[Senate Hearing 107-986]
[From the U.S. Government Publishing Office]
S. Hrg. 107-986
DIRECT TO CONSUMER ADVERTISING (DTC)
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CONSUMER AFFAIRS, FOREIGN COMMERCE AND TOURISM
OF THE
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
JULY 24, 2001
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
ERNEST F. HOLLINGS, South Carolina, Chairman
DANIEL K. INOUYE, Hawaii JOHN McCAIN, Arizona
JOHN D. ROCKEFELLER IV, West TED STEVENS, Alaska
Virginia CONRAD BURNS, Montana
JOHN F. KERRY, Massachusetts TRENT LOTT, Mississippi
JOHN B. BREAUX, Louisiana KAY BAILEY HUTCHISON, Texas
BYRON L. DORGAN, North Dakota OLYMPIA J. SNOWE, Maine
RON WYDEN, Oregon SAM BROWNBACK, Kansas
MAX CLELAND, Georgia GORDON SMITH, Oregon
BARBARA BOXER, California PETER G. FITZGERALD, Illinois
JOHN EDWARDS, North Carolina JOHN ENSIGN, Nevada
JEAN CARNAHAN, Missouri GEORGE ALLEN, Virginia
BILL NELSON, Florida
Kevin D. Kayes, Democratic Staff Director
Moses Boyd, Democratic Chief Counsel
Mark Buse, Republican Staff Director
Jeanne Bumpus, Republican General Counsel
------
SUBCOMMITTEE ON CONSUMER AFFAIRS, FOREIGN COMMERCE AND TOURISM
BYRON L. DORGAN, North Dakota, Chairman
JOHN D. ROCKEFELLER IV, West PETER G. FITZGERALD, Illinois
Virginia CONRAD BURNS, Montana
RON WYDEN, Oregon SAM BROWNBACK, Kansas
BARBARA BOXER, California GORDON SMITH, Oregon
JOHN EDWARDS, North Carolina JOHN ENSIGN, Nevada
JEAN CARNAHAN, Missouri GEORGE ALLEN, Virginia
BILL NELSON, Florida
C O N T E N T S
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Page
Hearing held on July 24, 2001.................................... 1
Statement of Senator Dorgan...................................... 1
Statement of Senator Fitzgerald.................................. 48
Statement of Senator Wyden....................................... 2
Witnesses
Calfee, John E., Ph.D., Resident Scholar, American Enterprise
Institute...................................................... 20
Prepared statement........................................... 22
Chockley, Nancy, President, National Institute for Health Care
Management Foundation.......................................... 16
Prepared statement........................................... 18
Cloutier, Mark, Policy Director, RxHealth Value.................. 49
Prepared statement........................................... 51
Dolinar, Richard, M.D., Endocrinologist, Endocrinologist
Associates..................................................... 59
Prepared statement........................................... 61
Glover, Gregory J., M.D., J.D., on behalf of The Pharmaceutical
Research and Manufacturers of America.......................... 34
Prepared statement........................................... 36
Ostrove, Nancy, Ph.D., Deputy Director, Division of Drug
Marketing, Advertising, and Communications, Food and Drug
Administration................................................. 3
Prepared statement........................................... 5
Shaw, Michael S., M.D., Executive Director, EthicAd'.. 52
Prepared statement........................................... 54
Wolfe, Sidney M., M.D., Director, Public Citizen's Health
Research Group................................................. 29
Prepared statement........................................... 32
DIRECT TO CONSUMER ADVERTISING (DTC)
----------
TUESDAY, JULY 24, 2001
U.S. Senate,
Subcommittee on Consumer Affairs, Foreign Commerce and
Tourism,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:33 p.m. in
room SR-253, Russell Senate Office Building, Hon. Byron Dorgan,
Chairman of the Subcommittee, presiding.
STATEMENT OF HON. BYRON L. DORGAN,
U.S. SENATOR FROM NORTH DAKOTA
Senator Dorgan. The hearing will come to order.
My name is Senator Dorgan. I am Chairman of the
Subcommittee, and I will be joined by Senator Fitzgerald and I
believe Senator Wyden and some others on the Subcommittee. They
are delayed with other Senate business on the floor and in
other committees. So we are going to begin without them and
they will join us later.
The hearing today is to discuss the issue of prescription
drugs advertising directed to consumers, what is it about, what
is its purpose, what does it do to the cost of prescription
drugs in this country. We want to talk about that from a range
of different perspectives.
It is hard to turn on the television or open a newspaper or
a magazine these days without seeing an advertisement for a
prescription drug. I have a few of them here. You have the
opportunity with this to vote no on your favorite all-star for
the all-star game, the 2001 all-star game in Seattle. You get
to vote for your favorite all-star and also are able to see
that you ought to be considering taking Claritin. It is an
advertisement for Claritin on the all-star ballot.
This is a full-page ad from the Washington Post a month or
so ago. It says ``What is a better way to lower my blood
sugar?'' Then it advertises a medicine to do so, with a free
30-day supply coupon, despite the fact that, of course, you
must go to a doctor and get a prescription. This actually
offers a free 30-day supply coupon for this medicine.
This is a Ladies Home Journal, a rather popular magazine. I
just pulled out a few of the ads in this magazine. It is full
of direct advertising to consumers. ``Are you someone who is
forgetful? Are you repeating questions? Are you having trouble
finding words?'' It might apply to all of us, Senator Wyden. If
so, here is a prescription medicine you need to have. Go see
your doctor, tell him what you want prescribed for you.
What about estrogen loss? Here is what you ought to do, go
tell your doctor about those symptoms. Rheumatoid arthritis,
here is a way to solve it: go tell your doctor.
Dan Reeves, who I saw last night on television in fact, is
also here in this magazine. Dan Reeves says: ``Lowering my high
cholesterol became even more important than football.'' So this
Atlanta Falcons coach says to me last night on television, and
to you and to the world in this ad, that we ought to be
considering Zocor and we should talk the with our doctor about
Zocor.
Direct-to-consumer advertising for medicines that are
prescribed by a doctor and available to those the advertising
is directed toward only with the prescription of a doctor, what
is its purpose, is the impact, good, bad? Does it increase the
cost of prescription drugs? In the last couple of years we have
had increases in the cost of prescription drugs, both because
of utilization and also price inflation, of 18, 19 percent a
year. Is some of that caused by direct-to-consumer advertising?
Are there benefits to it? If so, what are they?
We want to talk about all of these issues today, and we
have invited a number of witnesses what I think will be able to
give us some information about it from a number of different
perspectives.
I could go through a whole series of data that talks about
increased prices for prescription drugs. I want to just make a
point about this hearing. I happen to think that there are
wonderful, life-saving, breath-taking new prescription drugs in
this country, good for those who develop them, good for those
who market them. Part of it comes from public funding and
investment in public-funded research. Part of it comes from
privacy research.
But life-saving drugs only save lives if you can afford
them. Those who cannot afford a life-saving drug are not going
to have their lives saved by that particular drug. So we want
to talk about all of these issues today, focusing especially on
the questions that have been raised increasingly by people: why
am I the target of a substantial amount of advertising for
prescription drugs that can only be achieved by me with a
prescription by a doctor. Doctors increasingly tell us that
they have patients coming to their office telling them what
kind of medicine they want. That is a result of prescription
drug direct advertising to consumers.
This is a rather recent and new approach. Only in recent
years have we had direct advertising to consumers of
prescription drugs. So this hearing will explore the impact of
that.
Let me call on my colleague Senator Wyden from Oregon for a
comment.
STATEMENT OF HON. RON WYDEN,
U.S. SENATOR FROM OREGON
Senator Wyden. Thank you, Mr. Chairman, and thank you
particularly for your leadership. You have been extremely
involved in a whole host of prescription drug issues. You and I
have been tackling these issues now for 20 years and it is a
pleasure to be able to team up with you. This is exactly what
the Consumer Affairs Subcommittee ought to be doing, is
tackling these kinds of issues, and I commend you for your
effort.
I have been interested in these questions since my days as
director of the Oregon Gray Panthers, and I think you are
right, Mr. Chairman, there is no question that these ads have
had an extraordinary impact on the Nation's senior citizens in
particular. I think it is important to look now at the
ramifications of what these ads mean.
Suffice it to say there are a whole host of issues that
have to be addressed and a variety of competing interests that
need to be balanced. I do not think that the American people
want us in the United States Senate to be the arbiter of what
information they get as long as that information is accurate.
But at the same time, they do think that we ought to look at
the health implications, for example, of massive amounts of
advertising, as you have touched on. That is an area that
really has not been examined.
There are First Amendment rights in this country to
communicate and the government's policy has been that accurate
information ought to be made available. But at the same time,
one ought to take a longer view, a view that gets out beyond
just looking at an individual prescription and look at the
health consequences of massive amounts of advertising, and that
has not been done.
The other aspect of all of this is that even without the
kind of advertising that has gotten most of the attention today
in the magazines and television and other sources that have
been touched on well by you, by the time many older people and
consumers come to their doctor's office they come today armed
with an enormous amount of information from the Internet. So
clearly as we look at the ways in which consumers get
information, we are going to have to look at all of the various
sources, and the Internet--we saw that yesterday in our e-
health hearing at one of our other subcommittees--has had
revolutionary impact in terms of people's access to information
and its consequences, both for their pocketbook and for their
health.
So I look forward to working with you and again appreciate
your leadership.
Senator Dorgan. Senator Wyden, thank you very much.
Let me call our first witness. The first witness today will
be Dr. Nancy Ostrove, Deputy Director of the FDA's Division of
Drug Marketing, Advertising, and Communication. If Nancy
Ostrove would come forward I would appreciate it. We would ask
those in the audience to please turn off cell phones.
Dr. Ostrove, thank you very much. You are, I understand,
going to discuss with us the rationale behind the FDA's 1997
advertising guidelines. We appreciate your being here and hope
that you will address in your testimony some of the issues that
we raised.
STATEMENT OF NANCY OSTROVE, Ph.D., DEPUTY DIRECTOR, DIVISION OF
DRUG MARKETING, ADVERTISING, AND
COMMUNICATIONS, FOOD AND DRUG ADMINISTRATION
Dr. Ostrove. I hope to. Good afternoon. I am Nancy Ostrove,
Deputy Director of the Division of Drug Marketing, Advertising,
and Communications at the FDA. We are the group that regulates
prescription drug promotion. Thank you very much for inviting
us to discuss our oversight of what we call DTC, the promotion
of prescription drugs directly to consumers.
FDA looks at DTC as kind of a double-edged sword. There is
real potential value in getting patients to recognize the
symptoms or the non-symptoms of undertreated conditions and
getting them treated. Ads can help in this respect. There is
also the potential for increasing the inappropriate use of
medications for patients who do not need them or should be on
other medications.
The available research in this area is equivocal. You can
find support for just about any position you want. My written
testimony touches on some of the research we have conducted or
examined. What it adds up to is that FDA is not aware of any
evidence that DTC promotion is increasing inappropriate
prescribing. On the other hand, there is evidence that DTC
promotion may be encouraging patients to obtain additional
information about their conditions and products and to talk to
their health care providers about health issues that they have
not raised before.
There are three important things to understand about our
authority. One is that the act and the regulations focus on the
content, not the existence, of prescription drug promotion. Two
is that the law does not make a distinction between targeted
audiences. The law has never banned prescription drug
advertisement to consumers. Up until the early 1980's it just
was not done. Three, the act specifically prohibits us from
requiring pre-clearance of advertisements except under
extraordinary circumstances.
My written testimony also contains some details of the
history of DTC promotion, but for today let us start in 1985
with FDA's announcement that the regulations for overseeing
promotion directed toward health care professionals also
provide sufficient safeguards to protect consumers. After we
made this announcement, we started seeing more and more print
advertisements.
But the current debate over DTC did not really heat up
until we issued a draft guidance that specifically addressed
broadcast. You see, the regulations had always allowed TV and
radio ads. Any ad, print or broadcast, that makes a claim about
a product also has to include the product's most important risk
information. Broadcast ads also have to do one of two other
things. They either have to give every single risk from a
product's approved labeling or have a mechanism for ensuring
that the audience can get the labeling.
In the late 1980's product sponsors felt they could not
include every single risk in a TV ad and get the networks to
air the ad--they still believe that--and FDA was not sure that
it was feasible to have a mechanism that would ensure that
patients could get the product information required as an
alternative to presenting every single risk.
But by the mid-1990's many changes had occurred in the
marketplace, and in technology, and that included increasing
acceptance of the Internet, increased availability of print
ads, and common use of toll-free telephone numbers to get
information. Given these changes, we came to believe that
sponsors could in fact ensure that consumers could get the
additional product information conveniently.
So in 1997 we issued a draft that we finalized in 1999 of
guidance that gave advice on how sponsors could meet the
regulatory requirement for product information disclosure for
broadcast ads by giving references to multiple sources of
information; not just one source but many. At the time we
issued the guidance we said that we would assess the impact on
the public of it and of DTC promotion in general.
We closely monitor DTC promotion and especially broadcast
ads to ensure that the information that consumers need to
understand any claims and the product's risks is understandably
presented. Even though the sponsors do not have to submit their
promotional materials until the time they appear in public,
most sponsors voluntarily submit the broadcast ads to us for
review and comment.
Because of this voluntary cooperation, we believe that we
review most product claim broadcast ads before they appear,
although we do not know in truth whether we review most
reminder and help-seeking ads.
To sum up, at this time we are not aware of any evidence
that DTC promotion is harming the public health. However, we
continue to examine the issue. We intend to continue closely
scrutinizing DTC promotion, working with industry to ensure
that broadcast ads comply with regulatory requirements, and
taking timely enforcement action when it is appropriate.
Thank you for your patience. I will be happy to answer any
questions.
[The prepared statement of Dr. Ostrove follows:]
Prepared Statement of Nancy M. Ostrove, Ph.D., Deputy Director,
Division of Drug Marketing, Advertising and Communications, Food and
Drug
Administration
Introduction
Mr. Chairman and Members of the Subcommittee, I am Nancy Ostrove,
Deputy Director of the Division of Drug Marketing, Advertising, and
Communications (DDMAC) of the Center for Drug Evaluation and Research
(CDER), Food and Drug Administration (FDA or the Agency). DDMAC
regulates prescription drug promotion and helps ensure that FDA-
regulated industry complies with the applicable provisions of the
Federal Food, Drug, and Cosmetic (FD&C) Act and implementing
regulations.
I am here today to talk about promotion that manufacturers of
prescription drugs (product sponsors) direct toward consumers and
patients. This is referred to as ``direct-to-consumer'' promotion or
DTC. Such promotion uses multiple avenues for reaching lay audiences,
including, but not limited to: television and radio advertisements,
print advertisements, telephone advertisements, direct mail, videotapes
and brochures.
It is important to understand the scope of FDA's authority in this
area. It is also important to understand the different types of
advertisements that are directed toward consumer audiences.
Statutory and Regulatory Authority
The FD&C Act and regulations do not distinguish between
professional and consumer audiences. Section 502(n) of the FD&C Act
specifies that prescription drug advertisements must contain ``a true
statement of . . . information in brief summary relating to side
effects, contraindications, and effectiveness'' of the advertised
product. The implementing regulations (Title 21, Code of Federal
Regulations [CFR] Section 202.1), originally issued in the 1960s,
specify, among other things, that prescription drug advertisements
cannot be false or misleading, cannot omit material facts, and must
present a fair balance between effectiveness and risk information.
Further, for print advertisements, the regulations specify that every
risk addressed in the product's approved labeling must also be
disclosed in the advertisements.
For broadcast advertisements, however, the regulations require ads
to disclose the most significant risks that appear in the labeling. The
regulations further require that the advertisement either contain a
summary of ``all necessary information related to side effects and
contraindications'' or provide convenient access to the product's FDA-
approved labeling and the risk information it contains.
Finally, the FD&C Act specifically prohibits FDA from requiring
prior approval of prescription drug advertisements, except under
extraordinary circumstances. Also, the advertising provisions of the
FD&C Act do not address the issue of drug product cost.
Types of Advertisements
There are three different types of ads that product sponsors use to
communicate with consumers: ``product-claim'' advertisements, ``help-
seeking'' advertisements, and ``reminder'' advertisements.
Advertisements that include both a product's name and its use, or that
make any claims or representations about a prescription drug, are known
as ``product-claim'' advertisements. These ads must include a ``fair
balance'' of risks and benefits. In addition, they must provide all
risk information included in the product's FDA-approved labeling or,
for broadcast advertisements, provide convenient access to this
information. In our regulations, the phrase ``adequate provision'' is
used to identify the convenient access option. Unlike the ``product
claim'' ads, ``help-seeking'' advertisements and ``reminder'' ads need
not include any risk information.
A ``help-seeking'' advertisement discusses a disease or condition
and advises the audience to ``see your doctor'' for possible
treatments. Because no drug product is mentioned or implied, this type
of ad is not considered to be a drug ad and FDA does not regulate it.
The second type of advertisement that does not need to include risk
information is called a ``reminder'' advertisement. The regulations
specifically exempt this type of ad from the risk disclosure
requirements. Like ``help-seeking'' ads, the ``reminder'' ad is
limited, although in a different way from ``help-seeking'' ads.
``Reminder'' ads are allowed to disclose the name of the product and
certain specific descriptive (e.g., dosage form) or cost information,
but they are not allowed to give the product's indication or dosage
recommendation, or to make any claims or representations about the
product. The exemption for ``reminder'' ads was included in FDA's
regulations for promotions directed toward health care professionals,
who presumably knew both the name of a product and its use.
``Reminder'' ads serve to remind health care professionals of a
product's availability. They specifically are not allowed for products
with serious warnings (called ``black box'' warnings) in their
labeling.
Evolution of DTC Promotion
Prior to the early 1980's, prescription products were not promoted
directly to consumers and patients. Instead, product sponsors often
produced materials that were given to health care professionals to pass
on to patients if they thought this would be appropriate for particular
patients. In the early 1980's, a few companies started advertising
products directly to patient audiences (specifically, older people
concerned about pneumonia and people taking prescription ibuprofen to
treat arthritis pain). As a result of questions and concerns about
promotion directed toward non-health care professionals, in 1983 FDA
requested that sponsors suspend DTC ads to give the Agency time to
study the issue.
The industry complied with this request, and during the ensuing
moratorium FDA conducted research and sponsored a series of public
meetings. In 1984, the University of Illinois and Stanford Research
Institute jointly sponsored a symposium to discuss consumer-directed
prescription drug advertising from a broad research and policy
perspective. On September 9, 1985, FDA withdrew the moratorium in a
Federal Register (FR) Notice (50 FR 36677), which stated that the
``current regulations governing prescription drug advertising provide
sufficient safeguards to protect consumers.''
During the early 1990's, product sponsors increasingly used
consumer magazines to advertise their products. These ads typically
included a promotional message together with the ``brief summary'' of
adverse effects, similar to that used in physician directed ads. The
``brief summary'' statement, which frequently appears in small print,
is not very consumer friendly. In the 1990's, product sponsors also
started using television advertisements in a limited fashion.
Television advertisements were limited because FDA and industry did not
believe that it was feasible to disseminate the product's approved
labeling in connection with the ad. The extensive disclosure needed to
fulfill this requirement essentially precluded the airing of such ads.
For example, one way to satisfy this requirement would be to scroll the
``brief summary,'' which would take a minute or more even at a barely
readable scrolling rate. The industry, therefore, resorted to
television ads that did not require risk disclosure.
By the mid-1990's, product sponsors started placing ``reminder''
ads on television. Because these ads only mentioned the name of the
drug, however, they were extremely confusing to consumers, who, unlike
health care professionals, were not knowledgeable about the name and
the use for these products.
In response to increasing consumer demand for information, FDA
began to consider whether broadcast advertisements could be constructed
to ensure access to product labeling, the only alternative to including
all of an advertised product's risk information. FDA considered
suggestions about providing access to multiple sources of product
labeling as a means of satisfying the requirement that consumers have
convenient access to FDA-approved labeling when manufacturers broadcast
a ``product-claim'' advertisement.
In August 1997, FDA issued a draft guidance entitled: ``Guidance
for Industry: Consumer-Directed Broadcast Advertisements'' that
clarified the Agency's interpretation of the existing regulations. The
Guidance described an approach for ensuring that audiences exposed to
prescription drug advertisements on television and radio have
convenient access to the advertised product's approved labeling. The
proposed mechanism consisted of reference in the broadcast
advertisement to four sources of labeling information: a toll-free
telephone number, a website address, a concurrently running print
advertisement, and health care professionals. Following a comment
period, and detailed review and consideration of the comments, FDA made
only minor changes to the draft guidance, and issued it in final form
in August 1999 (64 FR 43197, also found at www.fda.gov/cder/guidance/
1804fnl.htm). In announcing the final guidance, FDA advised that the
Agency intended to evaluate the impact of the guidance, and of DTC
promotion in general, on the public health, within two years of
finalizing the guidance.
Stakeholder Perspectives
A number of stakeholder groups have expressed strong interest in
DTC promotion. Those that are positive about DTC promotion assert that
this practice will:
Improve consumers' knowledge of drugs and drug availability.
Encourage consumers to talk with their health care providers
about their health problems.
Allow consumers and patients to have a greater role in
decisions about their own health care that they say they
desire.
Improve communication between patients and their physicians.
Improve appropriate prescribing by allowing physicians to
get more information about their patients from their patients.
Lower the cost of prescription drugs.
Not all stakeholders are positive about DTC promotion. Opponents
assert that DTC advertising will:
Confuse consumers about drugs.
Make it appear that prescription drugs are safer than they
are.
Interfere with the patient-physician relationship because
patients will insist that their physicians prescribe the
advertised products.
Increase inappropriate prescribing.
Raise the cost of prescription drugs.
