific categories, high cholesterol
and mood and anxiety disorders.

The idea was that we really wanted to talk about the interaction first
and the advertising second so we wanted to focus on those cases where
people came in and initiated a discussion about a brand of an advertised
drug with a physician. Ask them questions about what the interaction was
like and then at the end we asked questions about, \"Did the patient
mention an ad? How did you feel about that?\" So on and so forth.

In this regard, this is sort of similar and objective to what I think of
as the first part of the FDA summary where physicians were asked
questions about the last time someone came in and talked to you about an
advertised drug. In that regard I\'m going to try to make some
comparisons between what we found and what that survey subsequently
found.

Very short word on methodology here. Fifteen-minute interviews with a
total of 417 physicians. Two hundred of them were treating mood and
anxiety disorder patients. Two hundred of them were treating cholesterol
patients. This was conducted through the Market Managers Cozant
Physician Panel.

A few words about the panel. Market Measures has been maintaining
physician panels for quite some time. We had done some work. They had
released some data that suggested that these physicians had as far as
anyone could tell fairly typical attitudes about DTC and about how it
worked and so on and so forth.

We have also subsequently done and at the time had also seen a little
bit of work essentially validating responses gotten from panelists to
responses gotten through sort of random digit dialing of physicians.

Very, very similar responses. We feel very good about the methodology
and the specific process was that physicians were recruited and they
were told, \"The next time a patient comes in and initiates one of these
discussions, call this number.\" They called the number and they were
taken through a short interview. Again, the idea was that the trigger to
the interview was a patient coming in and initiating a discussion.

One of the things that we found was that a lot of people who initiate
discussions with their physicians mention ads but not everybody. Roughly
half to two-thirds of patients actually mentioned an ad as part of that
interaction.

What we asked physicians then was essentially two simple straightforward
yes or no questions. \"Did the fact that the patient saw an ad for this
medication have a positive impact on the interaction?\" When we asked
that, 56 percent of the physicians who were treating the high
cholesterol patients said, \"Yes. In fact, it did have a positive
impact.\"

Two-thirds of the physicians treating a patient for mood and anxiety
disorder said, \"Yes, it has a positive impact.\" We asked the follow-up
question. \"Did it have a negative impact?\" What we found was that
non-zero but substantially smaller numbers of physicians saying that it
had a negative impact.

The thing I find interesting is when these results were presented
yesterday, this is not that different from the pattern that we saw in
the FDA survey done somewhat differently trying to assess essentially
the same issue. We are seeing more often physicians are reporting
positives than negatives.

I also saw \-- I really don\'t have time to get into it but we when
asked on an open-ended basis what were the positives and what were the
negatives, very similar to the answers that Dr. Aikin presented
yesterday.

We also asked physicians and, again, this is in advance of bringing of
the subject of advertising, what did this patient ask about. This is a
very hard thing to read but what we saw is that patients who mentioned
an ad were far more likely to ask the doctor\'s opinion of lots of
interesting things.

The doctor\'s opinion of the drug, the doctor\'s opinion of side
effects, the doctor\'s opinion of efficacy, and, in some cases, actually
the doctor\'s opinion of cost and whether the thing is covered by their
health plan. So what we\'re seeing is, in one sense, essentially a more
thorough discussion among people who were prompted to come in and
mention an ad.

Another thing that we found, although on a fairly small basis because so
many of these patients actually ask their doctors a lot of questions, is
a tendency for physicians to be more likely to bring up topics that
someone who mentioned an add didn\'t ask about. There was a hypothesis,
and at best now it remains a hypothesis, that perhaps in response to
this discussion things were traded for the physician and he or she
brought them up.

We also asked people about what kinds of products patients were asking
about. In both cases well over 80 percent of physicians said that the
patient asked for a product that was appropriate for them. At the time
we wanted essentially the physician\'s opinion on was this product
appropriate.

We also asked them about the discussion itself. Around three-quarters of
physicians said that the drug discussion was actually a valuable \--
they found it to be a valuable part of the office visit.

Again, in the data that I had submitted to you folks, the full range of
responses is there. If you want to look at means and things like that,
they are certainly there. The point is on this particular measure the
thing tilts very highly to the top of the scale, appropriate products,
valuable discussion.

The FDA obviously didn\'t ask these particular questions but I did want
to point out I think this is very consistent with some of the stuff that
we saw presented yesterday which is the patient\'s tend to come in the
estimation of physicians and ask for drugs to treat a condition that
they have.

They tend to know what condition it treats and, very significantly in
Dr. Aikin\'s data, the vast majority of them don\'t try to influence
their treatment in a way that the physician feels would be harmful. So
as a score card on what patients are asking about, this actually, I
think, pretty good.

The other question that we asked is, \"How much pressure do you feel to
prescribe?\" Again, these are only asked of physicians who are
responding to a specific drug request. There are two things that I think
were interesting in these data.

One is that the scale very much tips towards the not-a-lot-of-pressure
end, far more so than to the lot-of-pressure end. Again, relatively few
physicians saying they feel very pressured. The other thing is that we
were able to look at this among patients who mentioned an ad versus
patients who didn\'t mention an ad. The numbers are really not that
different.

I think one of the issues that we need to think about when we are
talking about pressure to prescribe and the potential for it to be
driven by advertising is to think about whether we are picking up an
advertising effect or an effect of being asked for something and is it
the request that causes pressure or is it the advertising that causes
pressure because you could end up with very different conclusions.

Once again, just to sort of continue my theme of comparing this back to
the FDA survey, again, I think a very similar sort of reaction. Some
people feel pressured. Most people tipping towards the not-pressured end
of the scale.

Lastly, I would like to talk a little bit about this idea of commitment.
Again, we from both a health perspective and also from a business
perspective believe that it is critically important that once someone is
on a therapy that they need to stay on it.

We asked some questions in this study of physicians who granted requests
for products. Whether they believed that having been given a product
that they asked for, a patient would be more likely to a range of
compliant behaviors. The answer pretty strongly was yes. That, in fact,
they were more likely to fill the prescription.

They are more likely to take it as directed. They are more likely to
tolerate side effects. Again, I think this links back to one of the
benefits that physicians said they saw in the fact that an ad was
mentioned as part of the interaction which made patients more receptive
to therapy.

The other thing that we saw is that two-thirds of physicians said that
they also believe that giving this person a drug that they ask for was
more likely to make them more receptive to other things like diet and
lifestyle change. Again, some evidence that at least there was an
expectation here that this would be positive.

There\'s been a lot of talk over the last two days about the impact of
DTC on compliance. I would like to offer up two other pieces of data
that I have submitted to the agency. One is a longitudinal study that we
were involved in which tracked people, the subsequent behavior of people
who got a product because they requested it and compared that to the
subsequent behavior of people who got a product that they hadn\'t
requested.

We did see across five or six categories that people who requested a
product did, in fact, tend to stay on therapy longer. Again, I thought
that the engagement is a positive thing.

Another study that was done by a different company independent of Pfizer
which maintains another panel of people looked at the refill rates among
people who were aware of ads for a product that they were taking and
they did, in fact, find some evidence that people who were aware of ads
for their products tended to have higher refill rates.

