UNITED STATES OF AMERICA

FOOD AND DRUG ADMINISTRATION

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CENTER FOR DRUG EVALUATION AND RESEARCH

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PUBLIC MEETING

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MONDAY

SEPTEMBER 22, 2003

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

FDA PANEL MEMBERS PRESENT:

DR. THOMAS ABRAMS, Director, DDMAC, CDER

DR. KATHRYN AIKIN, DDMAC, CDER

GLENN BYRD, Center for Biologics Evaluation & Research

DR. MARTINE HARTOGENSIS, Center for

Veterinary Medicine

MS. MELISSA MONCAVAGE, DDMAC, CDER

DR. NANCY OSTROVE, FDA Office of Planning

DR. PETER PITTS, FDA Office of External

Relations

FDA PANEL MEMBERS PRESENT (continued):

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:

DR. SHARON ALLISON-OTTEY, Coshar Medical,

Inc.

LYNN BENZING, Patient Marketing Group,

Inc.

DR. RUTH DAY, Duke University

DR. JULIE M. DONOHUE, Harvard Medical

School

DR. ROBERT DUBOIS, Zynx Health

Incorporated

LINDA GOLODNER, National Consumers League

DR. ANGELA V. HAUSMAN, University of Texas

DR. BARBARA MINTZES, University of British

Columbia

CAROL ROTHKOPF, Time, Inc.

DR. PETRA T. SCHULTZ, Mayo Clinic

EDWIN SLAUGHTER, Rodale, Inc.

ALSO PRESENT (continued):

DR. JOEL WEISSMAN, Massachusetts General

Hospital Institute for Health

DR. HENRY N. YOUNG, University of

California

C-O-N-T-E-N-T-S

PAGE

Welcome, Tom Abrams, RPh 7

Opening Remarks, Janet Woodcock, M.D. 17

The Impact of Direct-to-Consumer Prescription

Drug Advertising on the Physician-Patient

Relationship, Kathryn Aikin, PhD 24

Questions 40 National Surveys

DTC and the AA Physician and Patient,

Sharon Allison-Ottey, M.D. 45

Effectiveness of and Attitudes Toward

Medication Advertising,

Linda Golodner 60

The DTC Information Process,

Carol Rothkopf 68

Consumer Reaction to DTC Advertising

of Rx Medicines 1997-2002,

Edwin Slaughter 76

Consumer and Physician Reports on

The Health Effects of DTCA,

Joel S. Weissman, PhD 90

Questions 103

C-O-N-T-E-N-T-S (continued)

[PAGE]{.underline}

Effects of DTC on Prescribing

Effects of DTC Advertising of

Prescription Drugs on the

Treatment of Depression,

Julie M. Donohue 134

Pharmaceutical Promotion: Perhaps

Don\'t Throw the Baby out

with the Bathwater,

Robert Dubois, M.D., PhD 142

How does DTC Affect Prescribing?

A survey in Primary care

environments, Barbara Mintzes 155

Assessment of Impact of DTC Advertising

of Rx Drugs on Consumers and

Prescribers, Petra T. Schultz,

PharmD 167

Questions 175

Advertising Effectiveness

The Role of Drug Marketers in Providing

Consumer Tools and Information

Needed to Enhance Public Health,

Lynn Benzing 199

C-O-N-T-E-N-T-S (continued)

[PAGE]{.underline}

Cognitive Accessibility of Rx Drug

Information, Ruth Day 212

DTC Advertising and Its Impact of

Patient Healthcare Behaviors,

Angela V. Hausman, PhD 224

Does DTC Promote Shared Decision

Making? A Preliminary Study,

Henry N. Young, PhD 236

Questions 242

Closing 256

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

(9:00 a.m.)

MS. CUNNINGHAM: Good morning. We\'re going to go ahead and start. The
hurricane hasn\'t finished messing with our meeting. I\'m sure several
more people will be dribbling in. Parts of the city still do not have
lights. So I want to thank each and every one of you who have made the
effort and were able to arrive here on time.

Our Moderator for today is Tom Abrams. He is the Director of our Drug
Marketing, Advertising, and Communications group, the division under the
Office of Medical Policy. And he is going to take over for me. Tom?

DR. ABRAMS: Good morning. And welcome to the FDA Public Meeting on
Direct-to-Consumer Promotion, also referred to as DTC. I will review the
format and purpose of the meeting, speak to the ground rules, and then
provide some opening comments.

Increased spending on DTC, particularly broadcast advertisement has
stimulated public interest and public debate about the possible benefits
and possible negatives to public health. There is a wide range of
opinions about DTC and the FDA has heard many in anecdotal reports.

So what is the effect of DTC on public health? FDA is relying on data
not on anecdotal reports to guide its policy and to its evaluation of
DTC's impact on public health.

When the FDA published its final guidance in 1997 on broadcast
advertisements, we stated that we would do an evaluation of DTC and we
also committed to do research in that area.

To that end, we completed three national surveys. The first survey was a
consumer survey in 1999. The second survey was a consumer survey that
was completed in 2002. And we completed a physician survey in 2002 also.

We also requested groups who were doing research in DTC to make their
data publicly available. It\'s important to note that others have
different approaches to research and may focus on different factors. So
these data will be very useful to FDA in addition to FDA\'s own data.

And that brings us to the objectives of today\'s meeting. And that is to
enable the Agency and other persons and other organizations to present
its research on DTC. This meeting is not to discuss policy. It\'s not to
discuss opinions about DTC but to gather data.

Before I go over the agengda, let me now introduce the members of the
FDA Panel. And going from your right to left, we have Dr. Kathryn Aikin,
Social Science Analyst in the Division of Drug Marketing, Advertising,
Communications in CDER.

Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and
Research.

Dr. Robert Temple, the Director of Office of Medical Policy in CDER.

Going down to the Panel on the floor, Glenn Byrd, the Chief of the
Advertising and Promotional Labeling Branch in CBER.

Dr. Martine Hartogensis, Advertising and Promotion Liaison at the Center
for Veterinary Medicine.

Dr. Nancy Ostrove, Director of Risk Communication in the Office of
Planning.

And Deborah Wolf, Regulatory Counsel in the Center for Devices and
Radiological Health.

Okay, now for ground rules. We\'ll be using the same ground rules as
used in Part 15 hearings. And they include the following:

This meeting is informal, the Rules of Evidence do not apply. No
participant may interrupt another participant during the presentations.

Only FDA Panel and the presenting panelists may ask questions after the
presentations are over initially. If time permits, we will open the
questioning up to the floor and that will be limited to one question per
person at that point.

This meeting will be transcribed. 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.

Time is limited. We have a full two-day meeting. So we are asking the
presenters to limit their presentations to 15 minutes. After the
presenters go on the panel, we will limit the question and answer period
to 30 minutes.

For your comfort and safety, the rest rooms are located just outside the
auditorium and in the lobby registration area. No food or drink is
permitted in the auditorium. And please for your safety note the exits
for this room.

Okay, the agenda. After I conclude the introduction, Dr. Janet Woodcock
will provide some opening remarks. Then Dr. Kathryn Aikin will present
the data from FDA surveys and then take some questions.

There will be a 15-minute break and we\'ll reconvene for the first
panel. We\'ll then break for lunch and reconvene at 1:30 for an
additional two panels.

Well, DTC has generated a lot of interest from many groups. Industry is
spending about three billion dollars a year on DTC. And spending has
increased significantly in the past six years as have a number of
broadcast advertisements appearing on TV.

But there was not always DTC. So I think it may be useful to review how
DTC got to where it is today. Let\'s start off with some basics. First,
there are no laws or regulations that prohibit promotion directly to the
consumer.

Second, the regulations focus on the content and not the extent of the
promotion.

So it\'s legal for companies to promote directly to consumers. And there
is no legal limit on the amount of money a company can choose to spend
on DTC.

FDA regulates for content of promotion to ensure that it is truthful,
not misleading, and is balanced. Regulation of promotion is an important
function as prescription drugs are different from other products because
of the risks associated with their use.

Therefore, it is critical that the ads are truthful, not misleading, and
balanced. By balanced, meaning having a candid representation of the
risks associated with the use of the product presented when the product
is promoted.

I mentioned before that DTC spending is about three billion dollars a
year. And to put that in an appropriate context, we need to note that
the majority, over 80 percent of the promotional dollars that industry
spends, are still for promotion directed to health care professionals.

When we look at the evolution of DTC, we cannot ignore the fact that
society has changed as well and the effect that this may have had on
DTC. Basically consumers are seeking more information about their health
and about prescription drugs.

What we take as givens today were not always so. For example, not too
many years ago, many pharmacies did not put the drug name on
prescriptions when they dispensed them to patients. So some patients did
not even know the drug name that they were taking. So they couldn\'t
even get the point of attaining additional information about the
product.

Going back even further, looking in the [Federal Register]{.underline}
of 1938, there was a reference that stated, \"Drug labeling is to be
written only in such medical terms as are not likely to be understood by
the ordinary individual.\"

Well, things have change significantly. Now prescriptions are labeled.
Consumers are seeking additional information about their health and
about prescription drugs. Companies are developing special information
inserts called patient package inserts for some of their products.

The Internet has come into wide use. And people are seeking additional
information from the Internet. When Kit Aikin presents the FDA data, you
will see that the percentage of folks seeking information about
prescription drugs from the Internet increased from 18 percent in 1999
to 38 percent in 2002, just three short years.

This change, consumers seeking more information about their health, is
not unrelated to the growth in DTC. As people sought more and more
information about prescription drugs, industry found it beneficial to
advertise directly to the consumer.

So looking at direct-to-consumer promotion and just going back just a
couple of decades, there was not DTC. In the 1960s and 1970s, all the
promotion was directed to the health care professional.

But then things started to change. In the early 80s, the first DTC ads
appeared for two products, one an arthritic drug and another a vaccine.
There were some concerns about this given that people weren\'t familiar
with it and didn\'t know what the impact would be.

As the result of these concerns, in 1983, FDA asked industry for a
voluntary moratorium on DTC to allow a time to review the situation.
After meetings, research, and discussion, FDA lifted its request for
this voluntary moratorium in 1985 stating that the regulations provide
sufficient safeguards to protect consumers.

And that is how DTC began.

Let me define three types of of advertisements that followed this
period. First, full product advertisements. These full product
advertisements are an advertisement that contains both claims about the
drug product as well as its risks.

Reminder advertisement \-- reminder advertisements states just the name
of the drugs.

And third, help-seeking advertisements. These ads describe a medical
condition and encourage consumers to seek medical consultation if they
have symptoms of this particular condition.

So in the late 80s, DTC ads began. And in the 1990s, DTC print full
product ads really increased greatly. However, during the same time
period, there were not full product advertisements on TV, for the most
part. And this was largely due to the fact that there was a lack of
clarity of how industry could fulfil an existing regulatory requirement
called adequate provision.

What was being placed on TV instead were the reminder advertisements.
Ads that just named the drugs. However, these reminder advertisements
actually caused confusion.

FDA received a lot of feedback from both consumers and health care
professionals stating that these advertisements were not productive,
that they were actually causing confusion in that the patients would go
into the physician thinking that the product was for another use than
its indicated use.

In the mid-1990s, industry started efforts to get full product
advertisements on TV. One of the regulatory requirements of a broadcast
ad is either to have the ad accompanied with a brief summary, the brief
summary being the page of risk information that is next to the body of
the advertisement in print ads, a lot of information. They could have
the ad accompanied with that or provide what is called adequate
provision. Well, since it was not practical to scroll the brief summary
on TV, industry focused on how they could fulfill the requirements for
adequate provision.

And what adequate provision means is providing access of the product
labeling to the wide-range of viewers that may be viewing the
commercial. People differ in their information-seeking behavior. Some
are active information seekers, others are passive.

There are different levels of concerns about privacy, different levels
of sophistication when it comes to technology. So an approach was needed
to reach as many of these people as possible.

And that brings us up to 1997 and the draft guidance on broadcast
advertisements. People have stated the FDA changed the law in 1997 or
FDA loosened up its regulations in 1997, and that\'s why we see
television advertisements for prescription drugs.

FDA did not change the law or loosen up our requirements. What FDA did
was provide clarification to an existing regulatory requirement. The
1997 draft broadcast guidance describes one way to satisfy the adequate
provision requirement through a multi-component approach.

In 1999, the [Federal Register]{.underline} announced the final version
of the broadcast guidance. FDA stated it would do an evaluation of DTC
and requested that individuals or groups doing research in this area to
make it publicly available. And that brings us to today\'s meeting,
hearing the research.

We look forward to hearing the research on this important topic. I thank
you for your interest in participating in this meeting. And a couple
panel members have arrived. Peter Pitts, the Associate Commissioner of
External Relations and Daniel Troy, Chief Counsel for FDA.

I would like to now introduce Dr. Janet Woodcock, the Director for the
Center of Drug Evaluation and Research.

DR. WOODCOCK: Thanks, Tom. Can everyone hear me?

I\'d like to also extend my welcome to all of you who have braved the
storms and come to our meeting this morning.

You\'ve just heard an account of the recent history of the evolution of
direct-to-consumer advertising. The meeting that we\'re holding now over
the next couple of days is intended to air the research that will help
shape the future policy of DTC advertising.

But before we consider the questions that face us now, I\'d like to take
the larger view of patient and consumer access to medical information.
The phenomenon of DTC advertising must be seen within the larger picture
of the evolution of the patient\'s and consumer\'s role in their own
health.

In the middle of the last century, medical information was very much the
province of the physician as Tom as already alluded to. This was viewed
as proper that the patient might not know the name of their medication
and that their prescriptions be written in a manner that they could not
read. That was viewed as protective of the patient.

Diagnosis, prognosis, and treatment plans were usually shared in a
general way with patients. But in no means was a patient expected to
advocate on his or her own behalf. Indeed, in the late 1970s, when I
became involved in medicine, this model still largely prevailed.

It was not until the time of HIV and cancer activism in the late 1980s
that the concept of patient empowerment really took hold. And I think it
is no coincidence that around that time we began to see, again,
reemergence in the interest, as Tom has already said, in
direct-to-consumer advertising.

Several other forces were also active at that time. First, outcomes
researchers had shown that patient values and preferences could drive
the choice of appropriate treatment given the fact that that each
therapy had both risks and benefits.

Who should choose among them but the person who stood to experience
these risks or benefits? And what should shape their choice but their
own personal values? These were somewhat novel concepts when they were
introduced at the time.

Second, the rise of managed care in many forms led patients to believe
that the health care system could not always be completely relied upon
to act in their best interests at all times.

These forces coming together have resulted in a shift in the general
societal perception of who needs what information. And of the dynamics
of medical decision-making in general.

More recently, as Tom alluded to, the wide public availability of the
Internet and its search capacities has provided access to a massive
array of medical information of strikingly variable quality. The genie
is now fully out of the bottle.

These larger societal forces provided the backdrop for the shift in the
use of direct-to-consumer prescription drug advertising. What had been
actually unthinkable in the 1950s, such as the discussion of medical
conditions openly on television, has become commonplace today.

However, now we are exploring the impact of these changes on the public.
And the health of the public. Despite representations to the contrary,
the impact of direct-to-consumer advertising is neither wholly negative
nor wholly positive. And I think we can probably all agree on that.

This meeting is convened to provide a forum for the research evidence on
DTC impact on various sectors and from different points of view.

A number of groups have expressed serious concerns about the impact of
widespread direct-to-consumer advertising. A basic issue, which I\'ve
already alluded to, is the effect on the doctor-patient relationship.
And even the whole notion of the learned intermediary.

It is of some concern that an ad would make an individual feel so
confident about their own diagnosis and treatment as to make a demand
for a particular drug and even to doctor shop until finding a willing
prescriber. This tension is, of course, exacerbated by the distrust
arising from the formulary management plans that now exist.

There is also worry that the basic nature of advertising will lead to
over expectation of benefit and dismissal of risk by those not well
versed in the science of pharmacology.

A corollary concern is that the physician will be basically coerced into
less than optimal prescribing by patients\' demands. This could lead to
harm from inappropriate use of medicines.

Another related concern is that widespread advertising of medications
promotes several patient and consumer misconceptions from some people\'s
points of views.

First, that many common and relatively minor complaints of daily life
represent diseases. This has been called the medicalization of life. And
second, the perception that all life complaints can and perhaps should
be treated with a pill.

Each of these concerns go deeply into the basic values and beliefs about
health and are more difficult to address as research questions. But they
are very important to be discussed.

Finally, there is concern that DTC advertising is unnecessarily driving
up spending on drugs by increasing the inappropriate use of drugs and by
causing prescriptions of expensive drugs to be written in lieu of just
as appropriate low cost drugs.

All these concerns are legitimate research areas that should be
addressed. On the other side of the question, there are potential
benefits of direct-to-consumer advertising to be evaluated.

First, consumers can be further empowered and educated to the range of
choices available to them. And this should not be underestimated. This
is a reflection of the societal trends that I referred to earlier.

Second, there are many under-treated illnesses that represent public
health problems, very serious public health problems. These include, for
example, hyperlipidemia, hypertension, and depression, just to mention a
few.

Direct-to-consumer advertising of medication for these conditions, some
maintain, could increase awareness of the symptoms and of the need for
diagnosis and of the availability of therapy.

As a counterpoint to the medicalization argument, some contend that wide
discussion of certain conditions can destigmatize them and bring
individuals in for treatment who would otherwise avoid treatment. And I
think there is some evidence of this happening.

One important research topic is evaluating to what extent DTC
advertising promotes more widespread but actually needed therapy versus
inappropriate prescribing.

It is clear that direct-to-consumer advertising does raise controversy
and interesting issues and there are many unanswered questions about its
impact. The research to be presented over the next two days begins to
address these questions.

Clearly, high quality data on direct-to-consumer impact is an urgent
need of policy makers. This research is not easy to do. And we thank the
intrepid investigators who have taken on this field and who have come to
present their results today and tomorrow.

Given that direct-to-consumer advertising is likely to remain, an
on-going question is can it be made better or more useful. The session
on the brief summary on which there is rare and near universal agreement
that it can, indeed, be made much better, should shed some light on this
particular question. And that\'s of particular interest to me.

In closing, I would like to thank both presenters and participants as
well as the organizers of this meeting for coming together to discuss
these important research results. Thank you.

DR. ABRAMS: Thank you, Dr. Woodcock. Now we will have Dr. Kathryn Aikin,
the Social Science Analyst in the Division of Drug Marketing,
Advertising, and Communication to present the FDA data of the three
national surveys.

DR. AIKIN: Thank you, Tom. Good morning everybody. Congratulations on
making it downtown.

What I\'m going to present today is a very small slice of the three
surveys we have done, the two patient surveys and the one physician
survey on the impact of DTC on the doctor-patient relationship.

This is not going to be the entire data set. I can\'t present that in 20
minutes. But a thorough and detailed analysis of these three surveys
will be presented in our final report, which should be available
sometime later this fall.

Looking first at the patient results, a quick overview of our
methodology. We\'ve done two surveys, as Tom has mentioned. Both were
national probability samples done by telephone.

In 1999, we had 960 respondents who had been to a doctor in the last
three months. And in 2002, we had 943 respondents who had been to the
doctor in the last three months. So the focus of our analyses of these
two surveys is the comparison between \'99 and \'02.

And I will be jumping around a bit from topic to topic. And it\'s simply
a function of the amount of time that I have.

Looking first at the brief summary, we have found that in 1999, 27
percent reported that they read all or almost all of the brief summary
typically when they encountered it in a magazine ad but only 16 percent
reported this in 2002.

On the good side, more people knew it was there. But when we asked
people how much of the brief summary they read when they were actually
interested in the ad, 45 percent reported that they read all or almost
all of the brief summary. And this is actually very interesting
considering that the consumer-friendly brief summary format is not yet
the norm.

So when people are actually interested in the ad, they will make the
effort to read the brief summary. If it were easier for them to read, we
might actually see an increase in this number.

Looking next at advertising and consumer behavior, we found that 43
percent of respondents in 2002 said an ad for prescription drug had
caused them to look for more information, either about their health or
about the drug itself. This is a significant decrease from 1999.

The doctor, pharmacist, nurse, and reference books continue to be the
most used sources of information. However, as Tom mentioned, we are
seeing a 20 percent jump in people who say they use the Internet to
search for more information. And this is consistent with the reports of
people going online to look for more information.

When we asked people what information they were looking for, most people
reported they are looking for information about side effects. In
comparison, not as many people are looking for information about
effectiveness, benefits, and certainly not about cost. Now this may be a
function of the fact that cost information is not that readily
available.

Eighteen percent of respondents in 2002 reported they had asked their
doctor about a new medical condition or illness that they had not spoken
to a doctor about before. This, again, is a significant drop from 1999.

Now 18 percent might seem high if you assume that 18 percent of people
are going in to ask a doctor because of an ad.

But when we asked people why they had been to a doctor most recently,
the most common reasons are still that they had a previous condition,
that it was time for a checkup, or they had not been feeling well, or
they had a sudden symptom or illness. Very few people reported that they
are going in to see their doctor because of an ad for a prescription
drug or because they wanted a drug they had seen advertised.

So we are not seeing hordes of people running to their doctor because of
an ad or because they want a prescription drug they had seen advertised.
And this is a multiple response question. People can say yes to more
than one.

We looked next at what the doctor did as a function of whether the
patient asked about a prescription drug generally or whether they asked
for a specific brand of drug. And we don\'t have a comparison here from
1999 because in that survey, we did not ask people who thought their
doctor would keep them on their current drug this question. And we also
had a slight skip pattern error.

But if we look at the 2002 responses, we see that among those people who
asked about a specific brand of prescription drug, they were more likely
to be prescribed the drug that they asked about. And they were also less
likely to be recommended no drug in comparison to people who just asked
about a drug in general.

Looking last at patient reported attitudes about DTC advertising, these
are all close-ended questions on a five-point scale from agree strongly
to disagree strongly. And what we see across many of these questions is,
again, a decrease in attitudes from 1999 to 2002.

And I\'ll start first with the biggest drop. And that is I like seeing
advertisements for prescription drugs. In 1999, 52 percent reported that
they agreed strongly or somewhat with this question. And only 32 percent
reported that they agreed strongly or somewhat with with this question.
And what we don\'t have is a comparison to other types of advertising.

It may be that people just don\'t like advertising. And that the novelty
of prescription drug advertising has worn off.

Advertisements for prescription drugs help make me aware of new drugs.
We got the most agreement with this particular question.

But, again, we are seeing a decline in 2002, 86 percent agreed strongly
or somewhat in \'99 and 77 percent agreed strongly or somewhat in 2002.
But that\'s a very high level of agreement. So most people are saying
that advertising does make them aware.

Advertisements for prescription drugs give enough information for me to
decide whether I should discuss the drug with my doctor. Again, a drop
from 70 percent to 58.

Advertisements for prescription drugs help me have better discussions
with my doctor. Here a drop from 62 percent to 43 percent.

And finally, advertisements for prescription drugs help me make better
decisions about my health. And here we see a drop from 57 percent to 32
percent agreeing strongly or somewhat.

Now interestingly, we do not see a change in attitudes for whether or
not prescription drugs give enough information about the possible risks
and negative effects or possible benefits and positive effects.

People are similarly agreeing with the fact that \-- I\'m sorry, about
59 percent say that they do not give enough information about the
possible risks. And about 40 percent say they do not give enough
information about possible benefits and positive effects.

Similarly, advertisements for prescription drugs make the drugs seem
better than they really are. We see no change over the two years.

And advertisements for prescription drugs make it seem like a doctor is
not needed to decide whether a drug is right for me, we get a high level
of disagreement with this question.

And finally, I would not talk with the doctor about an advertisement for
a prescription drug because it would seem like I did not trust my
doctor. Again, we see a similar response over the two years.

Looking next at the physician survey results, our physician survey was
also conducted by telephone from a random sample of physicians from the
AMA Physician Master File.

We had 500 physicians, 250 general practitioners, and 250 specialists in
the area of dermatology, allergy, pulmology, endocrinology, and
psychiatry. And we chose these four areas because at the time we fielded
the study, these four areas had the highest level of DTC spending. So
the focus of the analysis on this questionnaire is the difference
between general practitioners and specialists.

Looking first at the impact of DTC on the patient interaction, we asked
physicians to focus on the most recent interaction they had had with a
patient who had initiated a discussion about a prescription drug and
told them that he or she saw it advertised.

The majority of physicians could remember such an interaction. And also
the majority of them said it was either very or somewhat representative
of other patient encounters who had discussed a prescription drug.

When we asked the physician whether the fact that the patient seeing the
advertisement had any beneficial effects for the interaction, 41 percent
said yes, it had had beneficial effects.

And then when we asked in an open-ended fashion what those beneficial
effects were, physicians were more likely to say that they had better
discussions with the patient and that the patient was more aware of
treatments as a result. And remember, this is an open-ended question.

The only difference we had between specialists and general practitioners
on this was that specialists were more likely to say that the patient
was more likely to consider using a prescription drug was a benefit.

When we asked whether or not the patient seeing an ad had created
problems for the interaction, 18 percent of the physicians said yes, it
was a problem.

And when we asked again in an open-ended fashion what problems it
caused, the most common responses were that they had to spend time
correcting patient misconceptions and that the prescription drug was not
needed or the patient did not have the condition.

And we did not see any differences statistically between general
practitioners and specialists. But again this is a very small group and
there are only 82 physicians in this particular question.

Looking next a prescription inquiries, we separated the patients, again,
into whether the patient asked about a drug and whether the patient
asked for a drug.

Looking at just asking about a prescription drug by brand name, we find
that GPs and specialists have about the same rate of patients asking
about a drug by brand name. And when we look at whether or not they
actually have the condition the drug treats, again we see approximately
equal responses.

So the patients coming into the general practitioners and the
specialists and asking about a drug by brand name are equally likely to
actually have the condition, which is somewhat reassuring.

Now when we look at whether or not the patient asked for a prescription,
and again we\'re making the distinction between asking about and asking
for, we do see approximately equal levels of patients asking for a
prescription for both general practitioners and specialists.

And, again, approximately equal levels of physicians reporting that they
gave the patient a prescription at this visit. However, when we look at
whether or not the physician reported the patient asked them to
prescribe a specific brand name drug, we see that general practitioners
are being asked more often than specialists and they are also
prescribing the brand name drug more often than specialists when the
patient asks.

When we look at the reasons the physicians give for not prescribing, the
most common responses are a different drug was more appropriate, the
drug was not right for the patient, or the drug had side effects the
patient was not aware of, although we do see some differences between
general practitioners and specialists on this question.

These top three responses, specialists are more likely to say that this
is the reason that they did not prescribe compared to general
practitioners.

General practitioners, however, are more likely to say that a less
expensive drug was available, the patient did not need a prescription,
they needed to change their behavior or lifestyle, the brand was not on
the formulary, or the patient can use an over the counter drug.

When we asked physicians whether the patient tried to influence the
course of treatment in a way that would have been harmful, the vast
majority of them say no. They did not try and do that.

However, about half the physicians said they felt not at all pressured
to prescribe at that visit. However, GPs are more likely to say that
they felt pressured to prescribed compared to specialists.