Finally, there is a group of stakeholders with a less polarized
view of DTC promotion. They believe that such promotion has both
benefits and risks, but that it should be strictly regulated, and that,
preferably, all DTC materials should be ``pre-approved'' by FDA. They
often assert that there are potential public health benefits associated
with patients visiting health care providers about untreated diseases
or conditions, particularly those that appear to be under treated in
the population and that are responsible for long-term harm (for
example, high cholesterol, high blood pressure, diabetes and
osteoporosis).
Current Situation
FDA recognizes that drug promotion raises certain issues for health
care professionals and different issues for consumers, in light of
differences in medical and pharmaceutical expertise. For this reason,
FDA has monitored DTC promotion, and especially broadcast promotion,
very closely to help ensure that adequate contextual and risk
information, presented in understandable language, is included to
fulfill the requirement for fair balance and to help the consumer
accurately assess promotional claims and presentations.
Product sponsors of prescription advertisements are required to
submit their promotional materials to FDA around the time these
materials are initially put into public use. FDA receives approximately
32,000 of these submissions per year, for all types of promotion,
including promotion to health care professionals. Product sponsors also
can submit draft materials to FDA for review and comment prior to using
them. DDMAC has made it a high priority to provide comments to product
sponsors on voluntarily submitted draft broadcast advertisements within
a reasonable time. In fact, although it is not required, a majority of
product sponsors voluntarily submit their broadcast advertisements to
DDMAC for prior review and comment at some point as advertising
materials are being produced. Product sponsors may ask for review and
comment at the very initial stages of production (by supplying the
words they intend to use along with rough drawings of their proposed
graphics), or at the later stages of final videotape production. DDMAC
only gives final comments on final videotapes because inappropriate
presentations can turn an otherwise acceptable advertisement into an
unacceptable one (for example, by pacing the risk disclosure too
rapidly, including multiple distracting visual images during the risk
disclosure, or including images that overstate the efficacy of the
product beyond what is supported by substantial clinical evidence).
Since January 1997, sponsors of about 65 prescription drugs have
aired ``product-claim'' advertisements on television or radio. A small
number of prescription biological products also have been advertised.
Nine products fall into the allergy category (nasal and ocular anti-
histamines, and nasally administered corticosteroids), while another
eight products treat skin or hair-related problems (acne, cold sores,
rosacea, baldness, unwanted facial hair, nail fungus). More
importantly, ten products are designed to treat diseases that are
believed to be under treated, including high cholesterol and heart
disease, and mental health problems like depression. Five products to
treat or prevent osteoporosis or menopausal symptoms have been
advertised. Other advertised products are approved to treat such
conditions or diseases as asthma, Alzheimer's Disease, arthritis,
chronic obstructive pulmonary disease, diabetes, insomnia, migraine,
obesity, overactive bladder, serious heartburn, smoking cessation, and
sexually transmitted diseases. Most of these are serious problems where
patients are in the best position to recognize symptoms.
It is important to note that DDMAC does not know how many different
advertisements have aired in broadcast media for these 65 drugs. There
have been multiple campaigns for a number of the products, including
the allergy and high cholesterol products. In addition, many campaigns
include different length ``product-claim'' commercials, as well as
multiple short ``reminder'' commercials. DDMAC does not track the
number of different broadcast advertisements that are submitted.
Further, because ``help-seeking'' advertisements, if done properly, are
not considered to be drug ads, most product sponsors do not send them
to DDMAC under the submission requirements for prescription drug
promotional materials. Therefore, we have no measure of how many of
these have been in the public domain.
Enforcement Related to DTC Promotion
Since 1997 FDA has issued:
30 ``untitled'' (or ``Notice of Violation'') letters on
``product-claim'' broadcast advertisements. Such letters
request that the violative promotion be stopped immediately.
Product sponsors virtually always comply immediately with this
request.
3 ``warning letters'' on broadcast advertisements. This is a
higher-level enforcement action, and requests that a remedial
campaign be conducted by the company to correct the impressions
left by the ad.
12 ``untitled'' letters on purported ``reminder'' broadcast
advertisements.
3 ``untitled'' letters on purported ``help-seeking''
broadcast advertisements.
Most of the violations cited were because the ad overstated or
guaranteed the product's efficacy, expanded the indication or the
patient population approved for treatment, or minimized the risks of
the product, through either inadequate presentation or omission of
information.
Since January 1997, the Agency has issued:
44 ``untitled'' letters that addressed DTC print
advertisements or other promotional materials, including
purported ``reminder'' and ``help-seeking'' materials.
1 ``warning letter'' for a specific DTC print advertisement,
and 1 ``warning letter'' that included a DTC print
advertisement as part of an overall misleading campaign.
Generally, the violations involving print ads making ``product-
claim'' ads were similar to those cited above. Nearly all ``reminder''
ad violations were the result of representations about the product that
triggered the need for full disclosure of benefits and risks. ``Help-
seeking'' ad violations were due to a particular product being implied
in the message. As noted above, however, FDA cannot determine how many
specific advertisements serve as the denominator for assessing how many
have resulted in enforcement action compared with those that have not.
Research on DTC Promotion
A number of groups have been conducting research on DTC promotion.
Much publicly available research consists of surveys utilizing samples
of consumers or patients to examine attitudes about DTC promotion and
self-reported behaviors related to DTC promotion in the context of
patient-physician visits and use of prescription drugs. The groups
sponsoring this research include: Prevention magazine, TIME Inc., the
National Consumers League, and American Association of Retired Persons.
Partial results of a few surveys of physicians have been made publicly
available. FDA remains concerned, however, about the representativeness
of the physician survey sample.
In 1999, FDA sponsored a telephone survey that focused on a
national probability sample of patients who had seen a physician for a
problem of their own within the three months prior to the survey. The
results of this patient survey suggested that patients are seeking
additional information as a result of DTC promotions that they have
seen. This information was sought primarily from health care
professionals, and secondarily from reference texts and family.
Generally, between 10 and 20 percent of respondents said that they
sought additional information from the sources referenced in broadcast
advertisements--toll-free telephone numbers, websites, and print
advertisements. A major result, and one that is consistent with results
of Prevention's national surveys, is that a significant minority of
respondents said that a DTC ad has caused them to ask a doctor about a
medical condition or illness they had not previously discussed. This
could represent a significant and positive public health benefit,
particularly if these patients are talking about undiagnosed heart
disease or other serious disorders.
The survey results also suggest that DTC advertisements are not
significantly increasing visits to a physician's office. For the most
part, patients said that they had recently visited their doctors for
the traditional reasons: because it was time for a check-up (53
percent), because they were feeling ill (42 percent), or because they
had a sudden symptom or illness (41 percent). Only two percent said
that they had visited their doctor because of something they had seen
or heard. Of those patients who had a conversation with their doctor
about a prescription drug: 81 percent said that their doctor had
welcomed the question, 79 percent said that their doctor discussed the
drug with them, and 71 percent said that their doctor had reacted as
though the conversation was an ordinary part of the visit. Only four
percent said that their doctor seemed upset or angry when the patient
asked about a prescription drug. According to the patients, therefore,
physicians seem to be reacting well to questions about prescription
drugs. Finally, only 50 percent of these patients said that their
doctor gave them the medication discussed. Thirty-two percent said that
the doctor recommended a different drug. Twenty-nine percent of the
respondents indicated that behavioral or lifestyle changes were
suggested by the doctor. It therefore appears, from FDA's patient
survey, that physicians are comfortable denying prescriptions when the
prescription would not be right for the patient.
A small number of patients who were denied prescriptions said that
their doctors told them why. Reasons included: the drug was not right
for the patient; the doctor wanted the patient to take a different
drug; the drug had side effects of which the patient was unaware; the
patient did not have the condition treated by the drug; the patient did
not need a prescription drug; the patient could use a non-prescription
drug; and there was a less expensive drug available.
Patients also were asked about their attitudes concerning
prescription drug advertisements. Their answers indicated somewhat
mixed feelings. Eighty-six percent agreed that these ads help make them
aware of new drugs, 70 percent agreed that the ads give enough
information to help the patient decide if they should discuss the
product with a doctor, and 62 percent agreed that ads help the patients
have better discussions with their doctors about their health. Only 24
percent agreed that DTC ads make it seem like a doctor is not needed to
decide whether a drug is right for someone. In contrast, 58 percent
agreed that DTC ads make drugs seem better than they really are, 59
percent agreed that ads do not give enough information about the
advertised product's risks and negative effects, and 49 percent agreed
that these ads do not give enough information about the benefits and
positive effects of the advertised product.
Next Steps
In issuing both the draft and the final broadcast advertisement
guidance, FDA stated its intent to assess the impact of the guidance,
and of DTC promotion in general, on the public health. FDA is also
aware that privately funded research is being planned to examine the
effects of DTC promotion. At present, FDA is not aware of any evidence
that the risks of DTC promotion outweigh its benefits. FDA intends to
carefully examine all available data, to determine whether the public
health is adequately protected.
This concludes my prepared remarks. I will be glad to answer any
questions you may have on this topic.
Senator Dorgan. Dr. Ostrove, thank you very much.
You indicated near the start of your testimony that the FDA
is not aware of any information that would suggest
inappropriate prescribing as a result of direct-to-consumer
advertising. The fact that you are not aware of information,
does that suggest no information exists or no studies have been
done, or is it just that you are not aware of them?
Dr. Ostrove. Well, it does not suggest that no information
exists. Certainly there might be some. We have tried to make it
clear to the public and we have asked in many circumstances and
in many venues for any information that would be useful to our
assessment of the impact of DTC promotion. People have come
forward. There have been studies that have been done looking at
patients. There have been some studies of physicians. The
representativeness of the samples is a little questionable. We
recently participated in a design conference that HHS sponsored
to try to encourage research into this area.
So it is not that it necessarily is not out there, but it
certainly has not been brought to our awareness.
Senator Dorgan. One of the next witnesses, Nancy Chockley,
President of the National Institute for Health Care Management
Research and Educational Foundation, says in her testimony:
``In an analysis we will be releasing soon, we have found that
the 50 drugs most heavily advertised to consumers in 2000 had
aggregate sales increases last year of 32 percent compared to
14 percent for all other drugs.''
Can you give me an analysis of that? That follows a comment
she makes in her testimony: ``Direct-to-consumer advertising
appears to be inducing significant new demand for prescription
drugs and thus contributing to the recent sharp rise in
pharmaceutical spending.'' Do you agree or disagree with that
conclusion?
Dr. Ostrove. I think it is extremely difficult to tease out
the impact of direct-to-consumer advertising, given the other
factors that are involved. In addition to DTC advertising, the
manufacturers are out there advertising to health care
professionals, and in many cases when they have a DTC campaign,
and if they are smart, the first thing that they do is they let
the health care professional know about that campaign, because
they do not want the prescriber to be blind-sided.
So at the same time you are having a campaign to consumers,
which by the way is also seen by health care professionals,
there is also a separate campaign that is going to the health
care professionals. In addition to that, of course the
manufacturers put their money where they think the market is.
So they are going to spend more where they think that there is
a market for something.
So this is one of the issues that was raised in the design
conference, how do you tease out the impact of DTC without
doing a controlled study, which we are not aware that anyone
has done and would be a fairly significant undertaking.
The other piece of that is that even if there is an
influence of DTC on utilization, our concern is, our question
is, is that appropriate? Are people going in and appropriately
talking to their doctors about conditions that are important
for them and that in fact they have, and are they getting the
appropriate treatment, or is it increasing inappropriate
treatment? That is what we have no data on. I do not think that
the data that are going to be a part of this report are likely
to address that.
Senator Dorgan. That is an important question, I think, and
if we have no data on it should we aspire to get data and, if
so, how? Does the FDA propose that we aspire to get such data?
Dr. Ostrove. Well, the FDA has in fact requested a number
of times to the industry and to other interested stakeholders
that research be done to look at this. The agency itself, of
course, has--the agency itself is doing what research it feels
it can do. We recently in 1999, we did a survey of patients,
people who had seen their doctors in the last 3 months, and we
are hoping to do another one. We are also hoping to do a survey
of physicians and looking at their experiences with DTC and how
it has influenced their practices.
So we are doing what we can in this area, and we have
encouraged the private sector to do the same. We have not seen
anything as yet. We are aware that at least some manufacturers
are interested in doing this, but we really do not know where
that is.
Senator Dorgan. But I am wondering whether it should be the
manufacturers that would do such a study. They obviously have
an interest in the outcome of the study. Should there not be
some independent party doing a study? Should the FDA be
recommending some mechanism in government to have a study
completed?
Dr. Ostrove. Well, certainly HHS is interested in this
whole area, in the cost issues as well as in FDA concerns,
which is the public health issues and the protection of the
public health. It is difficult for me to answer whether this
should be done. Certainly I think on a theoretical basis, yes,
it should be done. Then it is a matter of who is going to do
it, how is it going to get done.
As I said, one of the reasons for kind of hoping that the
manufacturers would do it is the relative--the resources that
they have.
Senator Dorgan. But you would agree that manufacturers have
a vested interest in the outcome?
Dr. Ostrove. Yes.
Senator Dorgan. It seems to me not logical that you would
have someone do a study who has an interest in the outcome of
the study.
Dr. Ostrove. It would be best for an uninterested party, a
party that does not have a vested interest, to do this.
Senator Dorgan. Senator Wyden.
Senator Wyden. Thank you, Mr. Chairman.
Let me start, if I could, Dr. Ostrove. Chris Castle, who I
met when I was teaching gerontology in Oregon, recently said--
she is now chairman of geriatrics at Mount Sinai in New York.
She said recently: ``Direct to consumer advertising has made a
huge impact on sales of medications which are not always the
best medications for people to take.''
Would you by and large agree with that statement of Dr.
Castle's?
Dr. Ostrove. That is a very general statement, a huge
impact on medications that are not always the best. I am not
sure exactly what data she is basing that statement on, so it
would be difficult.
Senator Wyden. In your opinion, are there any ramifications
for the use of generic drugs in this whole focus on direct-to-
consumer advertising? As we know, in many instances, not always
but in many instances, the generic drug is cheaper. It sure
looks like the bulk of the advertising direct-to-consumer is of
the more expensive brand names. I would be interested in your
knowing whether you think there are any ramifications in this
trend for the use of generics?
Dr. Ostrove. I think certainly there are potential
ramifications for the use of generics. The innovator
manufacturers clearly have greater resources, monetary
resources to advertise their products than the generic
manufacturers do.
What is kind of interesting is, at least from some of the
data that we have from our study, is that when patients went in
to see a doctor and talked to the doctor about a particular
prescription product, in only 50 percent of the cases did they
actually get the product that they had discussed. In a number
of cases what ended up happening is that they got another
product.
My suspicion is that--and we do not have the actual details
of this, but in many of those cases it may have been case where
the gatekeeper prescriber said: You know, I am glad you came in
to talk to me about this condition; you do have this condition,
but you do not need that drug, it is more expensive, or it is
not what you need; here is one that has been out on the market
a long time, it has got a better safety profile; why do you not
take it.
So certainly in some cases that is what I believe happened.
We also know that in that certain percentage of the cases the
doctor told the patient that what they needed was behavioral
and lifestyle changes.
So the gatekeeper--the physician or the prescriber, excuse
me, is acting as a gatekeeper in these particular situations.
So it is hard again to kind of tease out how much of that is
going to be influencing the use of generics. Hopefully,
physicians will be using this, prescribers will be using this
opportunity as kind of a learning opportunity, a point to
communicate with the patient.
Senator Wyden. This is an area I am going to follow up with
you and others in government, because I think Senator Dorgan is
absolutely right. What we hear about from our constituents,
older people and others, is the affordability question. I am
very concerned about the ramifications of direct-to-consumer
advertising for access to generics. If you just look at the ads
that Senator Dorgan held up, these are blockbuster brand name
drugs, they are exciting products. You do not seem to see the
same kind of focus on marketing this way on generics. I think
we need to do follow-up work in this area.
Dr. Ostrove. If I can add one more thing, we have also
looked at the products that are being advertised most heavily
to consumers and in many cases for those products they are
breakthroughs and there are no generics. I am not saying that
is true in all the cases, but in many of the cases there are
not generics available.
Senator Wyden. It is a fair comment, and one of the things
I think we ought to look at is the evolution of how this drug
comes into market and what happens when it goes off to a
patent.
Dr. Ostrove. Absolutely.
Senator Wyden. Let me ask you just a couple of other
questions. I appreciate Senator Dorgan's indulgence. A number
of physician groups across the country have been urging
resolutions through their state societies to in effect block
this whole trend. What their argument largely appears to be is
that they feel the this trend in advertising is interfering
with the doctor-patient relationship, that the pharmaceutical
industry in some way is intruding into the doctor-patient
relationship.
Do you think there is any validity to that argument?
Dr. Ostrove. We have heard a lot of anecdotal reports from
physicians that they feel that DTC advertising is interfering
with the doctor-patient relationship. We have also heard
anecdotal reports from other physicians that it is improving
the relationship they have with their patients, because the
patients are coming in, they are more informed, they are more
willing to take their medication, in other words their
adherence is better.
Our data--in our survey we asked patients how their doctor
reacted to the discussion of the prescription drug when they
had these discussions. The majority of them, in the high 70's,
low 80's, said that the doctor was very good about it. Very few
of them, only 4 percent I think of the patients, said that the
doctor seemed to be disturbed by their interaction.
So it would appear that the physicians are doing a pretty
good job on the whole of dealing with patients. The patients do
not perceive any problems. But this is an area that we feel
needs more research and it is one of the reasons why we would
like to do a survey of a representative sample of physicians,
to get it from their perspective.
Senator Wyden. That would be helpful as well.
The last question I wanted to ask: Do you see any
relationship between direct-to-consumer advertising and this
trend toward coupons and guarantee programs? The concern is I
think you all have had discussed with you is that they use
these coupon programs and these discount programs to sort of
bring people in, but they bring them in on the most expensive
drugs again, and that this has been tied in some way to the
direct-to-consumer advertising trend.
What, if anything, has the agency picked up on that?
Dr. Ostrove. Well, it is a marketing technique.
Senator Wyden. Are you troubled by this? Are you concerned
about what I have described?
Dr. Ostrove. We have looked at the whole area and we are
troubled by some--more troubled by some things than others.
Senator Wyden. Tell me what part of this troubles you,
then?
Dr. Ostrove. Anything that gets into the cost issue, where
apparently a product is being touted for its cost benefits as
opposed to its clinical benefits, is troubling. But in terms of
our authority, these coupons, these offers, unless they are
false or misleading, lacking in fair balance in some way, or
involving an omission of material fact, there is not a good
argument for us to object to them on the basis of the
regulations.
Senator Wyden. I understand that. My time is up, but I
think it goes again to the point that I was making, that if
they are accurate so be it, but I am troubled by the fact that
you give people, you give senior citizens discounts on
something, so in effect you get them tied, you get them bonded
to a certain kind of pharmaceutical at a very expensive price.
Then the coupon program is over and they have developed an
affinity for that product and it is sort of cemented by direct-
to-consumer advertising.
I just want us to start looking at what is really going on
in the marketplace, and that is why I think what Senator Dorgan
is doing is important and I appreciate it.
Senator Dorgan. Thank you, Senator Wyden.
Dr. Ostrove. One other piece with regard to that. I hope I
am not interrupting.
Senator Dorgan. That is fine.
Dr. Ostrove. But there is a value or at least there appears
to be some data that indicate that direct-to-consumer
advertising actually makes it more likely that people will take
their medications, will continue on their regimen, will fill
their prescriptions. Given that noncompliance is such a big
problem in taking medications, there is that other side of it,
that if people in fact do become committed to their medications
perhaps they will use them more appropriately and not stop
taking them, or at least go to their doctors if they do.
Senator Dorgan. Will you submit that information for the
record that you just cited? Is there a source for that?
Dr. Ostrove. A survey that Prevention magazine has done. I
believe that they asked those kinds of questions about
compliance in their 1998 and 1999 surveys.
Senator Dorgan. Dr. Ostrove, how large is the Division of
Drug Marketing, Advertising, and Communication?
Dr. Ostrove. We have 32.
Senator Dorgan. You seem to, based on the questions I have
asked and Senator Wyden has asked, seem to come down on the
side of suggesting this is really a good thing. You have used a
little cautionary language, but by and large as I interpret
what you are saying, on balance you think direct-to-consumer
advertising is probably fine, probably helps. Is that a good
way to summarize what you just told us?
Dr. Ostrove. Well, I am not sure--it is the double-edged
sword metaphor. I guess we believe that there are good aspects
to it, but we believe that there are potentially not so good
aspects to it as well. So we are hoping for a balance.
Senator Dorgan. When I started today I held up this, which
is a Washington Post full page ad, ``What is the better way to
lower my blood sugar,'' and then it provides a medicine, name
of a medicine, and a free 30-day supply coupon. If you read
this in all the smaller type, you understand that you have got
to get a prescription from a doctor.
But someone who is not a careful reader would just see, I
have got a high blood sugar level, I get a free 30-day supply.
Is this the sort of thing you look at in terms of advertising?
You have how many people looking at that at your agency?
Dr. Ostrove. We have 14 reviewers who do primary reviews
and one of them is devoted full-time to direct-to-consumer
advertising. Yes, we look at the overall presentation.
Senator Dorgan. 14. The consumer advertising has increased
very substantially, as you know, in recent years, the rampup
since 1997. Have the resources that you employ to respond to
these increased at all?
Dr. Ostrove. Well, the person who is devoted to direct-to-
consumer is a relatively new--yes, we have kind of moved
resources around. We prioritize our workload as a function of
what we think is important out in the marketplace, so we
respond to changes in the marketplace.
Senator Dorgan. When you said a person, there is more than
just one person?