Again, it\'s hard to find the causality in here. It could go either way
but certainly the idea goes along with a fairly established economic
theory that advertising has an opportunity to reinforce choice. So, in
summary, we think there is a lot of evidence. I certainly think there\'s
a lot of evidence that talks about the importance of DTC and its ability
to motivate.

I think we have seen a lot of data and I applaud the fact that so many
people are collecting data on the interaction between health care
professionals and patients as it relates to DTC. I think we saw a lot of
data suggesting that by in large it\'s a positive interaction, that
physicians find it to be beneficial, that patients find it to be
beneficial. I think we are beginning to see not only some data that
suggest that DTC can increase persistence, but we are also beginning to
see an industry that is increasingly focused on using communication to
consumers as a way to increase persistence.

With that I thank you.

MS. MONCAVAGE: Thank you. Now we\'ll entertain some questions from the
panel.

Dr. Aikin.

DR. AIKIN: I was going to address this to Dr. Magee but I think I\'m
going to address it to the entire panel. We\'ve heard from your data
that one advantage of DTC is that it gets the patients in to speak with
their doctor, gets them off the couch. We also heard from Dr. Smith\'s
data that it increases awareness. I think we\'ve heard some other
presentations that also confirm this.

It seems to me that both of those things are done fairly well with help
seeking advertisements. What is the added benefit to the
physician/patient interaction or the public health by having product
claim advertisements on top of that?

DR. MAGEE: I think that\'s an excellent question. My personal experience
and from some of the studies that we\'ve done is that both product
advertising and disease specific advertising appeal in different ways to
difference audiences and both of them actually lead toward movement.

There is something very empowering to a patient to be able to actually
come in and speak about a specific type of treatment. On the other side
of it, if you are the doctor, there is something very direct and
efficient about that type of inquiry.

Way before there was DTC I can remember a fellow coming in up in Vermont
to me and he had torn out a piece of the [National
Inquirer]{.underline}. He threw it in my face and he said, \"Doc, what
do you think about zinc?\" You could tell that asking me very directly
about a form of therapy placed him very much on par with me and I had
the opportunity to say directly, \"Not much.\"

So I think there is some benefit in utilizing the actual product
advertising from a strictly health consumer empowerment point of view.
It is a backdoor way that is quite accessible to the patient to
pathophysiology back to physiology back to prevention. That\'s the way
the doctors walk it down when they get one of these inquiries.

If a patient thinks they are actually going to get something specific, a
form of therapy that may work better or may have less complications or
may change the quality of life. It is highly motivating compared to a
general ad that says, \"You really need to take care of your heart.\"

DR. SMITH: One of the more popular ads that I saw on television when I
was there was for a weight loss drug where a person was out running and
their Barka-lounger was chasing them. Every time they turned around a
corner, it turned around the corner and it chased them telling them that
they need to lose weight and then this drug could help them.

I can\'t use words like physiology sort of stuff. I\'m an economist but
from a public policy standpoint, maybe it\'s not a bad idea to use
Pfizer\'s money to make public health messages if they indeed have these
general health effects rather than using the government\'s own scare
resources for these same messages.

When I saw the similar messages that the government of New Zealand had
produced, given that the obesity epidemic is even more pronounced there
than it is here, I don\'t know what the popular kid\'s word is today but
lame comes to mind about go see your doctor if you\'re overweight,
versus something dramatic that actually ended up bringing a lot of
people into their physician\'s offices. Maybe sort of the creativity of
the private sector motivated around selling product that actually has a
public benefit here.

MR. THUMMA: I\'m neither an economist nor a physician so I\'m not sure
what words I can use. I guess the answer that I would give you to that
is that increasingly we are seeing that people process information in
different ways. People look for information in different places and
different people respond to different messages.

The one piece of data that comes to mind, and I\'m not sure I\'ll
remember her specific numbers correctly, but when Linda Golodner
presented her study from the National Consumer League yesterday and they
asked people, \"Why did you go see your doctor?\" she got a couple of
different answers.

One was, \"To go see what the best way to treat my condition was,\"
which would sort of be the outcome of potentially a health seeking ad or
that sort of an answer. There was another one, though, which was, \"To
go see if the product I heard advertised was right for me.\"

I don\'t think that this has been researched well enough to be able to
tease out how many people do we potentially lose if we eliminate that
\"see if a product is right for me\" group versus how many people do we
make up if we do more or better or more creative health seeking ads.

I think what you see in a lot of cases is a combination of health
seeking ads, of branded ads, of websites, of all sorts of things. It may
be that\'s because this is a relatively new discipline and we haven\'t
figured out what the exact balance ought to be. Hopefully we\'ll find it
over time or it may that is the right balance and we just haven\'t
proven it yet.

MS. MONCAVAGE: Dr. Temple.

DR. TEMPLE: This is for anybody and it is admittedly a hard question
because looking at the impact in direct-to-consumer advertising is
always compounded by the fact that the drug is probably mostly newly
available, that there\'s multiple other kinds of promotion going on at
the same time.

Having said that, however, it was striking that John Calfee couldn\'t
see any blip in the lipid curve which is sort of the one thing you would
like to see everybody triumph with and which has had very substantial
promotion.

I just wondered whether there were some counter examples to that where
there was reason to think that direct-to-consumer promotion
particularly, perhaps starting at a particular moment in time, had
actually made a difference on something.

I guess I would divide it into something we really think is important
like getting a blood pressure lipid controlled. Even something that is
not as important. Now much does anybody know about the actual impact of
that particular component of medical information?

I should say we, the FDA, has a strong bias in favor of at least trying
to enlist the patient in support of various activities, risk management
and something like that. One of the things we do is we make the patient
package insert. Well, that\'s trying to get the patient involved. just
wondered whether there were data that anybody knew about.

MR. THUMMA: Let me see if I can jump in first so I don\'t have to be the
last one to answer. I think that there \-- I mean, one of the things I
think that a lot of the analysis here points out, and those of us that
have tried to sort of do this for a living sort of agree with this, is
that when you\'re talking about estimating the effects of advertising,
you are looking at something that is really hard to do and so it\'s not
a surprise that some people have found effect and some people haven\'t.

There was data presented earlier today and it was the study that was
done with the \-- it was published by the Kaiser Family Foundation which
was econometric work that did, in fact, find a volumetric effect from
direct-to-consumer promotion across a number of categories. This was the
study that talked about what percent of the utilization increase could
be traced back to DTC. I know of other folks who are working on similar
sort of things.

Also, a piece of survey data in my particular study. One of the things
that we asked and is in the data that I submitted, we asked physicians
was the person who showed up, and in the case of the cholesterol
category had they been previously diagnosed, and were they untreated
prior to this visit.

What we found was significantly more of the patient who mentioned an ad
were, in fact, previously undiagnosed and previously untreated. A lot of
them were previously diagnosed, may or may not have been treated. There
was a lot of continuing therapy. But we did see a significant
difference.

I think one of the things that has surprised me most in all of this is
how close the various survey measures and how close some of the
econometric work sort of converge on the number of patients or the sort
of impact of this stuff. It is a significant impact, it is a significant
utilization driver, but it is by far not the largest one. So it\'s just
an ugly thing to try to estimate.