Lastly, we\'re going to look at attitudes. And this is a rather busy
slide. But try not to be alarmed. We have ordered it from most agreement
to least agreement. And there is a second slide that follows up.

This is a closed four-point item scale very well to not at all. And we
find that physicians believe that patients understand very well that the
drug is only available by prescription. So prescription status is coming
across very clearly.

Also, that only a doctor can decide if a drug is right for a patient.
And, to a lesser extent, what condition the drug treats, and so on.

However, they believe that they understand less well the possible risks
and negative effects of the drug, the limitations of the drug\'s
efficacy, and who should not use the drug. And what is interesting is
that these three items often make up the bulk of the major statement in
broadcast ads.

When we look at beliefs about potential positive effects of DTC on
patients and practice, we find there are no differences between GPs and
specialists on these items.

And we find that there is the most agreement that patients are aware of
possible treatments, that it makes patients more involved in their
health care, and that it makes patients ask better questions.

We find much less agreement with likely to use their medications
properly and makes hard to reach patients come in who would not
otherwise come in. However, we do see differences between general
practitioners and specialists on beliefs about potential negative
effects of DTC.

And, again, I\'m going to start with the most agreement. And in each
case, GPs are more likely to say that these are a problem than
specialists.

Here we find that in both cases the majority of physicians believe that
DTC confuses relative risks and benefits. Now, GPs believe this more
strongly than specialists, but we are still getting 90 percent of
physicians saying that this is a problem, at least a little bit.

They also think that DTC makes patients think drugs work better than
they actually do. Again, GPs statistically more than specialists, but
still a high level agreement with this question.

Here again, GPs saying that it makes patients want advertised drugs over
any others. And here it is mostly just a shift out of the not at all.
And want expensive drugs over less expensive treatments.

GPs believe more than specialists that it makes patients ask for
unnecessary prescriptions. And expect to get a prescription for every
condition. Now here we have less agreement but still the majority of GPs
saying it causes anxiety about potential diseases and anxiety about
potential side effects.

Now on the two questions about causing tension between you and your
patients and causing questioning and second-guessing of diagnoses, we
really get very few physicians saying that this is a great deal of a
problem, but still more GPs than specialists saying that this is a
problem.

Now if we look at the overall impact of DTC on patients and practice, we
do find that general practitioners are slightly more negative than
specialists but this really is probably a shift out of the no effect.

GPs are much less likely than specialists to say that DTC is not having
any effect. So if you look at it that way, GPs are simply more polarized
than specialists on this question.

So in summary, we find that DTC ads are very good at increasing
awareness of potential treatments but they are not very good at equally
conveying information about risks and benefits very well. Physicians
believe patients understand the benefits much better than the risks. And
they also believe that DTC confuses patients about the relative risks
and benefits of prescription drugs.

Patients don\'t typically read the brief summary although they will read
it if they are very interested. But again, consumer-friendly brief
summaries are not yet the norm in brief summary. And as we start to see
an increase in consumer-friendly brief summaries, this number may
actually increase.

Patients are still using their doctors as the number one information
source when they look for more information as the result of an ad. And
pharmacists and nurses are still highly regarded as sources.

Brand specific requests are likely to be accommodated. Patients who ask
about a brand are more likely to be prescribed that brand than patients
who just ask about a drug in general. However, the vast majority of
patients who do ask about a brand have the condition that the drug
treats.

General practitioners are more likely to prescribe a requested brand
than specialists and they are also more likely to feel more pressure to
prescribe than specialists are.

Patient attitudes about many aspects of DTC have become less positive
over time although some have not changed. And general practitioners
report more negative beliefs about the potential negative effects of DTC
ads than specialists.

Physicians are evenly divided in opinions about the overall impact of
DTC on patients. About one-third feel it is positive, one-third feel it
is negative, and one-third feel it has no effect.

But GPs do report a more negative overall impact of DTC on their
patients and practice than specialists. This may be because GPs are
often the first line. And they get all the requests whereas specialists
tend to have a more select patient population.

And I\'m happy to take your questions. Yes?

MS. WOLF: Do you have information on whether \-- if patients see ads for
more than one product in the same class for drugs, whether that has any
impact on how they look at each ad?

DR. AIKIN: Whether the number of prescription ads seen has an impact on
how they respond?

MS. WOLF: For different products for the same condition.

DR. AIKIN: We didn\'t actually measure that particular. We have number
of prescriptions seen in the last three months. And that doesn\'t seem
to have an impact. The year effect is much stronger than number of
prescriptions seen. But we don\'t have a measure of how many
prescription ads they\'ve seen in each class.

DR. OSTROVE: Kit, I\'ve got a couple of questions. Did you find any
differences as a function of say patient characteristics or
demographics?

DR. AIKIN: We did find some. We\'re still working on the details of
that. But, again, the year effect is much stronger. That holds even when
you take into account the demographic differences.

DR. OSTROVE: Okay. And physicians see these ads also. Is there any way
to separate out \-- I mean they, especially with regard to the attitude
questions, is there any way to separate out the impact \-- so what
they\'re getting from their patients and they\'re getting from their own
perceptions of the ads?

DR. AIKIN: Only to the extent that we can direct them in the questions
themselves to focus on the impact of DTC on their patients and practice
and not to think about how well they, themselves, can educate their
patients.

To the extent that they can separate those two, it\'s a good measure. To
the extent that the can\'t separate those two, we may be getting spill
over from physicians who have a very negative personal attitude
regardless of how it is impacting their patients.

DR. OSTROVE: Thanks.

DR. ABRAMS: Any questions from the presenting panel?

DR. TEMPLE: Do you have any sense of whether the people who prescribed
the brand name that they were asked to prescribe feel bad about that?
Did they feel pressured? Any sense from anywhere whether they feel
pressured? Anything like that?

DR. AIKIN: Just to repeat the question in case you all didn\'t hear it.
Do we have a sense of whether or not physicians feel bad or feel
pressured to prescribe the brand?

We don\'t have a sense of whether or not they feel bad about it. We do
have a sense that physicians who are asked to prescribe a brand do feel
more pressured to prescribe it than those who are not asked to prescribe
a brand.

DR. PITTS: Were there any anecdotal pieces of information that would
lead you to believe that the doctors who felt badly about the \-- felt
negatively about DTC ads also felt negatively about detailing?

DR. AIKIN: We didn\'t collect any information about detailing. And we
didn\'t get any anecdotal reports in our \-- we had one last question.
Was there anything else that they wanted to share with us? And we
didn\'t get any anecdotal reports about detailing unfortunately. But
that was not really the focus of the survey either.

MR. TROY: This may be jumping the gun and it may be an unfair question.
But there have been quite a number of surveys that have been done over
the past couple of years.

And I was wondering if you have a general impression as to whether or
not the results that you have found are in line with the results of
those surveys or are there things that leap out to you as major
differences between the data that you collected and that others have
collected?

DR. AIKIN: Well, to the extent that we asked similar questions, I think
that our results are consistent certainly with the results from
[Prevention Magazine]{.underline} and the Kaiser Family Foundation. But
I don\'t want to steal Ed\'s thunder.

I think we have unique measures in the amount of pressure that the
physician is perceiving. And that\'s very interesting to us. I would
just say that the extent to which we asked similar questions, we do see
similar results. They do vary somewhat.

I think we have slightly different responses in our \'99 survey than
[Prevention]{.underline}. We tend to have higher overall levels of
people searching for information in \'99 compared to 2002. And higher
numbers of people talking to a doctor about a drug.

But in 2002, they seemed to be coming back down to the levels seen in
other surveys. So whether we were overestimating in \'99, it\'s hard to
say.

MR. TROY: You said that unique measures in the amount of pressure \--
did the other surveys ask about that and not find the same things? Or
did they just not ask about it?

DR. AIKIN: The other surveys have been with patients and not physicians.

DR. PITTS: I\'m sorry, one more question. When you say pressure, is that
more friction pressure or perseverance pressure?

DR. AIKIN: Perceived pressure to prescribe. How pressured did you feel
to prescribe a drug for the patient at this visit?

DR. TEMPLE: Obviously we\'re all interested in the data. And the
questions arise to me because it seems to me that patients and
physicians are in different states of knowledge power. I would
intuitively say that a physician who thinks the drug is the wrong drug,
that\'s all the ammo needed to convince the patient it\'s the wrong
drug.

And yet it seems like maybe that\'s not so. So it will be very
interesting whether other people and information show that.

DR. AIKIN: I should also note that there probably is a baseline level of
pressure to prescribe that is being included here.

Simply based on the results that you see about over-prescribing of
antibiotics for viral infections would seem to indicate that physicians
do feel some pressure to prescribe anyway.

And whether DTC is increasing that significantly is something that we
really can\'t tease out from these results. But it is useful to note
that least when asked about a specific brand of drug, there is more
pressure to prescribe.

DR. ABRAMS: Any questions from the presenting panel? Linda?

MS. GOLODNER: Yes, I was wondering if a consumer sees an ad for a drug
that they are already taking, if you asked any questions about
compliance, of understanding the importance of taking that drug if they
are taking it already.

DR. AIKIN: We didn\'t track people by whether or not they had seen an ad
for a drug that they were currently taking, we simply asked in general
in the 2002 survey, makes me more likely to remember to take my
medications.

And I don\'t have those results summarized here but we did find that
about 40 percent of patients reported that they agreed strongly or
somewhat that it reminds them to take their medications. Physicians,
interestingly, were more likely to agree than consumers.

DR. ALLISON-OTTEY: The demographics, what percentage of both the
physicians and patients surveyed represent minority groups from the FDA?

DR. AIKIN: The physician survey was predominantly caucasian and
predominantly male. So to the extent that that represents the AMA Master
File, it may be accurate. But again, it\'s a highly male sample.

The consumers were about 70 percent caucasian, 12 percent
African-American, and I\'m sorry, I don\'t know the other percentages.
We had slightly fewer minorities in the 2002 sample. And a slightly
higher income and education level. We believe that the slightly higher
income is due to the fact that more people were willing to say what
their income was in the 2002 sample.

DR. WEISSMAN: Hi, did you have any information on the physician\'s
practice settings? Anything about whether they had formularies or
whether they were in a managed care setting and how that might have
effected how they behaved or how they thought?

DR. AIKIN: We did collect information about whether or not they were in
a group practice, solo practice, and whether or not they were part of an
HMO, PPO, managed care or some other group. And I don\'t have those
results summarized here.

But, again, when we looked at the differences between general
practitioners and specialists, even taking into account the type of
practice, the difference between those two groups still came out
stronger than the demographics.

DR. ABRAMS: Any questions from the floor? Please come up and speak into
the microphone. Thank you. And will you please identify yourselves? Who
you are and what organization you are with? Thank you.

MS. ALLEN: Yes, I\'m Amy Allen. I\'m from the National Women\'s Health
Network. There has been some research showing that patients make certain
assumptions or have certain beliefs about safety of a drug based on the
fact that it is being advertised. Or assumptions about whether the ads
have been approved by some sort of body like the FDA.

And I wondered whether you gathered any information about that kind of
assumption or perception from patients?

DR. AIKIN: We only had one question, which I did not summarize here. And
that was only the safest prescription drugs are allowed to be advertised
to the public. After speaking with some other experts, we\'ve come to
the conclusion, that may not be the best question because it leaves
itself open to a number of different interpretations.

And what we\'ve also found is that we have quite a level of people who
don\'t know. Who say I don\'t know. And I think that indicates that they
just don\'t know how to answer the question. So yes we did have one
question. But it\'s not methodologically sound. So I haven\'t presented
the results here.

MS. ALLEN: Thank you.

DR. ABRAMS: Any other questions from the floor?

(No response.)

DR. ABRAMS: Okay. I would like to thank Kit. Great presentation.

DR. AIKIN: Thank you.

DR. ABRAMS: We will now take a break. We\'ll reconvene and begin
promptly at 10:30. So if you could be here a few minutes before that,
that would help facilitate things. Thank you.

(Whereupon, the foregoing matter went off the record at 9:30 a.m. and
went back on the record at 10:30 a.m.)

DR. ABRAMS: Okay, if everyone could take their seat, we\'ll start. The
next panel is the National Survey Panel. It consists of five presenters.
Each presenter will be presenting for 15 minutes. There is a timer on
the podium to keep this on track.

And then after all the panel members have presented, we will have a
question and answer session, first with the FDA and the presenting
panel. So our first panel member is Dr. Sharon Allison-Ottey from Coshar
Medical, Incorporated.

DR. ALLISON-OTTEY: Good morning. Good morning. Okay. Am I up? I\'m going
to swiftly go through our surveys.

And I\'m here with two hats. The first hat is I am Principal
Investigator for the survey of the National Medical Association, which
I\'ll talk about in a minute.

But I\'m presenting really two landmark studies that focused on the
perceptions of DTC on African-American physicians and minority patients.
Both studies have been published in a peer review journal of the
National Medical Association.

As a way of a reminder for many of you, the National Medical Association
is the nation\'s oldest and largest association of physicians of color.
We represent over 25,000 physicians in this country.

And because of our relationships with numerous private and public as
well as federal entities, it requires that we develop national position
statements on everything in health care. And we are and do believe that
the NMA is the nation\'s leading thought leader as it relates to
minority health.

So in an attempt to begin to come up with our position on DTC, we
decided, unlike other organizations, to not just kind of get a bunch of
physicians in a room and say what do you think.

We said we\'re going to go to our own data. So we developed a survey
asking physicians of color their perceptions and their real life
experiences with DTC.

I think it is important to note that the African-American physician
traditionally treats a greater percentage of minority patients than
their counterparts so these views may or may not be different.

The survey instrument quickly for the physicians survey, we got the
basic demographic information and then asked 15 pertinent questions
directed at DTC ads. We looked very closely at the FDA study and other
studies to develop the questions so we did not do a [de]{.underline}
[novo]{.underline} survey.

And also we asked for general comments. I do advise that you get a
reprint of the article because we thought it was very important to add
the general comments. What the doctor on the street is actually writing
and saying about DTC.

We had over 1,098 respondents. We disqualified 212. So the data that
I\'m talking about is the collective thoughts of over 886 physicians.

This was pretty much split down the middle, 50-50, the females by .2
percent more as it relates to female versus male. Median years in
practice 16.5.

The average age was in their 40s. And then the primary care specialties,
internal medicine, family practice, OB-GYN, and peds were the
predominant specialties and then the subspecialties and the surgical
specialties were present.

The type of practice, solo practitioners were number one with 30 percent
of those respondents in that category. Second was the private group and
then third would be academia.

Now, of the physicians surveyed, 95 percent had personally seen an ad in
the two months prior to the survey.

And then we asked what is the ethnicity of the patients in your
practice. And you can see the data. Fifty-five percent of the patients
seen by these physicians were African-American.

Now, on this series of questions, you could say there is both a positive
and a negative effect. So it is important for me to preface this. We
asked specifically is there a positive benefit of the ads to patients?
Fifty-five percent said yes. And you can see the other numbers.

What about to the physician, is there a positive benefit? Forty-four
percent said no, there is not. Forty-two percent said yes, there is.
What about to the pharmaceutical company? Seventy-five percent said yes,
there is a positive benefit obviously to the pharmaceutical industry.

And then is there no positive benefit to anyone. Ninety-three percent
said \-- well, actually only seven percent agreed with that statement
and 93 percent disagreed.

Now, to the series of negative effects for patients. Fifty-two percent
said yes, there is a negative effect for patients. What about to the
physician? Fifty-one percent said there is a negative effect of the ads
for physicians. To the pharmaceutical industry, 64 percent said no there
is no negative effect, and that\'s a double negative but anyway, 64
percent there is not a negative effect.

And what about to anyone? Fifteen percent of those surveyed agreed that
there is no negative effect of the ads to anyone while 64 percent \--
I\'m sorry, 64 percent indicated that there was no negative effect of
the ads to anyone.

Now on this slide, we basically asked who has the most to gain and the
least to gain. You can see that from the most to gain, first was the
pharmaceutical industry. Second was the patient.

From the least to gain, first was the physician and then the least to
gain in this category, the patients came in number two from having both
the most to gain and the least to gain from the ads.

Specific questions to practice, have patients come into your office
solely because of the ads? Thirty-six percent of those surveyed said
yes, while 64 percent said no.

Have patients asked you for your opinion? Ninety percent of the
physicians that were surveyed said yes, I\'ve been asked my opinion
based on the ads.

Have you been asked for a specific treatment? Seventy-two percent said
yes versus 28 percent that said no.

Now, particularly as it relates to communication, and this is something
that a lot of the literature has reported. And one of the biggest
benefits, we believe, if DTC ads are beneficial, this is an area that we
would be very concerned with.

Do you feel that the ads promote increased communication? Forty-eight
percent of the physicians surveyed said yes versus 33 percent no, 19
percent said I really don\'t know.

What about patient education regarding disease state? Fifty-three
percent said yes, we do believe that this promotes increased patient
education.

Compliance, one issue of major concern for both the physician study and
the patient study, now 56 percent of the physicians surveyed said I
don\'t believe that there has any effect on compliance while 27 percent
said I\'m unsure, and 17 percent said yes, there is.

We believe that even 17 percent \-- and if you\'ve ever had a diabetic
try to follow a diabetic diet and take their insulin or whatever, a 17
percent compliance rate, I think, is significant.

As the result of the ads, have you changed your prescribing habits?
Eighty-nine percent of our physicians said no, nine percent yes, and two
percent said unsure.

Do you feel additional pressure to justify? Sixty-one percent said no.
But we believe it is very significant that 38 percent of the physicians
said that yes they do feel pressure to justify. And we saw the FDA\'s
data actually, and this percentage was a bit higher.

Are the ads more beneficial to minority patients? The physicians that
answered the survey at least said no.

Now in summation, the majority of physicians have been asked about DTC
ads, really their medical opinion. The majority have also been asked for
specific treatment. When we come down to \-- and I will discuss briefly
the position of the National Medical Association, the majority do
believe that DTC ads promote increased communication between the doctor
and the patient.

And that there is a benefit particularly as it relates to increasing
awareness. However, we do not believe that the ads make the patient more
compliant. And, overwhelmingly, physicians deny having changed their
prescribing habits.

Although a significant \-- and a significant percentage, although not
the majority, of MDs do feel an additional pressure to justify. And we
think that is significant. There is no additional benefit for the
minority patient.

The official position which is published is that we want as an
organization, and I do stand as the principal investigator of this study
and on the Board of Trustees of NMA, we want to make sure that the
NMA\'s voice is heard. And the minority patient\'s and physician\'s
voices are heard on this subject.

And so we welcome giving continued input and expertise to the FDA. We
have some thing internally that we\'re doing to look at this issue
because anything that touches the physician or the patient, the NMA must
become involved with.

Now we do recognize that there is an educational benefit, particular as
it relates to increasing awareness. Now given that statement and the
disparities in health care as it relates to minority populations, we
encourage cultural diversity and sensitivity in any ads produced by the
pharmaceutical industry.

A little example \-- and we also encourage given number four in our
position, that there is an educational benefit that if you are trying to
increase awareness, for instance, on hyperlipidemia, well if we know
that African-Americans are going to suffer disproportionately from
cardiovascular disease, make sure that you are increasing awareness in
media that will touch the African-American patient.

And then as a physician organization, we must ask that the
pharmaceutical industry let physicians know, because our data has shown,
that our patients are going to come in and ask questions or opinions
about advertisements that they see, let the physician and health care
provider know prior to releasing any major marketing study.

We also encourage internally our physicians to continue to use peer
review journals and other traditional methods of acquiring medical
education. However, we also know that we must be aware of the
advertisements that are out there and what is touching our patients.

So speaking of patients, what about the patient? There was a study, and
this is a landmark study as well, assessing the impact of
direct-to-consumer advertisements on the African-American patient. This
is a multi-site survey of patients during their office visit.

I believe as to date there has not been another study done in the U.S.
looking at patients at the time of their office visit. So this is not a
phone survey. It\'s not a Web survey. This is when patients went to
their doctor\'s office at five sites around the country.

What happened? Not only what happened and what were their perceptions
coming in but also what did the physician do? Over 1,065 patients in
African-American physicians offices \-- and you can see the states
listed there which we believe is a good cross-section of the country
were surveyed, 91 percent of the patients were African-American, 5
percent Hispanic, Latino, or Mexican, 3 percent caucasian.

As I said, this is the first major study of DTC that was conducted in
the physician\'s office. And literally when the patients got their blood
pressure taken, they were asked these few questions. It was a normal
part of the visit.

We also followed the physician behavior and physicians were asked to
complete a brief survey at the end of the session, blind by the way.
Seventy-six percent of patients had seen or heard the ads in the two
months prior to the visit, 23 percent had a question for the physician
as the result of the ad.

And DTC ads prompt action? Which I think is a big question. Six percent
and only six percent of patients stated that they made an appointment
based on the ad, 21 percent said I want to discuss this specific
medication with my doc, 11 percent planned on asking for a specific
prescription, and actually 44 percent looked for more information.

And that\'s just basically what I discussed.

The patient survey findings include 23 percent said that they were more
likely to take a medication if they saw or heard it advertised. This is
very significant getting back to compliance data. Forty-eight percent
said that the ads helped them make better decisions. And the majority
felt that their physicians would basically treat their questions just as
they would any other question.

What did the doc do? Sixty percent said that they discussed the
medication with the patient, 33 percent of the doctors actually
prescribed the medication. And this we did not ask the doctors if they
prescribed. We looked at charts as well.

Seven percent gave information and told the patient that they would
discuss it the next visit. Fifty-four percent basically said it was a
positive interaction while 46 percent said it really didn\'t make a
difference.

The patient survey conclusions \-- the data is not vastly different from
other published studies. African-American patients do report less
exposure and they do rely on the physician to direct prescribing. There
is no detrimental effect on the patient-physician relationship and
significant compliance information is needed.

We believe that even the percentage shown of the patients that said that
they would be more likely to take medication, we think that would be
significant.

Now, to date, this is the most comprehensive \-- these two are the most
comprehensive studies of African-American and minority patients. And we
certainly believe that there is more room to be done especially as it
relates to disease burden in this population.

And one thing that is very important for us to look at is compliance in
looking at further studies, looking at the data as it relates to
exposure and compliance.

Okay? I made it. Thank you.

DR. ABRAMS: Thank you, Dr. Allison-Ottey. Our next presenter is Linda
Golodner from the National Consumers League.

MS. GOLODNER: Thank you. The National Consumers League, in case you
don\'t know, we were founded in 1899 and we represent consumers and the
marketplace and on workplace issues. And we do research, education, and
advocacy on a number of different areas.

Often we will bring together government, consumers, public interest
groups, health professionals, and industry to try to reach a consensus
on issues. And I will be talking about some of the consensus work that
we\'ve done on direct-to-consumer advertising.

Health care is a major program of the National Consumers League. We also
are involved in fair labor standards and food safety and other products
that might be regulated by the FDA.

With regard to direct-to-consumer advertising, we had held some
stakeholders meetings in 1996 and 1998 shortly after the ads had become
a little more familiar to consumers. And at that time, we did present
some surveys and research data that we knew about that the National
Consumers League had done and what others had done.

The purpose of those stakeholder meetings were to create a consensus, a
document to serve as recommendations to the FDA on how to revise and
improve DTC promotion.

The most recent survey that we\'ve done was in October of 2002. And the
full survey data will be available on FDA\'s Web site. And I\'m just
going to give you a few of the highlights from this survey. It relates
to a lot of the questions that were asked by the FDA. But we asked a few
more that they didn\'t.

The purpose of the survey was to examine the effectiveness of medical
advertising to adults, particularly among seniors. And we did do over
sampling with some senior citizens.

First of all, we asked what in the advertisement interested them. And
those, of course, that saw the advertising, they said that they or their
family member has the condition.

They wanted to learn more about the medication. It might have been a new
med. There was interest in the condition or concern about risk if they
are taking that drug.

We asked why it was of interest. It said do you have or a member of your
family has the condition described in the ad? And 77 percent who saw the
ad and had interest, that was the reason why they did look at the ad and
want to seek more information.

The presence of the condition also made a difference. We asked which
most applies to you? And what most applied to people, 43 percent said I
take the medicine that was advertised, 19 percent they take another
medication for the same condition. About 8 percent said the ad provided
new information about the condition or disease.

What action did they take after seeing the ad? This was important for
us. We wanted to see after they saw the ad, what they did and if they
went to their doctor and that sort of thing. More than half of the
adults who were interested did take some action.

Thirty-one percent decided to talk with their doctor at the next
appointment. Twenty-six percent did seek more information. And 16
percent contacted the doctor immediately. Those that did do this, they
decided to talk to their doctor when they had the next appointment was
31 percent. And these are the graphs from that last line.

Those that sought more information, 16 percent did turn to a pharmacist,
14 percent looked at a medical book or a drug reference book, 14 percent
visited general information on the Internet. And one in ten did talk to
a nurse or called an 800 number after seeing the ad.

We asked about how the doctor reacted. People wanted to know if the drug
was right for them.

So 64 percent that contacted the doctor or by visiting or calling when
they sought this additional information, 14 percent decided the
medication was not for them. This was after seeking that information. Or
it wasn\'t right for a member of their family. And 11 percent decided
that they or a family member did not have the condition or the
medication that it was treating.

When they did visit the doctor, and as you know in a survey you sort of
work down and this ends up to be about five percent of all adults who
actually did go in and talk to their doctor after seeing the ad about
the medication that interested them, half said they wanted to find out
if it was right for them while one in three said that they wanted to
find the best way to treat their condition.

One in ten said they actually wanted that drug that they saw advertised.
The result was that 42 percent of those who saw the medicine in the ad,
in fact was prescribed. Thirty-six percent said the doctor appreciated
the fact that the consumer brought up the condition that they thought
they might have.

Four percent prescribed another medicine. Only two percent said that
they were upset that the consumer had mentioned the medicine in the ad
as part of the discussion at the doctor\'s office.

Then we asked how you reacted after. How it made you feel in that you
were able \-- 24 percent said it made them feel that they were able to
be a partner with their doctor in making health care decision, 21
percent said that it made them feel more informed about the medicine
advertised, and 19 percent said it made them better able to address the
health condition and talk to their doctor about those conditions.

Of those who did talk or visit a doctor, we asked after you got home,
did you feel that drug was, in fact, rightly prescribed? And 71 percent
said that, in fact, that prescription drug did help them and one in ten
said that it didn\'t help.

Now we asked some attitudes about advertising of prescription drugs
generally. And the question we asked is what is your feeling about
advertisements? And it was a one to five scale.

You might not be able to read this but it said 60 percent said that
advertisements just make pharmaceutical companies sell their drugs. Half
of them said that ads describe the side effects or risks so that they do
understand them. Half of them said that advertisements encourage people
to ask for drugs that they don\'t need or cannot take.

And some of the other attitudes were about 36 percent said that
advertisements are confusing, 30 percent said advertisements remind
people to take their medicines or refill their prescriptions. And about
25 percent said that advertisements for medicines should only be in
medical magazines for doctors.

So I think consumers are starting to understand that ads will be
directed to them. And it\'s not just for doctors to see.

The conclusions were felt were that consumers used the ads to learn more
about drugs or conditions that are of interest to them. And that
patients do talk to their doctors about the drugs and conditions.