Dr. Ostrove. Oh, absolutely. All the primary reviewers--the
primary reviewers work on different classes of drugs, and
depending on the class they will work more or less on DTC
advertisement. Some classes have very little DTC, other classes
have a lot.
Senator Dorgan. My understanding is in 1998 the FDA issued
158 warnings and untitled letters regarding promotional
materials, drug promotional materials, both for direct-to-
consumer ads and detailing. In 1999 it went from 158 down to
107, in 2000 it went down to 79. What is this decrease
attributed to? Is there less enforcement or is there better
compliance?
Dr. Ostrove. I think there are probably a lot of factors
that go into that. We are in the process of looking at how best
to structure things so that we can use our resources most
effectively. I am not really sure how to attribute that
decrease. We have had some turnover. That may be part of it. We
are spending a lot of time on kind of advisory activities, and
the hope of that is to get the information, to get the
promotional materials, before they reach the public. So again
on a voluntary basis, manufacturers can submit their
promotional materials and we give advice and comment.
So some of the change may be due to that. Some of it may be
due to more people working on educational----
Senator Dorgan. Would you submit for the record an analysis
of that after you have had a chance to visit with your agency?
Dr. Ostrove. Happy to do that.
Senator Dorgan. Again, one would expect as direct-to-
consumer advertising dramatically increases, and it really
has--I think all of us understand that--one would expect FDA
warnings not to drop by 50 percent, but would expect them to
probably keep pace with the increase in promotional
advertising, because there is a lot of money at stake. This is
a large industry with a very substantial bankroll that is
advertising very, very aggressively.
What I see is a decrease by 50 percent of the warnings and
untitled letters that you are sending out. Somehow that seems
to suggest to me a less aggressive enforcement attitude with
respect to this.
Dr. Ostrove. Well, actually let me clarify that, please.
You were talking about all of the untitled and warning letters,
and that deals with--actually, most of those are toward
professionally directed materials. I do not have the numbers
with me, but I can get the numbers back to you that would
demonstrate that in fact our enforcement of direct-to-consumer
promotion has not decreased in the last 5 years.
Senator Dorgan. We will just ask you to submit that for the
record.
Dr. Ostrove. I will definitely do that. *
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* The information referred to was not available at the time this
hearing went to press.
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Senator Dorgan. Dr. Ostrove, thank you very much for being
with us. We appreciate your testimony.
We would like to ask the next panel to come forward: Dr.
Stephen Findley, Director of Research and Policy, the National
Institute for Health Care Management; Dr. Sidney Wolfe,
Director, Public Citizen, Health Research Group; Dr. Gregory
Glover, attorney-physician, representing the Pharmaceutical
Research and Manufacturers of America, PhRMA; Dr. John Calfee,
a Resident Scholar at the American Enterprise Institute.
We welcome all four of you. We have asked that you submit
your statements for the record and ask that you summarize your
statements in 5 minutes. Let me begin--we have Nancy Chockley
here in place of Stephen Findley. Let me begin with Ms.
Chockley, President of the National Institute for Health Care
Management. Would you proceed.
STATEMENT OF NANCY CHOCKLEY, PRESIDENT, NATIONAL INSTITUTE FOR
HEALTH CARE MANAGEMENT FOUNDATION
Ms. Chockley. Yes. Good afternoon, Mr. Chairman and
Senator. Thank you very much for this opportunity to testify. I
am Nancy Chockley, President of the National Institute for
Health Care Management Foundation. We are a research and policy
group based here in Washington. We get our funding from health
plans, from the government, and from private foundations. We
have been doing a lot of work looking at the pharmaceutical
industry and what is driving expenditure growth. I would like
to make just a couple of points, four points really, here today
on what we have been finding.
One is that, as you already stated, direct-to-consumer
advertising appears to be inducing new demand for prescription
drugs and thus contributing to the recent sharp rise in
pharmaceutical spending. Specifically, the data show that the
drugs driving the growth in utilization and sales are also the
drugs that are most heavily advertised. Simply put, we have
found what Madison Avenue has known all along: advertising
works.
In an analysis, as you mentioned before, that we will be
releasing probably in the next month, we found that the 50
drugs most heavily advertised to consumers in 2000 had an
aggregate sales increase last year of 32 percent compared to
about 14 percent for all other drugs, which by the way number
over 9,800 drugs. So we are looking at 50 versus about 9,800
drugs.
A large portion of the increase in sales for the 50 most
heavily advertised drugs comes from a sharp increase in the
number of prescriptions filled for them. As the chart over here
illustrates, the combined number of prescriptions for these 50
drugs was up almost 25 percent last year. You compare that to
the other 9,800 drugs, they were up less than 2 percent. So it
does appear that it is having an impact.
I would like to note, though, that these numbers are
preliminary and we are still working on them. But let me give
you a specific example with Vioxx. We found that the growth in
sales for the new arthritis drug Vioxx contributed more than
any other single drug to the 19 percent increase in retail
prescription drug spending in 2000. Sales of Vioxx shot up from
$330 million in 1999 to $1.5 billion. So that is an over a
billion dollar increase in sales in just 1 year.
Perhaps not surprisingly, Vioxx was the most heavily
advertised prescription drug in the Nation in 2000. Its maker,
Merck, spent over $160 million promoting the drug to consumers.
With the success of direct-to-consumer advertising and the
new avenues open to reaching the consumers, we would predict
that the pharmaceutical industry will be spending more to reach
out and market directly to consumers. This expansion will
follow the trend that you have alluded to. Over the last 3
years 1998 to 2000, spending on direct-to-consumer advertising
has almost doubled.
It is important to note, though, that the $2.5 billion
spent on direct-to-consumer advertising really is only a small
part of what the industry spends in total in promoting their
drugs. They spend about $15.7 billion in total, $2.5 billion on
DTC ads.
As was referred to earlier by Nancy, we do not know how
direct-to-consumer ads are affecting the physician-patient
relationship or how they are changing health outcomes for
patients. We need more studies on this and some of the work
they are doing--there was a meeting with the Department of
Health and Human Services on this. But we really need more
information. Prevention magazine is really kind of out there in
front and that is a little scary when you are talking about
such a big industry.
But they have found some interesting things, including that
when a consumer comes in and asks for a specific drug 70
percent of the time they walk out with that drug. So it clearly
is having an impact.
While some contend that direct-to-consumer ads are a
valuable source of information for consumers, we must recognize
that the information in such ads is not packaged for the
benefit of the public's health, it is really meant to sell a
specific drug. In this unique consumer market, direct-to-
consumer ads prompt consumer behavior without providing
substantive and complete information about the advertised
product, treatment alternatives, or the disease.
In conclusion, I would like to say that for consumers to
make really informed decisions they need better, more balanced
information on prescription drugs and we should facilitate that
in two ways. One is I think we should raise the standards for
direct-to-consumer ads and what is in them. I guess we will be
hearing from some other groups on that point.
But also, I think that we need to organize the different
stakeholders in this industry with government leadership to try
to provide an independent source of information. What we are
spending on prescription drugs is going up, as you said, 19
percent a year. You are debating about adding Medicare
prescription drug benefit. It really behooves us all to come up
with an independent source of information so we can actually
make some good comparisons between treatment options.
[The prepared statement of Ms. Chockley follows:]
Prepared Statement of Nancy Chockley, President, National Institute for
Health Care Management Foundation
Good afternoon, Mr. Chairman and Members of the Subcommittee. Thank
you for the opportunity to testify today on this important issue.
I am Nancy Chockley, president of the National Institute for Health
Care Management Foundation. The NIHCM Foundation is a non-partisan,
non-profit group. We conduct research on health care policy issues and
manage health projects with funding from health plans, the government
and private foundations. One of our research priorities has been and
continues to be analysis of the pharmaceutical marketplace. Two of our
recent studies are included in the supporting materials, and the others
are available on our web site.
I will focus my remarks today on four key points:
L1. Direct-to-consumer advertising appears to be inducing
significant new demand for prescription drugs, and thus contributing to
the recent sharp rise in pharmaceutical spending. Specifically, our
data show that the drugs driving the growth in utilization and sales
are also the drugs that are being most heavily advertised to the
public. Simply put: DTC advertising works.
LIn an analysis we will be releasing soon, we have found that the
50 drugs most heavily advertised to consumers in 2000 had an aggregate
sales increase last year of 32%, compared to 14% for all other drugs
(which number about 9,850).
LAs the chart behind me illustrates, most of the increase in
sales for the 50 most heavily advertised drugs came from a sharp
increase in the number of prescriptions filled for them. Combined, the
number of prescriptions for these 50 drugs was up almost 25% from 1999
to 2000. In contrast, the number of prescriptions for all other
prescription drugs increased less than 2%. I would like to note these
numbers are preliminary.
LTo give you an example, we found that growth in the sales of the
new arthritis drug Vioxx contributed more than any other single drug to
the 19% increase in retail prescription drug spending in 2000. Sales of
Vioxx shot up from $330 million in 1999 to $1.5 billion in 2000.
Perhaps not suprisingly, Vioxx was the most heavily advertised
prescription drug in the nation in 2000. Its maker, Merck, spent $160.8
million promoting the drug to consumers.
L2. The success of DTC advertising, combined with computer
technology which is opening up new ways to reach consumers directly,
lead us to predict that drug companies will continue to expand their
efforts to market their products directly to consumers. This expansion
will follow the trend seen over the last three years: from 1998 to
2000, spending on direct-to-consumer advertising has almost doubled. In
2000, the pharmaceutical industry spent $2.5 billion on DTC ads. It is
important to note this accounts for only a portion of the $15.7 billion
total expenditure on promotional spending for prescription drugs.
L3. We don't know how DTC ads are affecting the physician-patient
relationship or how they are changing health outcomes for patients. We
need more studies to better understand the role marketing is playing.
The Department of Health and Human Services held an important
conference on this issue in May, and the FDA is also currently studying
this question. We strongly encourage more federal funding of research
that helps explain the impact of marketing on health and health care.
L4. While some contend that DTC ads are a valuable source of
information for consumers, we must recognize that the information in
such ads is not packaged for the benefit of the public's health. It is
meant to sell prescription drugs. In this unique consumer market, DTC
ads prompt consumer behavior without providing substantive and complete
information about the advertised product, treatment alternatives, or
the disease.
For consumer decisions to be truly informed, consumers must be
provided with better, more balanced information on their prescription
drugs. We should facilitate this by: one, raising the standards for the
content of DTC ads; and two, organizing collaboration among key
stakeholders in the health care industry and the government to develop
objective sources of information that compare treatment options.
Currently, consumers and physicians rely on the pharmaceutical
companies as their primary source of information on pharmaceutical
products. With prescription drug expenditures increasing by almost 19%
a year and Congress looking at adding a prescription drug benefit for
Medicare beneficiaries, the timing is right to address the scarcity of
unbiased pharmaceutical information that exists. It is essential for
physicians and consumers to have access to a source of information
which may help them to discern and compare the benefits and costs of
pharmaceutical products. The government could play a key role in
facilitating such a vital information source.
Elaborating on the preceding points
In September 2000, we released our first research brief on DTC
prescription drug ads. In May 2001, we released a study on
pharmaceutical spending in the retail marketplace in the year 2000.
Although we will not be releasing our next study of DTC ads until
September, we have included in this testimony data on ad spending in
2000 which will be published in that study.
Pharmaceutical companies spent $2.5 billion on all forms of DTC
prescription drug ads in 2000; 85% of that total was spent on the 50
most heavily promoted drugs.
Like the Vioxx example given earlier, we found that growth in the
sales of the heavily-promoted antiulcer drug Prilosec was responsible
for a substantial portion of the rise in overall pharmaceutical
spending in 2000. Retail sales of the drug rose from $3.6 billion in
1999 to $4.1 billion in 2000. It's now the best selling drug in the
country. Prilosec's maker, AstraZeneca, spent $107.7 million promoting
the drug to consumers in 2000. It was the second most heavily promoted
drug.
It is important to note that DTC ads are only one factor among many
factors that drive the sales growth of a product. While it is feasible
that DTC ads are playing a comparatively small role relative to these
other factors, our data and recent surveys indicate otherwise.
Recent studies by the FDA and Prevention magazine have found, for
example, that consumers are quite receptive to the ads. They are not
only aware of them; they appear to be acting on them. In a recent
survey by Prevention magazine, conducted in June 2000, 32% of
respondents who had seen or heard a drug ad--and 90% had--talked to
their doctor about an advertised medicine or the disease it targets. Of
this group, one in four asked their doctors for a specific medicine
they had seen advertised. And 70% of those who made such a request
walked out of the office with a prescription for that specific drug.
Let me translate those percentages into numbers of people. If 150
million adults saw the ads, 48 million will have talked to their doctor
as a result, 12 million will have asked for a specific drug, and 8.4
million will have gotten it that same day.
This brings me to another central point I want to make today: we
don't yet know whether DTC advertising is, on balance, beneficial or
detrimental.
Are the ads leading to the inappropriate use of some drugs? Are
they compromising the safe use of some drugs, leading consumers to
believe the drugs are safer or more efficacious than they may actually
be? Are they inducing demand for drugs that would not otherwise be
first-line treatments?
I am sure we will all agree today that we will soon need to know
the answers to these questions. Opinions about the effects of DTC ads
will not suffice in the long run. We strongly support research that
probes these issues.
Research is needed to better understand the positive role that DTC
ads could be playing. If studies find that DTC ads are inducing
millions of Americans to go to the doctor for needed visits and that
they are then getting appropriate care they would not otherwise get,
then DTC advertising may be a powerful new tool to help create a
healthier population. If, on the other hand, studies find that
prescription drug mass media ads are inducing millions of inappropriate
prescriptions, then we may have to conclude we have a problem.
Until studies can determine the impact of DTC advertising, we will
have to weigh carefully what we already know about the benefits against
the social and health costs of DTC ads.
Furthermore, we must recognize that DTC drug ads are not primarily
designed--and probably never could be--as public health tools. They are
designed to successfully market specific products. Quite simply,
consumers need other sources of information on prescription drugs to
make truly informed choices. We would recommend that the Department of
Health and Human Services initiate a process to examine how that might
come about. All health care stakeholders should be involved.
My final point today is one that often gets overlooked in this
debate. Spending on DTC ads is growing at a time when pharmaceutical
companies appear to be increasingly reliant upon the earnings of their
blockbuster drugs. The power of DTC ads could be an incentive for drug
companies to invest resources in extending the exclusivity of their
blockbuster drugs, instead of investing in the development of
innovative new products. To the extent that DTC ads give companies
further inducement to protect their aging blockbusters, DTC ads may ill
serve public health.
The health of the population is best served by an industry that is
putting the maximum amount of money into developing truly innovative
new drugs for the most serious life-threatening and debilitating
diseases. The public's health will not be advanced as much if drug
companies focus disproportionately on inducing potentially
inappropriate consumer demand for repackaged or slightly improved drugs
to treat a range of non-threatening conditions.
Prescription drugs help millions of Americans live normal,
productive lives, yet they are unique consumer products. They have the
potential for serious harm as well as great benefit. They are part of a
complex system of medical care that must be ruled first and foremost by
science and careful human judgement. Congress has long recognized the
complexity and uniqueness of the pharmaceutical marketplace in their
regulation of this industry. The growth of DTC advertising poses new
questions about how consumers perceive prescription drugs and use them.
DTC ads--just as the products they promote--appear to have the
potential for benefit but also for harm.
Thank you.
Senator Dorgan. Ms. Chockley, thank you very much.
Mr. Calfee, I understand that you are to catch a plane to
leave the country.
Mr. Calfee. That is right.
Senator Dorgan. So we will call on you so that you can
testify and leave the country, and I hope it is not a
reflection on your testimony here.
[Laughter.]
Senator Dorgan. But why do you not, so that we can
accommodate your time issue, why do we not let you proceed, Mr.
Calfee.
STATEMENT OF JOHN E. CALFEE, Ph.D., RESIDENT SCHOLAR, AMERICAN
ENTERPRISE INSTITUTE
Mr. Calfee. I appreciate it. I want the record to reflect
that I planned to leave the country, I made plans to leave the
country before I made plans to testify.
I have submitted written testimony and I have some briefer
remarks to read into the record right now. Mr. Chairman, I
would like to thank you for inviting me to testify today on the
effects of direct-to-consumer advertising of prescription
drugs.
Economic research has shown that advertising makes markets
work better. For example, advertising increases the incentives
for manufacturers to create new or improved products.
Especially important is the ability of advertising to provide
information. Society has yet to discover another mechanism that
is the equal of advertising in its power to provide crucial
information in a concise, usable, and memorable format, and to
provide that information to those who need it most.
The question today is whether the prescription drug market
provides yet another example of the benefits of advertising or,
on the contrary, is an exception to the rule. There are good
reasons, I believe, to expect direct-to-consumer advertising of
prescription drugs to be a valuable tool for consumers and
patients. The medical literature documents that millions of
consumers remain undiagnosed or untreated for serious medical
conditions for which useful drug therapies exist. A prime
reason appears to be that consumers are not aware of therapies
that could help them, especially therapies that are relatively
new or are improvements over older treatments.
Examples of such undertreated conditions include
depression, diabetes, obesity, high blood pressure, and
elevated cholesterol. In most cases, it is consumers themselves
who must take the initiative to see their physician and discuss
their symptoms and possible treatments.
A striking example of this situation was provided this past
May in a Federal report on the treatment of elevated
cholesterol. That report came from the National Cholesterol
Education Program at the National Institutes of Health. It said
that millions of middle aged and elderly people could reduce
their risk of a heart attack by one-third or more if they begin
taking one of the powerful statin-class drugs for reducing
serum cholesterol.
But again, consumers must take the initiative in order to
realize these benefits. What is needed is to get essential
information about cholesterol and heart disease to the
consumers who need it. Now that the flurry of publicity about
the NIH report has passed, it is up to advertising to do the
real work of alerting consumers.
I believe it is fair to say that direct-to-consumer
advertising is likely to provide consumers with essential
information about cholesterol and heart disease faster and
better than any information program mounted by governments,
public health organizations, or health care providers.
The proposition that advertising can help consumers in
dealing with prescription drugs is not merely theoretical. We
now have ample evidence of the benefits of direct-to-consumer
advertising. Much of this evidence can be found in the consumer
surveys conducted by the Food and Drug Administration,
Prevention magazine, and other organizations. These surveys
show that consumers like DTC advertising and they think it
helps them talk to their doctors about medical conditions. DTC
advertising inspires consumers to learn more about illnesses
and drug therapies. It tends to make consumers more aware of
both the benefits and risks of pharmaceuticals as many
consumers read and pay attention to the risk information in
advertising.
Twenty-seven percent of respondents in the FDA survey were
prompted by ads to talk to their doctors about medical
conditions they had never previously discussed with their
doctors. DTC ads also remind patients to refill their
prescriptions and to have confidence in the value of continuing
their therapies, as was pointed out by the FDA spokesman just
earlier.
Fortunately, there is little convincing evidence of adverse
effects from DTC advertising. Expenditures on DTC ads are only
about 2 percent of total spending on prescription drugs. There
is little reason to think that DTC ads raise prices. Average
prices in the heavily advertised statin drug market, for
example, have been stable for the past 6 years despite
escalating demand.
DTC advertising is also unlikely to contribute to overall
expenditures on prescription drugs except to the extent that
ads encourage patients to obtain needed therapies that they
would otherwise do without. There is little, if any, evidence
that DTC ads have caused systematic inappropriate prescribing.
Risk-benefit information in ads tends to be reasonably
balanced. Indeed, the FDA would hardly tolerate anything else.
Only about 4 percent of respondents to the FDA's 1999
survey on DTC advertising said that they had encountered
adverse reactions from their doctors when they talked about
advertised drugs. In fact, overwhelming proportions of survey
respondents in the FDA survey reported that when they asked
their physicians about advertised drugs their questions were
met with tolerance and respect and were treated as ordinary
parts of physician-patient interactions.
In conclusion, DTC ads appear to be providing consumers
with a useful, even essential, tool in today's rapidly changing
health care market.
That concludes my remarks. I would be glad to answer
questions.
[The prepared statement of Mr. Calfee follows:]
Prepared Statement of John E. Calfee, Ph.D., Resident Scholar, American
Enterprise Institute
Mr. Chairman, I wish to thank you for inviting me to testify today
on the effects of direct-to-consumer (DTC) advertising of prescription
drugs. I am an economist who has devoted considerable attention to
advertising, health care markets, and the pharmaceutical industry.
During 1980-1986, I served in the Bureau of Economics at the Federal
Trade Commission, where I specialized on consumer protection, including
advertising regulation. Some of what I say today is drawn from my
recently published book, Prices, Markets and the Pharmaceutical
Revolution (AEI Press, 2000). That book is available from the
publisher, AEI Press, and is also downloadable from the American
Enterprise Institute website (www.aei.org). Earlier, I wrote a book on
advertising, Fear of Persuasion: A New Perspective on Advertising and
Regulation (London: Agora; North American distribution by the American
Enterprise Institute). I have also written numerous articles and book
chapters on pharmaceutical advertising and related topics, and recently
presented the results of a new empirical study of the effects DTC
advertising for the statin class of cholesterol-reducing drugs (Calfee,
Winston, and Stempski 2001). Much of this testimony is based on a
recently released paper on what we can learn from consumer surveys on
DTC advertising (Calfee 2001).
This statement addresses four topics: (1) the relationship between
DTC advertising and prescription drug prices; (2) the relationship
between DTC advertising and prescription utilization and costs; (3) why
DTC advertising is likely to help consumers and patients; and (4) what
consumer research can tell us about the impact of DTC advertising.