DR. MAGEE: I have a couple of thoughts that were triggered by your
question. One thought was this. As I\'ve been doing this work over the
years, and especially of late, as the health consumers have begun to
gain speed, and in a study a year or two ago we asked doctors and
patients nationwide, \"How well prepared is the patient to manage their
own health?\"

The patient said, \"We\'re 50 percent of the way there.\" And the doctor
said, \"Well, we think they are about 30 percent of the way there in
terms of education.\" Whichever is right. You can see to the right of
those bars are the opportunity for working together on education.

But what I found is as it began to gain speed, there is a natural
tendency organizationally to wonder is the patient really having the
wool pulled over their eyes or are they actually capable of making their
own decision? There is this subtle trend that\'s out there that now that
we\'ve addressed physician paternalism somehow fall back on
organizational paternalism to protect the patient from their own
decision making.

I think we\'ve got to be very careful to put that issue on the table
because with this issue of consumer empowerment, you are either for it
or you\'re not. If you\'re not for it, then you set up all sorts of
blocks to protect the patient from themselves.

If you are for it, you really have to go all the way and allow them to
take the risk of managing their own care. Now, I tend to believe that is
done within the construct of the patient/physician relationship for a
lot of different reasons.

One of them the experience in the UK where they have actually managed to
drive patients and doctors in opposite directions in terms of
expectations and created more adversarial type of behavior which is not
helpful to anybody. So that was one thought that was triggered.

The second thought was that we tend to underestimate the enormous
progress we\'ve made. When my dad practiced medicine, the office was
attached to the house in the early \'50s, the EKG machine was just about
to be invented. My parents smoked at the table because they didn\'t
really realize what smoking did to you.

We had no understanding that diet might be the reason why that
35-year-old guy dropped dead on the softball field. I mean, that was in
our own lifetime. And so the knowledge base and our progress not only
doctors but \-- alongside them and society overall is moving very, very
quickly.

We need to recognize that this relationship will continue to evolve. The
knowledge base is going to go quicker. We have to have a way of
continuing the dialogue in a public way. One of the benefits of this
type of advertising is that individual family and caregivers are getting
it all together. They have all sort of seen it together in the mass
media.

At least it provides a common platform to debate whether this is a good
choice, a bad choice. At least they have common language and tools that
they are using as part of this engagement with each other. The fact that
they are empowered and it\'s going to go forward is something we\'ve got
to continue to reinforce and the fact that they need to do it together
rather than in opposition to each other I think is another thing that is
very worthy of reinforcing.

DR. SMITH: I\'m not exactly sure what question you asked but what I
heard you ask with economist ears was what is the return on investment
in this game. I would be very distressed if I were spending money for,
say, cholesterol reducing drug advertising and didn\'t see any benefit
from that.

We are now undertaking research again in New Zealand comparing the ad
spending and the consumption. There appears to be a relationship there,
although it appears to be more of a market share relationship rather
than expanding the pie relationship.

But it occurs to me that it is almost as tricky as looking at what is
the return on the investment from Coca-Cola advertising for Vanilla Coke
when Vanilla Pepsi comes up immediately? There are very few classes of
drugs where there is one party that is advertising for it and the others
aren\'t.

It\'s possible that it is foolish spending that, you know, \"Johnny
jumped off the roof, Mom. Can\'t I as well?\" But it\'s also hard to
reject that it isn\'t protecting the market share.

DR. MAGEE: And I guess I would add to that. Certainly the companies are
doing well but I would think the families are probably doing better.
When you get a whole new break-through type of understanding like we\'ve
had with cardiovascular disease in a 10 or 15-year period, it\'s pretty
understandable that drugs like statins explode in use.

They explode in use because the doctors and patients negotiating this
type of decision, a couple of hundred thousand times a day decide that
it\'s worth the time, effort, and money to utilize these things.

If you look at the barriers toward actually getting to the point of
purchasing a product and staying on it, that\'s not an insignificant
barrier. I have always felt that doctors don\'t prescribe willy nilly.
Patients don\'t fill these prescriptions willy nilly.

If, in fact, in a sustained way you have product support, it is because
both of them together have come to the conclusion that it\'s worth
giving up something in order to get the benefits of these products.

DR. TEMPLE: That was all helpful. I was asking because in the arguments
that go back and forth about whether this is a good thing or a bad
thing. One of the things that people who like to do direct-to-consumer
advertising like to say is that a lot of it, at least, is directed at
helping patients get things they really do need.

I was just curious how much evidence we have that it really can move
those things. My longer-term interest is that there are certain parts of
medical life that are badly underserved.

I think a lot of people are trying to think about how to get blood
pressure control better, how to let people know that systolic pressure
counts which obviously not enough people know, etc., etc. This is at
least conceivably a tool that can be used and I was just trying to see
how much we knew about how good it is.

DR. MAGEE: And I think that our knowledge base is growing but we are
probably in the early stages of some of this. To me the critical point
is to get earlier engagement than we have been able to successfully do
in the past to continue to rapidly up-brand medical lexicon and disease
understanding on the part of consumers and to force as much as possible
these individuals together so that they can look at their decisions and
negotiate the best decisions possible within an individual and family
context.

The logical way both doctors and patients will go is toward prevention
if we can just get them there. There is nothing logical about letting a
disease get to the point where it has control over your functionality
and forces you into an emergency room or an operating room or a
hospital. The critical thing I think is to get them there and once they
are there to have a good encounter and then to figure out whether it\'s
worth the resources for prevention.

MS. MONCAVAGE: We have one more question and then we\'ll take a short
break.

MR. TROY: Dr. Smith, you\'re not from North Carolina, are you?

DR. SMITH: Go Heels.

MR. TROY: It has been speculated that one of the reasons why most
European countries do not allow DTC advertising is \-- this is somewhat
cynical \-- because they also have nationwide health care systems and
are the providing and payer in addition to regulator and so, therefore,
they have somewhat of a disincentive or incentive to suppress
utilization.

It was interesting for me to hear you say that New Zealand has, I guess,
what is like a single payer or national health care system but still
allows DTC advertising. This may be a question more probably directed at
a lawyer than an economist but do you know how that came \-- maybe an
historian \-- how that came to be? Does New Zealand have any kind of a
first amendment? Do they recognize commercial speech being protected in
other contexts? How is it and why is it?

DR. SMITH: I think this requires more of a sociologist than an economist
but I need to make two points on this. One is that it is not a country
in love with regulation or government. It is a very free market oriented
piece of land.

Therefore, there are far fewer regulations almost across the board than
one would observe in many other countries which might make the presence
of national health insurance more of an anomaly than the fact that they
have direct-to-consumer advertising.

The other aspect is that as a country they have a great dependence upon
the rest of the world for guidance. There are only 3.8 million people in
the country, sort of like suburban Chicago in size. Their FDA equivalent
isn\'t all that much more than the people in this room so that the drug
approval process is somewhat derivative of what happens in Australia and
the United States.

The regulatory process somewhat derivative but with a tendency not to
regulate rather than to regulate. The fact that it has been permitted
since \'81 but hasn\'t actually happened in practice until the
commercial effort of the United States made it more readily available, I
think, is probably the reason why now.

MS. MONCAVAGE: Peter, you had one question.

MR. PITTS: Interesting stuff, gentleman. Thank you. You\'ve used words
like empowerment, engagement, collegiality, partnership which is nice to
hear. I didn\'t hear a lot of friction or pressure as we\'ve heard from
previous panels.