But we also felt that consumers recognize that this is advertising and
that pharmaceutical companies do want to sell drugs. And I think that as
we get more and more drugs advertised, that people will recognize it as
a car dealer wants to sell a car, a pharmaceutical company wants to sell
medication.

The recommendations that were made when we had the stakeholder groups
get together, these meetings were done in the late 90s but they are
still appropriate. And one of the recommendations was that the old law
must be amended to address direct-to-consumer advertising and not just
direct-to-physician advertising.

Also, that the brief summary should be reformatted to provide important
risk and benefit information in consistent, balanced, and useful format
in plain language. Also that it could be, in fact, in a med guide
format. Also the adequate provision requirements of broadcast guidance
could be adapted to print format.

Also one recommendation was that the standardized information panels
that are effective in other FDA-regulated products, for instance
nutrition facts, supplement facts, and the drug facts which appear on
OTCs could be done for prescription drugs in the ad. Or it could be
available when a consumer receives that prescription at the pharmacy.

It could be a format that could be adopted for use in the promotional
ads and in any materials that are handed out to the consumer. Also a
recommendation was that advertisers must be more cognizant that
consumers are not necessarily taking away all the important health
information that they should from an ad.

I think that the survey we did and the survey FDA did and some other
surveys that we\'ll be talking about, consumers cannot sometimes
identify the disease or the drug which is indicated. Some consumers
don\'t recall the balance, both the serious and most common risks.

And we feel that pharmaceutical companies should improve these ads so
that there is better comprehension and retention of the most important
information, for instance on those people who should not take a
particular drug.

And finally, DTC promotions should not be false or misleading obviously.
It should be fairly balanced. It should help consumers seek additional
information. And we feel it is a useful tool for patient-health
professional communication.

Thank you.

DR. ABRAMS: Thank you, Ms. Golodner. Our next presenter is Carol
Rothkopf from Time, Incorporated.

MS. ROTHKOPF: Good morning. Today I\'m going to take you through the DTC
information process.

To give you a little bit of a background on the research Time,
Incorporated has done in this category, we\'ve had five waves of
direct-to-consumer research from 1998 to 2003. In each case, our reports
have been developed with feedback from the pharmaceutical industry.

In Wave 5, our current one, we sought to find out three things:
determine the DTC information process by stage, and I\'ll get more into
that in a bit, investigate compliance in health care issues, and to use
Claritin as an example, and examine the impact of switching prescription
medications to over-the-counter status.

Because we only have 15 minutes today, I\'ll only be going over the
first point.

As far as the methodology, all of our respondents were pre-qualified.
They had to have been sufferers that were diagnosed by health care
professionals within the last two years and taking prescribed
medications.

We looked at seven conditions as a net, allergy, arthritis, cholesterol
disorder, high blood pressure, diabetes, GERD, and depression. And then
we looked at the information process by stage, pre diagnosis to post
diagnosis.

Our measurement was sources of information for these conditions and
treatments. And the sources used were media sources, not just
advertising but also editorial, and health care programs on TV, health
care professionals, the Internet, health care Web sites in general, as
well as pharmaceutical company Web sites. We looked at direct mail,
medical journals and books, and brochures in doctors\' offices.

We had over 5,000 respondents in the survey. It was a telephone
interview conducted in July of 2003 by C & W Marketing Research. And C &
W Marketing Research does a lot of consumer confidence surveys for the
Federal Reserve Board. They also do a lot of political party research
for Medicare and Medicaid.

The research company identified four different stages. In the first one,
self-diagnosis, the sufferer feels that something is wrong with them and
they start examining the sources of information that are out there that
I just described to you.

In stage 2, that\'s called the investigating stage. And the respondent
goes \-- some of the respondents go one step further. And they start
some sort of treatment regime. And that could be taking an
over-the-counter medication, trying to lose weight, stop smoking, or
exercising.

In stage 3, they are going to the doctor. And this is the shortest of
all of the stages. For some people, it is very quick. They go to the
doctor. They may have an allergy and get a prescription. Others may
have, for example, hypertension. And the doctor may say let\'s look at a
lifestyle change for you and come back in six weeks.

And in stage 4, this is the current state that the respondents are in.
They are taking the prescription medication and they still are
investigating different sources to learn more about their illness and
their medication.

Now before I show you everything by stage, you have a look here at the
net numbers. And as you would expect, the doctor was the number one
source used more than anything else.

And what is very interesting is Internet health sites were number two at
79 percent, which is much higher than Internet Web sites for
pharmaceutical companies, which were at 20 percent. That was followed by
friends and relatives at 29 percent.

And looking at the media sources, TV is a bit over 24 percent, magazines
a bit under 24 percents, and newspapers are at 21 percent.

We found a lot of similarity in the first two stages in what was
happening. The Internet is the number one source. We found that across
the board, magazine articles and ads and newspaper articles and ads more
so than TV programs were used as sources.

And for all the three media, TV, magazines, and newspapers, the edit or
the TV show about a medical condition or drug was used more than the
actual advertising.

The only reason we have doctors and nurses down in these two stages is
that some of the respondents had a friend or a relative that was a
doctor or a nurse and gave them some information or they may have gone
to a dentist and discussed their health care problem with the dentist
and got a bit of information.

And what is also important is that friends and relatives appear to be
equally as important as the media sources. And medical journals are at
nine percent in stage 1 but they jump up to 15 percent in stage 2.

It\'s a busy chart so I\'m going to use some of my notes. In stage 3,
you can see that the person has gone to the doctor, okay? And, of
course, the numbers for the doctor and the nurse jump up.

And once the doctor becomes a factor, the other sources of information
go down as far as usage. Health care Web site go down. Media sources are
used less. Magazines and newspaper articles are used more than TV
programs. But TV advertising is also used more that magazine and
newspaper advertising.

Usage of friends and relatives goes down. And medical journals and books
and pharmacists are used more than the paid media sources.

In stage 4, again, the doctor is the number one source but the usage
does go down. And usage of other sources then begins to go up. Usage of
the Internet is going back up, especially for the health care Web sites.
TV and magazines are the leading advertising sources more so than
newspapers. And magazine edit and TV programs lead newspaper edit.

Here we see that usage of medical journals is at its highest point and
usage of the pharmacist is also at its highest point.

Now here I\'ve isolated the three major media sources used in DTC
advertising. And you can see a little bit more clearly that in stages 1
and 2, magazines and newspaper ads are used more whereas in stages 3 and
4, it\'s magazine ads and TV ads that are used more.

The research house actually took everything one step further than we
asked them to. And they looked to see how accurate people were in
diagnosing themselves and adopting some sort of treatment routine. And
I\'ll read you those definitions.

The accuracy of self-diagnosis is the percentage of self-diagnosis that
was accurate among those who used specific sources of information in
stage 1. The diagnosis was made by a health care professional in stage
2.

The other definition accuracy of treatment supposition is the percentage
of respondents in stage 2 whose assessment of their treatment option was
accurate. The treatment option was made by a health care professional in
stages 3 and 4.

So here we\'re only going to look at stages 1 and 2 and how accurate
they were. In stage 1, you can see that using a doctor, nurse, or
pharmacist proved to have the more accurate diagnosis, followed by
medical journals and books, Internet health care sites, magazine,
newspaper ads and articles were more accurate than TV sources.

And in each case, the edit produced a more accurate diagnosis than the
advertising.

When we get to stage 2, we find that actually the medical journals and
books were a bit more accurate than the health care professionals.
Health care professionals followed. And then doctors\' offices,
brochures and pamphlets, Internet health care sites, and mail
solicitations.

As far as the media, magazines and newspaper ads lead TV in accuracy as
a source of information. And magazine articles and TV programs lead
newspapers.

And here we\'ve just broken out the three media sources so that it is a
little bit more clear. And you can see that in stages 1 and 2, it\'s the
magazine ads and newspaper ads that produce a more accurate
self-diagnosis. And in stage 2, it\'s the magazine ads and newspaper
ads.

This slide is not from our study. It\'s from a study called the MARS
OTC/DTC Study. And it\'s a study with 40,000 respondents that the
pharmaceutical companies initiated. Cantor Research does all the field
work.

And this question is sources of health care information that consumers
value very much or somewhat. And they were allowed to choose this on a
four-point scale: value very much, somewhat, not very much, or not at
all.

And you can see that magazines are the number one most valued source at
27 percent, followed by TV ads at 23, and newspapers at 17.

So what does all this say? Well, among sufferers who take prescribed
medications, there are four stages in the information gathering process.
Each stage shows measurable differences between the sources of
information and their use by the sufferer.

Advertising plays an important role in the initial stages of the
information process, stages 1 and 2, and in stage 4, the current state.
Among media sources, magazines demonstrate a high level of accuracy when
it comes to helping the sufferer diagnose their ailment and probably
treatment.

And the research shows that a balanced media mix maximizes the
effectiveness of the advertising message.

DR. ABRAMS: Thank you, Ms. Rothkopf. Our next presenter is Ed Slaughter
from Rodale, Incorporated.

MR. SLAUGHTER: Good morning everyone. I think it\'s still morning, yes.
Okay. All right.

I wanted to show everyone today highlights really from research that
we\'ve been doing for the past six years on consumer reaction to DTC
advertising.

This is research that we started in 1997. We like to mention that
because we started the first field work with this project before DTC
advertising kind of went through its big change, which took place with
the issuance of the 1997 draft guidance for broadcast advertising.

So all the figures that you see for 1997 actually happened pre-guidance
with data collection in spring of that year.

All of the research is funded solely by [Prevention
Magazine]{.underline} and [Men\'s Health]{.underline}. These magazines
are the nation\'s leading consumer health magazines in the United States
with over 19 million readers. We\'ve been telling people how to be
healthy without using prescription drugs for 53 years.

The research methodology from one year to the next stays pretty
consistent. We have always done full probability national telephone
surveys and the samples have ranged from about 1,200 to 1,600 in size.

The research company that we use to data collection for these projects
is Princeton Survey Research Associates. They do a tremendous amount of
work for not only Kaiser and the Harvard School of Public Health, but
also for the Pew Research Center for the People and the Press among
other organizations.

And they do a nice job of not only sort of assessing how people
integrate information, news information, but also health information,
which is one of the reasons that we wanted to go to them.

We are addressing about six of the questions that were raised by FDA. I
won\'t go through all of these for the sake of time. But they are part
of the public document associated with our results as is the full
written report that we publish every year based on the results from this
research.

So what is just the overall awareness of DTC? We asked a very
straightforward question which is have you ever seen an advertisement
for a medicine you can only get with a doctor\'s prescription? Or
haven\'t you ever seen an ad like this?

And you can see from 1997 through 2002 some fairly steady growth. It has
plateaued in 2001 and 2002 so that about 85 percent of the nation\'s
adults say yes, in fact I have seen that kind of ad.

When we do ask questions on each year\'s survey having to do with
specific brands of medicine and whether or not people have seen
advertisements for those and we asked generally about between 10 and 14
different medicines, if you do a net across them, that is yes to any one
of them, you see that overall awareness of DTC advertising in the United
States is about 98 percent, 99 percent.

So really almost everybody in the U.S. has seen this form of
advertising.

What is public opinion regarding the advertising? It tends actually to
be fairly positive in our assessment, people believing that it
encourages them to find out not just about the advertised medicine but
also about the condition that medicine treats.

It alerts people to symptoms of conditions that they may have. It tells
people about new treatment options. It also allows people to be more
involved in their health care. And also, interestingly, a total of 64
percent either somewhat or strongly agree that the advertising is done
responsibly.

That isn\'t to say that consumers aren\'t, at times, necessarily
circumspect about the advertising with 61 percent also saying these ads
providing this information could actually scare people into thinking
that they have conditions that they don\'t actually have.

And there is also a minority, 36 percent, who believe that the
advertising, in fact, could cause tension between doctors and patients.

Now there are sort of two ways to look at this idea of information
provision. One is how good a job does the advertising do at providing
the information. And the other is is it providing the right kind of
information for the consumer to have a conversation with their doctor
about the advertised drug.

What we can see overall is that for the most part, half or a little bit
more of consumers believe that the advertising is doing at least a good
job of telling consumers about the benefits of taking the product, about
serious product warnings, and also about annoying but not serious side
effects, things like headache and dry mouth and those types of things.

The more interesting question, I think from my perspective, is whether
or not the advertising is actually providing consumers with the kind of
risk and benefit information that they need to have in order to have an
intelligent conversation with their physician about the advertised
medicine and about the risks and benefits associated with taking those
products.

And what we can see is when we look at magazines by themselves and
television by itself, and we just simply say to consumers in this
telephone survey, think now please about only the ads you\'ve seen in
print. Tell me whether or not those ads provide you with the kind of
risk information you need to talk about risks, with the kind of benefits
information you need to talk about benefits.

And we can see that about half, slightly more in each case saying I am
getting the kind of information that I need in order to ask these
questions. In total, that is sort of the net, they are either saying yes
for magazines or broadcasts, about 68 percent, around two-thirds of
consumers saying they are getting it from either one of these sources.

Either from broadcast or from print, they\'re getting the information
they need in order to ask these questions about the advertised drugs.

Now this whole idea, this whole issue of whether or not consumers are
being informed particularly as it pertains to broadcast is an
interesting one. And we wanted to examine whether or not the references
being made, and which are mandated by the current guidance, are being
followed and used by consumers.

And what we find is that for Web sites and toll-free numbers, about one
in ten consumers roughly are saying that because they saw this reference
in a broadcast advertisement, they are, in fact, going to check these
sources for additional information. The number is slightly smaller for
magazines. It\'s about four or five percent.

Again, when we do a net across this, that is people who have used any
one of these sources, we see about 19 percent of consumers who have seen
a DTC ad, or approximately 37 million people saying I have, in fact,
gone and checked one of these secondary sources because I saw it
mentioned in the broadcast advertisement.

So, again, we are seeing that the advertising is encouraging information
seeking around, perhaps, the condition or the medicine itself.

When we look at this a little more closely and we asked consumers what
is that you looked for when you went to one of these secondary sources,
we find that many of them say you know I\'m looking for a medicine that
I\'ve never used before, which isn\'t surprising, they did get sent
there as a consequence of an ad.

The other thing that is interesting is that they are information seeking
for someone else. So this whole idea of caregiver and the idea that I\'m
not just looking on my own behalf but I\'m also looking perhaps for a
spouse or a child or an aging parent I think is very, very important.
And we may be actually providing a mechanism for consumers to help in
their caregiving practices and care-giving behaviors.

When it comes to the brief summary page, I think that we\'re finding \--
and I\'ll speak of it in these terms \-- the same kind of troubling,
perhaps, results that some of the other organizations are seeing. And
I\'ll again put it in this way.

Only about 54 percent of consumers who say that they\'ve looked at print
ads say they even recall or remember seeing the brief summary page, 12
percent saying they read it thoroughly, and the rest saying only looking
for key information or skimming it. Fully 46 percent don\'t have any
recollection of seeing the brief summary page at all.

Among those who are looking at it and checking the information on it, we
see that they are looking for key and important information. Certainly
they are looking for side effects information, nausea, drowsiness,
interaction with other drugs, precautions against taking the medicine
under particular conditions such as pregnancy, or using heavy machinery,
whatever it may be. And also warnings for people with particular
conditions such as high blood pressure or asthma.

So they are \-- once you can get them into that brief summary page,
there does seem to be some indication that they are looking for key
pieces of information or important information that could effect their
course of treatment.

What is the trend in talking to the doctor about an advertised medicine?
Well, it\'s remarkably unchanged.

In 1997, again before the great onslaught of broadcast advertising, we
saw 31 percent of the nation\'s adults, of adults who had seen an ad,
saying, \"I have, in fact, talked to my doctor about an advertised
medicine.\" By 2002, that figure, unchanged, at 33 percent of consumers
saying that they had talked to their doctor about an advertised
medicine.

To sort of expound a bit on what Kit had said where she said there
didn\'t seem to be hordes of consumers, the joke I like to make is we
don\'t have angry mobs of consumers with torches and pitchforks
stampeding towards the doctor\'s office because they saw an ad on
television or in a magazine.

What is happening, though, is that perhaps, and we only have one data
point on this, it is the first year that we asked this question, that we
have about 31 percent of the consumers, about a third of those who have
talked to their doctor, saying that they\'ve had multiple conversations.

And that translates to about 20 million people in the United States who
have had multiple conversations about medicines, about advertised
medicines. And so what may be happening is that we\'re kind of creating
a kind of energized core of consumers who are very active and very
proactive in their health and are talking to their doctor frequently
about advertised medicines.

We then take this question to the next step which is not only did you
just have a conversation with your doctor about the medicine but did you
actually ask your doctor to prescribe it?

And, again, this figure also remains incredibly flat from 1997 to 2002,
30 percent of the 33 percent who initiated a conversation say that they
actually reached the point where they request the medicine by name.
Again, that number is very flat.

The other way to look it, I think, is that 70 percent of consumers never
ask for, much less demand, a prescription medicine from their doctor.
Still, it winds up to be about 19 million consumers, projected 19
million consumers in the United States who have requested an advertised
medicine by name.

What is the result of that request? In 2002, we see that about 79
percent of everybody who asked for a drug by name actually receives that
medicine.

Now when we look back at the broader base of people who are just having
a conversation and those who actually ask for it, and ask them if their
doctor has ever recommended non-drug therapy, we can see that from 2000
to 2001, that percentage actually increased from 53 to 60 percent of
these consumers.

So just because they go in and have a conversation with their doctor
about an advertised medicine, doesn\'t mean that they are going to get a
drug. Many of them come out with recommendations for lifestyle changes,
dietary changes, or with a suggestion to take an OTC or whatever it may
be. But a large proportion of these people walk out with a
nonprescription drug therapy.

What is the proportion of consumers who tell us that they have, in fact,
talked to the doctor for the first time about a medical condition as a
consequence of DTC advertising? That\'s also holding steady. We have
about 15 percent which is now pretty much in line with what the FDA has
found in its latest survey.

And again, that\'s about 29 million adults telling us that they had
talked to their doctor about a health condition for the first time as a
consequence of seeing a medicine for that condition advertised.

How many of these people ask their doctor to prescribe the medicine, the
drug that treats that condition? Well, it has dropped over the last
several years from 30 percent in 1999 down to 17 percent in 2002. Still
that\'s about five million consumers making requests for medicines for
previously undiscussed health conditions.

And what we can see is that about four million consumers, 80 percent of
those who ask wind up getting that medicine. So a pattern that is very
similar to the public in general when they go in and talk about a
condition and ask for a medicine.

Despite the fact that there seems to be a lot of activity around DTC
advertising from the consumers perspective and, honestly, you know 19
millions requests is a lot of requests for prescription medicines based
on advertising, we see on a self-reported basis, absolutely no change in
the proportion of U.S. adults who self-report as taking a prescription
drug.

We also see no change in the average number of prescriptions that they
take. So, again, this evidence or argument, there seems to be a run on
prescription drugs as a consequence of DTC advertising, certainly
hasn\'t been borne out by our data.

What is the willingness of the doctor to talk about these medicines?
Again, this is from the consumers perspective so we don\'t have
physician data on this, but clearly the consumers believe that the
doctor is very willing to talk to them about advertised medicines.

Twenty-seven percent believe that their relationship with their
physician actually improved as a consequence of having this
conversation. Seventy-two percent say it stays the same. Only one
percent say it got any worse.

When we asked people who didn\'t get the drug that they asked for,
whether or not they disagreed with that decision, the n is very small
here, at only 30 but still about 44 percent of them said, \"Well, you
know, I did kind of disagree with that.\"

When you look at all consumers who have been exposed to a DTC
advertisement, only one percent ever get into the situation with their
disagreeing with the doctor\'s decision about whether or not to give
them an advertised drug. And only two-tenths of one percent ever reach
the point where they are \"shopping for a doctor\" to give them an
advertised drug.

In summary, consumers have positive opinions about DTC. They like the
fact that it informs them about new treatments, alerts them to symptoms.
There is room for improvement, however, I think there is room for
improvement in the provision of risk information in particular.

And I think we need to be more selective about the kind of information
that we begin to give the consumers. And we have to be more creative
with the provision of that information in the brief summary.

One-third of consumers talk to the doctor about an advertised medicine.
That figure is unchanged since 1997. DTC has encouraged about 29 million
people to talk for the first time about a condition. Consumers do not
demand advertised medicines. We have no evidence of that.

Rx use shows no significant change since 1997 and the start of broadcast
advertising. And DTC does not appear to negatively effect the
doctor-patient relationship, at least not from the consumers\'
perspective. Thank you.

DR. ABRAMS: Thank you, Mr. Slaughter. Our next speaker is Dr. Joel
Weissman from the Massachusetts General Hospital Institute for Health.

DR. WEISSMAN: I want to begin by thanking the FDA for inviting me to
speak today and also to acknowledge my co-authors from Harvard, from
Mass General Hospital, and from Harris Interactive.

I\'m going to talk today about two surveys from Harvard-Harris, national
DTCA surveys. One was on the general public and one was a survey of
physicians. And our purpose, although similar to some of the other
surveys you\'ve heard where we asked our fair share of opinion
questions, was also to focus a bit on what actually happened during the
patient-physician encounters.

Both surveys, similar to the FDA, focused on what we call the DTCA
visit, which was the most recent physician visit during which patients
discussed a drug that they saw advertised. And both studies were jointly
funded by the American Medical Association Industry Roundtable Steering
Committee and selected members of the ad hoc working group on the
Economics of the Pharmaceutical Industry.

The methods were similar between the two surveys. The general public
survey was a telephone survey. We had 3,000 consumers or patients. We
had a 53 percent response rate. It was a nationally-representative
sample. And the results were published last February in [The Journal of
Health Affairs]{.underline}.

The physicians survey was a mailed survey. We limited it to specialties
that saw office patients so we didn\'t include things like
anesthesiologists and pathologists. We had 643 physicians, again a 53
percent response rate. And that paper is under review.

For the consumer survey, we had three questions that we asked. And the
first was what sorts of conditions are associated with DTCA visits. And
the second was what actions are taken during DTCA visits in the sense
that a lot of economists in particular are concerned with what is called
spillover effects.

Obviously the drug companies are interested in getting the patient to
use their \-- to buy their drug but there may be some other sorts of
actions that are taken as the result of that foot traffic in the
doctor\'s office. And then finally, what outcomes are reported as a
result of DTCA medications.

The DTCA visits resulted in a number of new diagnosis, many of which we
found to be important. And I should just mention to those of you on the
panel who have a printed version of this talk, I took out some of the
slides because I realized it was a bit long. So I hope that you don\'t
have to skip too much.

But the first thing that we found was that when we asked patients to
talk about their conditions and then we asked them did a medical
professional actually tell you you had the condition, which we defined
as diagnosis, that about 46 percent of the conditions were about a
condition that already existed.

Twenty percent did not receive a diagnosis, and those we believe were
largely due to routine checkups and so on. And about 25 percent of
patients who came in and had a DTCA visit or a discussion with their
physician about a drug had a new diagnosis.

And then we looked at those diagnoses and we compared them with a list
that was put out by the Institute of Medicine and the Agency for Health
Care Research and Quality and they had a list of high priority
conditions that they devised based on the prevalence of the condition,
the expense, and the policy relevance. And we found that 43 percent of
the new diagnoses were high priority according to this list.

And just to jump ahead, for the physician survey, the number was
similar. It was about 31 percent of the new diagnosis that were high
priority.

We also found that DTCA visits often led to prescribing the advertised
drug. I think other surveys have found that. But we also found that it
led to the use of a range of other health services.

Now first of all, just scanning this list, at least 95 percent of the
patients reported that they walked out of the office with at least one
of these actions taken.

And what we did also was we were concerned that, as other people have
said, that people make appointments or schedule appointments with
physicians for a variety of reasons. And we didn\'t want to try and
attribute all of these actions to DTCA.

So what we did was we asked patients how influenced they were by DTCA to
make that office visit. And we separated the groups into those that were
highly influenced and not highly influenced or low influenced. And we
actually found that the results were pretty similar.

About 47 percent high influence had prescribed the DTCA drug compared to
41 percent low influence although the differences were not statistically
significant. Any drug, about 71 percent, almost three-quarters, of the
patients were prescribed any drug in addition to the one that they
talked about.

Slightly fewer patients who said they were highly influenced by DTCA
were referred to a specialist. Fewer also received a lifestyle change
recommendation from their physician. About the same number had a
recommendation to look at OTC drugs, over-the-counter drugs. And, again,
slightly fewer patients who were highly influenced had a diagnostic test
that was recommended.

Then we also found that few patients reported adverse health outcomes
from taking DTCA or other drugs. And what we did was we asked the
patients what their outcomes of care were from taking the drugs. And we
concentrated on the drugs that they were prescribed, that they filled,
and that they took as prescribed.

And basically about four out of five patients felt that their overall
health was much or somewhat better. About four out of five also thought
that they had a change for the better in terms of the lab tests. Not on
this slide also about four out of five patients also felt that their
symptoms improved.

And we also looked at whether or not they were talking about the DTCA
drug that they received versus some other drug that they received. And
the results were almost identical.

Now let me change gears for a minute and turn to the physicians survey.
And the first question we had from the physicians survey was what do
physicians perceive to be the effects of DTCA on their patients and
their practices. And these are similar to some of the other surveys and
so I\'ll go over them quickly.

But first of all, we found that U.S. physicians agreed somewhat or
strongly with the statements that it encourages patients to seek
treatments that they don\'t need, about three-quarters. About 80 percent
felt somewhat or strongly that DTCA does not provide information on
risks and benefits in a balanced manner. And about 31 percent felt like
DTCA made their patients less confident in their judgments.

We divided these sort of perceptions into negative aspects and positive
aspects. These are obviously the negative ones.

And then we asked them about positive aspects of DTCA. And, again, these
are the percentages that somewhat or strongly agreed. And we found that,
again, about three-quarters of physicians agreed that DTCA helped
educate and inform patients about treatments available to them.

About two-thirds said that it helped them have better discussions with
their patients. And about 45 percent felt that it increased patients\'
compliance with physicians\' recommendations, tests, or recommendations.

And what these two slides say is obviously that there is a mixed opinion
out there among physicians, that it is not 100 percent against DTCA and
it is not 100 percent supportive of DTCA. It kind of depends on what you
asked them. And it also depends on who you ask.

The second question is what proportion of physician visits involve DTCA
discussions. And for what conditions. As I mentioned earlier, one of the
things that we really tried to measure and assess in our surveys is a
little more about the epidemiology, if you will, of the
patient-physician encounter.

And the first question we found was that only a small percentage, about
3.1 percent of all physician visits involved the DTCA discussion. What
we did is we asked the physician how many patient visits they had in the
last week. And then we asked them how many of those visits actually
included a discussion with a patient about an advertised drug.

And in focus groups, we tried two weeks, we tried a month, to see if we
could go back further. They weren\'t so comfortable with talking about a
month. But they were pretty comfortable talking about their recollection
of what happened in the last week.

And I think this is the first published number of sort of the, you know,
how big is the bread box of DTCA discussions. Then we asked about the
most commonly discussed conditions. Recall earlier that I talked about
what proportion were high priority. This is a listing of the most common
conditions.