DTC Advertising and Prescription Drug Prices
Expenditures for out-patient prescription drugs have been
increasing at about 15% annually (Berndt 2000; NIHCM 2001). Several
studies have found that about three-fourths of these increases have
been caused by expanded usage and switching to newer and more effective
drugs, while price increases have accounted for only about one-fourth
(Berndt 2000; Dubois et al. 2000; RxHealth Value 2001). Even this
modest role for price increases is overstated, because standard
measures of pharmaceutical prices fail to take into account
improvements in the quality and value of new drugs or drugs that have
found expanded uses (Triplett 1999).
These facts suggest that even if DTC advertising increases prices,
such an effect has been quite limited simply because overall price
increases have been small. But there is little reason to expect DTC
advertising to significantly increase prices at all. Research has
generally found that advertising tends to reduce prices, rather than
increase them, primarily because advertising makes markets more
competitive (Calfee 1997, p. 10-11, and citations therein).
A current example of the separation between DTC advertising and
prescription drug prices can be found in the market for the statin
class of cholesterol-reducing drugs such as Pravachol, Zocor, and
Lipitor. Total expenditures for statin drugs have increased rapidly,
making this one of the largest therapeutic categories in terms of total
sales (NIHCM 2001). Statin drugs have also been among the leaders in
DTC advertising (NIHCM 2001). Yet average statin drug prices have been
stable or even slightly declining, according to data from the widely
respected market research firm, IMS Health (proprietary data supplied
to author, summarized in Calfee, Winston, and Stempski 2001). Moreover,
the oldest statin drug, Mevacor, is about to go off patent. Hence
average statin drug prices may substantially decline in the future.
DTC Advertising and Prescription Drug Expenditures and Utilization
DTC advertising totaled approximately $2.6 billion in 2000 (Adams
2001). This is about 2% of total prescription drug expenditures, which
were recently estimated at $132 billion (NIHCM 2001). Clearly, even the
total elimination of DTC advertising would have a negligible direct
effect on total pharmaceutical costs.
The real question, however, is whether DTC advertising pushes
expenditures upward and if so, whether it increases expenditures
inappropriately. There is little evidence that recent increases in drug
expenditures have been caused by inappropriate prescriptions. For
example, a recent unpublished study of the rapidly growing statin drug
market found no tendency toward less appropriate prescribing in this
rapidly growing market (Dubois, et al., 2001). On the whole, increases
in drug utilization seem to be driven primarily by the fact that health
care organizations, physicians, and patients find many of the newer
drugs to be extremely valuable. In fact, there is strong evidence that
many of the most effective drugs are underused, rather than overused
(see citations in the next section). Hence public debate has focussed
on how to pay for more extensive drug therapy, rather than on how to
curtail it.
Whether DTC advertising is actually increasing usage has apparently
been the subject of very little systematic research. In an attempt to
fill this gap, I and two co-authors undertook a study of the statin
drug market (Calfee, Winston, and Stempski 2001). Using proprietary
data on DTC advertising, other forms of promotion, statin
prescriptions, statin sales, and cholesterol-related office visits,
plus other data, were found no detectable influence from DTC
advertising or other forms of promotion on the volume of statin
prescriptions, which simply increased steadily throughout the study
period regardless of large fluctuations in DTC advertising. One reason
for the apparent lack of a short-term connection between advertising
and prescriptions is the fact that several steps must take place
between the time when a consumer reacts to an ad and when that consumer
receives a prescription (initial physician visit, cholesterol check,
advice for life-style changes, etc.)--if a prescription is written at
all.
This is not to say that DTC advertising does not increase sales for
advertised brands. But the evidence suggests that prescribing decisions
are dominated by the physician's advice, which may involve non-drug
therapy, a generic prescription, or an over-the-counter drug
recommendation, as alternatives to prescribing the advertised brand.
Why DTC Advertising Is Likely to Help Consumers and Patients
Decades of research have established that advertising makes markets
work better by providing information and enhancing competition (Calfee
1997). Advertising is especially useful for providing consumers with
essential information that they would otherwise ignore, fail to
receive, or receive too late. The Federal Trade Commission, which
regulates most advertising, has emphasized that advertising plays an
essential role in improving consumer information and otherwise
improving markets (FTC 1996).
There are compelling reasons to expect DTC advertising to improve
the prescription drug market. Some of the most important medical
information--especially relatively new information--often fails to
reach physicians or patients in a timely manner. This situation is
reflected in the proliferation of practice guidelines for physicians,
and also in published findings that medical practice often falls well
short of what can be achieved by following even the least controversial
aspects of consensus guidelines (Calfee 2000, p. 24-26). Consumers and
patients, of course, tend to be even less well informed than their
doctors.
Many of the most valuable new drugs involve conditions or illnesses
that require consumers to take the initiative in seeking medical advice
for dealing with depression, for example, or to learn whether one is at
risk for heart disease and if so, what can be done to reduce that risk.
A number of studies and consensus statements from the medical community
have documented the existence of large numbers of under-diagnosed and
undertreated consumers who suffer from serious, yet treatable medical
conditions such as elevated cholesterol, depression, obesity, diabetes,
and hypertension (Calfee 2000, p. 24-26).
A new report from the National Cholesterol Education Program at the
National Institutes of Health illustrates these trends. That report
concluded that elevated cholesterol should be treated much more
aggressively than in the past, even as earlier studies have found that
most persons who should have been treated under the previous guidelines
were in fact not treated and often, not even identified (NIH 2001).
These circumstances dictate that patients and consumers must play
an active role in their own health care. In particular, consumers need
to acquire information about medical therapies, talk to their
physicians about medical symptoms and conditions, and decide with their
doctors how to deal with illnesses and conditions.
Both the FTC (1996) and the FDA have noted the potential value of
DTC advertising in addressing these problems. The Food and Drug
Administration, in particular, has stated, ``It [DTC advertising] is
consistent with the whole trend toward consumer empowerment. We believe
there is a certain public health benefit associated with letting people
know what's available.'' (Stolberg 2000). Even the American Medical
Association, whose constituency has traditionally opposed prescription
drug advertising to consumers, recently issued a statement that
concluded, ``If used appropriately, direct-to-consumer (DTC)
advertising has the potential to increase patient awareness about
treatment options and enhance patient-physician communication.
Advertising directly to the public educates patients, enabling them to
better understand and participate in medical care.'' (AMA 2000). In
1998, Lancet, a leading British medical journal, ran an editorial
arguing that DTC advertising would benefit European consumers.
What Consumer Research Can Tell Us about the Impact of DTC Advertising
In August 1997, the FDA relaxed its regulatory requirements for DTC
advertising on broadcast media including television (Calfee 2001, FDA
1997). This decision triggered large increases in the volume of
television DTC advertising while also prompting a shift from print to
broadcast media. In August 1999, after a two-year review, the FDA
reaffirmed its new policy, while also announcing its intention to
review DTC advertising again in 2001 (FDA 1999a). This past March, the
FDA announced the beginning of its latest review, which will include
commissioning surveys of both consumers and physicians (FDA 2001).
In the meantime, several studies have appeared on the impact of DTC
advertising. These consist primarily of a number of nationally
representative surveys of consumers. The most notable examples include
a 1999 survey commissioned by the FDA itself (FDA 1999b, 1999c), and a
series of surveys commissioned by Prevention Magazine (1999, 2000).
Other more limited, but nonetheless useful research includes national
consumer surveys by AARP, the National Consumers League, and NewsHour
with Jim Lehrer (with the Kaiser Family Foundation and the Harvard
School of Public Health); a survey of California consumers (Bell, et
al. 2000), and content analyses of individual DTC ads (Wilkes 2000). I
focus here on the findings from national surveys, especially those by
the FDA and Prevention Magazine.
DTC Advertising and Consumer Information
The national consumer surveys have provided a number of useful
findings on the relationship between DTC advertising and consumer
knowledge about prescription drugs. One finding is that DTC ads provide
a reasonable balance of information about both benefits and risks. In
the FDA survey, for example, there was little difference in the
prominence of benefits vs risks or warnings, and 70% disagreed with the
statement that DTC ads ``make it seem like a doctor is not needed to
decide whether a drug is right for me.'' In a response to a 1999
Prevention survey question about whether advertising made respondents
feel more or less confident about drug safety, 70% said ``no
difference'' or ``less confident.''
The surveys also supply direct and indirect evidence that DTC
advertising provides valuable information to consumers. Responses
revealed very high levels of awareness and attention to DTC ads, as the
proportion of respondents recalling DTC ads ranged between 72% (FDA
survey) and 95% (aided recall in the 1999 Prevention survey). Such high
awareness levels strongly suggest that consumers gained information
about the core topics of DTC ads: details on a variety of medical
conditions, potential therapies, alternative dosages, and other
important topics, in addition to risk information. The potential value
of making so much information available through advertising is clear
from the AARP survey results, in which 27% of respondents said their
doctors seldom or never discussed pharmaceutical risks, and another 18%
said physicians did so only sometimes, while 27% said their doctors
rarely or never discussed alternative drug therapies.
The bulk of respondents (on the order of 80% in the FDA survey)
noticed information on benefits, risks, and warnings. Substantial
proportions read some or all of the fine-print risk information in
print ads, and readership was much higher for those who had a special
interest in the advertised drug. In particular, the FDA survey found
remarkably high levels of readership of the fine-print risk information
in print ads: 40% said they read half or more of that information,
another 26% said they read a little of it, and 85% said they would read
all or almost all of the information if they were especially interested
in the drug. The Prevention survey obtained roughly similar results,
also finding high levels of attention to detailed risk information.
The surveys also suggest that DTC ads motivated consumers to seek
additional information from numerous sources, including, of course,
their own doctors. Of special importance is the finding that DTC ads
opened up new topics for consumers to investigate. Twenty-seven percent
of respondents in the FDA survey were prompted by ads to talk to their
doctors about medical conditions they had never previously discussed.
These results are consistent with the fact that many of the most
heavily advertised drugs treat conditions that are widely believed by
the medical community to be undertreated, such as elevated cholesterol,
depression, obesity, diabetes, and hypertension.
Of special interest in the FDA survey was the balance of
information on risks and benefits in DTC ads. A series of detailed
questions revealed a remarkably balanced assessment. Asked what kinds
of information they saw in ads, 87% of respondents said, ``the benefits
of the drug,'' while 82% said, ``risks or side effects,'' and 81%,
``who should not take the drug.'' The proportion of respondents who
thought ads lacked information on benefits (49%) was nearly as large as
the proportion who though ads lack information on risks (59%). The
Prevention surveys provided similar results.
DTC Advertising and Patient-Doctor Relationships
Both the FDA and Prevention surveys document that large majorities
of consumers agree that DTC ads provided sufficient information to
prepare to talk to their doctors--70% in the FDA survey. But
advertising was far from a dominant influence. In the FDA survey,
respondents said the main reasons for expecting a new prescription
were: past prescription history, information from friends or relatives,
and previous discussions with physicians.
Large majorities of respondents to the FDA survey reported
favorable assessments of their talks with their doctors, and
encountered no resentment or other unfavorable reaction. This is
apparent from the numbers in Table 1. Most respondents said their
doctor welcomed their questions (81%), reacted as if those questions
were an ordinary part of a visit (71%), and proceeded to discuss the
drugs with the patient (79%). Only 4% said their physician ``seemed
angry or upset.'' Equally important, of those who had not asked such
questions of their physicians, only 3% expected to encounter an adverse
reaction if they were to ask such a question in the future. Eighty-five
percent of respondents were satisfied or very satisfied with their
discussions with physicians about advertised drugs, with only 7%
unsatisfied or very unsatisfied. Finally, 62% agreed or strongly agreed
that DTC ads helped them have better discussions with their physicians.
Table 1. Physician Reactions When Asked About an Advertised Drug
------------------------------------------------------------------------
Question 33: ``Which, if
any, of these possible
Question 28: ``Which, if reactions do you think your
any, of these possible doctor would have if you
reactions did your doctor asked about a prescription
have when you asked about drug you had seen
the [advertised] drug?'' advertised?'' (May say
``Yes'' to more than one.)
------------------------------------------------------------------------
Welcomed 81% 69%
question
------------------------------------------------------------------------
Discussed drug 79% 82%
------------------------------------------------------------------------
Reacted as if 71% 56%
the question
were ordinary
part of visit
------------------------------------------------------------------------
Got angry or 4% 3%
upset
------------------------------------------------------------------------
None of the 2% 1%
above
------------------------------------------------------------------------
Don't know/ 1% 2%
refused
------------------------------------------------------------------------
Sample size 220 607
------------------------------------------------------------------------
Adapted from: Food and Drug Administration, Center for Drug Evaluation
and Research, Division of Drug Marketing, Advertising, and
Communications. Attitudes and behaviors associated with direct-to-
consumer (DTC) promotion of prescription drugs: main survey results.
Available at: http://www.fda.gov/cder/ddmac/dtcindex.htm. Accessed May
1, 2001.
In 26% of the discussions motivated by advertising, according to
the Prevention survey, patients said they requested prescriptions for
specific brands, and they usually got one. We do not know, however, the
extent to which these requests arose from discussions in which
physicians had already made clear that the decision was up to the
patient, perhaps because the choice was obvious or because any of
several alternatives was acceptable. In the FDA survey only about half
of physicians wrote a prescription when asked about a specific drug.
These surveys provide no reason to suggest that these requests and
questions about specific advertised drugs tended to yield inappropriate
prescriptions.
Overall Consumer Attitudes Toward DTC Advertising
Consumers generally like DTC ads and find them useful. In the FDA
survey, those who liked DTC ads outnumbered those who did not by nearly
two to one. Eighty-six percent said the ads ``help make me aware of new
drugs,'' and 62% said DTC ads help them have better discussions with
their physician about their health. In the 1999 Prevention survey, 76%
thought that ads ``allow people to be more involved with their health
care,'' 72% said that DTC ads ``educate people about the risks and
benefits of prescription medicines,'' and 63% said that DTC ads ``help
people make their own decisions about prescription medicines.''
Finally, 76% of respondents to the National Consumers League survey
agreed that prescription drug ads ``increase consumer knowledge about
medicines,'' and 78% agreed that prescription drug ads ``increase
consumer knowledge about disease.''
Positive Spillovers from DTC advertising
Survey research also provides something that may be surprising to
most observers: evidence that DTC advertising provides spillover
benefits to consumers, beyond any gains realized by the manufacturers
who pay for the ads. One spillover benefit, for example, is increased
consumer awareness of the simple fact that virtually all prescription
drugs are risky and have side effects. This must be clear to anyone who
has perused a few of the ``brief summaries'' in print ads or noticed
the staccato list of warnings in TV ad voice-overs. In addition, the
1999 Prevention survey found that physicians tend to provide more risk
information to those patients who ask about advertised drugs.
A second category of spillover benefits is the dissemination of
information about new, previously undiscussed conditions. Advertising
about elevated cholesterol, obesity treatments, and the like do not
invariably lead to prescriptions for the advertised drugs. On the
contrary, when ads induce patients to talk to their doctor, most
patients do not actually ask for or about the brand whose advertising
sparked the discussion, and when they do, the result is a mixture of
prescriptions for the advertised drug, prescriptions for a competing
drug, recommendations for OTC drugs, and advice to change life-styles
or behavior. Ads can raise awareness of the need for a particular type
of drug to treat a particular condition, but the benefits of that
consciousness-raising may go to the patient and to competitors rather
than to the advertiser.
A third spillover benefit is to call consumers' attention to
nondrug approaches to improved health. Many ads start out by mentioning
the value of dietary changes and exercise. When DTC ads succeed in
getting consumers to talk to their doctors about obesity, diabetes,
depression, and cholesterol levels, those consumers probably learn that
behavioral and life-style changes are the first line of treatment. In
response to a 2000 Prevention survey question asked of respondents who
said that ads had caused them to talk to their physician, 53% said
their doctor had mentioned a nondrug therapy for their condition. The
proportions were much higher for certain conditions: diabetes (77%),
high cholesterol (92%), and obesity (84%).
Finally, a fourth example of spillover benefits is inducing
compliance with drug therapies. Research has shown that inadequate
compliance with physician instructions when taking prescription drugs
is an extremely common and dangerous problem (Calfee 2000, p. 19).
Advertising is an excellent vehicle for inducing better compliance
because consumers tend to pay attention to advertising for brands they
use. It is no surprise, therefore, that the FDA survey found that
consumers pay special attention to ads for drugs they are taking or in
which they have a special interest.
In 2000 Prevention survey, about half of those respondents taking a
prescription drug recalled seeing an ad for a drug they were using.
Thirty-six percent said the ads made them feel better about the safety
of their prescriptions, while only 3% said the ads made them feel
worse. In response to a crucial question--``Do ads make you more or
less likely to take your medicine regularly?''--``more likely''
outscored ``less likely'' by 22% to 3%. In addition, 33% in the 1999
survey said that prescription drug ads reminded them to have their
prescriptions refilled.
There is no reason to expect the reminder powers of DTC advertising
to be restricted to the advertised brand. Although no research appears
to have been done on the topic, these survey results strongly suggest
that by reminding patients to take their medicine and refill their
prescriptions, DTC ads tend to encourage patients to persist in their
drug therapy.
Conclusions
There are good reasons to expect DTC advertising to provide
valuable information to consumers and otherwise improve the health care
market. The emerging evidence on DTC advertising effects, particularly
the results of consumer surveys by the FDA, Prevention Magazine, and
others, indicates that DTC ads are in fact providing substantial
benefits while avoiding most or all of the problems that some analysts
have suggested DTC ads could bring.
This evidence goes far toward explaining why the FDA reaffirmed its
policy of permitting DTC advertising in August 1999. Indeed, the agency
noted at the time that ``FDA is unaware of any data supporting the
assertion that the public health or animal health is being harmed, or
is likely to be harmed, by the Agency's actions in facilitating
consumer-directed broadcast advertising'' (FDA 1999b). The FDA is to be
congratulated for persisting in its policy toward DTC advertising in
the face of criticism and opposition from diverse segments of the
health care community. Equally worthy of praise is the fact that the
FDA commissioned a well-designed consumer survey that could easily have
uncovered severe problems with its new policy, rather than providing
support for the policy (which it did, of course).
We have learned at least six things from the leading consumer
surveys and other evidence on DTC advertising. First, we can largely
rule out the possibility that DTC advertising is causing systematic
consumer deception, including the inappropriate downplaying of risks
and side effects. The FDA and Prevention surveys, in particular,
addressed this topic in so many ways that it is very unlikely that
widespread consumer deception has escaped detection by the FDA
regulators.
Second, DTC advertising provides valuable information, and not just
on obvious topics such as potential treatments and dosages, but also on
risks and side effects. On the whole, DTC advertising appears to
increase the salience of both risks and benefits from drug therapy.
Third, the information in DTC advertising motivates consumers to seek
additional information from many sources, but especially from
physicians and pharmacists. Many of these consumers ask about
conditions they had not previously discussed with their doctors.
A fourth finding is that from the patient's perspective at least,
DTC advertising is causing almost no tension in the doctor's office.
Very few respondents--usually well under 5%--encountered resentment or
resistance when they brought up what they had seen in advertising, or
asked about specific drugs. Fifth, consumers like DTC advertising. They
think it helps them in making decisions and in talking to their
doctors.
Sixth, DTC advertising yields significant spillover benefits that
go to consumers rather than to advertisers. Such benefits range from
heightened awareness of the inherently risky nature of prescription
drugs to better compliance with drug therapies and even motivation to
pursue life-style and behavioral changes that may obviate the need to
use pharmaceuticals. In particular, ads reminded consumers to take
their medications and to refill their prescriptions. Overall, DTC ads
appear to make patients more comfortable with the risks and benefits of
the medicines they take.
Overall, these survey results are strongly supportive of a
situation in which consumers are motivated by advertising first to seek
additional information--specially from physicians, and particularly for
previously untreated or inadequately treated conditions--and then to
work with their doctor to reach a decision about what if any
prescription drug to use.
References
Adams, C. (2001) ``FDA plans to review policy allowing direct-to-
consumer drug ads for TV,'' Wall Street Journal. March 28, 2001, p. B1.
American Medical Association (2000) Council on Ethical and Judicial
Affairs of the American Medical Association, ``Direct-to-Consumer
Advertisements of Prescription Drugs,'' 55/1 Food and Drug Law Journal
119-124.
Bell, Robert A., Michael S. Wilkes, and Richard Kravitz (2000)
``The Educational Value of Consumer-targeted Prescription Drug Print
Advertising,'' 49/12 Journal of Family Practice (December).
Calfee, John E. (1997) Fear of Persuasion: A New Perspective on
Advertising and Regulation, London: Agora; North American distribution
by the American Enterprise Institute.
Calfee, John E. (2000) Prices, Markets, and the Pharmaceutical
Revolution. American Enterprise Institute, Washington, D.C.
Calfee, John E. (2001) ``What Consumer Surveys Show About Direct-
to-Consumer
Advertising of Prescription Drugs,'' available from author and from
the Coalition for Health Care Communication (www.cohealthcom.org).
Calfee, John E., Clifford Winston, and Randolph Stempski (2001)
``The Effects of Direct-to-Consumer Advertising for Cholesterol-
reducing Drugs,'' presented at the University of Chicago Conference on
The Regulation of Medical Innovation and Pharmaceutical Markets, April
20-21, 2001.
Dubois, Robert W., Charles M. Alexander, Sally Wade, Andrew Mosso,
Leona Markson, J.D. Lu, Soma Nag, and Marc L. Berger (2001) ``Growth in
Use of Lipid Lowering Therapies: Bad News? Good News? Or the Wrong
Question?'' Draft available from Robert W. Dubois, Protocare Sciences,
Inc., 2400 Broadway, Suite 100, Santa Monica, CA 90404.