Obviously this is dialectic. Why the change? Why all of a sudden are we
talking about collegiality and partnership empowerment and not about
pressure and people speaking out of turn?

MR. THUMMA: I can certainly start with that. I think in the data I
presented we did actually ask about and speak about pressure and what we
saw is very much like what I think a lot of people have seen, is that
there are some physicians who do, in fact, feel pressured when patients
make requests whether they\'re driven by DTC or whether they are driven
by the age old phenomenon of, \"My best friend is on this drug.

Perhaps it ought to be right for me.\" There is some pressure. I think
we have consistently seen, though, that the majority of physicians are
sort of headed towards the, \"I\'m not real pressured,\" end of the
scale.

I think the answer is that this is a process. It\'s a give and take
between patients and physicians. Dr. Woodcock earlier today \--
yesterday in her introduction used a phrase that you don\'t hear very
often which is the patient is an advocate on their own behalf.

I don\'t know if that constitutes pressure or whether that constitutes
collegiality or whether that constitutes a dialogue. I think there is
unquestionably a discussion going on there and some people are more on
either side of the desk are more comfortable with it than others.

I can assure you that there are people in America, consumers in America
who under no circumstances would make a request of their physicians, and
there are people who are perfectly happy to do that. I think what
you\'re seeing is a dialogue that most of the data that I have seen
suggest is reasonably healthy.

MR. PITTS: I guess my question is why has it happened?

DR. MAGEE: I think there are a number of reasons it\'s happened. Clearly
\-- changed. That is very obvious to physicians. At least in the U.S.
the doctors have largely kept up. I think part of the motivation is that
absent alignment the physicians run the risk of choosing others to
partner with.

I think the physicians have correctly realized that their long-term
future needs to be tied to the patient and they have taken active steps
to assure politically, economically, socially, and in other ways that
they remain aligned. That isn\'t to say that this hasn\'t tremendously
stressed the doctor\'s office to have this type of a conversion.

To have it on the backs of physicians has been a lot to ask of
physicians, but the truth of the matter is in spite of the fact that
it\'s hurt and in spite of the fact that it\'s caused them to work more
hours and feel more pressure than stress, in general they\'ve pulled it
off, or at least they\'ve gotten themselves more than half way there
which is pretty remarkable.

The other thing is that those of us who are tied to medical schools
through these periods have responded as well so today you\'ll see
curriculum that stress humanism, stress courses in professionalism and
patient communication. I, myself, beginning to agitate for curriculum
change that would actually teach physician skills in team dynamics and
skills in professional education in the curriculum because we think that
is what is going to be required in the future.

This, I think, has been a very dynamic period of time both for doctors
and their offices and also for medical education organizations in the
U.S. It\'s only this past year as we have begun to study what has been
occurring in other countries as well that we look at the U.S. and we say
in general they have done a pretty good job in trying to respond to what
has been a revolutionary change in the way that patients view health
care in the United States.

MS. MONCAVAGE: Okay. Thank you very much. We are a little behind
schedule so how about if we take a shortened break. Rose says no. 15
minutes. Please come back in 15 minutes promptly. Thank you very much,
panelists.

(Whereupon, at 2:55 p.m. off the record until 3:16 p.m.)

MS. MONCAVAGE: We are going to have one more panel of presentations. Our
first panelist is Dr. Alan Goldhammer from the Pharmaceutical Research
and Manufacturers of America.

DR. GOLDHAMMER: I would like to thank the FDA for the opportunity to
present here today. PhRMA is an active stakeholder in this issue as our
member companies are actively engaged in the research and development of
important new medicines to allow patients to lead longer, happier, and
healthier lives.

This hearing coupled with the recent public meeting on useful patient
information are important not only to FDA and PhRMA but also to the
consumers who benefit from the innovative new pharmaceutical products.

PhRMA is a strong believer in empowering patients with information about
their prescription drugs. Useful information increases patient knowledge
about disease states and treatment options ultimately resulting in
improved outcomes.

It\'s critical that FDA see the provision of useful information to
patients as a continuum. Company\'s traditionally provide physicians
with brochures that can be handed out to patients outlying the use of a
particular medicine. However, direct to consumer advertising of
prescription drugs provides yet another avenue for the transmission of
such information.

The Internet print and broadcast media are all being used by
pharmaceutical companies to present information to patients on their
pharmaceuticals. It is important to realize that pharmaceutical
communication directed towards consumers are developed as integrated
communication programs.

This slide shows you the individual element that are designed to work
synergistically to deliver a comprehensive consumer education that
ultimately results in superior health outcomes. Each medium whether its
mass broadcast, television, the Internet, 1-800 numbers, patient
education brochures, etc., has a specific role to play in this
communication process.

For example, given its broad-reach capabilities mass-reach vehicles such
as broadcast TV are effective at generating broad awareness of disease
states and products. In contrast, websites, fulfillment brochures via
1-800 numbers have the capacity to deliver a greater depth of education
but have a limited ability to generate broad reach unless advertised
through an external medium.

Therefore, the majority of DTC campaigns are designed to maximize
consumer education by harnessing the power of both mediums. Branded
pharmaceutical television commercials will always be directed at
interested viewers \-- will direct interested viewers to secondary
sources.

Product com websites or patient education brochures via a toll free
1-800 number where further extensive information on the disease state
the product package insert, the patient package insert, and other
helpful information can be easily provided. The goals of this
comprehensive consumer education program are typically achieved through
the use of this integrated communication campaign.

Recent statistics published in [Prevention Magazine]{.underline}\'s
fifth annual survey on DTC advertising of prescription medicines suggest
that such advertising may, in fact, represent an effective means by
which to improve the availability and quality of patient information.

As a result, pharmaceutical companies have made a significant effort to
develop DTC advertising that increases awareness and transmits useful
patient information. Since 1997 promotional spending excluding sampling
has grown steadily at an average annual rate of 16.2 percent.

Moreover, the percentages of consumers who say that advertising gives
them information but they need to talk about the benefits and risks show
significant improvement since their [Prevention Magazine]{.underline}\'s
2000 survey about consumer reaction to DTC.

Clearly DTC advertising has the potential to provide useful information
to consumers as 99 percent of consumers, an estimated 191 million
adults, have seen an advertisement for at least one of the 14
prescription drugs included in the survey.

Of those already taking medications, 69 percent of the consumers who
have seen the advertisements for their particular medicine say these ads
provide them with the risk information they need and 74 percent say they
provide benefit information that they also need in order to talk with
their physician.

In addition, DTC advertising may further encourage safe medication use.
That in the 17 percent of consumers taking a given medicine say that
they are seeing an ad for the medicine reminds them to take their
medicine thus improving compliance. An additional 12 percent are
reminded to have their medicines refilled.

DTC advertising also seems to encourage patient initiative as 66 percent
of patients recall references to a toll-free number, 58 percent recall
Internet websites, and 35 percent recall references to magazines where
the drug is advertized and there is further written information on that
particular product.

The projected number of consumers who visit the websites mentioned in
DTC broadcast advertisements is significant. The focus of PhRMA\'s
current research is on the Internet as a source for useful patient
information on prescription drugs.