And I\'m going to start by presenting the top conditions that were
reported by patients. And you can see that number one is allergies, it
goes down to arthritis, high cholesterol, diabetes, reflux, and so on.

And what we take away from this is the absence, at least in the top
conditions, of some of the very minor or lifestyle conditions that
people were concerned about. They are not being inundated with
discussions about toenail fungus and hair loss.

And then we compared it to the conditions that were reported by the
physicians about the last visit. And they were very similar with one
major exception. I don\'t know if any of you can think of what this is
but I\'ll show you now.

And that difference was that number one was impotence. And we believe
that this obviously has to do with a certain social desirability bias,
if you will. There are not a lot of men who are willing \-- patients who
are willing to tell a complete stranger over the phone that they have an
impotence problem.

But physicians had no problems with that. Other than impotence, the top
ten were very similar to the ones that the patients reported.

The third question is how often do physicians prescribe DTCA drugs to
accommodate patients\' wishes. And this is the question that really
addresses or at least begins to address the pressure issue which has
been raised by others.

And, again, you know, we went to the focus groups and we asked them, you
know, it was sort of obvious that physicians were not going to tell us
that they prescribed inappropriate drugs for their patients. And I think
common sense tells you the same thing.

But we were able to ask them some questions with the understanding that
there are different choices of drugs out there, that there are drugs of
different effectiveness that might be more or less appropriate for their
patients. And to try and \-- instead of put this in the frame of
pressure from their patients, whether they were trying to accommodate
their patients.

And what we found, I think, was pretty interesting. Forty-six percent
\-- and this is among the cases where the advertised drug that was
discussed was actually prescribed for the patient \-- and among those
cases, 46 percent of the physicians said that it was most effective drug
for the patient. That\'s the one you want to see.

Forty-eight percent, however, said it was as effective as other drugs
for the patient and they wanted to accommodate the patient\'s request.
And 5.5 percent actually said that other drug or treatment options were
more effective but they wanted to accommodate the patient\'s request.

Actually 5.5 percent, fortunately, is a very small number. We have
started digging into the data and some of that has to do with surgeons,
I think, who may be felt like there was a surgical option instead of an
option. But it still something of concern.

The study limitations from both studies, we didn\'t really have a good
control group. You really can\'t do a randomized control trial on DTCA
and the effects of DTCA in this country. There could be some possible
recall bias although in some cases, in particular for the physicians and
for the patients, we analyzed the subset of the data with a shorter
recall period and we got basically the same results.

Medical records would have provided more clinical detail. As I
mentioned, physicians are not going to tell you if they prescribed
inappropriately. But you might be able to get some of that information
out of a medical record.

The 53 percent response rate may miss some information from important
groups of patients or physicians although the ones who responded seemed
to be pretty representative of the national figures that we had.

And we actually weighted up to national figures and it didn\'t really
change that much. And then in some cases, we had predicted as opposed to
actual outcomes.

So in conclusion, we felt that DTCA discussions were associated with new
diagnosis, many of which were for high priority conditions. We also
identified some of the spillover effect, that DTCA discussions may
trigger health care consumption in addition to DTCA drugs although
certain actions were less likely for patients heavily influenced by the
advertisements.

The outcomes of treatment generally were reported to be positive
although some physicians, I didn\'t actually present this data,
perceived that there were little or no effect on patients\' overall
health. But even among the physicians, they also perceived generally
positive results from the drugs that they prescribed.

And we did not find evidence of a burden due to the discussion of minor
or lifestyle conditions or widespread negative outcomes that you might
assume would occur from inappropriate prescribing.

And secondly, when we looked at our patient accommodation questions, we
concluded that accommodating patients by prescribing advertised drugs,
especially when other equally effective drugs were available, is a
relatively common practice.

We thought that if heavily advertised drugs were found in the future
research to be more expensive, and this would be something that would be
a public policy condition, that such behavior could have cost
implications.

However, there were also cost considerations that could also result in
prescribing less expensive alternatives. And that this is something
which is probably negotiated between the physician and their patients.

And finally, accommodating patients by prescribing advertised drugs when
more effective treatments or drugs were available was pretty rare
although potentially cause for concern.

Thank you.

DR. ABRAMS: Thank you, Dr. Weissman. We will now take questions from FDA
and presenting panel members. And I\'ll start off with a question for
Linda Golodner.

Linda, you mentioned from your data 30 percent of patients said ads
remind them to take medicine or refill their prescriptions. Do you have
any other data or information about how DTC may effect compliance?

MS. GOLODNER: No, we didn\'t ask a lot of the compliance questions
although we did ask attitudes about whether or not people thought that
compliance was a result of the ads. And that was the number I gave.

DR. TEMPLE: This might be for Dr. Weissman but anybody else. Has anyone
yet or actually done or thought of taking a look at the result, an
independent external look at the result of an interaction where there
was a discussion of treatment based on a DTC ad. And looking at whether
the outcome met various standards.

This is easiest for hypertension where there are existing guidances on
what drug to use first, what drugs to follow, what goal to reach. And
examine to see whether the outcomes are different say for a setting in
which there was a DTC drug referred to and where there was not.

I don\'t quite know how to do this yet. But I\'m sure you probably do.

DR. WEISSMAN: I\'ve certainly thought about it but I haven\'t done it
yet. I don\'t know if anybody else on the panel has. I think maybe Dr.
Kravitz from out in California has done some work in that area?

DR. TEMPLE: You can think of some areas where there would be major
interest in that. There is a lot of interest in what the best therapies
are for hypertension. Everyone knows no one uses diuretics probably
because they are not advertised.

There are alternative drugs that probably work equally well but you
don\'t really know that until you look. And there are cost implications
obviously.

DR. ALLISON-OTTEY: I wanted to give a comment on that. I think that\'s a
great area and when I talked about looking at compliance, I think
that\'s a great new area to look at particularly as it relates to easy
things like hypertension or hyperlipidemia.

And then look at patients that state that they came in because of an ad.
And to follow those patients six months out. Because in our patient
survey, again, 23 percent of those patients said that the ads would make
\-- I would be more likely to follow a prescribed action.

So I think that just looking at those two parameters going forward, and
you also have the effect of behavior and lifestyle and other \-- I think
I heard someone on the panel \-- it\'s not just the drug. It is that
whole conversation talks now about lifestyle change.

DR. TEMPLE: It\'s also something that advertisers might think about. I
mean I\'m just trying to think of the ads I\'ve seen. Few of them
emphasize how important it is to stay on your lipid -lowering drug
although some definitely do.

But you can imagine a serious \-- I mean given the well-known drop off
of lipid treatments, you know, that has been reported in distinguished
journals, you might have thought that someone would focus particularly
on being sure you stay on the drug you have been prescribed, which
obviously has both a commercial and a health benefit.

DR. WEISSMAN: Also, you know, just another comment on the potential
study that you mentioned. I think one caution that I would put forward
is that it would be extremely difficult if you had a patient coming in
and talking about a drug, and if the physician say prescribes something
that may not have been appropriate, there has been other research on
sort of the academic versus commercial detailing.

And I think it is going to be very difficult in that situation to
discriminate between whether not it was direct-to-consumer advertising
or detailing or something else that the physician did in terms of
actually making that prescribing decision.

DR. TEMPLE: Yes, I\'m sure none of this is going to be easy.

DR. WEISSMAN: Yes.

DR. AIKIN: I have a couple of questions for Dr. Allison-Ottey. When you
mentioned that 38 percent of physicians felt additional pressure to
justify their prescription, could you expound a little bit more on who
they felt they were justifying to? And whether or not this additional
pressure to justify varied by the type of practice the physician had?

DR. ALLISON-OTTEY: Hello? Okay. It is to justify to the patient. And
that was a question. And we did look at all of the data, looking at
specialists versus the primary care physician. Really, it was not
statistically significant except for psychiatry, which is consistent
with other data that we\'ve seen.

Psychiatrists actually are very pro DTC and the sample comments that we
reported talked about stigma associated with disease and them feeling as
a group that there is decreased stigma. So that this helps them in
getting to depression particularly.

But it is, the 38 percent was additional pressure to justify to the
patient.

DR. AIKIN: Okay. And one additional question, in a number of your
questions, specifically do you feel ads promote increased communication
and patient education?

The number of physicians reporting that they are unsure often approaches
the number who say yes. Can you expound a little bit more on why you
think so many physicians feel unsure?

DR. ALLISON-OTTEY: I think this continues to be a gray area. And when
you look at in particular the physician study, you can answer
positive/negative equally. So we had physicians, and actually we pulled
some of the surveys out to just look, the same physician that would say
there is a positive benefit would also say there is a negative benefit.

And theoretically, it used inappropriately, they are right. And looking
actually statistically at that unsure box, there were some that, again,
when you put the two together, they are almost equal.

I think that we really don\'t know. And there has not been \-- there
have been studies done but there has not been a lot of work with
physicians to really in focus group sessions, to talk about and to talk
about their patients about that interaction and what is coming out. So I
think this is another area that we could further investigate.

This particular group of physicians, and remember these are primarily
African-American physicians so I\'m not sure if they are represented in
the other surveys that are out there as well.

DR. AIKIN: Okay, thank you.

DR. PITTS: I have a question for Dr. Allison-Ottey as well. But I\'d
like to open it up to the panel because I think your numbers seem pretty
much consistent across the board.

You mentioned that when you talked to doctors, they can identify that
there is a benefit for pharmaceutical companies and they can identify
that there is a benefit for patients. But they can\'t seem to identify
the benefits to themselves.

I\'m wondering A, why that is, and could it be perhaps be because they
perceive a disincentive for prescribing certain types of medications?

DR. ALLISON-OTTEY: I think that was interesting. While I think it is six
percent said that more patients \-- that patients directly came into the
office solely based on the ad, often the physician, particularly primary
care, will say, \"Well, is this driving more patients into my office?\"
That may be seen not as a \-- I mean as a benefit.

So if it is only six percent increase in your patients coming in because
of an ad, then you don\'t really perceive that I, as a physician, am
being benefitted. However, when you talk about compliance and that data,
again with the 23 percent, that is a physician benefit and a better
informed patient traditionally.

So in other questions, doctors said that was a benefit. They just
didn\'t recognize it as a benefit, I think. Do you understand what I\'m
saying?

DR. WEISSMAN: We also addressed the issue in some of our focus groups
that we held before the survey. And what came out there, I think, was a
time issue.

DR. ALLISON-OTTEY: Yes.

DR. WEISSMAN: That the physicians see this as impinging on the time that
they spend with the patient and where they would prefer to do something
else. And so I think that\'s where you get this mix of costs and
benefits.

DR. PITTS: Right. I mean assuming something else isn\'t necessarily
playing golf, you know, is it a financial disincentive?

DR. WEISSMAN: Well, again, now this is all anecdotal but no, some of
that is, you know, they prefer, for example, to spend the time talking
about preventive behaviors and maybe some other therapies that the
patient is undergoing. And maybe something that they thought was higher
priority.

DR. ALLISON-OTTEY: I have a comment on the time issue. On the patient
study, we timed the visits. And so the whole issue of does this increase
the time that the physician has to spend with the patient. Our data does
not suggest that.

Actually they were statistically deadlocked with if a patient brought up
an ad and asked for a medication versus did not. And so we began to kind
of tease away at the time issue by timing the actual visits as we
reported in our patient data.

DR. WEISSMAN: Of course the visits are somewhat restricted.

DR. ALLISON-OTTEY: Yes.

DR. WEISSMAN: I mean a lot of these, a lot of the doctors have to, you
know, get them in and out in 10 minutes or 15 minutes. So I wouldn\'t
expect there to be differences in the time that the patient spent with
the doctor. It\'s what actually happened which, of course, much more
difficult to get at.

MR. TROY: I was going to say before I ask my question that you might
think, as Bob and I were talking about, the fact that there are more
people coming to see doctors who wouldn\'t otherwise have seen doctors.

In the normal course, you would think that that is good for business
financially. And doctors would perceive it that way. It\'s interesting
that they don\'t.

I have what seems like a specific question for Mr. Slaughter. But it
then, I hope, leads into a somewhat broader question that picks up on
some of the things that have been talked about earlier.

In general, what we\'re trying to measure here is, of course, very
difficult to measure because it is sort of feelings, and motivations,
and perceptions, and things like that.

But there is at least one slide that you had which you would think that
you wouldn\'t have needed to ask it because there should be hard data
one would expect on Rx drug use. You asked about trend in self-reported
Rx drug use. And showed that it seemed to be essentially flat.

And you, therefore, concluded that Rx shows no significant change since
1997, the start of broadcast advertising. Well, I don\'t know the answer
to this but is that true?

That might be what people are self-reporting but we should be able
through IMS or other data to know whether or not indeed there are, since
1997, more prescriptions that have been, you know, that have been
prescribed and whether people are taking more prescription drugs et
cetera, et cetera.

So I\'m wondering, and this is going maybe for anybody on the panel,
whether you know whether or not that slide comports with reality? Does
anybody have any idea? I mean it\'s something we can, I think, check.
But \--

MR. SLAUGHTER: Yes, we haven\'t gone through the exercise which you are
describing, which I think is a good one, which is to go and look at what
the number of prescriptions were in 1997 and then track it through to
the present.

It\'s often not quite as easy an exercise as one might think. It often
depends on how new prescriptions are defined and so there are some
definitional issues. So there would be a little bit of teasing away at
the data.

We included this question because we don\'t see that \-- we see it as a
trending issue as something that should pick up on use of prescription
medicines. I don\'t know why someone would be more or less likely to say
they used a drug in 1997 versus 2003. So if there was an increase in
usage, it would be picked up in the self-reported data.

In other words, the magnitude of the error from the self-reported figure
versus the actual should be the same magnitude in 1997 as it is in 2002.

MR. TROY: That should be right. But then again one of the things that is
interesting would be to try and line up survey data with which at least
some people are pretty uncomfortable with whatever windows we can get
into reality, which gets to sort of the broader question that I wanted
to see if we could have any discussion on.

And that is \-- and the last time I gave a speech on DTC advertising,
this whole line of research was attacked as well, we don\'t know
anything because we don\'t have any randomized clinical trials, no
placebo base, no nothing. So, therefore, this is all useless.

I took some issue with that but you all are more of the experts. I mean
it is significant to me that all of you have done this kind of research
because I take it that that is, you know, the principal kind of research
that one can do to try and measure the effect of DTC advertising.

But, again, I don\'t know very much about this. But is it really the
case? I mean Bob mentioned some other kinds of trials or studies that
could be done. But would there be any possibility of any kind of \-- if
not, you know, a completely double blind study \-- even something
comparative.

Let me give you an example. And again, I don\'t know anything about the
New Zealand or the Australian health care systems, but are they
sufficiently close and comparable that since one has DTC advertising and
the other doesn\'t, that you could tell anything if you compared things
within those two systems?

Obviously our system and the Canadian system are very different. At
least that\'s the way it looks from here. But would there be any \--
and, of course, they get some spillover by seeing some of our ads, is
there any way to do any kind of comparative study, double blind study,
or anything else that would help us get a better sense of what the
effects of DTC advertising are?

I mean I throw that out to social scientists. I\'m just a lawyer. I
don\'t know the answer to that. But it seems like it is a question that
has come up and is worth discussing a little bit.

DR. WEISSMAN: I guess I could answer. First, in terms of your first
remark, there probably is a certain amount of, you know, research on
surveys because it\'s kind of like the drunk looking for the quarter
under the street lamp, that that\'s where they can look.

But we\'ve thought about a better study. And I think it is something
that \-- one interesting possibility would be to throw it open to the
pharmaceutical industry and say gee, you know, if you could do some
marketing in one area of the country and not in another area of the
country, and then look at \-- and then do some research on those two
areas of the country, you would have a terrific study there.

It\'s not something obviously that we, as researchers, can do. But that
would probably be the only thing you can do in this country. I don\'t
think that the international comparisons really work because there are
so many differences between the health care systems.

MR. SLAUGHTER: Actually, the same kind of idea popped into my mind as
the question was raised which is it is certainly not uncommon in
industry for any type of a product, whether it is packaged goods or
prescription drugs, I would imagine, for there to be a certain amount of
test marketing of promotional messages.

And so you could look at the behavior in the test market versus a
non-tested market perhaps and see how it might have effected treatment
or consumers likelihood to seek treatment within a category where the
advertising was presented and then in one where it was not.

MR. TROY: We might have even imagined and hoped that perhaps some
pharmaceutical company, some of whom might be represented here, might
have some of that data in their files.

MR. SLAUGHTER: I wouldn\'t be able to speak to that.

MR. TROY: All right.

DR. TEMPLE: Don\'t give up the international comparison too quickly. The
systems differ but you can look at change in response to a stimulus. For
example, just to think of one, every civilized country in the world
doesn\'t treat hypertension very well. We actually do better than most
from statistics I\'ve seen. But it\'s barely a third of people have
reached what everyone agrees is appropriate control.

Suppose two countries, one with DTC promotion and one without it, agreed
that they would like to get more people to whatever the current version
of the goal is.

And in one of those countries, namely ours, this was accompanied by a
full bore effort by everybody who makes any hypertensives to get the
word out. And in the other country, of course, that couldn\'t be done.
Only the government could do it. And we know that they don\'t do it that
well.

That doesn\'t seem an impossible study to do. And it would be worthwhile
to all the people who are a part of it as well as to the community.

DR. ALLISON-OTTEY: I have a comment on that. Remember that if we did
that study, even with the international markets, you would have to now
make sure that you control for the Internet, you control for magazine
subscriptions, and from other ways \-- you would have to almost have
patients in a glass bubble.

Because they would have to be able to have no outside input. And no
dishes or anything like that.

DR. TEMPLE: Well, remember, I\'m thinking about looking at change from
wherever you are. I\'m sure those other things would go up, go down, but
no one would make a systematic effort to change them unless that was
part of the intervention in which case they would.

It doesn\'t seem inconceivable. It requires a certain amount of
promotion that isn\'t directed at particular drugs or it is directed at
the disease as well as the particular drug or something like that. It\'s
my fantasy actually.

MS. GOLODNER: I think it might be possible to do that especially when
you see data for Australia. But especially in Canada, they see our ads.

DR. TEMPLE: Well, just don\'t let them.

(Laughter.)

DR. TEMPLE: I had a question, too. Does people\'s attitude toward \--
the physicians especially toward spending time, how positively they
feel, vary at all depending on what the ad is for?

When you look at the most commonly discussed conditions, some of them
are things where you might think the physician would be really very
gratified that the patient has finally come in, you know, cholesterol
and blood pressure would be in those categories, perhaps depression.

Some of the others you might not care as much because it is not as
important to their health. And has anybody looked at that question?
Because they seem very different in that way, the various promotional
efforts.

DR. WEISSMAN: We haven\'t looked at that. And I think \-- I suppose you
could. You\'d have to orient the question to that particular condition.
A lot of the questions that I think we\'ve asked on this panel are much
more global.

And so it\'s difficult to tie it \-- even if we wanted to look at our
own data and try and tie it to the conditions that the physicians
reported, I don\'t think we\'d be able to do that because their
perceptions and attitudes are much more global in nature.

MR. SLAUGHTER: We do see some modest variance, again from the consumer
perspective, in the likelihood of getting a requested medicine, in terms
of whether it is for \-- whether it\'s a lipid-reducing medicine or
arthritis or allergy.

And so one might be able to infer from that \-- not a level of annoyance
by the physician but rather that the physician is giving some other
recommendation. So there is variance, in other words, according to the
condition and type of drug asked for.

DR. TEMPLE: Yes, I was interested in the resentment about the time
spent.

MR. SLAUGHTER: Yes.

DR. TEMPLE: I mean really if someone comes in with high cholesterol, it
would be an odd physician who would resent the time spent.

DR. ABRAMS: Peter?

DR. PITTS: I have a question for Ms. Rothkopf. It was very interesting
the whole issue of stages of development and the communications tools
that moved the discussion along or not.

My question is that do the communications tools impact each other? In
other words, does having seen an ad on television drive a person to the
Internet? Or does a magazine ad drive a person to a magazine article? Or
does a television program make somebody more cognizant of a television
advertisement?

MS. ROTHKOPF: Yes, that, I\'m sure, happens with each of the major media
out there. We didn\'t measure that. We may look at that in an upcoming
survey. But I know for a fact that TV, newspapers, and magazines do
drive people to the Internet. We just didn\'t measure the degree for
each of the three media.

DR. PITTS: The reason that I ask is that if that is so, then it just
seems to pass the smell test. That a patient then going to the doctor
and saying well I saw this thing on the Internet, where he might
otherwise say, well I saw this ad and so I went to the Internet \-- and
now I\'m in your office.

So that the numbers might somewhat be skewed in that respect.

MS. ROTHKOPF: Yes, they definitely could be skewed in that respect. And
also the Internet numbers had nothing to do with advertising but there
is a lot of confusion on the part of the consumer and the patient as to
what is advertising and what isn\'t advertising. And that happens with
magazine and newspaper ads and articles. And it also happens with the
Internet, too.

DR. TEMPLE: Is there any indication that one of the reasons doctors
prescribe a different drug is that they thought another was cheaper? Do
they think about that at all? I don\'t think that was listed anywhere.

It said more appropriate. But no indication that they thought you could
get the same effect for less? Not that we regulate that. But I\'m
curious.

DR. ALLISON-OTTEY: Hello? As a walkie-talkie doctor, an internist, and
geriatrician, I can tell you that formularies probably have more of a
dictatorship, as I tell my patients all the time, that there care is
often dictated by formularies versus \-- and that being cost driven,
versus sometimes efficacy.

MR. SLAUGHTER: So I think Dr. Aikin has some data on that. When the
physician does not prescribe the drug. And I believe that the cost was
one of the \--

DR. AIKIN: Yes, for primary care physicians, they were more likely to
say that the reason they did not prescribe was because a less expensive
drug was available or it was not on formulary compared to specialists.

DR. ABRAMS: Okay. this is a question for Mr. Slaughter. But any panel
member may have information about this.

Often we focus on consumers who have not already been on a medication or
yet diagnosed with a certain condition. And I found it interesting that
one of your slides showed that 14 to 17 percent of the patients already
taking the medicine sought information about the drug.

In this instance, the decision has already been made to go on the drug
and to take it. I guess two questions. What kind of information were the
patients seeking? And any follow up to what effect this may have had on
their compliance or outcome?

MR. SLAUGHTER: Oh, okay. I think that the figure that you are referring
to is information seeking as it was motivated by a broadcast
advertisement.

And, you know, what we\'re seeing there is just this kind of fairly
constant overall effect that the broadcast advertising or \-- I\'m sorry
\-- in short, that there is a percentage of consumers who are motivated
to seek additional information from one of the secondary sources
mentioned in the broadcast ad.

And the primary reasons around that appear to be that they have an
interest in taking a medicine \-- interested in finding additional
information about a medicine that they have never taken before and that
about doesn\'t appear in our data. And may not exist in the kind of
strong way that some of us had thought that it did.

DR. ABRAMS: Nancy?

DR. OSTROVE: I\'ve got a couple of questions. Mr. Weissman, we\'ve heard
a little bit about concerns about risks and benefits. Did you ask the
physicians any questions about their perceptions of the patients\'
knowledge of the risks and benefits associated with the products?

Certainly you had an attitude question about doesn\'t provide
information about risks and benefits in a balanced fashion. Did you get
anything from them about what their perception of the patients\'
perceptions were? That\'s pretty complex.

MR. SLAUGHTER: The simple answer is no. (Laughter.)

DR. OSTROVE: And it took so long to ask it, too.

(Laughter.)

MR. SLAUGHTER: That\'s true. What you see is what we had. We asked those
questions. There were some positive aspects and it had to do with
information. But it is obviously their perception of what the patient
brings in. So I think indirectly you could probably interpret it in that
way.

DR. OSTROVE: Okay. And in other presentations, I\'ve seen you give,
you\'ve addressed the association between the perception of risk and
benefit information among consumers and reported behavior.

DR. WEISSMAN: Yes.

DR. OSTROVE: Is there something in particular that would be relevant to
the discussions that we\'ve been having here, especially as say it may
relate to either the brief summary or fair balance?

DR. WEISSMAN: Well, yes, Dr. Ostrove, I think that one of the things
that is more interesting, and certainly recurs often enough in the
analysis that we\'ve done, is that there does seem to be a persistent,
positive association between the presence of risk information in the
advertising and the likelihood that the consumers will, in fact, talk to
their doctor about an advertised medicine.

And in many cases, ask their doctor for that prescription. So I\'m not
going to say anything too strong about it but the conclusion or the take
away that we have in regard to this is that far from being a detriment
to the promotional capacity of the advertising, there seems to be a
beneficial effect to including risk information in the ads.

And may, in fact, increase the likelihood that the consumer will talk to
their doctor about the advertised medicine. And this is speculation now
but it may result in a better conversation between the two.

We also see this positive association popping up on the compliance side
where we asked consumers whether or not the advertising made them feel
better about the safety of the product. And we find that consumers who
have positive assessments of the risk information are, in fact, more
likely to say that the advertising makes them feel better about the
safety of the advertised drug.

Now I think that the implications for that start to be kind of
interesting because I\'m not sure, quite candidly, that the current
approach toward the provision of risk information is necessarily the
best one.

Well, the problems with the brief summary presentation, I think are
fairly obvious. You know the whole issue of mice type and unintelligible
language and those types of things are certainly ones that have to be
overcome.

But the other issue that I think might be worth exploring is the
provision of the risk information in broadcast advertisement. And I
don\'t think it is unfair to suggest that perhaps the presentation of
that risk information sort of treats all risk information the same.

And suddenly you are giving kind of the same weight to dry mouth as you
are to possible liver damage.

And so treating all drugs equally while it seems like it ought to be the
right thing to do on the surface, may, in fact, muddle the severity of
possible side effects because everything is treated in the same way,
insomnia and dry mouth versus more severe problems and more severe
warnings.

So I think we ought to pay attention to what information we give
consumers. And how it is provided to them.

DR. OSTROVE: If I can just follow up on that, Ms. Golodner, you had also
\-- you had in some of your recommendations, you had talked about using
some kind of a drug facts or other standard format for presentation of
information.

Do you have data that kind of led you in that direction particularly? Or
is this kind of based on other things that you have been involved in?

MS. GOLODNER: Just generally, that the \-- for instance, nutrition facts
has been just overwhelming supported by consumers. They use it. They
look at different products that they purchase. And certainly are more
aware of fats and calories in products, food products.

And I don\'t know if there have been any studies on the OTC label yet.
That\'s relatively new for consumers. But certainly it is a common
format for consumers.

And I should think it would fulfill some expectations that they might
have on being able to compare pharmaceuticals as well as seeing the
facts at hand immediately, what it is and what it will do for you.

MR. SLAUGHTER: We\'ve also looked pretty carefully at consumer use of
nutrition facts panel, the supplement facts panel, and the new drug
facts panel. And found in each of those sort of standardized formats
that underscore what Linda has said, that there does seem to be
significant improvement in consumer understanding and use of the
labelling when the standard format is provided.

DR. ABRAMS: Okay, we have time for one more question. Okay?

DR. TEMPLE: Actually I wanted to follow up on the answer to Nancy\'s
question.