Federal Trade Commission, Bureau of Consumer Protection and Bureau
of Economics (1996), ``Comments to the Food and Drug Administration on
Direct-to-Consumer Promotion of Prescription Drugs,'' January 11, 1996.
Food and Drug Administration, Center for Drug Evaluation and
Research (1997) ``Draft Guidance for Industry on Consumer-Directed
Broadcast Advertisements,'' July 1997; announced in Federal Register,
v. 62, n. 155, p. 43171-43173 (Aug. 12, 1997, Docket 97D-0302).
Food and Drug Administration, Center for Drug Evaluation and
Research (1999a) ``Guidance for Industry: Consumer-directed Broadcast
Advertisements,'' August 1999; announced in Federal Register, v. 64, n.
152, p. 43197-43198 (Aug. 9, 1999, Docket 97D-0302).
Food and Drug Administration, Center for Drug Evaluation and
Research (1999b) ``Questions and Answers on Guidance for Industry:
Consumer-Directed Broadcast Advertisements,'' August 1999; announced in
Federal Register, v. 64, n. 152, p. 43197-43198 (Aug. 9, 1999, Docket
97D-0302).
Food and Drug Administration, Center for Drug Evaluation and
Research, Division of Drug Marketing, Advertising, and Communications
(1999c) ``Attitudes and Behaviors Associated with Direct-to-Consumer
(DTC) Promotion of Prescription Drugs: Main Survey Results,'' available
at www.fda.gov/cder/ddmac/dtcindex.htm.
Food and Drug Administration (2001) ``Agency Information Collection
Activities; Proposed Collections; Comment Request; Assessment of
Physician and Patient Attitudes Toward Direct-to-Consumer Promotion of
Prescription Drugs,'' Docket No. 01N-0078, Federal Register: March 19,
2001 (Volume 66, Number 53).
Lancet (1998) Editorial, ``Pushing Ethical Pharmaceuticals Direct
to the Public,'' v. 351, March 28.
National Consumers League (1998) ``Health Care Information and the
Consumer: A Public Opinion Survey.'' Washington, D.C.: National
Consumers League (1701 K Street, NW, Suite 1200, Washington, DC 20006).
National Institute for Health Care Management (NIHCM) (2001)
``Prescription Drug Expenditures in 2000: the Upward Trend Continues.''
Washington, D.C.: NIHCM Foundation.
NewsHour with Jim Lehrer, Kaiser Family Foundation, Harvard School
of Public Health (2000a) ``National Survey on Prescription Drugs:
Toplines.'' Available at www.kff.org.
NewsHour with Jim Lehrer, Kaiser Family Foundation, Harvard School
of Public Health (2000b) ``National Survey on Prescription Drugs:
Highlights and Chartpack.'' Available at www.kff.org.
National Institutes of Health, National Cholesterol Education
Program (2001) ``Recommendations on Lipoprotein Measurement,'' from the
Working Group on Lipoprotein Measurement.
Prevention Magazine (1999) ``A National Survey of Consumer
Reactions to Direct-to-Consumer Advertising.''
Prevention Magazine (2000) ``International Survey on Wellness and
Consumer Reactions to DTC Advertising of Rx Drugs.''
RxHealth Value, ``Prescription Drug Expenditures Increase More Than
24%,'' downloaded May 17, 2001 from www.rxhealthvalue.com, summarizing
a May 2001 report from the Schneider Institute for Health Policy at
Brandeis University.
Stolberg, Sheryl Gay (2000) ``Ads that Circumvent Doctors: Want a
New Drug? Plenty to Choose From on TV,'' New York Times, January 23,
2000.
Wilkes, Michael S., Robert A. Bell, and Richard L. Kravitz (2000)
``Direct-To-Consumer Prescription Drug Advertising; Trends, Impact, And
Implications,'' Health Affairs, March/April.
Senator Dorgan. Mr. Calfee, thank you very much.
You must leave soon, is that correct?
Mr. Calfee. That is correct.
Senator Dorgan. Senator Wyden.
Mr. Calfee. But not immediately, please.
Senator Dorgan. Let me do this, if you do not mind, with
your permission. Let me hear from Dr. Wolfe and Dr. Glover. It
will take about 10 minutes, then we will have some questions.
We will ask the questions of you first so that you may leave.
STATEMENT OF SIDNEY M. WOLFE, M.D., DIRECTOR, PUBLIC CITIZEN'S
HEALTH RESEARCH GROUP
Dr. Wolfe. Thank you.
There is little doubt that false and misleading advertising
to patients and physicians can result in prescriptions being
written for drugs that are more dangerous and/or less effective
than perceived by either the doctor or the patient. It is
counterintuitive not to believe that misleading advertising, of
which there is quite a bit, and I will go through some of the
numbers, does not convince people as much or more than non-
misleading advertising, and therefore Dr. David Kessler's
statement, which I agreed with when he made it, that
advertising can cause death and injury if it results in
inappropriate prescribing, has got to be true.
The fact that there are not any studies of it, your point
Mr. Chairman, it is not that there are careful studies which
have shown no evidence of inappropriate prescribing. There are
not any good studies that have been done. As I said, the
evidence that the industry has is that when they do direct-to-
consumer advertising, as pointed out, in conjunction with
prescription advertising to doctors, the prescribing goes way
up. It is a combination of the both. An often misled prescriber
and a misled patient can combine to get a prescription written
that might otherwise not have been written.
This can then lead to a subsequent toll of deaths and
injuries that would not have occurred had safer, more effective
drugs been prescribed. Senator Wyden's question is also very
legitimate in the sense that inappropriate prescribing may be
prescribing a more expensive drug instead of a less expensive
drug, ultimately leading the patient not to have enough money
to take care of themselves. So from the standpoint of cost,
inappropriate prescribing can also be dangerous.
The more than 500 prescription drug advertisements that
have been found by the FDA to violate Federal laws and
regulations from 1997 to the present include approximately 90
direct-to-consumer ads. These numbers would be significantly
larger if FDA's Division of Drug Marketing, Advertising, and
Communication had more staff to investigate the rapidly
expanding area of DTC drug promotion.
As seen in the table included in my testimony--these are
taken from FDA's own data--there has been a sharp and steady
decrease during the last 3 years in the number of FDA warning
letters and notices of violation of FDA laws and regulations to
drug companies concerning prescription drug advertising. For
the last full year, mid-2000 through mid-2001, the total number
of advertising enforcement actions, 74, was less than one-half,
47 percent, of the 158 enforcement actions taken 3 years ago,
mid-1997 through mid-1998.
There is no evidence of an advertising/pharmaceutical
industry epiphany resulting in fewer illegal advertisements for
prescription drugs. Therefore the only plausible explanation
for this dangerous decrease is that the police force, DDMAC,
has not been strong enough in numbers of investigators, along
with the lack of adequate pro-enforcement leadership, meaning
from the Commissioner and the head of the drugs division, from
the top officials.
That this latter explanation, inadequate enforcement, is
correct will be seen--and my optimism comes out here--when the
FDA, with the urging and support of your committee and the
Appropriations Committee, begins to increase the number of
actions taken against these violative acts. Until then,
Americans, both physicians and patients, will be harmed by
prescribing decisions about which drugs to use based on all too
frequently false and misleading information from advertisements
which are much less likely now to be stopped because of poor
enforcement.
In addition to more staff, there is a dire need for direct-
to-consumer specific regulation since, other than the late
1990's guidance concerning TV advertising which Dr. Ostrove
spoke of, which is a guidance, not a regulation, there are no
regulations specifically written for direct-to-consumer
advertising. The FDA has been using regulations promulgated
after the 1962 Kefauver-Harris amendments that were clearly
intended for prescription drug advertising directed to health
professionals, such as doctors and pharmacists.
We have been urging the agency since the mid-1980's to
propose and finalize such consumer-specific DTC regulations
that would make it easier to evaluate the ads in the context of
patient, not health professional, comprehension.
Beyond more staff and direct-to-consumer specific
regulations, there is a need for much more enforcement power.
At present the FDA is limited to a notice of violation or
warning letter to companies found to violate the law or
regulations. Theoretically, in the face of multiple warnings to
the same company, criminal prosecution is a possible tool. This
latter power has only been used a handful of times in the past
30 years. To our knowledge, never has it been used for direct-
to-consumer advertising.
Despite a series of 11 illegal ads for Claritin, 8 of which
were direct-to-consumer, 14 illegal ads for Flonase and
Flovent, two drugs, one used for nasal problems and the other
for pulmonary problems--8 of these 14 illegal ads are DTC--and
5 illegal ads for Celebrex, one DTC, no criminal prosecution of
these companies. What is more, the ability to assess drug
companies large civil monetary penalties for advertising
violations could serve as a deterrent, but the FDA has no
authority at all to impose civil monetary penalties on any drug
company for anything, whether it is advertising violations or
anything else.
Senator Kennedy attempted to get such authority included in
the 1997 Food and Drug Modernization Act. It was fought hard
and successfully by the industry. If the FDA does not have the
ability to impose massive fines, if not criminally prosecute
these companies, the companies will just laugh and continue
violating the law with another violative ad.
Just briefly, a few articles that certainly do raise some
serious questions about some of the optimistic things that Dr.
Ostrove talked about and that Mr. Calfee talked about. In one
study researchers found that consumers rated the safety and
appeal of drugs described with an incomplete risk statement
more positively than those drugs for which risks were described
more completely. It has obvious implications since many direct-
to-consumer ads understate the safety of drugs.
Another study found that consumer beliefs that there was
prior scrutiny of ads, DTC ads, by the FDA and that they were
held to higher standards than other ads were generally wrong.
Another study on the educational content--we hear from the
industry these are for education; they are really not to sell
drugs; we just want to educate the public--found that, while
may ads provided information about the name and symptoms of the
disease for which the drug was being promoted, few educated the
patients about the success rate of the drug, how long you had
to use the drug, alternative treatments, including behavioral
change, which could improve their health, or misconceptions
about the disease. The authors concluded the ads provide only a
minimum amount of educational information.
Finally, one study asked patients what they would do if a
doctor refused to prescribe a drug that the patient wanted as a
result of a DTC ad. One-fourth of the patients said they would
seek a prescription elsewhere and 15 percent said they would
consider terminating the relationship with the physician. To
the extent that this obviously impairs the doctor-patient
relationship, this goes counter to what was said before.
Patients with these attitudes were ones who had a more
favorable evaluation of DTC advertising and who possessed more
faith in the current government regulation of DTC ads.
In closing, FDA resources and specific regulatory authority
to monitor the accuracy of drug safety and effectiveness
portrayed in DTC ads are dangerously inadequate and many
patients' perceptions of these ads and their subsequent
response to the ``information'' therein is similarly dangerous.
The present situation concerning DTC advertising is
unacceptable and it is our hope that your committee will
participate in initiating actions to remedy these serious
problems.
I would also request that a study put out by another part
of our organization, Public Citizen Congress Watch, related
very much to the issues that Senator Wyden raised about drug
costs and that you raise, be put in the record. It is called
``Prescription Research and Development Myths: The Case Against
the Drug Industry's R and D Scare Card.''
Senator Dorgan. Without objection, it will be put in the
record. *
---------------------------------------------------------------------------
* The information referred to has been retained in Committee files.
---------------------------------------------------------------------------
Dr. Wolfe. Thank you.
[The prepared statement of Dr. Wolfe follows:]
Prepared Statement of Sidney M. Wolfe, M.D., Director, Public Citizen's
Health Research Group
Because of the strong First Amendment in the U.S constitution,
there is no way that DTC prescription drug advertising could ever be
banned in this country. Having said that, however, there is an urgent
need for more fine-tuned, better-staffed and much tougher government
regulation of its content. There is little doubt that false and
misleading advertising to patients and physicians can result in
prescriptions being written for drugs that are more dangerous and/or
less effective than perceived by either the doctor or the patient. This
can then lead to a subsequent toll of deaths and injuries that would
not have occurred had safer, more effective drugs been prescribed.
The more than 500 prescription drug advertisements that have been
found by the FDA to violate federal laws and regulations from 1997
through the present include approximately 90 DTC ads. These numbers
would be significantly larger if FDA's DDMAC (Division of Drug
Marketing Advertising and Communication) had more staff to investigate
the rapidly expanding area of DTC drug promotion. Such advertising has
more than tripled in dollar volume from $791 million in 1996 to $2.5
billion in 2000. But the number of FDA staff assigned to reviewing and
investigating all of prescription drug advertising, during the same
interval, has only increased from 11 in 1996 to 14 at present. I have
been informed that there is, or will shortly be, an increase in DDMAC
staff to monitor such advertising and it comes none too soon. Even this
may well not be adequate.
As seen in the table on the next page, there has been a sharp and
steady decrease during the last three years in the number of FDA
warning letters and notices of violation of FDA laws and regulations to
drug companies concerning prescription drug advertising. From a peak of
84 such enforcement actions during the first six months of 1998, the
number has fallen steadily to 36 FDA actions during the last six months
of 2000 and an estimated 38 actions during the first six months of
2001.
For the last year (mid-2000 through mid-2001) the total number of
DDMAC advertising enforcement actions--74--was less than one-half (47%)
of the 158 enforcement actions taken three years ago (mid-1997 through
mid-1998). There is no evidence of an advertising/pharmaceutical
industry epiphany, resulting in fewer illegal advertisements for
prescription drugs. Therefore, the only plausible explanation for this
dangerous decrease is that the police force--DDMAC--has not been strong
enough in numbers of investigators along with a lack of adequate pro-
enforcement leadership from the top officials in FDA. That this latter
explanation, inadequate enforcement, is correct will be seen when the
FDA, with the urging and support of your committee, begins to increase
the number of actions taken against these violative ads. Until then,
Americans--both physicians and patients--will be harmed by prescribing
decisions about which drugs to use based on all-too-frequently false
and misleading information from advertisements which are much less
likely to be stopped because of poorer enforcement by the FDA.
In addition to more staff, there is a dire need for DTC-specific
regulations since, other than the late 1990's guidance concerning TV
advertising--which is a guidance not a regulation--there are no
regulations specifically written for DTC advertising. The FDA has been
using the regulations promulgated after the 1962 Kefauver-Harris
Amendments to the Food, Drug and Cosmetic Act that were clearly
intended for prescription drug advertising directed at health
professionals such as doctors and pharmacists. We have been urging the
agency since the mid-1980's to propose and finalize such consumer
specific DTC regulations that would make it easier to evaluate the ads
in the context of patient, not health professional, comprehension.
Beyond more staff and DTC-specific regulations there is a need for much
more enforcement power. At present, the FDA is limited to a Notice of
Violation or Warning Letter to companies found to violate the law or
regulations. Theoretically, in the face of multiple warnings to the
same company, criminal prosecution is a possible tool. This latter
power has only been used a handful of times in the past 35 years. To
our knowledge, criminal prosecution has never been used in the context
of DTC advertising, despite, for example, a series of 11 illegal ads
for Claritin (8 DTC), 14 illegal ads for Flonase/Flovent (8 DTC).
(Flonase and Flovent are the same drug in two versions, one used for
allergy, the other for asthma). There have also been five illegal ads
for Celebrex (1 DTC).
The ability to assess drug companies large civil monetary penalties
for advertising violations might actually serve as a deterrent for
companies who now just stop the violative ad, when requested by the
FDA, then create and massively disseminate a new one shortly
thereafter. The FDA currently lacks the authority to impose any civil
penalties for drug advertising or, in fact, for any other illegal drug
industry activity concerning prescription drugs. It is long overdue
that the Congress give the FDA this authority.
A search of the peer-reviewed, published medical studies concerning
DTC advertising yields findings that, for the most part, are also quite
worrisome:
In one study, researchers found that consumers rated the
safety and appeal of drugs described with an incomplete risk
statement significantly more positively than those whose risks
were described more completely. \1\ (This has significant
implications since so many DTC ads understate the safety of
drugs.)
---------------------------------------------------------------------------
\1\ J Health Communic 2000 Oct-Dec;5:349-69.
Another study found that consumer beliefs that there was
prior scrutiny of DTC ads by the FDA and that they were held to
higher standards than other ads were generally wrong. A
substantial proportion believed that only the safest and most
effective drugs could be advertised DTC and that the FDA
required prior review of ads. DTC ads led one-fifth of people
to request a prescription. \2\
---------------------------------------------------------------------------
\2\ J Gen Int Med 1999;14:651-7.
A study on the educational content of DTC ads found that
while many ads provided information about the name and symptoms
of the disease for which the drug was being promoted, few
educated the patients about the success rate of the drug, how
long you had to use the drug, alternative treatments including
behavioral changes which could improve their health, or
misconceptions about the disease. The authors concluded that
the ads provided only a minimal amount of educational
information. \3\
---------------------------------------------------------------------------
\3\ J Fam Pract 2000;49:1092-8.
One study asked patients what they would do if a doctor
refused to prescribe a drug that the patient wanted as a result
of a DTC ad. One-fourth of patients said they would seek a
prescription elsewhere and 15% said they would consider
terminating their relationship with their physician. The
patients with these attitudes were ones who had a more
favorable evaluation of DTC advertising and who possessed more
faith in the current government regulation of DTC drug ads. \4\
---------------------------------------------------------------------------
\4\ J Fam Pract 1999;48:446-52.
In summary, FDA resources and specific regulatory authority to
monitor the accuracy of drug safety and effectiveness portrayed in DTC
ads are dangerously inadequate and many patients' perceptions of the
ads and their subsequent response to the ``information'' therein is
similarly dangerous. The present situation concerning DTC advertising
is unacceptable and it is our hope that your committee will initiate
---------------------------------------------------------------------------
actions to remedy these serious problems.
Senator Dorgan. Dr. Wolfe, thank you.
Next on this panel we will hear from Dr. Glover. Dr.
Glover, and you are an attorney-physician representing PhRMA,
is that correct?
Mr. Glover. That is correct.
Senator Dorgan. Thank you. Welcome.
STATEMENT OF GREGORY J. GLOVER, M.D., J.D.,
ON BEHALF OF THE PHARMACEUTICAL RESEARCH
AND MANUFACTURERS OF AMERICA
Mr. Glover. Mr. Chairman and Members of the Subcommittee:
On behalf of the Pharmaceutical Research and Manufacturers of
America, I thank you for inviting me today to testify on
direct-to-consumer advertising of prescription drugs. I am a
licensed physician and a practicing attorney with the law firm
of Ropes and Gray and I specialize in FDA regulatory issues and
intellectual property law.
PhRMA represents the country's major research-based
pharmaceutical and biotechnology companies, which are the
source of virtually all new drugs in the United States. PhRMA
strongly supports direct-to-consumer advertising of
prescription medicines as currently regulated by FDA and
opposes any further restrictions on this pro-patient, pro-
health activity.
Under current practices, patients are now more actively
involved in their own health care than ever before. Rather than
remaining uninformed and relying entirely on an increasingly
complex health care system, patients are asking questions,
evaluating information, and making choices. Direct-to-consumer
advertising provides a valuable resource for patients to obtain
information about specific diseases, conditions, and
treatments.
Patients suffering from chronic conditions may be
dissatisfied with current treatment, but may be unaware that
different options are available with fewer side effects and
easier dosing regimens. Similarly, pharmaceutical
advertisements improve the public health by raising awareness
of conditions and diseases that often go undiagnosed and
untreated.
There are encouraging signs that direct-to-consumer
advertising is helping to address these issues. A survey by
Prevention magazine found that, as a result of direct-to-
consumer advertising, an estimated 24.7 million Americans
talked to their physicians about a medical condition they had
never previously discussed with a doctor. In other words,
millions of people who had suffered in silence were encouraged
to seek help.
A 1999 survey by Prevention magazine found that 27 percent
of respondents asked their physicians about conditions they had
not discussed before. These conditions ranged from arthritis
and heart disease to depression. In the 2 years that ads for a
medicine for erectile dysfunction have appeared, millions of
men have visited their doctors to request a prescription for
the drug. For every million men who asked for the medicine, it
was discovered that an estimated 30,000 had untreated diabetes,
140,000 had untreated high blood pressure, and 50,000 had
untreated heart disease. These numbers are striking and they
are just for one drug.
A growing body of evidence suggests that consumers like
direct-to-consumer advertising. A 1999 survey by FDA found that
those who liked these ads outnumbered those who did not by
nearly two to one. 86 percent said, the ads helped make me
aware of new drugs and 62 percent said the ads helped them have
better discussions with their physicians about their health.
A survey by Prevention magazine found that 76 percent of
respondents thought ads help people be more involved in their
health care and 72 percent felt the ads educate people about
the risks and benefits of prescription medicines.
There is also growing acceptance of this type of
advertising by doctors. A survey last year found the 64 percent
of doctors believe that such advertisements had helped educate
and inform their patients and 40 percent of the doctors
surveyed believed that ads have increased patient compliance.
Critics contend that direct-to-consumer advertising drives
up the price of drugs. In fact, while total pharmaceutical
expenditures are rising, price increases have been in line with
inflation. Most of the increase in drug expenditures has come
from the increased use of prescription medicines, including the
use of newer, more effective therapies.
The increased use of prescription drugs is a healthy trend.
Drugs not only save lives, they save by reducing the need for
alternative, more expensive care. Still, only 8.2 percent of
every health care dollar is spent on prescription medicine,
compared to 32 percent on hospital care and 22 percent on
physician and clinical services.
In summary, direct-to-consumer advertising helps address
consumers' need for information about diseases and treatments.
More important, direct-to-consumer advertising can improve
public health by starting a dialogue between patients and
doctors that may lead to a better understanding and treatment
of a patient's condition.
I hope you will support patients and oppose those
advocating adoption of a do not tell, do not ask policy, do not
tell people about new medicines and hope they will not ask.
That policy would be bad for the public health.
I will be pleased to answer any questions you may have.
Thank you very much.