As the FDA notes in question No. 9 in the [Federal Register]{.underline}
notice announcing this meeting, the rise of the Internet provides
consumers with significant amounts of information. Many PhRMA member
companies now have interactive websites to provide consumers with not
only the full prescribing information, that is, the drug label, but also
patient friendly information on prescription drugs.

Other medical information providers such as WebMD, RxList and Mediscape,
as well as a myriad of disease societies also provide significant
information on prescription drugs.

Finally, it is important to note that the FDA itself has made use of the
Internet as their website does contain useful consumer drug information
page that has information on all new drugs approved since January of
1998. Dr. Woodcock has a major initiative that\'s ongoing that PhRMA
supports that is their daily med web portal that will have information
on all prescription drugs when it\'s completed.

PhRMA surveyed a number of Internet websites that included the top 20
prescription drugs by sales in 2002, as well as many drugs in selected
disease categories. Each one of these drugs has a website that is both
easy to find and navigate.

According to the Nielsen/Net ratings, pharmaceutical company websites
are experiencing significant traffic. During the first quarter of 2003
over 12 million people visited these websites. This is roughly the same
number as during the fourth quarter of last year. The increasing use of
high-speed Internet connections is most likely responsible for the
decrease in average time spent on individual product websites.

The majority of pharmaceutical Internet searches are done for the
individual doing that search, or for a direct family member as can be
seen in this transparency. Consumers also use the Internet to get
pharmaceutical information on a wide variety of disease conditions.

These are just some of the statistics from the ePharma consumer report
that was issued earlier this year. As you can see, allergies and
depression are the two most frequently searched for conditions followed
by obesity, diabetes, high cholesterol, acid reflux, and hypertension.

Access to specific drug websites, as I noted before, is relatively
straightforward. Many sites have their own specific web address. That
is, drug name.com. They can also be accessed directly through the
company website which would be PhRMA the name of the company.com. And
also are easily accessible via search engines and there are also cross
references from disease society webpages as well as other third party
webpages.

What types of information are commonly found on pharmaceutical websites?
There\'s a host of information ranging from the full prescribing
information that is oriented toward the health care provider. Certainly
in all of the websites that we looked at, each one of them contained the
full PI.

This goes on down to a number of different types of presentations for
the inquisitive consumer. For products that have them, the FDA approved
patient package insert is provided. Pharmaceutical companies have also
employed a variety of different communication tools to provide useful
information as can be seen on the rest of this transparency.

Some pages also provide information for caregivers and may have links to
other third-party sites for further information on the underlying
medical condition.

I\'m now going to talk about some of the websites that cover specific
products that will give you a flavor for the type of information that is
out there for consumers.

This FOXAMAX webpage provides an example of how the Internet can assist
patients in communicating with their physicians. The question posed here
is whether a bone density scan should be done. Currently recommendations
from the National Osteoporosis foundation are presented.

In addition, as you can see on the left-hand side of the transparency,
there are hyperlinks to a wide variety of other pieces of information
that concern osteoporosis as well as whether FOSAMAX is the proper drug
for the person who is doing the search.

This page from the Faslodex website provides patient friendly
information on breast cancer and hormonal treatment. Links are provided
to subsequent pages that discuss the major topics including important
safety information on the drug. As with many other websites, there\'s a
choice menu on the left-hand column that allows the user to select other
topics of interest.

The next slide shows one of those pages and that is a discussion of the
drug\'s mechanism of action. In this particular case the importance of
the hormone receptor status is presented.

The next slide comes from the Ortho Evra page, a new alternative to the
birth control pill that uses controlled release patch technology. The
webpage provides patient friendly information on how to use the patch,
where to apply it, and how often to change it. Again, as is the
recurring theme with other webpages, there is a menu of other links that
provide further information on this pharmaceutical.

The INTRON A website takes an interesting and yet another approach
providing information for the caregiver. Many patients suffering from
series diseases need strong support from loved ones and friends. Such
assistance is particularly useful when the drugs that they are
prescribed may present a variety of side effects of differing severity.

In this web shot the focus immediately notes that fact. Other links
direct the reader to information on how to manage financial insurance
issues as well as addressing a wide variety of work related concerns.

Increasingly patients are interested in how their drug works. This is
the webpage from Sustiva, an anti retro-viral drug that is used for the
management of HIV infection. This graphic shows the viral life cycle and
how the drug interacts in blocking HIV reverse transcriptase, a key
enzyme needed for viral replication.

Many times patients are interested in information that will assist them
in understanding a medical condition so that they can have a more
informed discussion with their health care provider.

This symptom survey, shown on the next slide, provided by a leading
medical center engaged in allergy and asthma research, is located on the
Allegra website. It\'s important to note on the previous slide that
there is a link to the privacy policy on this page that addresses any
concerns perspective patients may have about filling out the online
survey.

The LilyDiabetes.com website takes another approach to providing useful
patient information. This page serves as a gateway to nutritional
information that can be helpful in managing diabetes. Help in planning
and timing of eating meals is offered to assist the patient in
maintaining appropriate blood sugar levels.

Finally, PhRMA would like to briefly address the potential barriers to
providing useful information which was addressed in \-- which was asked
for in question 14. Over the past several years PhRMA has partnered with
the Centers for Education and Research on Therapeutics, CERTs, as well
as FDA in a series of workshops designed to explore how benefit and risk
are assessed, communicated, and managed.

The jointly sponsored workshop on risk communication took place in 2001
and workshop participants agreed that more collaboration is required to
develop new approaches to risk communication. Participants agreed that
several important factors should guide the development of risk
communication as shown on this slide.

Finally, the direction of any future research whether it\'s done by FDA
or other stakeholders should bear these concepts in mind as programs to
assess the value of various means of direct-to-consumer advertising
including the Internet have to be structured.

Both benefit and risk communication must be assessed as they are
inexorably linked. In any questionnaire oriented towards consumers must
consider the whole spectrum of information they receive so the results
are thorough and not prejudice by an inadequate study design.

I would like to thank the agency for the opportunity to present today.

MS. MONCAVAGE: Thank you very much.

Our final speaker today \-- thank you for doing this, Gay \-- Ms. Gay
Kassan from [Parade Magazine]{.underline}. I was just telling her I was
in a similar position a couple of weeks ago.

MS. KASSAN: Thank you, Melissa. Good afternoon. Thank you for allowing
[Parade]{.underline} to present our findings on our first major health
care study, compliance, caregivers and the consumer. This study, we
believe, provides new insights and learnings on the impact of
direct-to-consumer advertising and the importance of the caregiver in
health care management.

Just to note, [Parade Magazine]{.underline} is the largest circulated
magazine in the country. We are seen in over 300 newspapers on Sunday.
We reach nearly 80 million adults every week.

Before conducting this study, we did a thorough evaluation of the market
place. This study is the product of a collaborative effort involving
pharmaceutical companies, health care, and general market advertising
agencies, DDMAC, nonprofit associations, an analysis of previously
released industry studies, and personal observation and experience.

Clearly there has been a need expressed to better understand how to
improve the degree to which suffers comply with their medication
regimen. Their health outcome and the impact on the health care
resources of this country lie in the balance.