All of these ads except reminder ads contain risk information. So, Mr.
Slaughter, when you said that people tend to go to the doctor more if
they see risk information, what did you mean exactly? If they are
impressed by it if it is horrible? Or something really bad? What drives
them in?

MR. SLAUGHTER: And, again, I\'ll be candid and say that a lot of this is
inferential. We\'re looking at an association in the data. Nevertheless,
that association has been fairly persistent. And so over time, we begin
to get a little more confident in it.

DR. TEMPLE: But can you say more about what the association \--

MR. SLAUGHTER: Yes, that\'s where I\'m heading right now. What we asked,
and we\'ve asked this in a number of different ways.

We asked consumers whether or not the ad has provided them with the kind
of information they need to have in order to talk to their doctor about
risk? And also the parallel question for benefits.

We also asked that question for how good a job the advertising did in
providing them with that information.

In both those examples, we find that consumers who say that the ad
provides them with the kinds of information they had are more likely to
talk to the doctor. That\'s somewhat of a self-fulfilling prophecy.

But on the other hand, we also see the same positive association taking
place where consumers say \-- consumers who say that advertising does a
good or excellent job at providing that information, are, in fact, more
likely to talk to their doctor.

DR. TEMPLE: So throw in some bad stuff. It looks like candor, right?

MR. SLAUGHTER: Well, I\'m not so sure it\'s that. I mean we have to
understand what has been really happening. I mean \--

DR. TEMPLE: I was just kidding.

MR. SLAUGHTER: Yes, I understand. But still it does beg the comment
which is part of the opening comments this morning had to do with
changes in the health care environment in the United States. That
consumers are becoming more engaged in their own health care decision.
And mostly, I would argue, out of necessity.

And in that mind-set, the inclusion of risk information gives them
additional information to have the confidence to have an informed
conversation with their physician about something that they know little
about in terms of having in-depth knowledge or expertise about the
subject.

I\'m going to feel much better about myself or I\'m going to feel much
more confident in my own ability to talk to my doctor about a medicine
if, in fact, I have a couple of things that might go wrong to ask him
about when I have that conversation. So that I don\'t feel sort of, you
know, uninformed or naive walking into this discourse.

DR. WEISSMAN: Also, I just wonder if I could just make one more comment
just about \-- because all of us are presenting research based on
surveys. And I know there has been some question about surveys and
methodology.

And I think that criticism seems to come from an unwillingness to
ascribe any of these actions or benefits or risks to direct-to-consumer
advertising. And at least our approach, myself and my co-authors, are
that any time there is three billion dollars spent on advertising, you
expect there to be some effect in terms of patients going to see their
doctors about something.

And then what we did was we used surveys to try and evaluate what
actually happens during those encounters. We found some benefits and we
found some things that may not be so good.

But on the whole, we felt that there were some benefits in terms of
improved, more diagnoses and about fairly important things. And we
didn\'t find that some of the things that people were afraid about which
is poor outcomes and a lot of attention paid to minor lifestyle
conditions.

DR. ALLISON-OTTEY: May I make one comment briefly? I think to, you know,
one thing that has to be said that I\'ve said a lot about these surveys,
please if this has an educational benefit or an awareness benefit and
brings the patient to my office, allow me then to be the physician.

Certainly looking at health literacy and the whole statement, the
average doctor cannot read and decipher all of the stuff on risk
benefits. But certainly we have to look at doctors being able to
communicate with their patients risk and benefits and allow the
advertisements while they may increase awareness, allow the doctor to be
the doctor.

It is my job to talk about positive aspects of a medication, if it is
efficacious, if you need it, and what the risks and benefits are in
layman terms or patient terms. Because I get the call at midnight. So I
think that has to be on the table. Allow the docs to be the doc.

DR. ABRAMS: Okay. I\'d like to thank the presenters. We had a real good
morning with great presentations. And questions and answers sessions.

We\'re going to break for lunch now. There are a number of
establishments upstairs serving food. We\'re going to reconvene at 1:30
for our two afternoon panels.

(Whereupon, the foregoing matter went off the record at 12:16 p.m.)

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

(1:37 p.m.)

MS. CUNNINGHAM: Okay, if everyone would please take their seats, we\'re
going to start back up so we can try to keep on time. Thank you.

DR. ABRAMS: Okay. Our next panel is here. Hello? Our first presenter
will be Julie M. Donohue from Harvard Medical School.

DR. DONOHUE: Good afternoon. I\'ll be presenting results from a study
funded by the Kaiser Family Foundation. This research addresses the
first question posed in the [Federal Register]{.underline} notice for
this meeting which is what is the effect of DTC advertising on consumer
and physician behavior and on public health? And I\'ll be looking at
what\'s going on in the antidepressant class specifically.

Let me start by putting this research in context. Obviously you heard
from all the survey researchers this morning that DTC works, that it
increases demand for prescription drugs. I think Ed said 15 million
people have seen their doctor about a drug they\'d seen advertised and
have gotten a prescription.

We also know from economic studies of DTC that it increases demand for
prescription drugs. A recent study by Meredith Rosenthal and colleagues
looked at demand for drugs in five classes and found that for a ten
percent increase in DTC spending, there was a one percent increase in
sales.

The weight of evidence to date suggests that the effect of DTC is at the
class level rather than at the individual product market share level. In
other words, DTC seems to increase the size of the pie and doesn\'t
significantly alter any drug\'s particular share of the pie. For this
reason, we may expect to see higher DTC spending among market leaders.

What we don\'t know about DTC advertising is the impact of this
increased demand on public health. And Dr. Woodcock raised a number of
issues that I\'ll just highlight again.

We don\'t know the extent to which DTC advertising is expanding
treatment for under-diagnosed conditions like depression, hypertension,
and high cholesterol. A related question is are these new prescriptions
appropriate?

Do the individuals have the condition for which the drug is advertised?
Or perhaps a less severe condition for which an over-the-counter
medication or a lifestyle change may suffice? We don\'t know the answer
to that question yet. And it deserves more work.

Another question is \-- and the extent to which these new prescriptions
are appropriate has implications for cost effectiveness of treatment
certainly but also for patient safety to the extent that the advertised
medications have some fairly significant side effects.

Another question related to the impact of DTC on public health is the
impact of DTC on adherence or compliance to medication therapy, which we
know is a really significant public health problem for chronic
conditions.

I\'ll be looking at these issues for people with depression and people
taking antidepressant medications. For a couple of reasons, we know a
lot about how to treat depression. National treatment guidelines have
been in existence for over ten years. Efforts have been made to
disseminate them widely. And yet there is a significant gap between what
we know how to do for depression and what actually gets delivered.

Only about half of people with depression receive any treatment at all.
And those who are treated seldom receive the proper dose or duration of
treatments so there are some real quality of care issues. And there is a
significant disease burden.

As many of you know, there has been a dramatic increase in the number of
people receive antidepressant medication over the last ten years. We
were interested in knowing to what extent DTC contributed to this trend.

Basically we\'re looking at a couple of questions. Does DTC advertising
effect whether someone initiates medication therapy for depression? Does
DTC advertising influence their duration of treatment? Because we know
that a lot of people drop off of antidepressant treatment prematurely.

And finally, does DTC advertising effect choice of antidepressant? And
for this question, we looked at all users of antidepressants, not just
people who receive a diagnosis of depression.

We looked at use of six commonly used antidepressant medications over a
four-year time period. As you can see, there is a great deal of
variation in use of DTC advertising by these medications. Some of our
study drugs spent nothing on DTC during this time period. And the ones
that did really varied with respect to the level and duration of their
DTC campaigns.

And our analytical strategy relied on linking this temporal variation to
changes in treatment patterns observed at the individual level. So that
if, you know, the argument is that DTC is really increasing access for
people with depression to treatment, we should see an increase in the
number of people filling prescriptions for antidepressants following
these periods of high DTC spending.

Likewise, if there is an impact of advertising on adherence to
medication therapy, we should see people staying on their medication
longer following these periods of high DTC spending.

We used data from four sources. The DTC spending data were monthly data
and they came from Competitive Media Reporting, which I think is the
only source of data on this issue.

We were also interested in looking at the effect of promotion to
physicians so we obtained data on detailing spending for these six
medications from Scott-Levin. We obtained data on the units of free
samples of antidepressants dispensed to physicians offices from IMS
Health.

And the individual level data came from Medstat\'s MarketScan database.
This is a claims administrative database that has the medical and
pharmacy claims, roughly 30 large employers who contacted with about 100
health plans over this time period. It is the pharmacy claims for about
five million covered lives.

We looked at spending over the time period. We looked at the effective
class level DTC spending on the initiation of medication therapy for
depression.

We compared people who were diagnosed during periods of low DTC
spending, less than 2.6 million dollars to spending in other quartiles.
And we wanted to see what was the probability of receiving drug
treatment for people in these various levels of DTC spending.

We found that people who were diagnosed following periods of high DTC
spending, over 18.5 million dollars in cumulative DTC spending, were
five percentage points more likely to receive medication therapy for
depression when compared to people diagnosed during periods of low DTC
spending of less than 2.6 million dollars at the class level.

When we looked at the effect of the availability of free samples, we
found no effect on whether or not someone initiated medication therapy
for depression. There was less variation in free sample spending over
this time period so it\'s more difficult to find an effect.

We also looked at the impact of DTC on duration of treatment. And for
this analysis, we allowed for people to be effected both by advertising
for the drug they were taking and for advertising for all other drugs in
the class. Again, we divided spending into quartiles.

Own DTC spending appeared to have no effect on the duration of
treatment. We defined duration, the proper duration of treatment as
getting four months of antidepressant treatment.

Others DTC spending, spending at the sort of total class level for other
antidepressants did have some effect. So that people who were diagnosed
during periods of high DTC spending, over 21.8 million, were about a
half a percentage point more likely to stay on their medication for the
appropriate duration of time when compared to people diagnosed during
periods of low DTC spending.

Looking at the impact of DTC spending on drug choice, when we looked at
everybody who filled a prescription for an antidepressant, DTC there was
no link between drug spending on DTC and its probability of being chosen
for a given individual after controlling for all kinds of things known
to effect drug choice: characteristics of the medications as well as of
the individuals.

When we limited the sample to people with anxiety disorders, DTC had a
small effect on drug choice. This isn\'t surprising given the fact that
anxiety disorders have been a major focus of some antidepressant
advertising campaigns.

On the other hand, detailing had a significant and positive effect on
choice of antidepressant. Drugs with the highest level of detailing
spending were roughly twice as likely to be chosen compared to drugs
with low detailing spending.

Again, this is controlling for drug characteristics like the amount of
time on the market, out-of-pocket price faced by the individual, other
drug characteristics known to drive choice of drug.

In sum, DTC advertising appears to effect whether someone receives
medication treatment for depression while detailing effects what
medication they receive. DTC clearly increased the number of people
receiving drug treatment for depression. And it had a very small impact
on treatment duration, a positive impact.

We found no effect of detailing or free samples on whether someone
initiated medication therapy or stayed on medication for the right
duration of time. But detailing did have a significant effect on drug
choice.

The implications for public health? I think DTC does have some public
health benefit, at least for this class of drugs. But the question
remains, and this is not an issue that we were able to look at with our
data, whether the new prescriptions were appropriate or whether they
represent overuse. That\'s something that is rather difficult to look at
with claims data.

DTC had little impact on \-- a very minor impact on adherence to
medication therapy. But, again, more work needs to be done in this area.

I\'ll just conclude by reiterating the fact that this is a difficult
area in which to do research, that I think the best approach is to use
lots of different methodologies, survey research, the kinds of analyses
that you\'ll hear about this afternoon. And this is just one piece of
that.

Thank you.

DR. ABRAMS: Thank you, Ms. Donohue. Our next speaker is Dr. Robert
Dubois from Zynx Health Incorporated.

DR. DUBOIS: Good afternoon. Well, from a clinical standpoint, there are
really two potential competing theories. The first is that DTC increases
unnecessary use of medications. It drives patients into the doctor\'s
office, asks for certain medications. The patient ends up on stuff that
they don\'t really need. That would be inappropriate.

Alternatively, that promotion leads to greater disease awareness. The
patient comes to the doctor. They have diseases treated that otherwise
would not be identified. And, in fact, variation in treatment is
reduced. This would be a good thing.

What I\'d like to do is basically to begin to look at is this an issue
of education or an issue of misleading folks. And to share some data in
a couple of different research arenas to do that.

And really to get at the question, I think, that has been raised a
couple of times this morning is from a clinical standpoint, what is
happening to the appropriateness of use.

Is it appropriateness of use getting better? Is appropriateness of use
getting worse? And really peel in from a clinical standpoint to do just
that.

And what I\'d like to do is really talk about two different research
arenas. One is in the area of statin therapy for patients with
cholesterol elevations.

If, in fact DTC is misleading folks, misleading doctors and misleading
patients, then you would expect A) there would be lots of inappropriate
use; and B) that there would be a temporal association between greater
DTC spending and greater inappropriate use of statins. So that would be
the first research I\'d like to touch upon.

The second is that there is a major tenet of quality assurance is that
variation is bad. That geographically if things are done differently in
one part of the country than another, this probably isn\'t good if
different patients, if similar patients are treated in very different
ways.

So one of the questions that had not previously been addressed is how
much geographic variation in the use of medications is there? And how
does that compare to the use of medical and surgical procedures? And
does this link back to promotional efforts?

So those are the two different things I\'d like to address.

The first is the statin research studies. This is a slide that basically
looks at the use of statins over the course of a number of years. And
the line that goes down the middle is basically when the promotion began
to increase.

So the question would be is there a significant difference in the rate
of appropriate use of statins prior to that line and post that line? And
that\'s what I\'d like to address.

To do that, we developed a set of criteria for what is appropriate. And
this was built upon the NCEP criteria and basically ended up with seven
levels of appropriateness. Level No. 1 is the most appropriate use of
the statin, working your way down to No. 7 which is the least
appropriate approach.

We then took those criteria and applied them to a group of patients who
were receiving this therapy, administrative data, claims data.

And then tried to ask the question after statistical adjustment, did the
rate of appropriateness change over time? The theory would be that there
tended to be more numbers of patients that were inappropriate candidates
that were on these drugs. That would be the theory.

This is the hierarchy which basically says that the highest, most
valuable, most cost effective use of statins are in patients who
currently have cardiac disease. They\'ve either had a cardiac event or
they have vascular disease that suggests they have serious
atherosclerotic problems.

Or working your way down the hierarchy, they have diabetes so they are
at great risk, or they have multiple risk factors for cardiac disease.
Working your way down to only a single risk factor or no apparent risk
factor, just a designation of hypercholesterolemia or there is nothing
in the data that would explain why the patients are on statins.

So this is basically the hierarchy that helps us to understand what
would be appropriate or inappropriate use.

This was the one time frame which basically shows the distribution
across appropriateness levels. There is a lot of data here which you can
ignore. The important thing is sort of No. 6 and No. 7. Those are the
people who apparently have very little, if any, reason for being on
statins.

No. 7 we could find no reason about those individual patients as to why
they were on statin therapy and category 6 were patients who had no
particular reason other than hypercholesterolemia.

But, of course, the important question is what happened next? What
happened next is over the two time frames, 1997 and 1999. There was a 60
percent increase in the number of patients using statins. So a lot more
patients began to receive therapy.

So now the question is did this added number of patients change the mix
of appropriateness? And specifically, were there more patients who
really didn\'t need the therapy or appeared not to need the therapy?

What we observed was no statistical difference. That between 1997, sort
of when DTC spending began to ramp up in a big way, and 1999, there was
no statistical difference across the appropriateness categories.

So at least for this drug class, and I have to underscore this drug
class, basically there was no difference associated temporally when
there was significant amount of DTC spending.

Obviously, this needs to be done in other areas so we can have a better
sense whether this was unique to one class or whether this was
generalizable. But the concept of applying appropriateness criteria over
time and seeing what happens, I believe is a productive way to begin to
look at this.

The second study I\'d like to touch upon looks at the issue of
geographic variation. There has been significant data over the last
number of decades that there is wide geographic variability in the use
of surgical procedures.

The likelihood of having your tonsils removed or having back surgery or
having bypass surgery varies from town to town significantly. And it
varies across the country significantly. Four fold variation, eight fold
variation, ten fold variation.

It has been a tenet of quality improvement that when you see variation
in care, similar patients receiving different approaches to management,
this can\'t be good because patients, if they have a common presentation
and there is evidence to support what works, should all be getting the
same thing.

So what wasn\'t known is how much variability there is in medications.
Is there more variability? Or less variability compared to surgical
procedures? And does this tell us anything about promotion and what that
might have had an impact of?

Again, this was a database built around claims or administrative
information. This was done in California. We brought together
administrative data from three of the largest health plans, had about
600,000 patients in it, a variety of different health plan types, HMO
and PPO, a variety of different drug benefit designs.

So we had a diversity of ways of looking at patient populations. And in
addition, we had both a medication observation as well as surgical and
medical procedures so we could do some one-to-one comparisons across
them.

What did we find? What we found was that rather than seeing four to
ten-fold variability or 400 percent to a thousand-fold variation for
procedures and medications, in the area of medications, we found only 30
to 40 percent or about one-tenth of the variation that one would
normally see in surgical and medical procedures

As an example, 49 percent or so of patients with asthma received an
inhaled corticosteroid, sort of the mainstay of therapy for patients who
have relatively mild or moderate disease.

And this varied from the highest-use areas that had 59 percent of the
patients down to the lowest-use areas, which is 40 percent. Which is
really a very, very narrow variation from community to community within
California. We divided California into 11 different regions.

But we looked at multiple different drug classes. We looked at multiple
different surgical and medical procedures to begin to look at this
issue.

And what we observed was, and this is the measure here on the y axis is
what is called co-efficient to variation. It\'s the standard deviation
divided by the mean. But suffice to say that the higher the number means
more variation from town to town, lower number means less variation.

And what we found was, as you can see, the medications on the left-hand
side was much less variability from town to town about the likelihood
that a patient with that condition would have that drug given to them
versus the procedures where there was much greater variability.

Now, again, this study was done in the latter part of the 1990s in terms
of when the patients were receiving the data. The interesting thing was
if we looked at one drug class, one of the drug classes had a
significant amount of variation and that was COX-2 selective inhibitors
which, at the time, was a relatively new drug. It pretty much had just
come out on the market.

One could then begin to envision that that was before any type of
promotion either to the doctor or the patient took hold. We haven\'t
repeated the study. The fascinating question would be is there less
variability over time with COX-2 inhibitors after they were on the
market for a longer period of time.

Now what does this mean? The fact that there was low variation from town
to town in medications, of course doesn\'t answer the fundamental
question, yes there is less variability but does this mean that all the
patients were getting the proper care? Or all the patients were getting
improper care?

What we observed was they were all getting similar kinds of care. So
obviously this study alone doesn\'t answer the question. Linking it back
to the statin study might help us to understand that.

The low variation could have been a phenomenon of managed care. It could
have been a phenomenon of something that was unique to California. It
could have been that these were clinical areas, although we studied lots
of clinical areas, where there wasn\'t any uncertainty.

The theory is that where there is uncertainty on the evidence or
consensus, there is wide variation on what doctors do.

On the other hand, if it\'s absolutely clear if you have a ruptured
appendix, that you have to have your appendix out, then there is very
little variability. And maybe we just miraculously chose only the areas
with lots of certainly. I don\'t think that was the case.

It could be that the drug arena is different from the surgical and
medical procedure arena in that the FDA requires more drug studies than
is available for back surgery. So that doctors have a stronger database
upon which to make their decisions, therefore less variability. And a
variety of other things.

Or it could be that the pharmaceutical industry in its promotion to
doctors or patients educates people so again there is less variation in
care. So there is a variety of different possibilities for low
variation.

Let me summarize by saying that despite significant pharmaceutical
promotion, we didn\'t observe any changes in appropriateness in the
statin area. Again, it\'s one drug class. We need to look at other drug
classes.

We did observe significantly less geographic variation in use of
medications and for the use of procedures. And obviously our research
was limited by the fact that we have only looked at a small number of
classes and there is more that needs to be looked at.

So where does this all go? It is my belief that the approach to
promotion cannot be done unfortunately at a high level. It\'s good.
It\'s bad. We should do more of it. We should do less of it. We should
have certain constraints. We shouldn\'t.

Unfortunately from a clinician standpoint, it\'s not that easy. It\'s my
belief that it has to be taken down to the drug class level. Which means
if there are drug classes where there is tremendous consensus,
tremendous evidence of what works \-- if you have asthma, inhaled
corticosteroids are a good thing for you.

If you\'ve had a heart attack, you really need beta blockers. From my
belief, I don\'t who care gets the message out there. It could be the
drug companies. It could be NIMH. If it\'s depression, it could be NHLB.
I don\'t really care. Beat the drums. Get the patients to the doctors.
Get them under therapy.

So if there is consensus, then promoting by whatever means I believe is
a good thing. On the other hand, if you are dealing with a drug where
there isn\'t consensus or there isn\'t strong evidence about which
patients absolutely need this specific therapy, then what happens I
think with greater promotion is you get more patients on the drug, more
patients who probably really, really need it, and some patients who
probably are of equivocal needs for it.

So unfortunately, as much as it would be nice to say we can have a
general approach, my fear is that it really has to be taken at the drug
class level. Now you probably can\'t mandate things at the drug class
level but you could mandate things at the level of evidence level.

So that there is a certain category that if you have this amount of
evidence to support it, X number of randomized control trials,
head-to-head comparisons, comparisons versus less expensive therapy, a
consensus panel that says yes there is consensus on this, then maybe DTC
or promotion is something that is widely supported.

On the other hand, if you have an area which doesn\'t need a certain
threshold of evidence, then there might be a slightly different policy
approach.

That might be something that is doable relative to saying yes we do one
thing for one drug class or something else for a different drug class
which probably would not be effective or not be a policy that could be
supported.

On balance, I would say don\'t throw the baby out with the bathwater. I
think there is good there but it needs to thought about from a clinical
standpoint and from a drug class-specific standpoint to get the full
effect.

Thank you.

DR. ABRAMS: Thank you. Our next speaker is Barbara Mintzes from the
University of British Columbia.

DR. MINTZES: Hello, I was very interested in the discussion at the end
of the last session which I felt was a bit of a lead in to my talk in
that I am going to be presenting about a \-- I don\'t know why my slide
isn\'t up actually \-- about a comparative survey in a U.S. city and a
Canadian city. And looking at consultations that were and were not
effected by DTCA.

And this was carried out in collaboration with colleagues from the
University of British Columbia, University of California at Davis, and
also York University in Toronto. And it was funded by Health Canada,
which is the Federal Department of Health in Canada.

It\'s the \-- there are two publications out of this study. The [British
Medical Journal]{.underline} published a very summarized report of key
findings in February 2002. And just earlier this month, the [Canadian
Medical Association Journal]{.underline} published a much more detailed
report.

Okay, so one of the differences between prescription drug advertising
and other advertising of products directed at the public is that the
person that the ad is directed to cannot simply go out and buy the
advertised product. They have to \-- for ads to translate into sales,
patients must go into their physician\'s offices and request
prescriptions.

And so one of the messages in direct-to-consumer advertising which is
ubiquitous is the message to go and ask your doctor about this product.
And in some cases, as in this example, to ask your doctor for a free
sample.

Now we did a comparative cross-sectional survey in physician\'s offices
in two direct-to-consumer advertising environments. Sacramento, a U.S.
city in which there is legal direct-to-consumer advertising, and in
Vancouver, a Canadian city where direct-to-consumer advertising is
illegal but there is cross-border exposure from the U.S.

We recruited primary care physicians to participate in the study for two
days each. And consecutive patients were enrolled in the waiting room,
adult patients, English speaking.

Patients filled out a questionnaire while they were in the waiting room.
And we asked about exposure to advertising \-- actually, the
questionnaire was geared much more on patient information on medicines.
So we asked about advertising within the context of questions about a
range of information sources.

And we also asked about reasons for the visit, demographics, and what
their expectations were out of the visit. The physicians filled in a
very brief questionnaire about newly initiated prescriptions and for
each newly prescribed drug, whether or not the patient had requested it.
We also asked them about any drugs the patients had requested that were
not prescribed.

So why this design? And we had a bit of this conversation, I think, in
the last session. To be able to compare prescriptions that were
requested by patients to those initiated solely by the physician.

So the aim there was to tease out the prescriptions that were initiated
in response to direct-to-consumer advertising as compared to, for
example, prescriptions for the same medication that would have been
initiated completely by the physician.

And then also to compare those consultations with other consultations to
be able to adjust for other individual factors like age, and health
status, income, et cetera, that influence care-seeking behavior. And
because we were looking at specific consultations, then to try to
minimize recall bias.

And the design was very similar to the design of studies that have been
carried out looking at influences on physicians, for instance,
prescribing antibiotics. And also on the influence of physicians
perceptions of patient\'s desire for medicines on prescribing choices.

So we wanted to know whether patients in Sacramento would report more
exposure to advertising, request more medicines, and receive more
prescriptions in response to requests than similar Vancouver patients.
And we also wanted to know about the effect of individual exposure in
both settings.

The questions for physicians were how likely a physician is to prescribe
an advertised medicine that a patient requests.

And then how likely physicians were to judge a prescribed requested drug
to be a possible or unlikely treatment choice for other similar patients
with the same health condition as compared to a very likely treatment
choice. And in doing so, we were trying to get at physician confidence
versus ambivalence in treatment choice.

So there were 78 physicians participated in this study, around half in
Sacramento, half in Vancouver. And there were 1,431 patients.

There were some differences in characteristics of the physicians, as
you\'ll see, very major difference in the proportion who were working on
a fee-for-service basis. Also there were more male physicians in the
Sacramento sample.

The patients were very typically of primary care patients about
two-third female. And the age distribution and reported health status
was quite similar. And in both settings, they tended to be higher than
average income and education and higher proportion of European decent,
caucasian, than the cities as a whole.

So what did we find? In Vancouver, nearly nine out of ten patients had
seen ads for prescription drugs. However, there was certainly a
difference when you asked about individual products in the proportion of
people who had seen ads for either half of six listed products or who
had seen ads for specific products.

And what we did is we chose \-- we actually listed seven products, the
seventh was Claritin. But Claritin had over-the-counter status in Canada
at that time and prescription only status in the U.S. And that was the
only product for which the advertising exposure did not differ
significantly.

So these, Viagra and Propecia is just to give you an example of
differences with a drug that lots of people had seen ads for versus one
that not many people had seen ads for.

We measured whether patients used advertising as an information source.
That was a measure of whether they had checked off ads as one of the
influences on a decision to see the doctor, they belief they thought a
diagnostic test was needed, or the belief that they thought a medicine
was needed.

And also whether they listed that advertising as an information source
that \-- or a preferred information source, first or second choice. So
it had to do with whether ads were checked off among other information
sources on the questionnaire.

And there was also a difference, about 2.7 \-- people from Sacramento
were nearly three times as likely to list ads as an information source.

The other question that we asked was whether people had a condition that
was treated by an advertised drug. And about ten percent more patients
in Sacramento said that they did.

So in terms of the requests for medicines, because we were collecting
information about every prescribed drug, so we were collecting
information about all of the patient requests and then used the
basically Competitive Media reporting-based data that had been published
by the National Institute for Health Care Management. Then also more
recent data on ads from Videomonitoring Service in order to construct a
list of products for which we could find evidence of advertising.