[The prepared statement of Dr. Glover follows:]
Prepared Statement of Gregory J. Glover , M.D., J.D., on behalf of The
Pharmaceutical Research and Manufacturers of America
Mr. Chairman and Members of the Subcommittee:
On behalf of the Pharmaceutical Research and Manufacturers of
America, I am pleased to appear at this hearing this afternoon on
direct-to-consumer (DTC) advertising of prescription medicines. I am a
licensed physician and a practicing attorney with the law firm of Ropes
& Gray, specializing in FDA regulatory issues and intellectual-property
law. PhRMA represents the nation's leading researchbased pharmaceutical
and biotechnology companies, which are leading the way in the search
for new cures and treatments that will enable patients to live longer,
healthier, and more productive lives.
This year, PhRMA member companies will invest more than $30 billion
to discover and develop new medicines. The mapping of the human genome
has opened new frontiers, new paths to better health, pointing the way
to treatments never dreamed possible. The industry is most encouraged
about the prospects for exponentially better treatments--and, possibly,
cures--for Alzheimer's, AIDS, arthritis, cancer, diabetes, heart
disease, stroke, and many other diseases.
Just a few weeks ago, for example, a breakthrough drug for leukemia
was approved. This medicine, which blocks the biochemical switch that
causes normal cells to turn cancerous, heralds a whole new era of very
promising cancer research. The FDA is reviewing an application for a
new, life-saving drug that reduced the risk of death from sepsis by a
dramatic 20 percent in a study published in The New England Journal of
Medicine. Sepsis kills more than 1,400 people every day and is the
leading cause of death in non-coronary intensive-care units with an
estimated treatment cost of $17 billion annually in the United States.
Left sitting on the pharmacy shelf, medicines don't do anyone any
good. Unless they are prescribed for patients, medicines cannot prolong
life, ease pain, reduce disability, or make life better. And unless
medicines are prescribed and used, they will not generate the funds
needed for private industry to continue to research and develop future
cures and treatments.
That is why PhRMA enthusiastically supports DTC advertising of
prescription medicines, which is regulated by the FDA, and opposes any
further restrictions on this pro-patient, pro-health activity.
Patients are seeking more information as they navigate the
increasingly complex maze that is our health-care system. We believe
more information is good. Medicines have been proven to be the most
cost-effective form of health care and can often keep patients out of
hospitals and nursing homes and help them avoid surgery and other, more
expensive forms of care. For example, a 1998 study sponsored by the
National Institutes of Health (NIH) found that treating stroke patients
promptly with a clot-busting drug nets an average savings of $4,400 a
year per patient by reducing the need for hospitalization,
rehabilitation, and nursing-home care. According to NIH, use of this
medicine could save the health-care system more than $100 million a
year.
Background
Over the course of history, the medical community has resisted DTC
advertising of prescription medicines. Physicians wanted tight control
over what information was conveyed to patients. In 1555, for example,
the Royal College of Physicians in London decreed that ``no physician
teach people about medicines or even tell them the names of
medicines.'' The fear was that people would use medicines improperly
and be harmed.
That attitude persisted for more than 400 years. As recently as the
mid-1980's, the FDA imposed a voluntary moratorium on DTC ads. After
the moratorium was discontinued, many pharmaceutical companies began
advertising their medicines directly to consumers, following FDA rules.
In 1997, the FDA issued guidelines that clarified the agency's
broadcast advertising requirements. No longer would the FDA require ads
to contain voluminous and often confusing information about a drug's
side effects in radio and television ads. Under the FDA's draft
guidance, ads must list major health risks as well as side effects, and
must set forth four ways for consumers to receive additional
information: through an 800 number, an Internet site, reference to a
print ad in a major national publication, and through their physician
or pharmacist.
The FDA's 1997 decision stemmed from a policy that had led to
ineffective and confusing advertisements. Prior to the 1997 guidance,
the FDA required that a brief summary of the prescribing information
for a drug had to be included in all advertisements that both name a
prescription drug and state its purpose, including broadcast ads. The
brief summary is an FDA-approved document that advises physicians, in
very technical language, how to properly use a drug. Because of
technical, scientific wording in the brief summary, it is very
difficult for patients and consumers without a medical background to
understand.
Prior to the 1997 guidance, pharmaceutical companies that wanted to
include both the name of a drug and the condition it was intended to
treat were forced to include the small print that constituted this
complicated prescribing information. While feasible in newspapers and
magazines, such ads were not possible for radio and television. This
prompted companies to advertise on television in more oblique ways
that, while meeting legal requirements, may not have been very helpful
to patients. In such ads, either the name of a medicine or the name of
the illness could be mentioned--but not both. Consumers were often left
to guess what disease a medicine was intended to treat.
This system was clearly unsatisfactory. As Dr. William Jacott, a
trustee of the American Medical Association (AMA), said at the time:
``The problem with the way the FDA currently regulates ads is that they
discourage companies from providing information that may educate the
consumer. The merest mention of symptoms and a drug requires that a
company also include reams of information that most people won't read
and many wouldn't understand anyway.''
In announcing the clarifying guidance in August 1997, Michael
Friedman, M.D., then FDA Lead Deputy Commissioner, said: ``Today's
action can help promote greater consumer awareness of prescription
drugs.'' And Robert Temple M.D., Associate Director for Medical Policy
at the FDA's Drug Division, said that, under the new guidance, ads
could inform consumers about new products about which they might not
otherwise learn. As an example, he cited a new generation of
antihistamines that don't cause drowsiness. ``You need to be told by
someone that those products are out there or you'll never know,'' he
said.
The Information Revolution in Health Care
Under current practices, patients now are more actively involved in
their own health destinies than ever before. The consumer movement and
the information explosion have empowered patients to participate in
decisions concerning their health care. Armed with information,
patients have become active partners with health-care professionals in
managing their own health care. And they are savvy consumers.
Rather than remaining uninformed and relying entirely on an
increasingly complex health-care system, patients are asking questions,
evaluating information, and making choices. Direct-to-consumer
advertising provides a valuable resource for patients to obtain
information about specific diseases, conditions, and treatments,
particularly in rural areas of the country where access to providers
and health-care information may be difficult.
Too often, many common yet serious conditions go untreated even
though effective treatments are available. Affected individuals may not
realize that they need treatment. Others who are aware of their
symptoms may not know that treatment is available. Patients suffering
from chronic conditions may be dissatisfied with their current
treatment, but may be unaware that different options are available with
fewer side effects or an easier dosing regimen.
Advertising, however, is only one source of user-friendly
information that consumers have at their disposal. Some 50 consumer
magazines focusing on health care reach the news stands every month.
Just about every television station in the country has an on-screen
physician.
The Physician's Desk Reference, or PDR, once confined to doctors'
offices, is now available in a consumer edition at pharmacy counters.
Internet users can surf tens of thousands of sites dedicated to health-
care topics. In fact, according to health-care consultant Lyn Siegel,
about 25 percent of online information is related to health care and
more than half of the adults who go on the web use it for health
information. So, while DTC advertising is an important source of
information for consumers, it is clearly not their only source. But DTC
advertising is the most accurate because it is regulated by the FDA.
DTC advertising helps to meet the increased demands of consumers
for information about diseases and treatments. Most important, DTC
advertising can improve public health. It is intended to start a
dialogue between patients and doctors. Often, this dialogue will not
result in a doctor prescribing the drug mentioned by a patient. But it
will prompt a discussion that may lead to better understanding and
treatment of a patient's condition. It should be emphasized, however,
that physicians ultimately decide whether therapy is needed, and, if
so, which therapy is most appropriate for a particular patient.
Underdiagnosis and Undertreatment
Pharmaceutical advertisements raise awareness of conditions and
diseases that often go undiagnosed and untreated. For example, the
American Diabetes Association estimates that six million Americans have
diabetes but don't know it. One third of the people with major
depression seek no treatment and millions of Americans are unaware that
they have high blood pressure. By informing people about the symptoms
of such diseases and the availability of effective, noninvasive
treatments, DTC advertising can improve public health.
There are encouraging signs that this is happening. Following are
just a few examples:
A survey by Prevention Magazine found that, as a result of
DTC advertising, an estimated 24.7 million Americans talked to
their doctors about a medical condition they had never
discussed with a physician before. In other words, millions of
people who had previously suffered in silence were encouraged
to seek help.
A 1999 survey by the FDA found that 27 percent of
respondents asked their doctors about a condition they had not
discussed before. Conditions ranged from diabetes and heart
disease to arthritis, depression, and other undertreated
conditions.
In the two years that ads for a medicine for erectile
dysfunction have appeared, millions of men have visited their
doctors to request a prescription for the drug. For every
million men who asked for the medicine, it was discovered that
an estimated 30,000 had untreated diabetes; 140,000 had
untreated high blood pressure, and 50,000 had untreated heart
disease. These numbers are striking--and they're just for one
drug.
A study by IMS Health, a health-care information company,
found that, in the one year after an advertising campaign for
an osteoporosis drug began, physician visits by women concerned
about this disease doubled.
According to a survey by Scott-Levin, a consulting firm, the
number of patients visiting their physicians for treatment of
depression has increased from about 17 million in 1996, before
treatments for depression were widely advertised to consumers,
to more than 20 million last year.
Some 19 million Americans have moderate to severe disability
from migraines, and 11 million of them are untreated or are
treated sub-optimally. Migraine sufferers miss more than 157
million workdays a year and cost U.S. employers as much as $17
billion annually in decreased productivity. The good news is
that, since migraine medicines began to be advertised to
consumers, the number of people who visited their physicians
for treatment rose from about 6,200,000 in 1996 to about
7,100,000 last year, according to a study by Scott-Levin.
Many health-care organizations reported an increase in
requests for information since DTC advertising restrictions
were eased in 1997. For example, the American Foundation for
Urological Disease experienced a 30-40 percent increase in
requests for information.
Spillover Benefits
According to a recent analysis of consumer surveys by John E.
Calfee, Ph.D., of the American Enterprise Institute, DTC advertising
also provides important ``spillover'' benefits to patients, which have
nothing to do with the specific products advertised.
One such benefit is an increased awareness that virtually all
prescription medicines have risks and side effects. In addition,
physicians, when discussing conditions highlighted in advertising such
as obesity and high cholesterol, are able to suggest lifestyle changes
to their patients. And DTC advertising also improves compliance--it
prompts patients actually to take their prescribed medicines. In
response to a Prevention survey question, 31 percent of the respondents
said that ads made them ``more likely'' to take their medicines
regularly, compared to only 2 percent who said they were ``less
likely'' to do so.
According to Express Scripts Senior Director of Outcomes Research,
Brenda Motheral, Ph.D., who was quoted in the Pink Sheet on March 5,
2001: ``People are sticking with their chronic medications in higher
proportions than what we've seen in the past . . . Probably a big
driver of that, based on some work that our group has done, is direct-
to-consumer advertising.''
The Views of Consumers, Physicians, and Regulators
A growing body of evidence suggests that consumers like DTC
advertising. A 1999 survey by the FDA found that those who liked these
ads outnumbered those who did not by nearly 2 to 1. Eighty-six percent
said the ads ``help make me aware of new drugs,'' and 62 percent said
the ads helped them have better discussions with their physician about
their health. A survey by Prevention Magazine found that 76 percent of
respondents thought the ads ``help people be more involved in their
health care'' and 72 percent felt the ads ``educate people about the
risks and benefits of prescription medicines.''
The best way to understand how patients feel about DTC advertising
is simply to listen to them. Following are comments from patients
written to PhRMA companies:
A patient with herpes wrote: ``For many years people have suffered
in silence and shame. Making it known that this product is available
helps those in need. Putting advertisements in magazines and television
was a wonderful idea.''
A patient with chronic obstructive pulmonary disease (COPD) stated:
``You have a commercial on TV that mentions COPD and educates the
public--in about 30 seconds--as to the prevalence of the disease. I
firmly believe more public education is not just useful but necessary
as the number of people with COPD increases. So I want to thank you for
raising public awareness of this dreadful disease, and also I want to
say thanks for helping to keep me alive these past ten wonderful
years.''
Finally, a patient with asthma wrote: ``My concern is the fact that
this product is not being advertised enough. I have cut back my asthma
episodes by 80-90 percent. I have had asthma since I was 3 years old
and am now 51. Please get the word out about how well this product
works.''
There also is growing acceptance of DTC advertising by doctors.
Historically, physician organizations, as well as individual
physicians, have expressed concerns about DTC advertising. However, a
2000 survey by Louis Harris Interactives and the Harvard University
School of Public Health found that 64 percent of doctors believe that
DTC advertising of prescription drugs helped ``educate and inform''
their patients, and 40 percent of the doctors surveyed believe the ads
increased patient compliance.
A 1999 survey by the FDA showed that, when patients asked
physicians about an advertised medicine, 81 percent of patients said
the doctor welcomed the question. Only 4 percent said their physicians
appeared angry or upset when asked about a medicine. According to
Prevention, only 26 percent of patients who talked to their physicians
about an advertised medicine actually asked for a prescription, while
72 percent asked for more information.
The AMA continues its support of accurate pharmaceutical
advertising as ``appropriate and legal,'' according to a letter by Dr.
Richard Johnson in the July 6 issue of the Bergen Record. Writing to
clarify recent reports about AMA's policy on DTC advertising, Dr.
Johnson, who heads the Association's relevant Reference Committee,
stated that the Committee provided language to the AMA House of
Delegates ``from numerous physicians who testified that DTC ads are
valuable because they sometimes educate consumers about health
conditions and possible treatments that inform consumers better.
Testimony also indicated that drug ads may encourage some patients to
seek out their physicians and have more knowledgeable discussions about
their health conditions and, if applicable, treatment options.''
The FDA, reaffirming in August 1999 its policy of permitting DTC
advertising, stated: ``FDA is unaware of any data supporting the
assertion that the public health or animal health is being harmed, or
is likely to be harmed, by the Agency's actions in facilitating
consumer-directed broadcast advertising.''
Increased Drug Utilization: a Positive Development
Critics of DTC advertising claim that it drives up pharmaceutical
expenditures. While total pharmaceutical expenditures are rising
because there is a growing realization of the value of prescription
medicines, drug expenditures still make up less than 10 cents of every
health-care dollar.
The fact that more patients are getting more and better medicines
is good news--for patients, for the health-care system, and for
society. Just a few weeks ago, the federal government published new
cholesterol standards in an urgent attempt to encourage people to
reduce their risk of heart attacks. The National Institutes of Health
recommended that millions more Americans should take cholesterol-
lowering drugs, which would nearly triple the number of adults using
these drugs. Dr. Claude Lenfant, director of the Heart Institute, said
that adherence to these guidelines could mean that heart disease would
no longer be the top killer of Americans.
Following are a few more examples of the cost-effectiveness of
medicines, using drugs that have been the subject of DTC advertising:
A cholesterol-lowering drug was found to reduce hospital
admissions by a third during five years of treatment, according
to a study by University of Pennsylvania researchers. In
addition, patients who were admitted to hospitals had shorter
stays and were less likely to need bypass surgery or
angioplasty. Said Dr. Sanford Schwartz, a physician and
economist at the University of Pennsylvania: ``This is both
good medicine and good economics.''
A study published in The Journal of the American Medical
Association showed that treating Type 2 diabetes with a
medicine to improve glycemic control improved the quality of
life for patients and helped keep them out of the hospital and
on the job.
A study published in Health Economics found that medical
costs declined by $822 per employee per year and absenteeism
dropped by nine days when depressed workers were treated with
prescription medicines. Savings from improved productivity and
the reduction in work loss and medical costs far outweighed the
cost of the treatment.
Advertising Promotes Competition
People often confuse total drug expenditures, which are going up
for the public-health reasons just outlined, and drug-price increases,
which have been in line with inflation in recent years. According to
IMS Health, total drug expenditures rose 14.7 percent in 2000. Of that
figure, only 3.9 percent represented price increases. The remaining
10.8 percent reflects utilization--the fact that more patients are
using newer and more effective medicines.
The increased use of prescription drugs is a healthy trend. Drugs
not only save lives--they save money in many cases by reducing the need
for alternative, more expensive care such as hospitalization,
confinement in a nursing home, and surgery. Still, only 8.2 percent of
every health-care dollar is spent on prescription medicines, compared
to 32 percent on hospital care and 22 percent on physician and clinical
services.
Historically, advertising has promoted competition and increased
volume of sales. If anything, this tends to lead to lower--not higher--
prices.
Conclusion
In summary, DTC advertising helps to meet the increased demands of
consumers for information about diseases and treatments. More
important, however, DTC advertising can improve public health. It is
intended to start a dialogue between patients and doctors that may lead
to a better understanding and treatment of a patient's condition.
Mr. Chairman and Members of the Subcommittee, I hope that you will
support patients and oppose those who advocate adoption of a ``don't
tell, don't ask'' public-health policy: don't tell people about new
medicines--and hope they won't ask. That policy would be detrimental to
public health.
Instead, I hope you will stand behind the patients' right to know
about new medicines, to seek information from a variety of sources,
including DTC advertising, and to work with their physicians to help
themselves to better health. Ultimately, a physician determines the
appropriate medical treatment and may or may not prescribe a medication
that may or may not have been advertised and mentioned by a patient.
Thank you very much. I would be happy to answer any questions.
Senator Dorgan. Dr. Glover, thank you very much.
Let me ask a question or so of Mr. Calfee, and if Senator
Wyden has a question for Mr. Calfee, and then we will allow him
to catch his airplane.
Mr. Calfee, you indicated that advertising makes markets
work better, something that I agree with. Are there peculiar or
unusual different circumstances with respect to advertising of
prescription drugs? Others on the panel have talked about the
need for regulation in this area of advertising. Do you believe
that in this area of advertising regulation is necessary? We
obviously now have some regulation. Some are calling for more.
Mr. Calfee. We have a lot of regulation. I would say the
prescription drug advertising is regulated more stringently
than advertising for any other products available in this
country. The FDA is unique, I think, among agencies in the
stringency with which it regulates advertising. Maybe the SEC
is somewhat equivalent with securities ads, but for ordinary
products, for products that people buy, FDA advertising is far
stricter than it is for any other products.
But in addition, the big difference, of course, is that you
need a prescription. Two colleagues of mine and I recently did
a study of advertising for the statin drugs, Lipitor, Zocor, et
cetera, and we gathered proprietary data to look and see what
happens in this market when DTC advertising goes up and down,
and it does go up and down very rapidly. We could not find any
connection between the gyrations in the advertising and changes
in the prescriptions of these drugs.
As far as we can tell, the reason for that is that an ad
may get you to talk to your doctor about a drug, but once the
drug comes up, once you are talking to your doctor, the
doctor's influence appears to be overwhelming over other
considerations. In the case of statin drugs, if you talk to
your doctor about a drug, the doctor probably will tell you:
Well, how much do you weigh, what is your diet, and things like
that, do you ever exercise, check your cholesterol, and then
probably put you through to some advice for some lifestyle
changes, and it is pretty far down the road before you may or
may not get a prescription, and then the prescription will be
whatever the doctor thinks you need, if anything.
Senator Dorgan. Mr. Calfee, that conclusion seems to be at
odds with the conclusion that Ms. Chockley talked about, saying
that the most heavily advertised drugs in 2000 had an aggregate
sales increase of 32 percent compared to 14 percent increase
for all other drugs. One would expect that, A, advertising
works and, if it works, those drugs that are the most heavily
advertised would have the highest increase in growth in sales.
That is exactly what Ms. Chockley was testifying to.
You seem to suggest that is not the case.
Mr. Calfee. Yes. I have looked at a lot of advertising
research over the years and it turns out that if you look at a
market you often see that advertising follows roughly the same
pattern as sales, but if you look very closely at the data
often what you find is something that Nancy Ostrove of the FDA
mentioned, which is that manufacturers tend to advertise
products that are doing well. In other words, they have found
that if a product is really doing well, then they may get more
payoff from the advertising, at least for their particular
brand, because after all what they are really advertising is
their brand, not the entire product category.
So often what you find is that advertising tends to follow
sales rather than leading the sales, and whether advertising
actually increases those sales is often a very iffy question.
It is very difficult to determine, and sometimes the
advertising does do something for the brands, but does not do
it for the whole product category.
Senator Dorgan. Mr. Calfee, you are describing something
that is foreign to my experience of study as an MBA student,
that advertising follows sales performance. That would rewrite
the book on marketing as I knew it.
Mr. Calfee. You will find some books that you would not be
able to rewrite.
Senator Dorgan. Maybe I did not read them.
Senator Wyden.
Senator Wyden. Just one if I could, Mr. Calfee, on this
question of the ramifications for generics, because this is--we
all acknowledge that there is virtually no studies at this
point, there is no analysis, and clearly more needs to be done.
But it seems to me that we do know that direct-to-consumer
advertising is increasing the volume of these drugs, these
brand name drugs.
You develop the affinity with your physician and the use of
that drug, and it just seems to me again conceptually that it
is likely that you will be using generics at some point.
Do you disagree with that?
Mr. Calfee. To the general principle that advertisement on
the whole on average tends to increase sales of a product, I do
not have any objection to that as a general principle. It turns
out that the effect is usually much less than what people think
it is.
Now, in the particular case of branded versus generics, I
guess the real question is whether or not advertising somehow
heads off a switch to generic drugs when generics become
available. There may be some effect in that direction. We do
not really know for sure. What we do know, of course, is that
when generics appear market shares shift very rapidly and
prices tend to drop very rapidly. So generics do quite well
when they get in the market.
Senator Wyden. Well, we are going to explore this. I heard
Dr. Glover say are we getting into a do not ask, do not tell
kind of relationship. I am for asking, I am for telling, but I
am also for looking at carefully some of the ramifications here
that have not been looked at. I think that is what troubles
Senator Dorgan and I.