Our hypothesis going into this study was that caregivers can positively
impact doctor visits, compliance, and persistence. Ultimately we would
conclude improve health care outcomes. Our objectives were to understand
the role caregivers play in health care management and compliance to
identify sources of information for both sufferers and caregivers, and
to understand the impact of DTC advertising on health promoting
behaviors for both targets.

We commissioned Market Measures Cozant to field what is actually two
studies. One looks at the adult sufferer population. The second examines
adult caregivers. Ten medical conditions were measured, allergy,
anxiety, depression, arthritis, asthma, diabetes, GI disorders, high
cholesterol, hypertension, migraine, and osteopetrosis representing
non-lifestyle conditions that could be either symptomatic or
asymptomatic.

These conditions were selected based upon their prevalence in the
population and their level of advertising spent. A 20-minute telephone
survey was fielded during May and June of this year and we are still in
the process of analyzing all the data it produced.

For the purposes of this study we have defined caregivers as a family
member or friend, someone who takes an active role in managing one\'s
health care. Former First Lady Rosalyn Carter has said that, \"There are
four types of people in this country, those who are caregivers, those
who have been caregivers, those who will be caregivers, and those who
need care.\"

According to the National Family Caregivers Association that represents
about 54 million adults, certainly a large portion of our population.
The first key finding we like to share was that only 40 percent of
sufferers say they have a caregiver. Of the 60 percent of sufferers that
do not have one, close to half indicated that they would like one.

There is a variance in the incidence of caregivers by condition.
Diabetes has the highest incidence, allergy the lowest. According to
Market Measures Cozant\'s analysis sufferers with caregivers tend to
describe their conditions as being more severe and less controlled than
their counterparts without caregivers.

I have discussed our primary objective was to better understand the role
caregivers play in patient compliance. We uncovered a number of key
attitudes and behaviors that are positively impacted by this
relationship. Emotionally 95 percent of sufferers responded that
caregivers positively influenced them, 93 percent are receptive to their
caregiver\'s involvement, and 79 percent feel that their caregiver\'s
help is necessary.

Although the emotional connection is certainly important, the measures
concerning actual behavior are what can impact outcomes and this is
where we see a very encouraging finding. Among sufferers with
caregivers, 89 percent responded that their caregiver encouraged them to
seek care, over two-thirds discussed treatment options, and 60 percent
remind them to take their medication. This is an important finding when
we address reasons for noncompliance shortly.

The caregiver\'s impact is seen in encouraging the sufferer to seek
care. Over the course of the past 12 months sufferers with caregivers
reported that they went to the doctor twice as often for treatment of
their condition when compared to sufferers without caregivers.

Now, we cannot fully attribute causation from this data alone because,
as we said before, those sufferers who claim to have caregivers seem to
have a more severe condition but we certainly feel this is worth further
probing.

Furthermore, sufferers with caregivers report that they are
significantly more likely to be actively involved in a healthier
lifestyle. They are more likely to be taking a prescription drug or some
other OTC or alternative therapy.

They are also 15 percent more likely to be using a non-drug therapy like
diet or exercise. And they are almost 60 percent more likely to be
involved with a program dealing with smoking cessation or alcohol
abstinence. All of these groups are statistically significant.

As you recall, we talked about certain behaviors and sufferers with
caregivers 60 percent of them said that their caregiver reminded them to
take their medication. This finding is certainly significant when we
look at the reasons for noncompliance.

We ask sufferers why someone might not take their medication exactly as
directed and we asked the caregivers to report why the sufferer they\'re
most closely connected with doesn\'t always take their medication as
directed. What we see is a very interesting correlation. Regardless of
who is questioned, forgetting to take is far and away the primary reason
for noncompliance. This has been found in a number of other studies as
well.

In convenience the end of noticeable symptoms, cost, and side effects
along with not remembering represent over 90 percent of the reasons
stated for noncompliance.

The source of health care information is another key area for learning.
As we\'ve seen in a number of previous industry studies, the health care
professional is the leading source of information for sufferers.

However, we do see some interesting differences here when we look at the
caregiver population. The Internet is regarded as the No. 1 source of
health care information. Fifty-nine percent of caregivers site the
Internet.

This correlates with a number of new studies we\'ve just heard in the
last day or two that identify the Internet as a growing component in
providing health care information.

Beyond that, comparing the differences between the two populations of
sufferers and caregivers, caregivers are 35 percent more likely to refer
to a reference book and 20 percent more likely to refer to a magazine or
newspaper for health care information.

We will now look at the impact of direct-to-consumer advertising on both
samples. Almost all sufferers and caregivers are aware of
direct-to-consumer advertising, although there are some differences in
the percent of awareness by population.

Both sufferers and caregivers ranked allergy as the condition they are
most aware of having seen a DTC ad for. We can see that the caregiver
percentages are equal to or higher than, in most cases, the conditions
as ranked by the sufferers.

When both sufferers and caregivers are asked where they have seen DTC
ads they tend to rank the media in a similar order. Television is first
closely followed by magazines, collateral materials found in doctor\'s
offices, direct mail and pharmacy, newspaper, Internet, and the radio.

Interestingly, caregivers are 14 percent more likely to have seen a
direct-to-consumer ad in a magazine, 29 percent more likely to have seen
an ad in the doctor\'s office, and 20 percent more likely to have seen
an ad in direct mail.

Caregivers, as we have reported in their information seeking behavior,
tend to be more aware of direct-to-consumer advertising than the
sufferer group, again we believe owing to their role as active
information seekers.

When we look at specific actions taken as a result of seeing a DTC ad,
approximately three-quarters of both sufferers and caregivers do take
some action. Forty-one percent of the sufferer group reports discussing
an ad with their spouse, relative, or friend. The caregiver is 37
percent more likely to have had a discussion with the sufferer.

Interestingly, caregivers are 42 percent more likely to look for
additional information about the condition and the sufferer. In fact,
over all against every measure caregivers are 10 percent more likely to
take a specific action.

For this slide we will examine behavior differences between the sufferer
population that has a caregiver and the sufferer population that does
not. Among the first things we notice are the striking differences.

Overall sufferers with caregivers are 23 percent more likely to take
some action than those sufferers that don\'t have a caregiver. They are
90 percent more likely to discuss an ad with someone. They are 34
percent more likely to look for information.

Addressing one of our primary objectives, improving compliance, they are
44 percent more likely to get their current medication refilled. They do
call or contact their physician and ask for the advertised medication
significantly more than their counterparts.

I should point out at this point we did not ask if they actually got the
prescription but we do know that they did ask for it. That certainly
represents another area for further probing.

In this slide we reflect that sufferers who are shown a
direct-to-consumer ad are 24 percent more likely to take some action
than those who see an ad on their own. They are 61 percent more likely
to discuss the ad, 58 percent more likely to look for information, and
43 percent more likely to get their current medication refilled.

Here again is very compelling information that demonstrates an important
difference, compliance, and persistence has when a sufferer is involved
with a caregiver.

As reflected on this slide we simply ask whether sufferers and
caregivers consider DTC a good idea. By over a two-to-one margin
sufferers believe it is a good idea. By almost a three-to-one margin
caregivers believe the same. It should be noted that this question
refers to ads targeted specifically to the patient or sufferer.

We also ask caregivers if they thought advertising to people like
themselves, in other words, caregivers, would be a good idea. Even more,
77 percent responded positively.