And then classified the products that people had requested as advertised
or non-advertised drugs. In the single consultation then, in Sacramento,
15.6 percent of patients requested a medicine from their doctor and 9
percent of Vancouver patients.

Now as a subset of these, 7.2 percent of patients requested advertised
drugs in Sacramento and 3.3 percent in Vancouver. And the differences
were highly significant after adjusting for other factors such as age,
sex, health status, income, education, and drug payment that might have
been related to the decision to request a drug.

Now this is looking at the number of listed products that \-- among the
list of products that we had, which was indicative only, we weren\'t
trying to get at all a large list of all of the drugs that were
advertised, we were able to then break people into higher-lower
exposure.

But just looking at the number of yeses that they had seen advertising
for specific drugs and the likelihood of people requesting that drug, as
the number went up, the likelihood \-- you know, there was a strong
correlation between the self-reported advertising exposure and the
likelihood that a person would request a drug.

And that was true as well for patients who had used advertising as an
information source and also who identified themselves as having a
condition treatable by an advertised drug.

So how likely were physicians to prescribe the drugs that patients
requested? Now for drugs \-- if any requested medicine, whether or not
it was advertised, 80 percent of the time patients in Sacramento walked
out of the consultation with a prescription for that drug.

In Vancouver, it was lower, 63 percent. But the difference was no longer
significant after adjusting for other, you know, for patient and
physician characteristics.

The proportion who received a prescription was much more similar for
advertised drugs, about three-quarters in both places. So the other \--
I\'ll just go a bit more quickly. I mean how does this relate to
prescribing in general in the two groups?

There was a higher rate of prescribing in the Sacramento sample than in
the Vancouver sample, which was marginally significant when looking at
new prescriptions and refill prescriptions together. It was attributable
much more to the newly initiated prescriptions.

If you then just take aside the people who had requested advertised
drugs and look at how likely they were to walk out of that consultation
with a prescription, they were much more likely than people who did not
request a medicine. In fact, nearly nine out of ten such patients
received at least one new prescription in the consultation.

And, you know, what that would suggest is, I think similarly to some of
the other research that has been done, that there could be an effect on
prescribing volume as well as specific products.

So then in terms of physicians\' confidence in treatment choice, whether
they judged a medicine to be a possible or an unlikely choice versus a
very likely choice for other similar patients, if the patient did not
request a medicine, in about one out of eight cases, so about 12 percent
of cases, the physician still said that he or she thought it was a
possible or unlikely choice for other similar patients.

If they requested a DTC advertised drug, it was 50 percent of cases for
the sample as a whole that the drugs were considered to be a possible or
unlikely choice. So it was a very large difference in terms of how
likely physicians said that they would be to prescribe the same drugs to
other similar patients.

We also looked at pressure to prescribe and I found the findings in this
study quite interesting compared to the findings of the FDA in that we
found a lot less pressure to prescribe reported overall as compared to
the FDA survey.

I mean this is different in that its multiple consultations with the
same physician rather than each physician saw approximately 20 patients
rather than it being one report per physician. But in terms of all
surveyed consultations, pressure to prescribe was reported in only three
percent of cases.

If a prescription had been provided, which is probably the appropriate
consultations in which to measure pressure to prescribe, it was around
six percent of the time that a physician reported pressure.

If a requested drug \-- so going down, these are all subsets of the row
on top in here. If a patient had requested the medicine, any medicine
whether or not it was advertised, around 16 percent of the time the
physician reported pressure to prescribe. And in consultations in which
a requested advertised drug was prescribed, 21 percent of the time they
reported pressure.

Now I should mention that most of the non-advertised drugs that were
requested were from classes such as antibiotics, benzodizepines,
analgesics which have been associated with inappropriate prescribing and
pressure to prescribe. So just in terms of implications.

If DTCA opens up a conversation between doctors and patients, out
findings would suggest that that conversation is highly likely to end
with a prescription, often despite the physician\'s ambivalence about
treatment choice. And the greater the exposure to advertising, the more
likely such a conversation will occur.

We certainly \-- I would have concerns about claims that the patient is
protected because a prescription is needed if physicians are prescribing
the drug that a patient requests three-quarters of the time. And
overall, the results suggest a negative effect on prescribing
appropriateness.

Now the study has limitations in that it is a cross-sectional survey
based on cluster sampling at a single point in time. You can\'t assume
broad generalizability and the patient population was higher than
average income and education. And also it would be impossible to control
for all U.S. and Canadian cultural and health system differences.

The strengths of the study were that it was possible to look at the
relationship between exposure requests and prescribing and that these
were similar in two different settings with very different health care
systems.

And that also it was a direct survey of patient-physician consultations.
And that because we were able to compare consultations effected by
direct-to-consumer advertising with consultations that had not been
effected, it was possible to look at the direction of effect of
direct-to-consumer advertising.

Also our findings were consistent with the increased proportion of
promotional expenditures going into this form of marketing. And with
some of the claims that are being made by advertising companies in order
to attract their pharmaceutical industry clients.

Thank you.

DR. ABRAMS: Thank you, Ms. Mintzes.

Our next speaker is Dr. Petra Schultz from the Mayo Clinic.

DR. SCHULTZ: First I would like to thank you all for the opportunity to
be here this afternoon. And I do want to take just one moment to clarify
my position versus where I was when this research was conducted.

I am currently with the Mayo Clinic and St. Luke\'s Hospital in
Jacksonville, Florida. I am the Coordinator of Therapeutic Policy
Management and Drug Information there. However, at the time of this
research, I was a resident in drug information practice at Shands
Jacksonville in Jacksonville, Florida. So there is the disconnect.

I\'m going to try to be brief in terms of background on
direct-to-consumer advertising because I think we\'ve already heard a
lot of it this morning. But I do want to take us back to the data that
were available in 1999 when this study was conducted.

You know since the release of the 1997 draft guidance for broadcast
adverting, the pharmaceutical industry has increasingly relied on
direct-to-consumer advertising to promote demand for prescription
products.

It\'s rare to get through a day where we and our patients are not
exposed to some type of an advertisement be it on television, on the
radio, or in the print media. And I think we\'re actually seeing that
expanded into some other realms as well now.

And in March of 1999 there were actually 40 brands marketed on
television and 100 brands marketed in the print media.

Now there are both positives and negatives to prescription drug
advertising. We do feel that it serves to educate patients with the hope
that a more informed patient will be able to made educated decisions and
become more compliant and responsible in terms of their health care.

Direct-to-consumer advertising does serve to promote product awareness
but I think in the end, we all have to remember that advertising is
intended to sell a product. And as ads may promote the use of new and
expensive brand name drugs over less costly and possibly safer drugs,
that leaves the potential consequence of inappropriate medication use.

The data that I had on spending at the time of the study goes back to
1996. There was an estimated 800 million dollars spent on
direct-to-consumer advertising. 1997 comes with the guidance and by
1998, spending was at an increased 1.3 billion dollars.

At the time of this study, 905 million dollars had been spent in the
first six months of the year. The information that I was able to pull on
prescription drug sales at that time showed a corresponding increase.

Sales in 1996 were approximately 72 billion dollars and increased to 94
billion dollars in 1998. Now this is probably a combination of not only
increased utilization of prescription medications but also an increased
cost of drugs.

As direct-to-consumer advertising increases consumer demand, health care
organizations are faced with the challenge of providing the most
effective and cost effective therapy possible.

Which leads me to the objectives of the study that we conducted at
Shands Jacksonville. We really wanted to determine the impact of
direct-to-consumer advertising on our patient population and our
prescribers.

And within that, we wanted to determine if our patients were actually
being exposed to the advertising \-- and I\'ll characterize our patient
population in a moment and why that is different than the general
population.

We wanted to determine the impact that direct-to-consumer advertising ad
on patient demand. And then finally to determine the impact on any
prescribing differences that we could see.

As I mentioned, the study was conducted at Shands Jacksonville in 1999.
Shands Jacksonville is a 760-bed private not-for-profit teaching
institution with general and specialty ambulatory clinics. It is a major
affiliate and the urban campus of the University of Florida Health
Science Center, located in Jacksonville, Florida.

Shands serves a largely indigent population within Jacksonville. It
contracts with the City of Jacksonville to provide care for all indigent
patients. And a large majority of the patients seen there are actually
offered prescription medications either at a reduced cost or free of
charge.

Shands does utilize a closed formulary system in an effort to contain
costs and also balance appropriate therapy. So adherence to that
formulary system is very important to the appropriate allocation of
their very limited resources.

This study was conducted as a two-part survey. One, a survey of patients
seen in either the Internal Medicine Ambulatory Clinic or the Family
Medicine Ambulatory Clinic. And then the prescriber survey was done for
physicians or any prescriber, which included physician assistants and
nurse practitioners also in those same clinic areas.

The patient surveys were distributed at clinic visits and the prescriber
surveys were distributed during noon conference and grand rounds
presentations.

To start with some patient demographics, our survey was completed
predominantly by female patients. We had 65 evaluable surveys, although
the first two slides you are going to see some missing information in
the demographic section.

Most patients reported an age between 50 and 59 years. And still a large
percentage left it blank. But into the information that we gained from
this, the majority of our patients, three-quarters reported that at some
point they had seen or heard some type of advertisement for prescription
drugs.

Of those exposed, approximately half reported that that advertisement
had made them want to try the medication.

And again of those patients who were exposed to some sort of
direct-to-consumer advertising, approximately one-third reported asking
their physician for a prescription and 91, excuse me, 65 percent of the
time those patients actually did receive a prescription. There\'s the 91
percent \-- 91 percent of the time that they received a prescription, it
was actually for the medication that they asked about.

For the prescriber portion of our study, the majority of the respondents
were internists followed by family medicine practitioners and we did
have some retired attending physicians in the audience in the well who
got our survey. The population was primarily residents and interns
within the first five years of practice.

This question we put in here kind of for our own curiosity not so much
to determine if direct-to-consumer advertising had an impact on their
prescribing directly but just to see if they had, themselves, been
exposed. Ninety-six percent did, indeed, report that they had been
exposed to some type of a direct-to-consumer ad for prescription
medications.

Nearly 90 percent reported that they had been asked by a patient to
prescribe a medication that they had seen in an advertisement. And while
the majority of the respondents did report less than ten times or less
than ten patients who had asked them, I think that some of this can be
related back to the relatively young practitioners that took part in
this \-- in the residency program at Shands.

During our physician survey, those who reported having been asked by a
patient to prescribe a medication based on a direct-to-consumer ad, 52
percent of the prescribers reported prescribing the medication at least
some of the time when the request was prompted by a patient.

And the majority reported that most of the time, they would have
prescribed the medication regardless of a patient request with slightly
greater than one-third reporting that rarely would they have prescribed
it.

One of the things that was interesting to me in these results are the
fact that none of the responders reported that they always would have
prescribed that medication regardless of a patient request.

So for a summary of what we found in Jacksonville, we did find that the
majority of our patients or the patients that were surveyed had been
exposed to some type of direct-to-consumer advertising. We weren\'t
really sure what to expect with the population focused there.

Greater than half were actually interested in trying a medication that
they saw in an ad. And about a third actually went to the next step and
asked for that prescription.

Most of the prescribers surveyed had been asked by a patient to
prescribe a medication seen in an advertisement and a majority of those
prescribers actually prescribed a medication at least some of the time.

And finally, although it may not be a significant \-- or it wasn\'t too
a significant extent, I do think that what we saw out of this was that
patient requests for medications based on direct-to-consumer advertising
were actually impacting prescribing by some of the physicians.

So where does this leave us? And as a pharmacist, this is near and dear
to my heart because I think that we have the potential to continue to
provide objective drug information to both consumers and other health
care professional and promote the appropriate and cost effective use of
medications.

Thank you.

DR. ABRAMS: Thank you, Dr. Schultz. We will now take questions from the
FDA and the presenter panels.

MS. CUNNINGHAM: And just a reminder, please speak into the microphone.
This helps with the transcription. And make sure your button is up.
Thank you.

DR. ABRAMS: Peter?

DR. PITTS: A quick question for Dr. Schultz. What percent of your
patient base in the survey were indigent?

DR. SCHULTZ: We didn\'t specifically look although it would have added
some to it. We didn\'t access their financial records. This was actually
approved by our IRB with an expedited review. And looking into patient
financial records probably would have slowed down that process
immensely.

DR. PITTS: But what percent of the overall care is indigent are?

DR. SCHULTZ: I would estimate greater than 50 percent, probably less
than 70. And it\'s changed a lot from 1999 until now although I\'m not
still there.

DR. TEMPLE: This is for Dr. Mintzes. The \-- your slides aren\'t
numbered \-- the critical slide, it seemed to me, that led to one of
your conclusions was the one that gave physician confidence in treatment
choice. Can you say a little bit more about what was asked there?

The heading says the medicine was judged to be a possible or unlikely
choice versus a likely choice for other similar patients. And in both
Sacramento and Vancouver, even where the patient didn\'t request the
treatment, they thought 12 to 13 percent of their treatments were in
that category, which makes you ask why did they prescribe it.

And then what did they \-- do you have any idea what they meant when
they said it wasn\'t a good choice? Was that a cost consideration or did
they actually give a person a drug they shouldn\'t have gotten? And
admitted it? What was going on there?

DR. MINTZES: Okay, what we were \-- I mean the question that they
answered was how likely would you be to prescribe the same drug to
another similar patient with the same health condition. And they could
check off very likely, probably, or unlikely.

So we were \-- and that was predetermined that we wanted to look at the
proportions that were very likely versus the possibly and unlikely. And
what we were trying to get at was the confidence in treatment choice. Or
whether the fact that the patient had requested the drug would have
shifted the product that the physician prescribed as compared to what
they might normally prescribe.

You couldn\'t \-- you know if you asked the physician directly was, you
know, how necessary was this prescription, they are legally responsible
for the prescription. They\'re not going to answer that question \-- or
they\'re not likely to answer that question honestly. So it was trying
to get at it.

And, of course, in some cases, you know, so in terms of the drugs that
the patient did not request, in some cases clearly the physician felt
that there was something different about the situation with this patient
that they would not have prescribed the same thing to another patient.

DR. TEMPLE: Okay, so no implied inappropriateness. It was just this was
an unusual patient.

DR. MINTZES: So, yes, this was an unusual \-- well, who knows.

DR. TEMPLE: Okay.

DR. MINTZES: I mean this is my guess that this was an unusual patient
and so I mean what we were interested in, on its own, if we just looked
at the requested advertised drugs and just looked at the answer to that
question, it would have said nothing.

I mean what we were interested in was looking at how it compared for
those particular prescriptions compared to other newly initiated
prescriptions by the same physicians.

DR. TEMPLE: But you have no sense whether they meant I gave him an ace
inhibitor because he asked for it but I would have used a diuretic or I
gave him something expensive and branded whereas ordinarily I would said
use a generic? Or just what was it that they were saying was different
about this from what they would usually give?

My presumption is they are not telling you I gave the person a drug the
person didn\'t need.

DR. MINTZES: Yes, they\'re not saying that.

DR. TEMPLE: So they must have meant something else by that.

DR. MINTZES: I think it was the choice of treatments really. So
sometimes, I mean there was \-- the questionnaire did have a place for
comments on the bottom. But the physicians tended to comment more when
they had refused a requested medicine. And had prescribed something
else.

And there were the occasional comments that say Allegra was on
formulary, Claritin wasn\'t, for instance as a reason. Or that \-- I
mean some \-- they also stated what they had prescribed, what else they
had done if somebody had requested a drug and they had refused.

And sometimes they had prescribed something else that was in the same
class. Sometimes they had prescribed, you know, in some cases, a person
would come in for a \-- had requested hormone replacement therapy. And
the doctor had prescribed an antidepressant, for instance. So it was
quite a different \-- a shift in terms of classes.

DR. TEMPLE: I guess for the next survey, that one should have a why
after it.

DR. MINTZES: A why? Yes.

MR. TROY: Dr. Dubois, I thought you did a \-- your study did a really
good job of showing where there was, as you put it, consensus how DTC
advertising reduced the variability. And you portrayed that as a good
thing.

Then towards the end, you said, \"Well, it looks like we have to go
class by class,\" and you suggested that where there is evidence of sort
of a lack of consensus, then maybe we need to treat that or we, if we
could, somewhat differently.

And I was wondering what the basis was for your conclusions about drugs
in which there is sort of less consensus, is it only the bar with
respect to COX-2 inhibitors because that\'s the only one that there
seems to be a fair amount of variation. And you said that was a new
product.

Was there something else that I\'m missing about what the different
classes of drugs were that lead you to the conclusion that you need two
different sort of approaches?

DR. DUBOIS: Let me answer the question by sort of taking a side step. It
wasn\'t that the COX-2 inhibitors was the linchpin that told me what to
do next. What it really was an observation that variability in drugs is
much less than anything else we do in health care, screening, surgical
procedures, medical procedures.

So why is it that there is less variation geographically in the use of
medications than every else in health care. And variability is bad. I
mean that has sort of been a major tenet.

So I came up with many different theories one of which could be
promotion. And I\'m not focusing on consumer directed promotion. It
could be detailing. It could be anything.

Obviously, there could be a lot of other things and I point you to the
fact that drugs have a lot more data, where there is more evidence and,
therefore, there\'s going to be less variability.

So point No. 1 is there seems to be less variability. Point No. 2 is the
question mark of is less variability necessarily a good thing? Yes,
everybody does the same thing. We all dance the polka. But the polka
isn\'t the right dance to be dancing. So there could be wide overuse or
wide underuse.

Basically from there then, the question is if, in fact, there is
consensus, or not consensus, if there is less variability, then is that
a good thing or a bad thing. And the point then comes if you have a drug
or a procedure or an intervention where everybody pretty much knows this
is the right thing to do, then promoting that, however you might do it,
is a good thing.

On the other hand, if you have something that it\'s not as clear, then
promoting might get everybody to do the same thing, but that doesn\'t
\-- and when I say the same thing, geographically the same thing, not
that all patients are treated the same, that may not be the wisest end
point.

So if we have a drug which is new or there is not a lot of status
studies or we really don\'t know which patients are the best candidates
but we hammer on it from a promotional standpoint, yes Doctor A may give
lots of patients this drug, Doctor B may give lots of patients this
drug. This may be true across the country. But that doesn\'t necessarily
mean we\'ve coalesced around the right amount.

That\'s why I raised the point \-- and this is known from the surgical
world \-- that hip fracture repair or an appendectomy where there is
lots of evidence about what to do, it tends to be fairly uniform across
the country, prostatectomy, hysterectomy, back surgery, when we really
don\'t necessarily have a clue, it varies a lot.

So I then extrapolated from the surgical world into the medication world
and made the same point that again, if we know what is right, then
promoting is probably a very good thing.

I\'m sorry, it\'s a long tangled argument. But this is a complex issue
which I am weaving together several trains of thought to get to that
point.

MR. TROY: It\'s useful, I mean one of the things \-- of course, Bob
could address more clearly \-- is we don\'t\' normally approve a product
until there is some fair degree of consensus that it is safe and
effective for the purpose for which it is intended.

But I guess what you are saying is well there is one standard for FDA
approval and then there is another standard for standard of care.
Because, of course, we don\'t necessarily, the moment we approve the
drug, expect that it would necessarily become the standard of care.

DR. DUBOIS: It\'s safe and effective but that doesn\'t necessarily mean
it is cost effective for all patients. COX-2 inhibitors are a great
drug. On the hand, if it\'s must me who needs to take two days because I
pulled my back out over the weekend, it may not be necessary. It\'s
safe. It\'s effective. It\'s going to be safer than the alternatives.
But it may not be the most cost-effective choice.

Whereas if you look more clinically detailed, you say, yes, there is a
group of patients that really need it, there is a group of patients who
probably don\'t need it. No harm done but may not \-- they are all safe
and effective but maybe we might look at it differently.

MR. TROY: And of course cost effective is not something we get into.

DR. TEMPLE: And the class picked up some baggage, too. So that\'s
effected \-- there might be a downside, there might not be. That\'s the
debate about it.

MR. TROY: So if you had your way, it sounds as if you were suggesting
there would be sort of one level for approval and a second for
eligibility for some kind of promotion?

DR. DUBOIS: Exactly. Yes, I mean your standards for approval today are
fine. It\'s just how much would you be permitted to promote to the
doctor? You certainly have criteria for what you can \-- what\'s the
threshold for when you can promote to the doctor.

And then maybe there would be a companion one of when you can then
promote more widely to the patient base. And again, if it reaches some
evidence threshold, and again we could define what that is or how you
get there, then maybe the floodgates would be open for everybody to
promote.

And if it\'s really much more uncertain, maybe newer in the life cycle
of the product, then it might be more cautious in terms of its approach.

MR. TROY: I could be wrong but I\'m not aware of many drugs where we
approve them but say you\'re not allowed to promote them.

DR. DUBOIS: That\'s why I\'m suggesting this could be a new step as to
how you make these decisions.

DR. TEMPLE: But sometimes we have to see all the promotion ahead of
time. Just one further thought on that. I suppose one could make, if a
drug had a particular problem of ambiguous information about how often
to use it and some good things and some bad things, one could try to
make extra sure those are well demonstrated in whatever promotion there
is.

DR. DUBOIS: Yes, I\'m definitely getting at the issue of cost
effectiveness. There\'s no way around it. And I don\'t think we, as a
society, can avoid it.

Now maybe the FDA mandate doesn\'t allow it. But as a society, this is
one of the issues when people are increasingly needing drugs, the cost
effectiveness is part of the equation. This is a way to handle it.

DR. AIKIN: I have a question but first a question of clarification. I
understand, Dr. Dubois, from this that variation is bad, large amounts
of variation are bad. I assume that\'s taking into account individual
differences in patients where differences in treatment might be
necessary. That variation is still not good? Just help me understand.

DR. DUBOIS: Yes, it\'s a general tenet of quality improvement, whether
it is in health care or anything else, that apparent variability,
apparent unexplained variability isn\'t a good thing.

If a bolt you are trying to make is a quarter of an inch and then it
varies by a lot from one bolt to the next, this is bad. If a patient who
presents with a constellation of findings gets completely different
therapies, that this also may not be good. That\'s a tenet.

Now at an individual patient level, obviously you might disagree. This
patient absolutely needed Therapy A and this patient absolutely needed
Therapy B.

In the appropriateness literature when we\'ve tried to explore this
issue, high-use areas, low-use areas as explained by differences in
patient characteristics, we haven\'t been able to explain it. So it\'s
unexplained based upon patient characteristics. Therefore, this is
something undesirable.

DR. AIKIN: Okay. And the question for both you and Ms. Donohue is you
made points about very narrow classes of drugs. To what extent do you
think that your results could be applied to all drugs or all classes of
drugs being advertised? And to what extent should it not be applied
broadly? This might not be answerable.

DR. DONOHUE: I\'ll give you a conservative answer which I would hesitate
to generalize beyond the class that I\'ve looked at. However, my
findings are consistent with research in cholesterol-lowering
medications for instance.

A study by Marta Wosinska at the Harvard Business School, she looked at
what she was calling partial compliance with cholesterol-lowering
therapy. And she found a very, very small effect for DTC.

She also looked at drug choice as a function of DTC spending. And,
again, found a very small effect for DTC relative to that of detailing.

So to the extent that we study these issues across classes and are
finding similar things, I guess I\'d have more confidence in the
results.

But there are some characteristics of depression and of the
antidepressant class that make it quite special. This is certainly a
disorder that\'s highly stigmatized. People treated for depression, the
condition itself is highly heterogeneous.

The effects of the drugs are very idiosyncratic at the individual level.
So I wouldn\'t want to generalize to all drugs or all advertised drugs.

DR. DUBOIS: I think that very little has been done in the area of
appropriateness on drugs. So I would be cautious to necessarily
extrapolate too far. I guess if I had to hypothesize, if your decision
about what is proper or not is based on risk and benefit, probably more
extrapolatable than if you include risk benefit and cost into the
equation.

And that I would say that there could be huge variations among drug
classes as I alluded to earlier.

DR. PITTS: Dr. Mintzes, a couple of questions on your study. I\'m a
little vague as to the protocol. Did all of the patients in Seattle,
they had seen DTC advertising. All the patients in Vancouver, they had
not. Or was it a mix between the two?

DR. MINTZES: No, no. All of the \-- they were patients who had come in
to see participating primary care physicians on pre-set study days. So
every patient who came into the waiting room was \-- who met inclusion
criteria, was asked to enroll in the study.

DR. PITTS: That\'s no problem.

DR. MINTZES: In Sacramento, 98 percent of the patients reported that
they had seen at least one prescription drug advertising within the last
year. And in Vancouver, it was 87 percent. So there was a difference but
it was a small difference.

DR. PITTS: I guess my question is \-- as you just tossed it away in a
brief bullet. That the difference between the two health care systems is
really an unimportant variable. And it seems to me that certainly with
B.C.\'s formulary system, it would be a significant variable.

Did you also look into the specific medications across the two cities?

DR. MINTZES: Well, I mean we collected information on what people were
asking for. And then what they were being prescribed. At the time, in
B.C. only people over 65 were covered by the B.C. Provincial Government.
And so, you know, would have been effected by the formulary directly in
that way. And people with specific chronic diseases.

The question with that is whether people actually know when they see a
drug advertised and, you know, think that perhaps it would be helpful
for them and go into their doctor\'s office whether they would know
whether it was on formulary or not.

I would have expected that among the subgroups that were covered by
formulary, that there would be a big difference in the prescribing rate
between the two places. And we didn\'t find a difference in prescribing
rate for DTC advertised drugs.

DR. PITTS: Why do you think that is?

DR. MINTZES: Pardon?

DR. PITTS: Why do you think that is?

DR. MINTZES: Well, I guess, I think that, you know, partly three-quarter
\-- so it was around three-quarters of the time, when the person left
the room with a prescription for the drug that they had asked for, I
thought that was a very high rate.

I mean it\'s consistent with the other data that has been presented
today. Whether it\'s, you know, I can add a lot of conjecture. Whether
it had to do with these being products that there also is a lot of
detailing to physicians for it at the same time is one possibility.

Another possibility is that \-- and, you know, in terms of in general
when a patient came in and requested a drug, the physician was quite
likely to prescribe it. And that\'s very consistent with other research
on social and non-medical influences on prescribing. So on physicians
tending to provide prescriptions when they perceive that a patient wants
it.

So I, you know, I would \-- that would be my answer for the explanation.
You know, the hypothesis that I went into this was that the prescribing
rate would have been higher for the advertised drugs in Sacramento than
in Vancouver. And that wasn\'t the case.

DR. PITTS: Did any of you in your studies take into consideration as
part of the doctor protocol recent visits by detail reps or anything
along those lines?

DR. MINTZES: I didn\'t collect information at all on detailing. I
wasn\'t able to get it.

DR. PITTS: Did it come up at all in any conversations with any of the
doctors?

DR. MINTZES: No, it didn\'t come up in the conversations with the
doctors. I mean the doctors mainly were filling in these questionnaires
and they could comment on each consultation.

Nobody commented to say either that they had provided a sample to that
patient rather than a prescription that they picked up at the pharmacy
or that a detail person had come in recently.