I will have some more questions in a moment. I know you
have to get a plane.
Senator Dorgan. Mr. Calfee, thank you for joining us today
and you are excused.
Let me ask a couple of questions of the others. Dr. Wolfe,
you in your testimony described part of what I was asking our
first witness about, Dr. Ostrove. That is the issue of
enforcement and enforcement of regulations specifically. You
indicated that you felt the FDA has had a reduced level of
enforcement even ad advertising has increased?
Dr. Wolfe. According to their own data, there is almost a
50 percent decrease in the last 3 years in enforcement actions.
As Dr. Ostrove said, that is a combination of both direct-to-
consumer and prescription, but I believe, contrary to what she
said, that there has been as much of a falloff, particularly in
the last year or so, in direct-to-consumer enforcement
activities.
I would be interested in seeing the data, but the point is
that the people there that she described, the approximately 13
or 14, are not much more than there were before there was no
direct-to-consumer advertising or virtually none in the early
nineties. It is nowhere near enough. The number of venues--
television, radio, print, and so forth--have just outstripped--
and whereas we ourselves strongly believe, have published a
number of books, some best-selling books on getting accurate
information to patients, they do not have drug ads in them and
they do not have a biased viewpoint. They have a review of
published studies and experts in every field.
When you start getting into the conflict of interest of
putting out ``information'' that is really primarily intended
to sell drugs, not primarily intended to educate, it needs
serious policing. The FDA is an agency in the public health
service. It is not doing an adequate job policing. I am told
they are interviewing some people now for some more positions.
We have made requests to the FDA commissioners for 10 or 15
years to ask for more than the number of positions they have in
this important part of the FDA.
Again to repeat what Dr. Kessler had said long ago and what
I agree with, everyone thinks about the drug approval process
as one which, if it goes wrong, a drug that is unduly safe will
get on the market and someone will die. People do not think as
much as they should about the advertising policing process,
because if people write a prescription, a doctor writes a
prescription based on his or her own advertising input to
patients, and it turns out that they could have written a
prescription for a safer drug, for a less expensive drug, the
patient does not do well.
This has to be policed much more than it has. Whereas the
number and amount of money being spent on direct-to-consumer
advertising has skyrocketed up, the other kinds of advertising
have also increased, not as dramatically, but the overall, as
mentioned, is close to $16 billion a year. It is an enormous
amount of money and the amount of money in FDA's budget to do
surveillance over it is inadequate. We need better policing.
Otherwise whatever is being done which is selling drugs is
being done on a sort of hucksterism kind of basis to the extent
that the ads are misleading.
Senator Dorgan. Dr. Glover, if in the last year there was a
19 percent increase in the cost of prescription drugs,
substantially because of increased utilization, some as a
result of price inflation, and if one believes that advertising
works and therefore, if advertising works, that has in part
contributed to that 19 percent increase--you may disagree with
that pretext--but if that is the experience, what do you expect
will happen on behalf of PhRMA with respect to the cost of
prescription drugs next year, the year after, the year after
that?
We have seen three very healthy double-digit years of cost
increases. Where is this heading?
Dr. Glover. Assuming that your facts are correct, first
off, we believe this is a difference between the price of
pharmaceuticals, which has remained in line with inflation, and
the cost of pharmaceuticals. The cost of pharmaceuticals is
driven both by price and by volume. In a society where you are
shifting your health care dollars from more expensive forms of
care, such as physician services and hospital stays, to the
pharmaceutical industry, it is a good thing and it is in the
public health and it is pro-consumer to have more of those
dollars go to prescription pharmaceuticals that keep people on
their jobs, in their communities, and out of hospitals and
consuming much more expensive care.
Therefore, while I cannot predict where the number is
likely to go in the future, we should applaud the possibility
that we will have newer and better medicines that people will
want to use, that physicians will want to use, in lieu of
putting people in hospitals and sending them to physicians at a
much higher cost overall to society.
Dr. Wolfe. I just want to I think correct the record. PhRMA
has repeatedly stated that the price increase--now we are
talking about price, not the volume, but the price increase--of
prescription drugs is in line with the consumer price index. I
have heard this over and over again. I looked at the data on
the consumer price index. From 1991 to 2000, a 10-year period,
the consumer price index for prescription drugs went up 1.7
times more than the consumer price index for all items, and in
the last 5 years it sent up almost 3 times more.
So this statement that this overall expenditure is largely
due to things other than price and that price is in line, to me
a 1.7-fold increase above the consumer price index in 10 years
and almost 3 times is not exactly in line. It is out of line.
It is not the only reason why we are paying more for drugs, but
it is an important reason.
Ms. Chockley. The 19 percent number is ours. It is from
NIHCM, and so I can tell you how it breaks down actually.
Between 1999 and 2000 retail prescription drug spending went up
by $20.8 billion. What we have found is 42 percent of it was
due to, the increase in prescription drug spending, was because
of the increase in prescriptions, so 42 percent. 36 percent was
due to a shift from less expensive drugs to more expensive
drugs, and 22 percent was because of just pure inflation.
Senator Dorgan. Dr. Glover, do you wish to respond, and
then I will call on Senator Wyden.
Dr. Glover. Certainly, in two respects. First off, the
NIHCM number of 19 percent is the percent that includes costs
other than the costs that are charged by the pharmaceutical
companies. It includes costs that are added on by retail
pharmacies to the costs that go to consumers.
Second, with respect to Dr. Wolfe's comments about the
inflation rate, it is not clear until we look at the numbers
whether 1.7 percent is substantially out of line.
Dr. Wolfe. 1.7 times, not percent. 1.7 times larger than
the consumer price index.
Dr. Glover. Dr. Wolfe, given that the consumer price index
inflation rate has been very small for the last 10 years, 1.7
times does not indicate the severity of any disparity that you
want to show.
So at any rate, our position, we maintain what I said as
being accurate, that we did not say that it was the same as or
lower than the CPI. We said it was in line with the CPI. It is
not twice the CPI, it is not ten times the CPI. We still stand
by our position that the majority of the price increase is due
to increased utilization, which is something that is good.
Senator Dorgan. Senator Wyden.
Senator Wyden. I will get us back to the more mundane
subject of direct-to-consumer advertising. Dr. Glover,
economics 101 suggests to me that the drugs that are going to
be advertised are the ones that are going to be money-makers.
It is just plain and simple. It is a marketplace economy. Those
are going to be the ones that get advertised. So drugs that
many people are going to need, but are ones that there is not
significant profit in, are not going to get the same kind of
attention in direct-to-consumer advertising.
So I wonder if what you are really talking about is an ask
and tell policy, but only with respect to drugs where you can
make a significant profit. That would concern me as well in
terms of the ramifications for our society. How would you
respond to that?
Dr. Glover. In the scheme of drugs that are patent
protected, I do not know what the difference is between the
advertising for those products that are more profitable than
others. Your earlier question suggested that you were drawing a
distinction between patent protected pioneer drugs and generic
drugs. Pharmaceutical companies----
Senator Wyden. I am not asking about that now. I am just
talking about economics 101. You advertise where you are going
to make money, and there are a lot of drugs folks need where
you are not going to make a lot of money. So it seems to me
that your asking and telling policy, which I happen to think
makes a lot of sense, I think that is in the interest of
empowering consumers, really is not one that applies across the
board, but it is an ask and tell policy that relates only to
drugs where there is a significant profit to be made.
Dr. Glover. Well, clearly, Senator, it only makes
commercial and economic sense for companies to advertise
products that they are most interested in selling. But you
cannot suggest that we are advertising profitable products in
lieu of advertising unprofitable products that could be equally
substituted for the same condition.
As FDA has indicated and as the pharmaceutical industry
will tell you, the products that get most of the attention are
products that are true innovations, that are having a
substantial impact on patient care. Those products are often
the same products that patients most need because what was
previously available was insufficient.
Senator Wyden. I am just dying to have somebody in American
enterprise show me where they are advertising unprofitable
products.
Dr. Glover. I do not think any industry intentionally
advertises unprofitable products, Senator.
Senator Wyden. I thought that is what you just said, that
there is no evidence of whether you are advertising profitable
products or unprofitable.
Dr. Glover. No, what I said, Senator, is that it is
unlikely to be the case that anyone is advertising a profitable
product for which there is an alternative that is less
profitable. These are drugs where there usually is no
alternative.
Senator Wyden. I just think that the policy of asking and
telling, which I support, ought to extend across the board, and
I do not get the evidence that that is the case. If there is
any information that you could supply us for the record that
would indicate that it is applying to a variety of these other
products where there are not significant profits to be made, I
would very much like to see it, and Senator Dorgan has made it
clear he is going to hold the record open.
One other question----
Dr. Glover. You should not expect that that information
exists, Senator.
Senator Wyden. Right. But you made the claim.
Dr. Glover. I made the claim.
Senator Wyden. That is why I was interested in it.
Dr. Glover. I made the claim that in every industry no one
intentionally advertises unprofitable products. You should not
expect this industry to be any different. I also made the claim
that the products that get advertised are the pharmaceutical
innovations. For those products there is no unprofitable
alternative.
Finally, as with every other industry, we do not force
people to advertise things that are not in their commercial
best interest.
Senator Wyden. Ms. Chockley, if I might, you called for an
independent source to try to make sure that people got accurate
drug information. That operation is going to be a busy one.
Suffice it to say they would have to handle information that
goes out over the Internet and information that is available
from a variety of sources.
Who do you think should be the independent source in this
country for monitoring the drug information that gets out?
Ms. Chockley. I think it has to include all stakeholders,
so it should include the pharmaceutical industry, it should
include the government, it should include doctors, most
importantly. But I think that we are going to continue to see
this trend increasing and the growth in pharmaceuticals I think
everyone is predicting is going to continue at this high rate.
I think it behooves us all to have an independent source of
information, both for consumers and for physicians.
Senator Wyden. So who sets this up? I am not clear. You
want all these various people to sit around----
Ms. Chockley. And therefore make it unworkable?
Senator Wyden. I thought it was an interesting concept. I
was curious how it would work.
Ms. Chockley. Well, I think that that is the direction that
we should move, then, is that there are a couple of--Rinehart
and some other researchers are talking about trying to come up
with more of an independent group that brings together the
different stakeholders.
What is very interesting and kind of gets to a couple of
the comments that you made is in the study where we showed that
prescription drug spending went up by 19 percent, if you
remember I said there were over 9,800 drugs. Half of the
increase was in 23 drugs, half the increase. So we could do a
lot by just looking at a few number of drugs in terms of
looking at how effective they are and when it is appropriate,
etcetera, to use them.
Senator Wyden. I will tell you, I think the industry has a
valid point when they say there are a lot of reasons why the
cost of drugs are going up.
Ms. Chockley. Sure.
Senator Wyden. There are a whole host of them, and we do
need to study the implications here. There is not anybody on
the planet today, if they were redesigning Medicare, would not
include a pharmaceutical benefit. I had a physician in
Washington County at home who put a senior citizen in the
hospital not long ago for 6 weeks because the person could not
afford an outpatient benefit. So of course pharmaceutical
spending went up in that kind of instance. But that was the
government's fault, that was not the fault of anybody in the
prescription drug industry.
But what I think Senator Dorgan has raised today are a
variety of issues that we ought to be looking at. We ought to
be looking at the implications on generic drugs. I have made it
clear we ought to be concerned about that. We ought to be
looking at the question of the doctor-patient relationship. We
ought to be looking at the area Dr. Wolfe has talked about,
ramifications for coupons and these programs that draw people
in and once they have got them there is an affinity there. I
think I made it clear to Dr. Glover that, while I support his
ask and tell policy, I want it extended across the board in our
society, and I am concerned about the ramifications that it may
apply only to these profitable drugs.
So all of you have given excellent testimony and I wish I
could spend the day with Senator Dorgan because he is doing
important work. But thank you for this time.
Senator Dorgan. Senator Wyden, thank you very much.
Let me just mention--let me ask a brief question, Dr.
Glover, and Dr. Wolfe wanted to comment, then I want to go to
the next panel. Dr. Glover, in response to questions posed by
Senator Wyden, he was asking I think a very specific
interesting question, and I think your answer was,
understandably, that the drug companies advertise where it is
profitable and in their interest to do so.
But then it seems to me what Senator Wyden was getting at
is if advertising direct-to-consumer is a public service and if
it is done only in circumstances where it is profitable to do
so for the industry, then it becomes only a public service to
the extent that it profits the industry with respect to those
specific drugs. Is that not the case?
Dr. Glover. That is clearly going to be--it clearly is
going to be the case that we will advertise where it seems to
be in our commercial best interest. We believe, however, and I
believe that other panelists will confirm this, that there are
spillover effects from our advertising for the drugs that we
want to, namely that we raise consumer awareness about certain
conditions for which there are treatments that were not
previously available; and second, what we think is more
important is that it stimulates a conversation with the doctor.
Where these patients go in, they do not always get the drug
that we have been advertising. They are often told they need to
change their health care, their lifestyle. Sometimes they are
given an over-the-counter drug and sometimes they are given
another prescription drug.
So while clearly we are going to advertise where we think
it is in our best interest, we believe there are going to be
spilloff effects there.
Senator Dorgan. Let me say that I think there are benefits
to direct-to-consumer advertising and I think there are risks.
I agree with Dr. Wolfe's opening statement that it is not the
case where I think the clock will be turned back on this issue,
but the risk questions I think in addition to the benefit
issues pose some very interested challenges for us.
Dr. Wolfe, you wanted to make a comment.
Dr. Wolfe. Just a comment on the now absent Senator Wyden's
question. One category of drugs where it is quite clear that
the drugs with the best record in terms of preventing death
from heart attack and stroke are the least advertised and the
most advertised are the ones that do not have as much evidence,
and that is for hypertension. Calcium channel blockers, which
do lower blood pressure but do not have anywhere near the
evidence of preventing stroke and heart attack that beta
blockers and diuretics do, are much more advertised and have
actually surpassed them in the number of prescriptions.
One can say why is it not that the companies that sell beta
blockers and diuretics, many of which are generically
available, to repeat that point, why do they not advertise?
Well, some of them are just small generic companies that mainly
cannot keep up with the brand name companies. But even some of
them who are brand name companies do not want to advertise
because they can make more money off of the much more expensive
and, at least as the evidence is right now, less effective
calcium channel blockers.
I think that is a good example where the advertising is not
limited just to the breakthrough drug that is much better than
anything else on the market.
Senator Dorgan. Dr. Wolfe, thank you very much. This panel
has been very helpful and I thank you for your testimony.
I am going to call on the next panel, and as I do I want to
recognize our ranking member, Senator Fitzgerald from Illinois.
Next we are to hear from John Gilensky, Executive Director of
RxHealth Value, Dr. Michael Shaw, Executive Director of
EthicAd', and Dr. Richard Dolinar, an
endocrinologist from Phoenix, Arizona.
Let me welcome our ranking member, who has been on the
floor of the Senate and is just now joining us, Senator
Fitzgerald.
STATEMENT OF HON. PETER G. FITZGERALD,
U.S. SENATOR FROM ILLINOIS
Senator Fitzgerald. Thank you, Senator Dorgan. I appreciate
your holding this hearing and I am sorry that it conflicted
with a floor speech I had to give about the problems at the
O'Hare Airport in Chicago, which I am sure you have experienced
at one time or another.
I think this is an important topic. I come to this debate
with a fairly open mind. I have not previously taken a position
on this issue. I come from a family where hardly anybody ever
used prescription drugs. To this day, I think the only thing
that my parents, who are in their seventies, have in their
medicine chest is aspirin. My parents were always cautious
about taking any kind of prescription medicine, and that is the
kind of orientation I have had in my own life with my own
family, too.
I do believe that consumers benefit by having as much
information available to them as possible. I am concerned,
however, that direct-to-consumer advertising has in its initial
years stimulated more usage of prescription drugs than perhaps
would be optimal. I think that consumers will have to over time
develop a healthy skepticism about those kind of ads. They may
not have had that same kind of skepticism with respect to
prescription drug advertising a few years ago because we did
not have those kind of ads before then.
I know my nine-year-old child, when he was a few years
younger, every time he saw an ad for a toy or for a cereal he
would tell me we had to get it, that that cereal is the best
cereal. I would say, how do you know that, and he would parrot
a television ad that he had seen. Now as he has gotten older,
he has realized that all those advertisements have to be taken
with a degree of skepticism.
Just as he has learned that, I think consumers probably
have to develop a healthy degree of skepticism with respect to
prescription drug advertisements. But I am not sure that I
would ever want to go so far as saying that we should prohibit
or ban companies from making those advertisements. But really I
come to this with a pretty open mind, and I want to compliment
Senator Dorgan for his interest in the area and for convening
this hearing.
With that, I welcome panel two.
Senator Dorgan. Senator Fitzgerald, thank you very much.
We have Mr. Mark--is it ``CLO-tier''?
Mr. Cloutier. Correct.
Senator Dorgan. Mark Cloutier--let me amend my earlier
announcement--Executive Director of RxHealth Value; Dr. Michael
Shaw and Dr. Richard Dolinar. Mr. Cloutier, why do you not
proceed.
STATEMENT OF MARK CLOUTIER, POLICY DIRECTOR, RxHEALTH VALUE
Mr. Cloutier. Thank you, Mr. Chairman. Senator Dorgan,
Members of the Committee: I am Mark Cloutier, Policy Director
of RxHealth Value, which is a national coalition of consumer
groups, labor unions, provider groups, business groups, and
employers, insurers and health plans, pharmacy benefit
management organizations, and academic researchers who are
committed to improving Americans' access to health-improving
prescription drugs.
As you can understand, a deliberative body comprised of
nearly 30 organizations will rarely arrive at a full consensus
regarding any issue. Remarkably, our membership has achieved
consensus regarding the recommendations I am offering regarding
direct-to-consumer advertising of prescription drugs to
consumers and patients. We believe safety is at stake. I
believe the fact of these consensus recommendations indicates
the fundamental importance of this issue for the members of
RxHealth Value.
It is our belief that this form of advertising affects the
health and safety of American patients and consumers. The
tremendous increase in the extent of direct-to-consumer
advertising of prescription drugs since the FDA removed the
requirement for brief summary of risk information in 1997 is
well documented. It is almost impossible to open a general news
magazine, view prime time television, or listen to the radio
and not see or hear advertising for prescription drugs.
Given that the prescribing physician is the decisionmaker
regarding the use of these medications, it is all the more
startling that so many resources are expended by drug
manufacturers to affect the attitudes of consumers and
patients. Although there is little evidence, as we heard from
Dr. Ostrove, currently available regarding whether consumer and
patient attitudes affect physician choice in prescribing, no
stakeholders in the health system and healthy economy have
suggested that the impact of such advertising is insubstantial.
Given the FDA's expressed interest in assessing the effects
of direct-to-consumer advertising, we expect more direct
evidence of impact will be available in the near-term future.
While we await the results of planned and pending studies on
the effects of advertising on the attitudes, behaviors, and
medical outcomes of consumers and patients, RxHealth Value
members are concerned that risk information in particular is
not adequately or effectively conveyed in direct-to-consumer
advertising.
One of our member organizations, AARP, recently conducted a
survey of members to assess the impact of direct-to-consumer
advertising, finding that the majority of those surveyed could
not recall ever seeing risk information in the ads. As you went
up in age cohorts, there was even less recall of risk
information. This poses a serious safety risk to consumers and
patients.
In our first public recommendation to the FDA presented 1
year ago at the National Press Club, RxHealth Value emphasized
the fundamental importance of protecting safety of patients and
consumers who are confronted by DTC advertising. Thus, RxHealth
Value recommends that the Congress direct the FDA to convene a
task force of key stakeholders, including the pharmaceutical
manufacturers who advertise prescription drugs, as well as
consumer groups, patient organizations, provider groups, payers
and relevant experts, to develop and test standards for
information disclosure in direct-to-consumer advertising, to
more carefully define the concrete meaning of fair balance in
disclosing benefits and risks of advertised medications, to
include disclosure of other appropriate therapies in addition
to alternative medications.
As you may know, the AMA approximately a month ago passed a
resolution calling on language ``Your doctor may recommend
other treatment options that may be equally or more
effective.'' We want to support that resolution.
To further define ``fair balance'' to mean that full
disclosure of risks and side effects be given equal print and
air time as the description of benefits in the same
communication.
RxHealth Value recommends that the appropriate agencies of
the Federal Government conduct ongoing research to evaluate the
effect of direct-to-consumer advertising on the health of
American consumers and patients. It is a given that many
Americans appreciate the increased awareness of diseases and
conditions and potential therapies which direct-to-consumer
advertising makes possible. It is also true that such
advertising can obscure potential hazards of the pharmaceutical
advertised and neglect the relative value of other forms of
therapy.
Only thorough independent research can demonstrate the
differential impact of such advertising upon the health choices
of American patients and physicians.
In conclusion, the members of RxHealth Value applaud the
Subcommittee for beginning the investigation of the effects of
this increasingly pervasive influence on the therapeutic
choices of American consumers and patients. We pledge our
assistance in implementing any of these recommendations we have
offered and thank the Subcommittee for this opportunity to
comment.
[The prepared statement of Mr. Cloutier follows:]
Prepared Statement of Mark Cloutier, Policy Director, RxHealth Value
Mr. Chairman, Members of the Subcommittee, I am Mark Cloutier,
Policy Director of RxHealth Value, a national coalition of consumer
groups, labor unions, provider groups, business groups and employers,
insurers and health plans, pharmacy benefits management organizations,
and academic researchers committed to improving Americans' access to
health-improving prescription drugs. (Our membership list is appended
below.) As you can understand, a deliberative body comprised of nearly
30 organizations will rarely arrive at full consensus regarding any
issue. Remarkably, our membership has achieved consensus regarding the
recommendations I am offering regarding Direct-to-Consumer (DTC)
advertising of prescription drugs to consumers and patients. Safety is
at stake. I believe the fact of these consensus recommendations
indicates the fundamental importance of this issue for the members of
RxHealthValue. It is our belief that this form of advertising affects
the health and safety of American patients and consumers.