We asked both samples how helpful they felt DTC ads were in informing
about available treatments, communicating side effects and risk
information, providing new information about treatment options,
reminding to refill prescriptions, and reminding to take medication.

Again, both sufferers and caregivers rank informing about available
treatments as the primary area DTC helps in communicating. Twenty
percent more caregivers than sufferers reported this finding, however.
Both sufferers and caregivers indicate DTC ads do not do as good a job
as communicating reminders to either refill or take current medication.

In response to specific requests from DDMAC, we have included questions
about the effectiveness of the brief summary. But because most consumers
might not be familiar with the term brief summary, Market Measures
Cozant, our supplier, recommended using the phrase \"fine print
appearing in or near the ad.\"

Just to be clear that some of these numbers may, in fact, take into
account some of the body copy, the text that appears in some of the ads.
Clearly one of the interesting points about this slide is the apparent
differences between the caregivers and the sufferers and their response
to seeing the fine print. Caregivers are 22 percent more likely to have
seen the fine print than the sufferers.

They are 53 percent more likely to read all of it and 23 percent more
likely to read most of it. This finding is consistent with information
presented yesterday by Dr. Aikin which showed the significant increase
in reading the brief summary when someone is very interested in the
condition.

And bringing it back to the doctor as gatekeeper, we see an interesting
relationship between the caregiver, the sufferer, and the impact of
seeing an ad on one\'s own versus being shown a DTC ad by your
caregiver. Sufferers with caregivers are 52 percent more likely to go to
the doctor sooner if they are shown an ad by their caregiver compared to
those sufferers that have seen an ad on their own.

So, finally, we can feel comfortable reporting that the results of the
caregiver compliance and consumer study strongly suggest that the
caregiver has a positive impact on health care management by improving
compliance, persistence, doctor visits, and ultimately a healthier
lifestyle. Thank you.

MS. MONCAVAGE: Thank you very much. Let\'s show our appreciation for the
panel. Thank you. Now Dr. Temple has some parting words for us. Oh,
questions. I\'m sorry. I\'m jumping the gun. It\'s question time. Dr.
Temple? Dr. Aikin?

DR. TEMPLE: Well, I have one. Why do you think your question about \--
this is for Ms. Kassan. Why do you think your question about the brief
summary didn\'t get the usual horrified response about how awful it is
that we hear over and over again. It seems almost to be consensus. It
sounds like people sort of liked it, or at least they did if they were
interested in it.

MS. KASSAN: Well, I think whenever you ask a question, the language you
use in the question will certainly direct some of the response. We
didn\'t ask it. We asked it pretty much straightforward. I don\'t have
the wording of the question in front of me but I can certainly provide
that.

I do think, though, that the interesting point of the slide is to show
that caregivers were far more involved in the reading of the brief
summary than the sufferer. They took a far more active role.

DR. TEMPLE: And were wiling to go through it even though it was small
print.

MS. KASSAN: Absolutely. Absolutely.

DR. TEMPLE: Then the question I had for Alan was the material you showed
from the Internet did not look like it was 6th grade level. Have you
taken a look at what level that was written at? Or since they\'re
volunteers in a sense and seek it out, does it not matter as much?

DR. GOLDHAMMER: There\'s a whole variety of different \-- these were
just illustrative and we tried getting from our member companies but
they range in a whole wide variety of spectrum of things.

I think probably the easiest one, at least in our estimation, my intern,
Ingram Hammon, who helped out on this one, we both felt that the
frequently asked questions approach which we are now starting to see in
more print advertising as well is probably a more amenable approach to
engaging the patient/consumer. It tends to be tailored at a simpler
level than, say, the brief summary type statements that everybody throws
their hands up about.

We didn\'t see a lot of material that would classify or meet your
definition of 6th grade level. I think we are really looking at things
that are probably at junior high, high school level and above.

DR. AIKIN: I also have a couple questions, one for Ms. Kassan starting.
It sounds like from your data that more DTC advertising should be aimed
at caregivers. If that were the case, what do you think the impact would
be?

MS. KASSAN: Well, it looks from the data, it would suggest that
sufferers would have a better outcome, that they would be more likely to
go to the doctor and they might be more likely to comply and be
persistent with their medication. I would have to say what the data
suggest is that it would have a very positive outcome. It\'s certainly
worth further analysis.

DR. AIKIN: And a question for Dr. Goldhammer. Did you measure anywhere
in your data what types of information patients were looking for when
they went on line or how many sources they tended to consult when they
went on line?

DR. GOLDHAMMER: No, we didn\'t do that. I think it has been the subject
of some third-party surveys. Our primary focus was looking at different
types of useful information. The data we got was primarily provided to
us by some of our member parties from a survey. It really focused on the
broad area, which diseases were being looked at. I think we came up with
probably the same numbers.

DR. AIKIN: Also just a follow-up for Ms. Kassan. Do you think that by
saying fine print people were thinking perhaps the fine print in the
main part of the ad as opposed to the following page?

MS. KASSAN: Well, I think, you know, there was some discussion about
what was the best way to get at the brief summary. In discussing it with
the supplier, they felt strongly that saying fine print around or near
the ad would refer back to the brief summary. There could potentially be
some confusion in some of the body text from the ad because, you know,
it does talk about dosing and it does talk about benefits and risks, not
to the same degree that\'s in the brief summary.

DR. ABRAMS: This question is for Ms. Kassan as well. You noted at some
of the actions in response to a DTC ad was to remind folks to refill
their prescription or remind them to take it. Was this just for the
particular drug that was being advertised or was it a class effect such
as the advertised lipid-lowering drug or all people taking a
lipid-lowering drugs would refill their prescriptions?

MS. KASSAN: This was asked for each of the 10 conditions that were
measured so it wasn\'t asked for a specific drug. The numbers that were
reported here represent an aggregation of the numbers but we could break
them out by condition if that answers your question.

MS. MONCAVAGE: Okay. We could take some questions from the floor. We
still have a little time. Okay. Now I think it\'s time for Dr. Temple.

DR. TEMPLE: Okay. This is not the easiest conference in the world to
summarize quickly. It\'s been an extremely interesting couple of days.

As the [Post]{.underline} told us this morning, the general feeling
about DTC advertising, at least as presented here, is at least modestly
favorable with some familiar concerns about the amount of time it takes
the physicians to deal with the consequences of having a more aggressive
and informed public, the tendency to promote principally expensive
branded products when there might be cheaper alternatives.

That\'s coupled with something we heard repeatedly which is the tendency
of doctors to try to respond to patient\'s requests unless they think
the drug is actually an inappropriate drug. At least it seems possible,
as Dr. Mintzes has suggested, that what you get is a drug that is not a
bad choice but in various possible ways may not be optimal.

There seems to be no suggestion that I heard that people get actually
inappropriate drugs. That doesn\'t surprise me too much. It would be a
strange doctor who would give somebody something that they didn\'t think
they really needed unless, of course, it was an antibiotic which, of
course, we know they do.

Ruth Day suggested that the ads are not as good as they good be at
communicating the risk parts for various reasons. That is clearly of
interest to us, although it\'s not obvious to me that the remedies are
going to be always straightforward. It seems at least possible that the
bad news comes in more difficult language than the good news. We
certainly need to explore that.