DR. PITTS: But nothing actually on the questionnaire relative at all to
detailing?

DR. MINTZES: No.

DR. TEMPLE: Tell me if you think there\'s a contradiction in here. I\'m
not sure. Julie Donohue said that the effects of direct-to-consumer
promotion is largely on the class, not on a specific drug.

One kind of inappropriateness or the question I asked you about before,
Dr. Mintzes was whether inappropriate meant they picked too expensive a
member of the class or something like that. So I guess I\'d be
interested in whether you think those two are at least partly
contradictory.

We don\'t know exactly what they meant by inappropriate so, that\'s hard
to say. And then the second question is whether even if they didn\'t
pick the best \-- the drug they would have prescribed most of the time
for that, in some of those cases a patient came in who wouldn\'t have
come in at all and who wouldn\'t have been treated at all, and that\'s
not in \-- so the drug they got is more appropriate than nothing even if
it wasn\'t the very best drug this doctor thought that he or she should
have given.

So appropriateness has something to do with both of those things, the
choice of drug and whether there is treatment at all. And I wondered
what you thought about that.

DR. MINTZES: Right, well and, you know, there is also the possibility in
there that the patient was right. And the doctor was wrong in terms of
other evidence of relative efficacy and safety of different treatments
for the same condition. So all of those things are possible.

I guess I was \-- what I was struck by was the high prescribing rate for
the specific product that was requested together with about half the
time the physicians saying that it was only a possible or unlikely
choice for another similar patient.

And, you know, I guess what I would say is that that is some indication
of a shift in prescribing choice that is related to the patient having
requested the drug.

DR. TEMPLE: And that\'s the part I wondered whether it was contradicting
the idea that the promotion effects the class not the individual drugs.
Those don\'t seem to be \--

DR. MINTZES: Yes, I mean \-- that\'s \-- and so I didn\'t look at it on
a whole class level. There does seem to be some kind of contradiction
there. I mean one concern that I would have in terms of appropriateness
is that if physicians are prescribing products that they are less
familiar with, that they may also be less familiar with
contraindications with a profile of adverse effects or even relative
efficacy compared to other more standard treatments that they tend to
give out.

So that would be a concern that\'s more of a global one that doesn\'t
directly come out of the survey results. You know, I guess in terms of
the effect on a class, and you know it\'s company-specific advertising
spending.

If you look at the pharmaceutical marketing literature, you look at
claims about returns on investment that are product specific.

That would happen whether you expanded that whole class and so maintains
your market share within that class or whether you were able to gain on
someone else\'s market share. So I\'m not sure in that sense whether
those findings are contradictory or not.

MR. TROY: Just to follow up on that, Ms. Donohue, I wonder if you would
agree with this statement that there are, of course, two kinds of
advertising at least. There is product awareness basically and then
there is brand loyalty.

And it sounds as if your findings are consistent with the hypothesis
where you would at least expect the current balance of 15 percent DTC
promotional \-- if the promotional budget is 15 percent spent on DTC and
the rest on detailing, it sounds like you would expect that to basically
continue.

Because thinking it from the perspective of a pharmaceutical marketer,
you know, sure I want to promote product awareness but mostly I want
brand loyalty. I want people to buy my brand.

And so if DTC advertising gets people aware of the product, I really
have to spend most of my time trying to get people to buy my brand which
is what we see right now, basically a 15 to 85 percent split.

It sounds like your research would suggest that that is roughly the
right ratio from the perspective of the pharmaceutical company.

DR. DONOHUE: Right. I mean we were really interested in looking at how
do people in the industry view these various forms of marketing. And it
does appear that there is some leveling off in spending on DTC
advertising.

There was this huge dramatic increase in the sort of late 1990s. It does
seem to be plateauing and conversations that we\'ve had with people in
the industry suggests that that\'s going to continue.

And there are also really a handful of therapeutic classes that lend
themselves well to direct-to-consumer advertising for a number of
reasons either the market needs to be big enough, the side effects
can\'t be too scary because you have to talk about them on national
television, you know there are a lot of different factors that go into
this decision.

Whereas every brand of drug gets detailed. And it\'s really \-- DTC is
about getting people into the doctor\'s office. But once they\'re there,
physicians are probably going to be pretty risk-adverse and they\'re
going to prescribe the drug that they feel most comfortable with, which
is usually the most commonly prescribed drug.

So, yes, I think that is a really logical conclusion to draw.

DR. ABRAMS: Okay, we have time for perhaps one more question. Nancy?

DR. OSTROVE: Ms. Mintzes, earlier on today one of the presenters, I
think it was Dr. Weissman, talked about accommodation of patient
requests and looking at \-- they used effectiveness rather than
appropriateness as kind of a measure.

And about, I think it was 48 percent of the physicians said that, you
know, it was as effective as other drugs for the patient and they wanted
to accommodate the patient request. So this gets back to the same thing
that you\'ve been discussing.

But so in relation to that, I\'d like to get a sense of your \-- well,
basically what I want to know is did you get separate breakdowns for the
medicine judged to be a possible versus and unlikely choice?

Because you could very well be looking at that whole possible choice as
well, it was just as effective and I wanted to accommodate the
patient\'s request so I don\'t know if I would be doing that with
another patient. Or did you put those both together in terms of the way
that you measured them initially so you can\'t do a breakout?

DR. MINTZES: No, I can do a breakout. And I\'ll have to send it to you
because they were mainly possible rather than \--

DR. OSTROVE: They were mainly possible?

DR. MINTZES: Yes.

DR. OSTROVE: So it wasn\'t \--

DR. MINTZES: And it was similar, for instance, on pressure to prescribe.
Most of the reports of pressure were a little pressure. Very few were
moderate to strong pressure. So in both cases, that\'s true.

DR. OSTROVE: Right. So because it would be very interesting to see those
breakouts.

DR. MINTZES: Yes. I can just send \-- I\'ll send you the breakdown.

DR. OSTROVE: Great. Thank you.

DR. ABRAMS: Okay, thank you to the panel. We\'ll take a short break and
reconvene at 3:15 for our final panel.

(Whereupon, the foregoing matter went off the record at 2:59 p.m. and
went back on the record at 3:17 p.m.)

DR. ABRAMS: Okay, welcome back everyone. We will begin with our final
panel for today. And the first presenter will be Lynn Benzing who is
with Patient Marketing Group, Incorporated.

MS. BENZING: Good afternoon. Thank you. I\'m very pleased to be here to
present the findings from our Consumer Experience Scorecard Project.

We took a little bit different approach than some of the research
you\'ve seen so far today. One moment \-- we\'re really looking at what
goes on after the patient sees the direct-to-consumer advertisement and
then asks for more information.

I think we have a technical team being recruited right now.

DR. ABRAMS: Okay. We\'re having some technical difficulties. We\'ll have
your slides up in a minute or two hopefully. Then we\'ll begin.

MS. BENZING: Great, thank you.

(Whereupon, the foregoing matter went off the record at 3:20 p.m. and
went back on the record at 3:27 p.m.)

MS. BENZING: As you know, direct-to-consumer advertising has received
both strong praise and criticism. We\'ve heard a lot of that, I think,
from both sides here today. Actually it has been credited with the power
to drive significant benefits or, in some cases, great harm depending on
which side is sort of presenting the case.

And it\'s really our view that DTC may be best simply at driving
awareness and getting consumers to raise their hand and say I want to
know more. The study that I\'m presenting today actually looks at what
happens after the consumer has raised their hand and say I want to know
more.

We approached this project with the premise that DTC advertising alone
could not accomplish the task of looking at more than just awareness but
understanding and ultimately influencing health behavior.

To speak about the unmet market need, just in summary, numerous studies
have shown there is a great consumer interest in health information.
Many, many studies have pointed out that consumers have a keen interest
in learning more about their conditions and how to manage them
particularly in chronic condition categories.

What we find, though, is that these information needs change over time
especially from on-going \-- after diagnosis and into on-going therapy,
busy medical practices today are simply not structured to fill this
continual and evolving demand for information.

Our research explored the use of DTC as an initiator for establishing a
relationship with patients that would fill the information gaps at
relevant points.

These were some of our initial assumptions. Brands can begin to
establish a relationship with prospects in patients from the very first
interaction. And all of these interactions are connected in the minds of
the consumer.

This relationship can actually be built up over time and we believe that
it matters if say a rude operator is encountered after a patient calls
in response to a television commercial or a fulfillment package takes
too long to receive.

This relationship that begins through DTC advertising can\'t do the job
of accomplishing the education, the well-timed motivation interventions,
and the relevant tailored messages that have been shown to be most
meaningful. So it just the beginning of a dialogue.

So to look at what is happening in that dialogue as time goes on, we
looked at patient contacts initiated based on over 110 unique campaigns
for over 60 brands. We conducted over 400 telephone interactions and we
looked and cataloged over 100 response vehicles that were analyzed.

For the evaluation part of our project, we established ten key
benchmarks for scoring the ability of the follow up material to create a
positive and meaningful interaction with the patient.

There actually is no benchmark established in pharmaceutical marketing
for what\'s called in some other industries relationship marketing or
loyalty marketing. There is no pre-established set of benchmarks in
pharmaceutical marketing.

So we built these metrics based on looking at customer loyalty drivers
across other industries as well as looking at the factors driving
compliance, persistency, and retention in pharmaceutical marketing.

Time does not permit me to explain the details of our measurement
scoring methodology today but let me say that we looked at each of these
ten factors. And they were objectively measured.

We looked at timeliness of response, relevance of materials, perceived
helpfulness, understandability, credibility, privacy, degree of
personalization, follow up, convenience, and overall tone of the
communications. And I\'ll actually be showing you some examples in a
moment.

There are distinct marketing approaches that can be employed as patients
move across the continuum from awareness of a pharmaceutical product
treatment option to adherence with therapy guidelines once the product
is prescribed.

I\'ve heard a lot of research today and in the past few years about
simply the awareness piece which is what DTC is primarily focused on.
And which is probably all you can hope to achieve from a 30-second
television commercial.

But actually that patient has to move through this whole continuum for
therapy to be effective. So what we\'re looking at today, though, is
just Phase One, the prospect trial and conversion initiatives.

Now let me show you some findings from our study data. And again these
are based on the metrics that I discussed earlier in terms of the number
of communications we looked at.

When a consumer calls that 800 number that is featured in television ads
or print ads, and this is in part so that they can get more information
as mandated by the FDA, when they call those 800 numbers, in a little
over half the cases, they reach an IVR versus a live operator.

IVRs are thought to be a little less friendly but they\'re also more
cost effective. So this is the split of what is happening in the market
today.

We also looked at specifically what these information packages contained
when a patient receives them. And the most common initial response
package consisted of a cover letter, a PI, and patient brochure, and an
outer envelope. Doctor discussion guides were very common \-- were
actually quite popular. We found these in over a third of the packages.

The use of incentives was also common and we\'re seeing this come on to
be more and more popular as time goes on. Actually over 30 percent of
the packages contained a free trial offer, a coupon, a pharmacy check, a
rebate offer, or some kind of promotional item.

The length of time it took to receive materials was strongly influenced
by whether the initial package was requested by mail or by phone.
Actually when phone requests were made, the fulfillment usually happened
within the first two weeks. Whereas if it was mailed in, it took more
like between two and four weeks before a response was received.

In terms of the ability to opt out of future communications, we saw this
in less than 30 percent of all the fulfillment materials, which we were
surprised by actually.

In terms of discreet packaging to protect patients privacy, actually the
majority of marketers were very discreet. And, in fact, the most common
copy on the outer envelope was, \"Enclosed is the important health
information you requested.\"

However, in a little over 20 percent of the cases, the outer envelope
specifically referenced what was inside. One example was, \"Before
eczema flares again, get your free offer.\"

In terms of disclosure of intended use of personal data prior to doing a
survey, about half explained the plans for the use of the data before
the questions were asked. And about half didn\'t.

So in other words, the operator might take you through this whole script
of information before telling you how that information was going to used
in about half the cases.

The majority of the packages were personalized only with the
requester\'s name and addressed. Tailored content, which is personalized
to that individual\'s needs, was only used about 20 percent of the time.
This has been shown to be more effective.

And on the other hand, no personalization whatsoever, \"Dear Interested
Party,\" or \"Dear\" \-- usually there might not be a \"Dear\" in a case
like that \-- just straight information was used also about 20 percent
of the time. And this has been shown to be less effective.

Multilingual support was only available about 30 percent of the time.
And in cases where it was available, it was almost always just Spanish.

In terms of survey use, about 20 percent of all the materials used a
survey. Those tended to be associated with the more sophisticated
programs that might have tailored communication associated with them.

And the most common questions were about the patient\'s condition and
their prescription drug use. And the most common survey length was
between seven and ten questions.

The most common call length was between four and six minutes. So when
you call to talk to somebody about getting more information, it usually
takes about roughly on average five minutes. Those that took less than
three minutes were most often just simply an IVR where you could leave
your name and address to get a package mailed to you.

Now appropriate reading level has been a source of debate within
advertising circles. Overly simplified materials can leave more educated
consumers frustrated with lack of in-depth information. Whereas complex
copy can be hard for people to understand.

So we found that 45 percent of the cases we tested fell into the eighth
or ninth grade reading level. And it was interesting because some of the
marketers that sent simply a PI actually tested the highest on reading
level because every PI went above eleventh grade reading level as you
would expect.

So in terms of application of our scoring model using the ten benchmark
criteria I introduced earlier, some of the key factors that
distinguished the leaders were these.

For example, high scorers had quicker response time, asked questions
that enabled them to make the follow up materials more meaningful, and
fell into the mid-range of the reading levels that we observed.

Alternatively, the low scorers tended to respond more slowly with a
one-size-fits-all approach. And also the leaders were more likely to
have included a more consumer-friendly PPI, which I know is something
that you\'ve been in favor of. And the low scorers never did this. They
just used the PI geared to a professional audience.

Now let me show you a sampling of some of the relationship-building
follow up materials being used in market today. A number of programs
include a multi-wave series of follow up materials. And some were very
elaborate.

Here is an example of a package for asthma sufferers that actually came
in a tin container. It included mock photographs of places you could go
if you had your asthma under control. It had a trigger tracker, which is
what it was called, which was something to help patients record
precursors to their asthma attacks.

This is an example \-- we saw quite a few examples of this where the PI
was simply sent as an obligatory response with no attempt at building a
relationship. Sometimes these were the only communications that were
received. And sometimes they were sent out initially before the more
comprehensive package could get to the patient. We assume that was to
fulfill the timing guidelines.

Many campaigns, as I mentioned earlier, included incentives. Here is an
example of a promotion that contained 90 dollars worth of total savings
in the form of 15-dollar rebate certificates.

Also included in this package was a cross-selling piece for other family
members. And we actually saw two kinds of cross-selling going on.
Messages from the brand geared to other family members as well as
messages geared to sell multiple brands to the same household.

Now here is an example of a practical tool for patients and caregivers.
We saw many, many examples like this where these were aids to help the
patient or the caregiver manage the condition. And diaries were quite
commonly used.

This is a piece for a drug to treat attention deficit disorder in
children that actually had an educational piece trying to help parents
apply behavior modification principles in conjunction with therapy.

Now, talk to your doctor guides were very common. And that would be
expected at this stage of the promotion where the marketing is geared to
drive patients to the doctor to have a conversation and get their first
prescription.

So we saw a lot of these talk to your doctor aides. And some were
actually very patient friendly so that the patient could simply check
off things and then hand it to the doctor to help facilitate that
discussion.

We saw some creative use of educational tools designed to engage
interest. Here is an example of a slide rule that was designed to help
patients understand acid reflux disease risk factors. And then an action
planner to help them manage symptoms.

We saw a lot of patient involvement devices like this. This was also an
asthma category promotion. And it had stickers. It was very colorful
with the stickers and a calendar to help patients reward their children
and help get the kids involved.

Examples of overall campaigns that rated highly included this package
which contained actually a placebo version of an actual patch because
this is a drug that is delivered via a patch. And there was helpful
instructional material on ease of use.

This package arrived promptly. It included a doctor discussion guide, a
pharmacy check, a brochure that scored well in terms of relevance,
helpfulness, and understandability.

This campaign provided a friendly patient PPI and had live operators
that were professional and polite. And the opt-out process was easy and
clearly defined.

This program featured live operators, fast response time, sensitive
materials, caregiver\'s segmentation, and a consistent empathic and warm
tone across all consumer contact points.

So I think you can see there really is a lot going on out there. And the
very comprehensive materials in market.

So I\'d like to say in conclusion, it\'s evident that relationship
marketing is maybe just beginning in this category. And not everybody
sees the value. It seems as though people were either on board and doing
some really innovative things or really doing very little in this area
at all.

It appears that there is really a lot that could be done to improve in
this category. But I would like to submit that this area holds a lot of
promise for achieving public health advancement through better patient
education and motivational support.

Thank you.

DR. ABRAMS: Thank you. Our next speaker is Ruth Day from Duke
University.

DR. DAY: Good afternoon. The topic is Cognitive Accessibility of
Prescription Drug Information. In the interest of time, I\'m going to
focus only on TV ads and the Internet today and hold hard copy for
another time.

The basic question of this research is how do people understand drug
information? And the answer is often with difficulty. And there are a
lot of reasons why that can be. For example, there is a heavy
information load, the information is complex and technical, et cetera.

But I\'d like to focus on the poor cognitive accessibility that often
occurs in some of this drug information. Cognitive accessibility is the
ease with which people can find, understand, remember, and use drug
information. And, of course, do so in a safe and effective manner.

The basic approach of research in my lab is to perform some cognitive
analyses first of the drug information, obtain quantitative measures of
various things, and then calculate the cognitive accessibility of
different types of information.

We then perform cognitive experiments to test the effect of these
variables on cognitive processes such as attention, comprehension,
memory, problem solving, decision making, behavior, and, of course,
ultimately health outcomes.

Let\'s begin by looking at TV ads and the cognitive analysis part of the
project. We looked at product ads for 29 drugs to begin with. And these
were the complete product ads for a variety of different indications.
They ranged in time from 30 to 60 seconds.

We performed a lot of analyses across sensory modalities, the visual,
the auditory, and so forth. And of particular interest had to do with
the speakers. So what are they saying? The content. When are they saying
it? Their timing. And how are they saying it? Various linguistic
structure measures.

And we also looked at overall measures such as overall affect, whether
the overall tone was basically positive, negative, or neutral at various
points in time.

Here is an example of a speaker time for one drug. And as you can see,
there are three bursts of speaker presentation. There is a brief one,
and a pause, and another brief one, and then a longer presentation later
in the ad.

Here is the same time line with the speaker information up top, which
I\'ve just shown you. And at the bottom you now see the overall affect,
starting out negative, getting neutral, and then getting positive. We
can now fill in the different topics that were being spoken by the
speaker or speakers.

And of particular interest are the side effects. And you can now see
where those side effects were presented in time. And that is negative
information, in a sense, and where it came relative to other types of
information.

So what is the location of side effects, very important risk
information, across all of these ads?

Before I show you those results, I\'d like to comment on a general
cognitive principle. There are many of them that we use in our research.
This is just one. It\'s called the serial position effect.

Hundreds of experiments have shown the following: if I present to you a
list of items, whether they are digits, or words, or whatever, and ask
you to recall them in order, here are your typical results.

People do better at the beginning and the ends of lists and do terribly
in the middle and just past the middle in particular. This has been
replicated many, many times.

So now going to side effects locations for the 30-second ads, where are
they occurring? Well, in the middle and just past to the middle. Let\'s
look now for the 45-second ads, similar location. And for the 60-second
ads, similar location.

So what can we conclude about the placement of side effects in these TV
ads and, of course, it is all about location, location, location. And
the results are basically that they are being put in a location that is
going to make it very difficult for people to process and retain the
information.

Let\'s move now to some linguistic analyses of these ads. Various things
about the content. Today I\'ll focus on benefits and risks. And also the
overall structure, the length, how much is devoted to each topic, and
various complexity measures from phrase structure to propositions. And
propositions are the number of idea units packed into a sentence.

Length is very straightforward as you could probably predict. Percentage
of total sentences in the ads averaging across all of these ads, 30
percent to benefits, only less than 10 percent to side effects.

Readability measures are quite interesting. I\'d like to have a caveat
first that readability is not the exact same things as
comprehensibility. However, it is easy to measure and does have
predictive value. And, therefore, it acts as a quick proxy for
comprehensibility.

So what we want to do now is to plot the grade level needed to process
information about benefits versus side effects in TV ads. And it turns
out that people need three more grade levels in order to process the
side effects than the benefits.

Now we can break this down for each individual ad where we do a
different score. So you get the readability level for benefits minus
risks. And here are all the drugs in that particular sample. So zero
basically means there is no difference between them. The upward going
lines mean that it is more difficult to process the benefits and the
downward going means that risks would be harder.

As you can see, there are many more downward going lines. And so now the
question is how do we compute fair balance?

We can put a zone around the zero difference plus or minus a grade level
or two grade levels or something of the sort and clearly see what the
outliers are. There are ads that have six to as many as eight grade
levels more needed in order to process the information in the risks as
opposed to the benefits.

I\'ll just mention one type of semantic analysis. We looked to see the
use of \'you,\' which is very inclusive, directly talking to the viewer
of the ads. And as you\'ll see, there are a lot of times that the word
\'you\' is used in the benefits, \"Target your total migraine,\" \"Help
you lose weight,\" \"Won\'t keep you up at night,\" and so on and so
forth.

Whereas the use of \'you\' is very rare, relatively rare for side
effects. And the side effect information tends to be said in ways such
as, \"Side effect may include,\" \"Or one out of ten may experience.\"
So benefits are things that may well happen to you. But side effects
will happen to \-- well, somebody.

All right. So how do we do experiments looking at these effects on
people? The basic approach is people will see an ad, maybe one ad, three
ads, and then we test their comprehension, memory, and problem solving
et cetera for benefits, risks, and other types of information.

So first of all we want to see how well they know these ads. And as you
can see, about 40 percent of people in the study I\'ve chosen to show
you today have seen the ad for these three drugs. And there\'s no
difference across the drugs.

Now when we asked people what is it for, the indication, which is a
benefit, people do quite well, 70 to 90-plus percent correct, know what
the ads are for. When we asked the same people what are the side
effects, you can see the performance goes way down.

There is a big contrast between what they know about the benefits and
what they know about the side effects. Well, you might say well there is
more side effects than benefits in the ad. You are absolutely right. At
the bottom of this graph you\'ll see however that that does not effect
the overall recall level because people recall just as many for a drug
with three side effects as one with nine.

All right. So the overall effect is that people are much better able to
understand and retain information about the indications and the benefits
than the side effects.

Let\'s turn now to the Internet and look at some of the cognitive
analyses. Here are the drugs in our initial sample that I\'ll be telling
you about today. These are drug product Web sites put out by the
company, usually accessed by drugname.com \-- not always but usually.

The home pages are quite interesting. Here\'s one. And I\'ll just
mention that we began these studies in 1999-2000. That\'s what I\'m
reporting today. But we have carried it up into the present year. And
there have been some interesting changes.

All right. Of main concern are the main buttons, the ones that really
organize the Web site shown here on this display. And we look at site
structure using a variety of different measures and the main buttons to
location of information and so forth.

Here are the results of this analysis getting the hierarchial structure
for a particular drug. And in each box \-- so the one at the top is the
home page, and the next level are all the main buttons. And then we have
numbers in each box, X and Y. X stands for the number of benefits on
that page. And Y stands for the number of side effects on that page.

And if you look down where the arrow is, you can start seeing what is
down there for the side effects. And has that side effect, that extra
one that is there, occurred anywhere else in the other pages or is that
the only place to find it. Because in general, as you move from left to
right, and then down the page, you are decreasing the probability people
are ever going to get there.

All right. I\'d like to shift now to the whole idea of the adequate
provision requirement. In the broadcast ads, they have to provide
multiple access to product labeling. There are various ways to do it.
And one of which is the Web site address.

So the TV ads drive people to the Internet to find the product labeling
should they so choose. And now the question is how easily can find the
PI? Well, there are a lot of problems here. What is it called? Where is
it located, et cetera.

The PI, the \'P\' could stand for a lot of things on these Web sites,
prescribing, product, package, physician, patient. The \'I\' could stand
for information, insert.

And so it\'s almost like a Chinese menu. Take one from column A, one
from column B. But there is often a column before that. So you will find
all of this nomenclature that you would have to click on across
different Web sites to get to the product labeling, from prescribing
information to patient information, et cetera, package insert.

You might say well that is interesting but so what? Well, let\'s do some
experiments to find out the so what. And in some of these experiments,
they are prediction experiments, people see the names of buttons and
have to predict what type of information will be there. And you can put
in all the button names and just for today in the interest of time, I\'m
going to pull out prescribing information versus product information.

All right, in this display we see that where people would look for side
effects would be much more likely \-- or they would be much more likely
to look for side effect information if that button says product
information. If it says prescribing information, they are far less
likely to go there.

So the patterns of what people would look for depends on what the names
of these buttons and links are. And there is another cognitive principle
called linguistic codability.

In the click experiments, people see the button names and ask where they
would go to find specific information such as benefits versus risks. So
this is a related study.

And as you can see, they would go to the product information to find
both benefits and risks. But they would be less likely to even visit
prescribing information. And certainly not to find side effect.

So these are ways to have people not be able to get the information
about side effects and other things. So in general there are a lot
things in the Web site information that are easy to find. The disease
state or health condition, drug benefits, take and send the survey, the
promotions. And it\'s harder, much harder in many cases to find the side
effects, other risks, and the product information.

So in conclusion what can we say about fair balance of benefits versus
risks. From what I\'ve told you today, it looks like there is a heavier
emphasis on the benefits than the risks. And in general, this is true.

Out in the real world, there are benefits and risks all the time. In
this cartoon here, somebody is ordering at a lunch counter and it looks
like the risks and benefits are in fair balance. They are written just
as large or small and so on and so forth.

In the drug information world, there are a lot of enhancements for the
benefits. And the risks, well, they\'re there, but they\'re a little bit
harder to find and understand and so forth.

So now here is the clincher for this research. That risk information may
well be physically present, everything that should be in the TV ad, the
Web site may physically present. But if people cannot find, understand,
remember, and use this information, it is functionally absent.

It\'s not there. They\'re not going to get there. They\'re not going to
find it. If they do, they may not understand it very well and be able to
use it.

So now let\'s go back to fair balance. What I\'ve said so far sounds a
bit gloomy but there are easy ways to assure fair balance of benefits
versus risks. And I think that the use of cognitive principles is a
significant key in designing these materials, in evaluating their fair
balance.

And if we use these principles, then we can use boost the overall
cognitive accessibility of both benefits and risks.

Thank you.

DR. ABRAMS: Thank you. Our next speaker is Dr. Angela Hausman from the
University of Texas.

DR. HAUSMAN: Thank you. Okay. I\'m actually down in Pan American for
those of you who don\'t know. Pan American is about as deep as you can
go in Texas and still pay U.S. taxes without being in Mexico. With all
the benefits of living in Mexico but U.S. taxes.

You need to know a little bit about our populations. I did this with
Steven Kopp, who is in Arkansas, and we did this survey in both
populations. My population is about 90 percent Hispanic, most of whom
are Mexican-Americans, most of whom are also bilingual although many of
them only speak Spanish. And many of them only speak English.

Levels of acculturation vary dramatically. Some are almost fully
acculturated. In other words, they are almost identical in many of their
cultural values with U.S. citizens. In many cases, the people have, even
though they have lived here for many generations, have not acculturated
and still have very much a Spanish, specifically a Mexican culture.

In terms of the income, the county where I live is one of the poorest
counties in Texas. And also one of the poorest counties in the United
States. But, of course, there are huge variations in that income.

The education levels vary from an eighth-grade education all the way up
to post-graduate degrees so we have quite a degree of variability.
We\'re not a colonia, if that\'s what you are thinking. You know it\'s
not all poverty, all destitute.

Steven Kopp\'s sample was from a panel in Arkansas. And that\'s more
representative of an Anglo population although we did have 13 percent
African-Americans in that population. And so we were able to make some
distinctions between the two.

We\'ve talked a lot about differences between \-- or the positives and
negatives of DTC advertising. So in the interest of time, I\'m really
going to skip this because it is very redundant.

The research questions that we have \-- and I have to tell you that
Steve and I are both marketing professors so we approached this very
differently than people who come from epidemiology, pharmacy, medicine,
because we come with a wealth of background on advertising to begin
with.

And so we were mainly interested in the attitudes towards the
advertising, the products that were advertising, how this effects
people\'s behaviors about buying the drugs, whether it effects
self-medication, and does it effect the physician-patient relationship
because I\'ve done a lot of work on physician-patient relationships.

We started with semi-structured interviews, which were not anecdotal.
These are actually scientifically collected although they do happen to
be qualitative data.

We had a diverse group of people, both Hispanics and non-Hispanics,
because about 250,000 people living in our area are what are called
winter tax stones and so they are retired from Minnesota, and Nebraska,
and places like that. So we had a lot of elderly also in the population
that we surveyed.

Next we used that information that was gathered from the interviews to
develop surveys. These were administered mainly in English although some
of my students, because they are bilingual, did translate then into
Spanish and collect them in Spanish.

But I don\'t know which ones were collected in Spanish and English. So
for our purposes, we really have to assume they were all collected in
English.

We also surveyed in Steven\'s area, we surveyed a sample of people from
across Arkansas that are members of the University of Arkansas Consumer
Panel. In the case of the Texas data, what you\'ll find is we used a
single ad that was sent out along with the questionnaire. This was an ad
for an allergy medicine since that is one of the most commonly
advertised drugs on the market.

And the non-Hispanic \-- the Arkansas data, what we did is we used four
different ads because we wanted to get at how the severity of the
disease that this drug treats effects advertising.

The assumption would be that things like allergies, which are not
life-threatening, people would view them very much the way they do any
other kind of advertising for a product. Whereas drugs that treat
life-threatening illnesses, and in our case we had a cholesterol
medication and a diabetes medication, the assumption would be that there
is a lot more cognition that goes into evaluating those kinds of ads
than into the ones that were for things like toenail fungus, which is
one of the other ones.

Toenail fungus has gotten beat up a lot today.

What I\'m going to do is I\'m going to present results on each of our
research questions. And I\'m presenting both the qualitative and the
quantitative data. And in some cases, they kind of support each other.
In other cases, you\'ll find that there are some difference across
these.

In terms of their attitudes towards the ads, some people considered that
the ads were just propaganda and so they really didn\'t give them any
credence whatsoever.

Others thought that it was exaggerated although some people thought that
because these were government regulated, that the ads were accurate.
That obviously the FDA would not allow these ads to be on TV if they
weren\'t 100 percent true and accurate. They also said that they were
honest and because of the strict guidelines, they were very accurate.

The quantitative data told us pretty much the same thing. The attitude
towards the ad, which is right here, was fairly similar and also fairly
high. These were a seven-point scale so it was at least somewhat was the
mean for both the Texas and Arkansas data.

Attitude towards the brand, we did find a huge difference because
Hispanics, in general, or at least my Texas data which were mostly
Hispanics, had a very much poorer attitude towards the brand than did
the Arkansas data. And I\'ll talk in a few minutes about why that
probably was.

Information relevance probably gets at what Dr. Day was just speaking
about in terms of their assessment of this information would help them
make decisions, it was generally somewhat negative. A little more
negative in Texas.

Almost everybody seemed to feel and unfortunately this is negatively
coated, so it\'s hard to see in this, but almost everybody felt like
this was approved by some government agency somewhere. Somebody saw this
and said that this was okay to put on TV or in the newspaper.

And their attitudes towards direct-to-consumer advertising, which was
really an assessment, that they felt like it was a good thing to
advertise drugs, were generally somewhat good. This was only a
five-point scale so these were pretty positive.

In terms of how it effected the behaviors, we start to see some more
mixing here. Some people thought that they were too honest and that the
side effects scared them, in some cases convincing them that they should
stop taking a medication because of the side effects. One person said
that they thought that it was unbalanced in favor of side effects.

I mean here you are going to get one disease, treat it, and you end up
with ten more, meaning the ten side effects.

Depression seemed to be one that was particularly of concern to the
people in the qualitative data in part because everybody felt like they
could see themselves as being depressed based on the relatively
simplified description of the symptoms. That it is fairly easy to say,
yes, I\'m probably depressed. I mean I\'ve not wanted to do my hobbies
lately. So I must be depressed.

We looked at correlations here. And what we did is we looked at people
who more frequently used some kind of media for information about their
ads, specifically about the ads, not about other features like medical
reports and things like that.

And we looked at how that correlated with some of their other attitudes
and behaviors. And we found that to support what drug manufacturers
would like is that there was a positive association between viewing the
ads and attitudes towards the brands. So it seems like when they see the
ads, they think more highly of the brands.

They also felt better about the information if they used drug
advertising more than those who didn\'t. Hispanics, or at least the
Texas data, what we found is that there was a positive association
between using the ads more and being confident that this was a good drug
for them to use.

And in Arkansas, we found that they had an increased likelihood of
purchasing this drug if they had the appropriate condition. Although you
can see from those means, in both cases, the patients felt like if they
had these symptoms, they would be very comfortable taking this drug.

One of the interesting things here was that we looked at professional
sources of information, from doctors, pharmacists, and nurses, and we
found that there was no association between using those more frequently
and any of these other attitudes.

We did find that younger patients were somewhat more likely to use
advertising than were older patients. But because this was not a
longitudinal study, we don\'t really know whether this is a function of
younger people being more comfortable with the direct-to-consumer
advertising or whether it is a function of them being younger per se.

There is also a positive association between the advertising and buying
prescription drugs without a prescription. And I\'ve done a lot work on
this and hopefully the FDA will be interested in this at some point, but
in the area where I live, we\'re 20 minutes from Mexico.

And so it is very common for people to just pop into Mexico and get
whatever drugs they need without a prescription and then pop back across
the border.

And there is an issue, it\'s called medical tourism of people who
actually schedule their trips or vacations to Mexico and other countries
like that for the simple purposes of getting drugs and other kinds of
medical services at much lower costs than they do in the United States.

We looked at regressions. And here we were looking at things that best
predicted the likelihood of purchasing these drugs and the confidence in
the drugs. And as we might expect, things like attitude towards the
brand, attitudes towards the advertising and information were the
critical predictors of these kinds of behaviors. And this model explains
almost 50 percent of the variance in drug choice.

One of the things you have to remember, though, is that the ad \-- being
more likely to view the ad itself effected each of these behaviors so we
really have a cumulative effect of the ad across these intervening
variables.

Hispanics were somewhat more likely than were the Arkansas data to use
the direct-to-consumer advertising to find out about drugs. Both groups
tended to use the Internet for information almost as much as they used
advertising itself. But doctors and pharmacists were still the most
commonly used sources of information for both of these samples.

They had relatively good attitudes about the brand and how it effected
their relationship. About three-quarters felt that the ads were approved
by the government. About 40 percent said that there should be more
direct-to-consumer advertising.

Practically half of the respondents used the ads to help them find out
about serious diseases that effect their health. About 40 percent asked
their doctor for advertised drugs which is just a tiny bit higher than
everyone else\'s finding here.

And only about 13 percent of the respondents felt that the ads reduced
their reliance on their doctor. So their doctor was still the primary
source of information for buying prescription drugs.

And they seem to rely more heavily on direct-to-consumer advertising
when they either didn\'t trust the doctor or when they already had a
poor relationship with their doctor.

All right. So some of the conclusions that we reached from this study,
in general, we found that patients liked and trusted direct-to-consumer
advertising, that the direct-to-consumer ads effected their attitudes
towards the products that were being advertised. These are typical ways
of assessing the effectiveness of the advertising.

We saw that direct-to-consumer ads helped patients feel empowered so
that they were better able to ask their doctor questions, that they were
better able to take charge of their own health care, that patients used
the direct-to-consumer ads primarily to supplement their doctor\'s
information and not to replace him or her.

There also was \-- interestingly there was no economic effect based on
any of the measures that we looked at. For instance, we looked at
income, whether they had insurance and what type of insurance, the
amount of money that they spent on drugs per month, and a scale that\'s
called price consciousness which reflects how much they are concerned
about how much things cost. And none of those had any effect.

The other thing that had no effect is it didn\'t matter which ad you
were talking about, whether they were talking about toenail fungus or
diabetes or cholesterol. All of ads seemed to have the same effect on
the consumers.

Now one of the things that from the qualitative data though is that it
suggests some latent problems. For instance, there does seem to be this
belief that because the government approves these ads, which they take
for granted, that these products must be effective. If they weren\'t
effective, then the FDA would stop the ads from being shown on TV and in
newspapers and magazines.

They use it to self-diagnosis. And given the ability of patients to get
drugs without a prescription in other countries and over the Internet,
this is going to become an increasingly serious problem.

There is a certain fear factor, being afraid to take the drug because
you find out about side effects in a way that is more meaningful to you
than it was on the product insert. They do tend to confuse symptoms with
drugs with side effects.

If you ask them to tell you about an ad, they\'ll describe an ad that
was for a different drug, that treats a different disease. And they fail
to recognize many of the side effects.

They also miss side effects, for instance, one of the people was talking
about Viagra and didn\'t mention several of the serious side effects
that are a potential from Viagra.

So that\'s basically our study. Thanks.

DR. ABRAMS: Thank you. Our next speaker, the final speaker for this
panel, is Dr. Henry Young from the University of California.

DR. YOUNG: Thank you. Good afternoon. Again, my name is Henry Young. And
I\'m a post-doctoral scholar at the University of California Davis.

Today I will present to you a study entitled Does Direct-to-Consumer
Advertising Promote Shared Decision Making? a preliminary study. Doctors
Earlene Lipowski and Richard Kravitz are contributors to this work. And
this data was collected at the University of Florida.

One concern shared by health care professionals, researchers, and policy
makers deals with drug advertising effects on patient behavior.

Proponents of drug advertising speculate the drug ads will encourage
patients to take an active and positive role in their health care. While
opponents contend that drug advertising will push patients to become
intrusive and demanding.

Drug advertising-induced behavior whether positive or negative may
ultimately influence the interaction between patients and physicians,
which could lead to a participatory or stressed relationship and a
variety of outcomes.

So the objective of this study was to examine the difference between
consumers intentions to seek additional information and their intentions
to request a prescription for an advertised drug in response to a drug
advertisement.

We conducted a survey in which we asked women college students about
their behavioral intentions in response to a prescription drug
advertisement for an oral contraceptive. We asked women who were of
child-bearing age to participate in this study. However, we excluded
medical, nursing, and pharmacy students.

Our study procedure involved exposing participants to a fictitious drug
advertisement and having the participants complete a questionnaire.
After the participants completed the questionnaire, we informed about
the advertisement \-- well, we informed them that the advertisement and
the prescription drug were fictitious.

We decided to use a fictitious advertisement of a product in order to
expose participants to a novel situation, a situation in which they were
confronted with a new and exciting product.

The fictitious product, Unigyne, was an oral contraceptive medication
that required only one dose per month. The Unigyne advertisement was
based on an advertisement for the oral contraceptive medication Ortho
Tri-Cyclen.

We redesigned the advertisement by a process that involved evaluations
from focus groups and advertisement credibility ratings.

This page shows the first page of the Unigyne advertisement. And the
second, which is a little hard to read, shows the second page of the ad.

The variables of interest in this study included information seeking and
requesting intentions. We defined information seeking intentions as
consumers intentions to ask their physicians for more information
regarding the advertised drug.

We measured information seeking intentions with a four-item instrument,
each item had an 11-point scale ranging from 1 to 10. We then calculated
a mean score to represent information seeking.

The following slide shows the information-seeking scale items. The items
used to measure information seeking focused on questions concerning the
efficacy, appropriateness, risk, and general information about the
advertised drug.

We defined requesting intentions as consumers\' intentions to ask for or
demand a prescription for an advertised drug from their physician. We
measured the requesting with a two-item instrument. Each item had an
11-point scale ranging from zero to ten. We then calculated a mean score
to represent requesting.

And again this slide shows the requesting scale items. And these items
\-- well the items used to measure requesting focused on two types of
requests: asking and demanding.

The inter-rater reliabilities for the two scales were co-efficient alpha
estimates of .9 for information seeking and .83 for requesting. A
confirmatory factor analysis verified the two-factor structure of this
data.

A total of 107 women participated in the study. The average age of the
participants was approximately 20 years. The age range was 18 to 33.
Approximately one-half of the participants were white and over 60
percent were sexually active and were oral contraceptive users.

The mean score for information seeing intentions was 8.6 and the mean
score for requesting intentions was 4.7. This difference between
information seeking and requesting was significantly different. We found
similar results in the sexually active and contraceptive user groups.

By examining the difference between each participant\'s information
seeking and requesting scores, we found that 93.5 percent of the
participants were more likely to seek information than a prescription
while only 3.7 percent were more likely to seek a prescription than
additional information.

Regarding specific information seeking scale items, participants
generally had higher intentions to ask about the advertised drug\'s
efficacy and risk. Regarding specific requesting scale items,
participants had stronger intentions to ask for a prescription drug than
to insist upon a prescription.

We also found that participants had moderate intentions to seek
additional information from additional sources.

The results of the study are limited by the use of students and a
fictitious drug. Nevertheless, we can conclude that drug advertising may
promote a shared decision-making process by inciting an exchange of
information between patients and physicians and by encouraging patients
to initiate discussions with their physicians regarding treatment
alternatives, efficacy, appropriateness, and risk.

These potential increases in information exchange and patient
involvement are some of the first steps in the shared decision-making
process.

Just for some future research ideas, future research may focus on
distinguishing the characteristics of drug advertisements that promote
constructive patient involvement. And perhaps such research could be
used to set standards for the delivery of promotional materials.

Also this research raises a concern regarding alternative information
sources. Our findings suggest that consumers may seek additional
information from sources other than health care professionals.
Additional research is needed to examine the quality and the effects of
these alternative sources.

Thank you.

DR. ABRAMS: Thank you Dr. Young. We will now have questions from FDA and
presenter panels. Dan?

MR. TROY: Sure. Ms. Day or is it Dr. Day?

DR. DAY: Dr. Day.

MR. TROY: I\'m sorry, Dr. Day. I take it the implicit if not perhaps the
explicit point of your presentation is that we should use these
cognitive tools to make sure that people are truly perceiving both the
risk information and the benefit information.

And if companies are in some way or another not adequately communicating
both, they somehow there is a role for the government in ensuring that
both sides are adequately balanced.

And to that end, I guess I have sort of two questions. One is how
ubiquitous or common are these concepts that you are talking about in
the marketing field? Are they, you know, are they sufficiently well
accepted that we could give guidance on them or take enforcement action
based upon them? That\'s the first question.

And the second \--

DR. DAY: Can I answer that one before you go on to the second?

MR. TROY: Sure.

DR. DAY: All right. The principles that I\'ve mentioned today, the
serial position effect, and linguistic coding, and lots of others are
very well known in the research literature on cognitive processes based
on laboratory experiments using a lot of different materials.

And the results have been replicated hundreds, and hundreds, and
sometimes thousands of times. They are really, really true.

The extent to which they are known in the marketing field varies by
where and by whom. But I think but I think that a lot of them are not
known in the marketing field and some are very well known. I think the
serial position effect, I do know is known and taught in some business
schools and so on.

But the nature of the data are sufficient that they are useful. And the
extent to which the marketing companies are then using them, I can\'t
really tell you. My experience with specific marketing companies is some
but quite limited.

And I know that in the ones that I\'ve worked with in the normal course
of my research, they are often surprised by some of the things that I
bring up.

MR. TROY: Interesting. I would wonder they wouldn\'t be spending more
time on these kinds of concepts.

DR. TEMPLE: They did seem to have found the retention trough for almost
\--

DR. DAY: Well, yes, as Dr. Temple has said, maybe indeed they know about
the serial position effect and have located the side effects in that
place on purpose. I don\'t know. Or if it is unintentional and they want
to have positive before and after the negative and so on.

But I think it would be very useful to have a showcase of what are the
basic cognitive principles that are important for comprehension and use
of drug information. And what are the laboratory studies and how can
they be used effectively and negatively.

And that is something that I am working on and hope to be able to share
soon.

MR. TROY: The question \-- and it may not be a fair question and you may
not know the answer to that. Is I wonder whether any \-- for example,
the FTC which has spent a lot of time thinking about how consumers
perceive data.

I wonder the extent to which they are using these concepts in their own
sort of thinking about what companies should and shouldn\'t be saying.
Whether they have been providing any guidance on it. And indeed whether
it\'s ever been used in any kind of enforcement action.

DR. DAY: That\'s something that interests me very much. And something I
would like to pursue. I can\'t really tell you, not being an insider in
the DOJ side of things. But I think that in the future, these things are
going to come to bear in a lot of settings.

For example, this is a little bit out there but in product liability
suits concerning prescription drugs, if a patient is harmed and wants to
sue someone, what are the choices? Whether it is legitimate or not, is
it the physician? They can\'t sue the government.

But what if we showed that the alternative ways to display say side
effects and other risk information so that you could increase
comprehension and correct prescribing by the physician as well as
comprehension and safe use by the patients by a large amount.

And some of my own laboratory studies show you can increase
comprehension and appropriate use by 80 percent. So then if we\'re not
using those ways of showing the information and somebody gets harmed,
where does the liability lie? It\'s a very interesting question for the
future.

MR. TROY: As soon as we finish rewriting the physician label, we may
need to rewrite it again.

DR. DAY: Well, there are a lot of things in the proposal rule for
physician labeling that are based on cognitive principles. And those
have been put to good use in the highlights section and the index and so
on. And they are based, in part, on this type of information.

MR. TROY: Thank you.

DR. TEMPLE: I was struck by how all the bad news came in the retention
trough, too. And I guess one \-- my question is is some of that perhaps
unavoidable? For example, it would be sort of silly to put the bad
effects first before you say what the thing is for. That would kind of
be goofy.

So you immediately lose the high retention part. You can\'t get that.
The side effects do come late in the thing although they may not be the
last thing which, I think, may be one of your points.

And then the side effects may have terminology in them that is
inevitably higher grade level because that\'s the name of the bad thing
that it does. So I guess one question I have is how fixable is some of
this?

DR. DAY: Right. Well, it\'s up to the FDA to decide \-- well, to look at
what is already in there and see if that is suitable. Has one really
serious side effect been left out or not? And so on.

What I do is look, given that it is in there, how favorably and
unfavorably placed are they? One thing that can be done to help fix is
to use another cognitive principle called chunking. Chunk together ones
that are really serious. And then the ones that are others.

So a given ad could say something like there is a possibility of a
serious side effect dah-dah-dah, and if you already have problems in
this area, talk to your doctor carefully first.

Others that may occur and may go away with use and dah-dah-dah are the
nausea, dah-dah-dah-dah. So by chunking the really serious from the
others, you don\'t get that effect of a whole slew of a lot of them.
That\'s one thing.

DR. TEMPLE: Which is what the highlights do essentially?

DR. DAY: Yes, yes. So there\'s frequency and there is severity. A lot of
patients are interested in frequency but severity is the thing they
really should know the most about.

Another thing is what all is going on during the presentation of the
side effects. Our analyses show there is a lot of other stuff going on.
And that can be one of the most joyous parts of the whole ad, the people
are running through the fields, and there are daisies, and they\'re
kissing, and it\'s wonderful, and so forth.

So there\'s the information load and multiple sources of information
happening all the time on top of the side effects as well. So there are
a lot of things that can be done to not scare away patients when they
hear the side effects but to increase the chances they\'ll retain them.

DR. PITTS: Let\'s pursue that line of thought. Isn\'t it also true that
in terms of cognitive mapping, if you are presenting the solution that
the problems often times get ignored because people are more focused on
the positive aspects of what is being said?

DR. DAY: Yes, yes. There is a lot of research on how people remember
positive better than negative. Someone at the University at Michigan in
social psychology showed that for a long, long time.

You know I am curious as to whether a general statement such as all
drugs have potential benefits and risks depending on how they are used
and who uses them.

And if that were something that got a big public education campaign,
people would understand that better and have a better framework for
storing I need to know about the benefits. I need to know about the
potential side effects.

DR. PITTS: So you also looked at, you alluded to before, the kind of bit
of slight of hand? That while the risks are being discussed, a child is
being thrown in the air and caught. Any further research on that?
Purposefully distracting from the audio?

DR. DAY: We have data on that. I didn\'t bring it today. I don\'t know
if it is purposefulness. But it certainly does happen.

MR. TROY: Although, of course, you just suggested something very
interesting. And that is that at times to have a conflicting image may
actually help in the cognition. I mean we traditionally say that if
there is too much going on at the same time that the side effects are
being read, that that is distracting from the main message.

But you are suggesting something I had not heard before. That if you got
a reassuring image at the same time that you got the side effects \-- I
think this is what you are saying \-- then that might actually help in
the cognition? Am I right about that?

DR. DAY: No, actually \--

MR. TROY: No?

DR. DAY: \-- well, it depends on the nature of those positive images. If
you are a young person and you see a young man and woman, you know,
coming together and holding and walking with their hands out, you may be
so interested in that, that there is a decrease in attention paid to
what the message is about side effects.

And if they are spoken very quickly, I mean I know we all know about ads
where it says, \"And side effects may include blah-blah-blah, and you
will feel better forever and ever.\" Or, you know, so there are multiple
things that can be going on.

I guess what I\'m saying is attention really has to be paid to what else
is going on at the same time, how that material is chunked, coded, that
is to say if it is prefaced with something: Here are the serious side
effects. These are mild and go away.

I do object to some specific language. There is one ad out now that says
side effects are low. And I have been doing experiments to see how
people understand what low means. Does that mean not very strong? Or not
very often?

So that kind of information where people can\'t interpret what it means
is objectionable as well. And if they say side effects are low and then
mention them, people might not pay as much attention to them.

So there are a lot of things going on around the presentation of the
risk information.

DR. PITTS: Is there a similar science towards print ads where risk
information could be placed up top more in the body of an ad as opposed
to in small print?

DR. DAY: Actually an interesting idea would be to follow the proposed
physician labeling and have some little highlight box at the top. And
where you always present the benefits and the main risks in some way,
and as other people suggested earlier today if that becomes some kind of
basic format, whether it\'s like drug facts or nutrition labels and so
on, that would go a long way towards educating the public that all drugs
have potential benefits and risks.

And I think that would be a great service. And if they are always there,
I think then people will get over this fear if there are all these side
effects, they don\'t want to take the drugs or doctor\'s fear that that
will happen to their patients.

I think it should be a standard thing that people should know. All drugs
have potential benefits and risks.

DR. PITTS: Is there data that suggests that people don\'t realize that?

DR. DAY: Well, we saw some in the slides today, I believe, from Dr.
Hausman, you know, that people are scared and don\'t want to take drugs
because there are side effects. There\'s that. And there was one of her
was, \"I already have one health condition, why do I want ten more?\"

Doctors fear it more than, I think, patients exhibit it. They often
bring that up. That they don\'t want to have all those side effects out
there. It\'s going to keep patients away from effective therapies.

DR. TEMPLE: I always worry about statement that appear all the time
because I think that people tend to discount something they\'ve heard
multiple times. But you\'re not worried about that?

DR. DAY: I\'m worried about that in general. But if it was something
that framed the structure of the information about drugs, I think it
would help. This is what is called an organizing schema.

DR. TEMPLE: Yes, that seems different. That\'s the box or standard place
where you expect it. But the general statement, all drugs have risks.

DR. DAY: Right. You don\'t have to say that all the time. But, you know,
I think some better education on that point. And whether it would be
through some kind of highlights box in the print ads, how it would
happen on the Internet and the TV ads, you know, we\'d work out.

DR. ABRAMS: Just to follow up on that. Obviously different products have
different amounts of warnings. Some more serious. How would you
distinguish a drug with a box warning that can be fatal versus one that
has just annoying side effects? How would you present those
informations?

DR. DAY: Well, I think there are some examples in the broadcast ads now
where some of the TV ads say serious side effects can occur from using
this drug and include dah-dah-dah-dah. Be sure to talk to your doctor.
Sometimes they often say about pre-existing health conditions, other
side effects include blah-blah-blah-blah.

And then they often couch it in that this drug is appropriate for people
who already tried all these other things and haven\'t worked. And so
there is more context information. So the benefit and the risk changes
as a function of how serious the condition is anyway, how susceptible
they\'ve been to treatment before.

DR. HAUSMAN: They could use a color scheme like the terrorist threats.
Use a color scheme.

DR. ABRAMS: In broadcast ads, companies often have a signal as you
alluded to to signal this is a serious risk. How about print
advertisements? How would you see sponsors approaching a print ad?

DR. DAY: There are a lot of ways to do that. In my lab, I develop
different display mechanisms. A little matrix which is frequency by
severity. Or just clustering all of the high severity and medium and
low. Changing the size of the print for each type.

I\'ve tried fans, it kind of looks like a fan or a tree diagram. And
with these different ways of displaying information that, in fact,
people have never seen before.

And we do test people who have say education through the six grade as
well as college and so forth, people who have never seen some of these
display mechanisms before still will have a great boost in their ability
to know what the side effects are. And also what action to take.

So we have problem solving tasks that say what would you actually do if
you are taking this medication and got this side effect? And people
don\'t really know. They might recall that things can happen but they
don\'t know what to do about it.

And we can boost their ability to know what to do to get medical
attention right away, tell the doctor at the next visit, or just keep an
eye on it by 80 percent. So there are a variety of different display
mechanisms for showing the side effect information and other risk
information.

I think it is really important because the benefits are getting across
quite nicely. And I don\'t think the risks are.

DR. ABRAMS: Okay. We\'re going to open up the questions to the audience.
So any questions from the floor?

(No response.)

DR. ABRAMS: Okay. Well, that\'s the end of the first day. FDA wishes to
thank the researchers for their excellent presentations and the
excellent Q & A sessions that followed each panel.

We wish to thank you for your attention and interest in today\'s
meeting. We\'ll have another full day tomorrow beginning at 9:00 a.m.
We\'ll have four panels, same location. Thank you.

(Whereupon, the above-entitled meeting was concluded at 4:40 p.m.)