Not discussed much at this conference but it is clear from what other
people have said is that there continues to be worry about the
medicalization of ordinary life, conveying the feeling to people that
whatever is bothering them is a disease.

On the other hand, if you look at what Joel Weissman showed us about the
most commonly discussed conditions, it\'s a little reassuring on that
point, or at least it is to me. The most common things included
diabetes, cholesterol, elevated blood pressure, depression, arthritis,
and pain.

That doesn\'t seem like medicalization of ordinary life particularly,
but then there were some others, impotence, allergies, heartburn and
reflux, and menopausal symptoms. Those are pretty real, too, I think
most people would say. At least the most common things don\'t
necessarily give rise to that charge, or at least they don\'t seem to to
me.

It seems at least possible that in addition to those concerns there are
some things that people are enthusiastic about DTC promotion. Not
possible. There are some things that people are enthusiastic about.

It would seem to have an enormous potential for increasing awareness of
under-treated conditions by enlisting the patient in his or her own
care, a familiar concept, but it hasn\'t been that easy to show that
this really happens.

It isn\'t entirely clear to me yet how hard people have looked but John
Calfee clearly couldn\'t see any effect at all of DTC promotion of
statins which is one he would like to be effective. I\'m not aware of
anything that suggest that people have gotten their blood pressure
better treated but blood pressure isn\'t that high on the list of things
that are discussed.

There is, as other people have discussed, however, some evidence that
direct-to-consumer promotion can influence the use of certain classes of
drugs, even if not specific drugs. Again, the evidence here is not
overwhelming.

There is also not much evidence so far that I saw to date showing that
it can improve compliance with drugs that one is already on, another
possible benefit of direct-to-consumer promotion that everybody would
value for appropriate drug classes. Those are all things that one might
perhaps look further at.

I have always been struck in looking at the direct-to-consumer arena at
what a large fraction of promotion actually is directed at people of two
types. One is people who don\'t know they have the disease because they
haven\'t gotten their cholesterol or blood pressure checked or haven\'t
gotten a bone mineral density or don\'t know that depression is an
illness and so on, on the one hand.

And, on the other hand, to people who have a complaint that they didn\'t
know needed or could benefit from a prescription drug because they
always used to handle these things themselves with OTC drugs.

You know, when all of the available allergy medicines were OTC drugs,
somebody had to tell somebody that there was one that didn\'t make you
sleepy or they never would have thought. They wouldn\'t have gone to
their doctor for it because you don\'t go to your doctor for a runny
nose, or most people don\'t.

Heartburn, it seems to me, is in that category. I think some people
would say it\'s being overdone but whether you think that or not,
heartburn, acid reflux disease, etc., used to be treated by
over-the-counter products and you have to tell somebody that there is an
alternative.

Pain, migraines, those are all things that many people took care of by
themselves by taking analgesics. And, of course, people didn\'t know
that erectile dysfunction was a disease until they were told that
appropriately. Now there can\'t be anybody who doesn\'t know it.

There are other conditions that probably people don\'t really recognize
as illnesses or don\'t even have a name for. Some of them are obvious.
Osteoporosis, osteopenia has implications but people with social phobia
probably don\'t know that\'s a disease. Some people would debate whether
it\'s a disease but I, at least, think it is.

And excessive/compulsive disease isn\'t an obvious disease. It\'s
strange behavior to people. We are, I\'m sure, going to see a fair
amount of attention to adult attention deficit disorder which, I\'m
sure, is going to be news to people that adults can even get but it\'s
fairly convincing that they can but they wouldn\'t know that by
themselves so one of the things that DTC promotion can do is tell them
about it.

It\'s hard to feel that it\'s not reasonable to let people know about
conditions they might have but have never explored and about conditions
that they didn\'t know could be treated with prescription drugs and, in
some cases, perhaps better than the available things.

But for all that, it\'s still not so clear how much DTC promotion really
affects all these conditions. One of the questions I would raise, it has
been talked about a little bit, is whether that is because ironically
there are too few ads that are institutional or help seeking in nature
and, therefore, are highly educational.

A question I have is whether use and sales would actually be more
influenced by educating people about, say, cholesterol and the need to
treat it than by a product directed ad which is perhaps dismissible as
promotion and an ad and, therefore, perhaps not as effective. That is
just a hypothesis and I don\'t know.

As probably everyone here knows, there certainly are people who have
criticized direct-to-consumer ads because they don\'t have enough
educational components. They don\'t tell you about alternatives and so
on. That really hasn\'t been a subject of these sessions however.

Certainly an area of long-standing concern both within the agency and
elsewhere is the so-called brief summary which, as we know, is neither
brief nor a summary. It is fair to say no one much likes it actually
except the [Parade]{.underline} study looked at.

They seem to be happy with it but no one likes the current small print,
the complete of every conceivable effect. We are very interested in that
already and will continue to be interested and we will probably have
some alternatives to suggest.

A point that nobody talked about here is the issue of reminder ads. If
you remember the history of direct-to-consumer promotion and our change,
one of the things that stimulated that is that people complained about
how stupid reminder ads were. They said, \"What is this? Somebody is
running through a field. What am I supposed to understand? What is it
for?\"

Having taken note of that, it\'s kind of odd that we are now seeing more
reminder ads than we used to. One wonders why that is happening.
Obviously they are not educational. They don\'t tell you anything. Our
guess to the reason is that they don\'t have to include any risk
information. Not an attractive reason for that. We are looking closely
at these and seeing whether we think there is a problem or not.

A subject that came up from Mr. Schirmer was the issue of comparative
advertising. That is an issue with both physician directed and patient
directed ads. It is very hard to disagree that knowing how one drug
compares with another is really important.

Probably after knowing that a drug is effective and well tolerated,
it\'s hard to think of anything more important than how drugs differ
from one another. The only difficulty is that conveying that in a fair
and balanced way is extremely difficult.

Many of the major problems we have in physician labeling involve
comparative claims. It is one of those things that ought to be well done
and probably is a good thing but it\'s really, really hard.

Finally, Drs. Woloshin and Schwartz urged more attention to describing
the effectiveness of drugs in a meaningful way. Again, how could anybody
disagree withthat. But as my question suggested, this is a really tricky
area.

It\'s hard to convey these things even for a medically sophisticated
audience and that\'s why the physician labeling for most drugs with
symptomatic benefits don\'t have the results of the clinical trials.
They just say they won and they don\'t actually give the data.

Our guidance on the clinical section of physician labeling says this
too. In many cases the outcome is dependent by who you decide to put
into it, what questions you chose to ask in this particular study.

It\'s hard to provide a result that is typical of all the results. It\'s
too easy to select the one that worked out. It\'s a very, very hard
thing to do. That\'s not to say it\'s not worth thinking about but it\'s
very hard.

So with those thoughts of where we need to think and what we might do,
let me extend thanks to everyone who spoke and to everyone who stuck it
out this long. We will be reading the talks and the transcripts and
seeing how we can clarify or improve things.

Thanks to the people who helped get this things going, Tom and Rose
Cunningham who was a fierce yeoman in making everybody do what they are
supposed to do. Terry Martin and others who helped. Good evening.

(Whereupon, at 4:07 p.m. the meeting was adjourned.)