The tremendous increase in the extent of DTC advertising of
prescription drugs since the FDA removed the requirement for the
``brief summary'' of risk information in 1997 \1\ is well documented
\2\. It is almost impossible to open a general news magazine, view a
prime time television program or listen to the radio and not see or
hear advertising for prescription drugs. Given that the prescribing
physician is the decision-maker regarding the use of these medications,
it is all the more startling that so many resources are expended by
drug manufacturers to affect the attitudes of consumers and patients.
Although there is little evidence \3\ currently available regarding
whether consumer and patient attitudes affect physician choice in
prescribing, no stakeholders in the health system and health economy
have suggested that the impact of such advertising is insubstantial.
Given the FDA's expressed interest in assessing the effects of DTC
advertising, we expect more direct evidence of impact will be available
in the near term future.
---------------------------------------------------------------------------
\1\ Draft Guidance for Industry: Consumer Directed Broadcast
Advertisements: Availability. Federal Register 1997; 62:43171.
\2\ Findlay, Stephen. Prescription Drugs and Mass Media
Advertising. NIHCM, Sept. 2000.
\3\ Bero, Lisa A. & Lipton, Shira. Methods for Studying the Effects
of Direct-to-Consumer Pharmaceutical Advertising on Health Outcomes and
Health Services Utilization. (Paper to be presented at ASPE Conference
on Methods to Assess Effects of DTC Advertising, May 30, 2001).
---------------------------------------------------------------------------
While we await the results of planned and pending studies on the
effects of DTC advertising on the attitudes, behaviors and medical
outcomes of consumers and patients, RxHealthValue members are concerned
that risk information in particular is not adequately or effectively
conveyed in DTC advertising. One of our member organizations, AARP,
recently conducted a survey of members to assess the impact of DTC
advertising \4\ finding that the majority of those surveyed could not
recall ever seeing risk information in the ads. This poses a serious
safety risk to consumers and patients. In our first public
recommendations to the FDA, presented one year ago at the National
Press Club, RxHealth Value emphasized the fundamental importance of
protecting the safety of patients and consumers who are confronted by
DTC advertising \5\
---------------------------------------------------------------------------
\4\ Foley, Lisa A. & Gross, David J. Are Consumers Well Informed
About Prescription Drugs? The Impact of Printed Direct-to-Consumer
Advertising. AARO: Public Policy Institute, April 2000.
\5\ Policy Recommendations. RxHealth Value May 10, 2000.
---------------------------------------------------------------------------
Thus, RxHealth Value recommends that the Congress direct the FDA:
To convene a task force of key stakeholders, including the
pharmaceutical manufacturers who advertise prescription drugs,
as well as consumer groups, patient organizations, provider
groups, payers and relevant experts, to develop and test
standards for information disclosure in DTC advertising.
To more carefully define the concrete meaning of ``fair
balance'' in disclosing benefits and risks of advertised
medications to include disclosure of other appropriate
therapies in addition to alternative medications.
To further define ``fair balance'' to mean that full
disclosure of risks and side effects be given equal print and
air time as the description of benefits in the same
communication.
RxHealthValue recommends that the Congress direct that the
appropriate agencies of the Federal Government conduct on-going
research to evaluate the effects of DTC advertising on the health of
American consumers and patients. It is a given that many Americans
appreciate the increased awareness of diseases and conditions and
potential therapies which DTC advertising makes possible. It is also
true that such advertising can obscure potential hazards of the
pharmaceutical advertised and neglect the relative value of other forms
of therapy. Only thorough, independent research can demonstrate the
differential impact of such advertising upon the health choices of
American patients and physicians.
In conclusion, the members of RxHealth Value applaud the
Subcommittee for beginning the investigation of the effects of this
increasingly pervasive influence on the therapeutic choices of American
consumers and patients. We pledge our assistance in implementing any of
the recommendations we have offered and thank the Subcommittee for this
opportunity to comment.
Senator Dorgan. Mr. Cloutier, thank you very much.
Next we will turn to Dr. Shaw.
STATEMENT OF MICHAEL S. SHAW, M.D., EXECUTIVE DIRECTOR,
EthicAd'
Dr. Shaw. Good afternoon, Mr. Chairman, Senator. On behalf
of EthicAd' and the health care community we
represent, thank you to the Subcommittee for this opportunity
to comment on direct-to-consumer advertising. This is the area
to which our organization is dedicated. EthicAd' is
an independent and neutral nonprofit organization composed of
leaders of the academic health care community. Dr. Michael E.
DeBakey is our chairman emeritus.
EthicAd''s goal is to promote the development of
DTC advertising in a manner that maximizes public health
benefits. We do not oppose DTC advertising, we are not critics
of the pharmaceutical industry. Rather, we support the idea
that industry should work with other stakeholders to define
voluntary self-regulatory standards for DTC. These standards
should be designed to assure the American public that the DTC
advertising they see represents reliable, accurate, and
trustworthy medical information.
The pharmaceutical industry has a long and honorable
tradition of collaboration with the health care community in
the development of high quality professional and patient
education programs. This traditional relationship is usually a
collaborative effort between the health care community and
industry. This system provides important checks and balances on
the marketer, and I am certain this distinguished body
understands the importance of checks and balances.
DTC represents a dramatic shift in this traditional
relationship. DTC removes these important checks and balances.
DTC provides an opportunity for industry to act autonomously to
develop and disseminate health care information for the
consumer without any outside input or review by the medical
community.
The issue is not the relatively innocuous television and
magazine advertisements. These highly advertised and visible
programs are closely monitored by the FDA. They represent only
the tip of the iceberg. Industry is investing hundreds of
millions of dollars in a wide variety of consumer web sites,
patient informational programs and relationship marketing
projects.
The overwhelming majority of these arrangements are not
reviewed by FDA. Who, then, assures the reliability of this
information?
Currently this DTC content is developed by marketing
departments and their advertising agencies, subject only to the
internal medical review within a given company. Most DTC
programs are not pre-approved by the FDA. Does this current
system assure consumers of reliable and unbiased health care
information? Industry has no uniform standards other than the
expectation that they will comply with FDA requirements. But
there are an estimated 60 to 70,000 pieces of DTC material
developed each year. The FDA has only 13 full-time reviewers.
As a practical matter, the FDA can review only a sampling of
these materials. Clearly, DTC presents great potential for
abuse.
There is a wide disparity in how different companies
approach DTC. Many pharmaceutical companies are socially
responsible and ethical in preserving consumer trust. Other
companies take a narrower view. They focus on DTC merely as a
mechanism to drive sales. The consumer is often unable to
differentiate between those DTC programs designed the promote
their health and welfare and those programs designed merely to
promote sales. There are no standards, best practices, or even
clear goals for DTC. There should be. We applaud the
exceptional work of FDA. The agency has balanced conflicting
demands of its stakeholders to review mountains of promotional
materials using extremely limited resources. FDA is the
American public's best protector in this area. It requires
increased resources to manage the increased demands placed upon
it by DTC.
But FDA regulations alone will not solve the DTC problem.
These regulations represent minimum legal requirements. They do
not and cannot and many would argue should not define optimal
behavior. Clearly, something additional is needed. We do not
believe that additional legislative action is required at this
time. Instead, we suggest that there is immediate need for
industry collaboration with other stakeholders in the
development or support of voluntary self-regulatory goals,
standards, and best practices. These standards will assure the
American public that the DTC health care information they
receive is reliable, understandable, and trustworthy.
Rather than wait for government or industry action, the
academic health care community that EthicAd'
represents has developed suggested standards and best
practices. These specific standards are summarized in my full
written testimony. We believe that reasonable people develop
responsible solutions. We welcome and need the active
involvement of the pharmaceutical industry and the oversight of
Congress and the FDA to implement voluntary DTC standards.
Thank you for the opportunity to share these views and to
answer your questions.
[The prepared statement of Dr. Shaw follows:]
Prepared Statement of Michael S. Shaw, M.D., Executive Director,
EthicAd'
EthicAd'
EthicAd' is a non-profit organization representing the
neutral and independent views of the academic healthcare community. The
EthicAd' Steering Committee and Advisory Board is chaired
by, Dr. Michael E. DeBakey, Director of the DeBakey Heart Center of the
Baylor College of Medicine, and Donna Hill Howes, R.N., M.S., Director
of Health Education for Time, Inc. Health. It is also composed of
leaders in medical education. Many of those members have collaborated
with the pharmaceutical industry in the development of professional
educational programs and materials. EthicAd''s Executive
Director, Dr. Michael Shaw, is a physician, educational filmmaker,
former-educational media specialist at the National Institutes of
Health National Library of Medicine and President of Shaw Science
Partners, Inc. in Atlanta, GA.
Part 1--Executive Summary
Direct-to-Consumer Advertising and Public Health
During the past two years, EthicAd' has studied the
legal, ethical and practical issues underlying DTC advertising. In
order to better understand the needs and views of the various
stakeholders, we obtained advice and input from the pharmaceutical
industry, regulatory community, consumer groups, healthcare
professionals, managed care providers, insurers and members of the
legislative community.
While a significant portion of the medical community and medical
organizations are opposed to DTC advertising, EthicAd'
maintains a different position. We respect the pharmaceutical
industry's long tradition of developing valuable and credible
professional educational programs. We believe that if industry takes
proactive responsible steps to develop voluntary goals, standards and
best practices, DTC advertising has the potential to make a significant
positive contribution to public health. We believe that the major
concern of healthcare professionals is not the existence of DTC, but
the informational depth, quality and focus of the current genre of DTC
advertising.
As a result of our research, we offer the following observations
about DTC advertising:
L1. The Pharmaceutical Industry Has Become a De Facto Member of
the Healthcare System
LDTC represents a dramatic departure from the traditional
relationship of the pharmaceutical industry to the healthcare
professional and patient. Prior to DTC, industry communicated directly
to the healthcare professional through the common language of
scientific studies and clinical data. When industry sponsored patient
education materials, these were distributed to patients only after
being screened by ``learned intermediaries.'' DTC fundamentally changed
this dynamic by enabling industry to provide healthcare information
directly to patients. Because no tradition or common language exists
for industry to communicate complex medical information to consumers,
by default the ``language'' used is predominantly one of merchandise
advertising. This emphasizes product image and brand awareness more
than education. While this mode of advertising is appropriate for most
types of consumer goods, society holds medical practice to higher
standards. EthicAd' believes that there is an important
rationale for asking industry to adhere to similar high standards.
Through DTC, the pharmaceutical industry has become a healthcare
provider and a de facto member of the healthcare community. In all
other instances, society requires that healthcare providers undergo
extensive training and licensure as a prerequisite for the privilege of
providing healthcare to the public. EthicAd' believes that,
when industry exercises the privilege of becoming a provider of
healthcare information, industry must take similar self-regulatory
steps to assure that the information it develops, sponsors and/or
provides adheres to ethical standards comparable to those of other
healthcare providers.
L2. DTC--The Tip of the Iceberg
LWhile DTC advertising is the most visible form of industry
involvement in the delivery of healthcare information, the scope of
this new relationship between industry and consumers goes far beyond
television and print advertising. In recent years, industry has been
systematically extending the ``reach'' of its marketing into less
apparent direct and indirect forms of healthcare information delivery
to consumers. These activities take various forms, from creating and
sponsoring disease-state Internet sites, to creating and sponsoring
patient advocacy groups whose goal is to promote patient information in
a manner that is consistent with product marketing strategy. These
activities do not necessarily fall within the category of ``direct-to-
consumer'' programs but under the headings of:
Relationship marketing;
Industry-funded patient support programs; and
Direct-to-patient marketing.
The scope and extent of these alternate forms of healthcare
information delivery to consumers are not necessarily reflected as DTC
spending. They can fall into other less apparent categories. Industry's
involvement in communicating directly with patients through these more
ambiguous channels is likely to expand exponentially given the rate of
industry's growing investment in consumer data mining sources such as
healthcare Web sites, online patient medical record systems, and
pharmacy benefits management databases. These forms of patient data
sources provide industry with the opportunity to market directly to
patients within a specific disease category in a manner that may not be
recognized as commercial advertising by patients and patients'
families.
L3. The Consumers' Need for Trustworthy Information
LBased upon discussions with consumers, we believe that the
public may be uncertain and confused about the reliability and
impartiality of DTC healthcare information. As alternate forms of
advertising, such as ``infomercials,'' expand, it will become
increasingly difficult for consumers to separate valid and unbiased
medical information from commercial product advertising. They are also
confused about educational efforts represented as ``independent'' but
actually funded by industry. Activities such as disease-state Web sites
may be represented as ``independent'' but may not necessarily be
unbiased. For example, an ``independent'' consumer Web site about a
cholesterol-lowering treatment may discuss the relative benefits of a
particular class of drug used to treat high cholesterol in a medically
accurate manner. But while the materials may be factually correct, they
may not provide sufficient emphasis upon the fact that lifestyle
modification (proper diet and exercise) might entirely eliminate the
need for medication. Thus, while consumers and patients have enormous
need for healthcare information, they are uncertain about whether they
can trust material developed though industry funding.
LAn important question is, if industry is going to play the
role of healthcare information provider, how can consumers trust that
the information provided is independent, unbiased, medically reliable,
and represents the patients best interest . . . not just the commercial
best interest of the sponsor.
L4. The Need for Voluntary Best Practices for DTC
LThere is enormous variability in the methodologies used by
different pharmaceutical companies in the development of DTC campaigns
and materials. Some companies take extraordinary steps to assure that
the DTC programs they sponsor provide significant public health
benefits. Those companies take systematic steps to gain input and
suggestions from independent medical experts, consumers, and patient
advocacy groups. Some companies develop comprehensive DTC campaigns
that include patient education and patient care materials developed in
collaboration with reputable independent third-party organizations and
institutions. Other companies have a more restrictive view of DTC. They
limit DTC activities to product advertising and promotion. Currently,
there is no set of standards or best practices, or even agreed upon
goals for DTC. Moreover, the consumer has no way to differentiate
programs developed using these ``best practices'' from those that
employ only a narrow commercial bias.
L5. FDA Regulations Represent the Legal Requirements, Not the
Highest Ethical Standards
LWe recognize that the FDA has ultimate regulatory authority
and commend DDMAC for its excellent performance in balancing the
complex needs of its stakeholders. However, there are limitations to
the FDAs role given limitations in its regulatory scope and its finite
manpower. While current FDA regulations are necessary to protect the
public, they are not sufficient to assure that DTC programs promote the
public good. The FDA has no regulatory authority to require that
industry develop DTC programs in a manner designed to promote public
health. For example, FDA regulations require that sponsors include a
``Brief Summary'' to accompany a product advertisement. The term Brief
Summary refers to complex, exhaustive labeling traditionally used to
inform physicians about the myriad of potential side effects and
complications associated with a given product. While the FDA
``encourages'' pharmaceutical companies to modify this Brief Summary
into a form that is understandable to patients, FDA regulations do not
``require'' pharmaceutical companies to do so. This is but one example
of how current FDA regulations protect the public interest but do not
require industry to act according to optimum standards.
LWe believe that there is enormous and immediate need for
industry to develop voluntary self-regulatory DTC goals, standards, and
best practices that promote development of consumer healthcare
information that is reliable, understandable and trustworthy.
Part 2
Goals and Standards in Direct-to-Consumer Advertising of Ethical
Pharmaceutical Products
Background
Advertising prescription drug products to consumers is a relatively
recent phenomenon. The most visible form of DTC advertising, television
commercials for prescription products where the indicated use of the
product was identified, has only been in existence since 1997 when the
FDA released its draft Guidance to Industry. Because DTC advertising is
so new, there has not been enough time to fully assess its impact upon
public health, or to evolve standards and best practices for DTC
advertising. EthicAd' has been studying this issue for more
than a year. It has obtained input from representatives of the
pharmaceutical industry, advertising industry, healthcare
professionals, regulatory agencies, patient advocates and, most
importantly, consumers. The ideas for DTC Standards described below are
based upon this research.
The pharmaceutical industry has a long and honorable tradition of
collaboration with the medical community and government agencies in the
development of new therapies and sponsorship of educational programs
designed to promote public health. DTC advertising represents a
fundamental shift in the nature of the pharmaceutical industry's
relationship to healthcare providers, patients, and the public
(``consumers''). Prior to DTC, industry made information available to
healthcare professionals who then served as learned intermediaries in
educating patients with information they deemed relevant. By permitting
industry to provide health information directly to consumers, DTC
advertising allows industry to function in a role traditionally
reserved to trained and licensed healthcare professionals.
EthicAd' is not opposed to DTC advertising. We believe
that providing the public with reliable, balanced, and understandable
information about diseases, treatments and prevention can result in
consumers developing more responsibility for their own health and well-
being. EthicAd' believes that it is possible for the
American people to derive public health benefits from DTC advertising
if industry takes positive, responsible, and constructive steps to
reduce the potential for bias in DTC information. Such voluntary
efforts would also reduce the need, or likelihood, of systematic
government regulation.
The Need for DTC Best Practices
The FDA has sole regulatory authority for promotional materials
involving prescription pharmaceuticals. However, FDA regulations
represent the minimum legal requirements, not optimal behavior.
Professional organizations, consumer groups and the legislative
community have raised serious questions about whether the current form
of DTC advertising contributes to public health and well-being or
merely raises the cost of pharmaceutical products and contributes to
public confusion. EthicAd' believes that it is critical for
the pharmaceutical industry to take voluntary constructive steps to
assure that DTC advertising develops in a responsible manner.
Just as all healthcare professionals are trained in a set of
ethical standards and their behavior monitored for adherence to those
standards, we believe that industry must take concrete positive steps
to assure that DTC information is consistent with the ethics of good
medical practice based upon the following principles:
By virtue of providing the public with health information
through DTC advertising, the pharmaceutical industry has become
a de facto healthcare information provider. As with any other
health care provider, this is a privilege and carries community
responsibilities.
In enjoying this privilege, industry must exercise social
responsibility to ensure that the information they provide to
patients and the public is honest, fair, balanced, and
comprehensive.
In addition, industry should accept responsibility for using
DTC advertising as an opportunity to collaborate with the
medical community, patient advocates and government agencies to
improve public health by dedicating a significant portion of
DTC budgets to providing the public with non-promotional
educational materials.
A Vision for DTC
EthicAd' is committed to promoting constructive change
in the field of DTC advertising. One of the first steps is to develop a
clear vision for DTC advertising.
We envision the next generation of ``ethical DTC advertising'' to
be Direct-to-Consumer programs developed by the pharmaceutical industry
in collaboration with other stakeholders (the medical community,
consumer groups, government agencies) that are designed to meet the
needs of the public for reliable, relevant and trustworthy information
while also meeting industry's need to build brand awareness and promote
appropriate use of its products.
There are several important elements to this vision. First, it
acknowledges the fact that the pharmaceutical industry is, and has long
been, an active participant in the health care system. Second, it
recognizes and accepts the fact that the pharmaceutical industry is a
business and not a charity. Industry participates in DTC because it
expects a return on investment. There is nothing inherently wrong with
this, but by definition, it does mean that industry has an inherent
bias. In order to create ``socially responsible'' DTC, it is important
to recognize, accept and adjust for that bias. This is the third
component, the need for collaboration and for systems of checks and
balances.
In order for DTC to meet the consumers desire for reliable and
trustworthy information, industry can correct its inherent bias through
collaboration with outside and independent advisors or organizations
willing to assure the credibility, reliability, and balance of the
information being presented.
EthicAd' Recommended Goals for DTC Advertising
The EthicAd' goals for Direct-to-Consumer advertising of
pharmaceutical products are:
L1. To provide consumers with substantive and reliable
information about pharmaceutical products and the diseases that they
treat.
L2. To provide materials that increase consumer awareness of the
signs, symptoms and treatment options for medical conditions.
L3. To provide a mechanism for industry to develop and deliver
materials to patients/consumers that can be useful in the patients'
care or improve consumers' ability to ask more informed questions of
their healthcare provider.
Best Practices for Development of Quality DTC by Pharmaceutical
Industry
EthicAd' has determined that many, but not all,
pharmaceutical companies take constructive steps to develop socially
responsible DTC. The following are industry best practices that some
pharmaceutical companies are already successfully employing in the
development of DTC programs:
L1. Ethical DTC advertising should provide consumers with
reliable and accurate pharmaceutical products available for the
treatment of a disease or medical condition without creating
misimpressions or unrealistic expectations regarding,
La. The specific patient population for which the product is
indicated,
Lb. The availability of non-pharmacologic means of therapy,
Lc. Results that patients can expect from treatment, and
Ld. Possible negative consequences from treatment.
L2. All materials developed through direct or indirect industry
influence and/or financial support should explicitly state the nature
of such support and the nature of influence exercised by industry over
the subject matter.
L3. When designing a DTC campaign, industry should develop an
advisory board of independent health care professionals and patient
advocates at the formative design stage of a DTC campaign. The goal of
this advisory board is to help identify the needs of patients and to
assure that the approach being developed is consistent with public
health interests. This best practice helps industry to create DTC
programs that balance the needs of the company with the needs of the
public and the healthcare community.
L4. In DTC campaign development, industry should conduct a formal
needs assessment of the informational and educational requirements of
individuals who have a particular disease. In essence, this is a step
to define what specific benefits a DTC campaign can provide for
consumers and patients.
L5. Industry should formally test DTC materials with consumers in
order to validate the materials educational efficacy. DTC materials go
through a rigorous process of focus group testing to assess how well
they convey the sponsor's message. This testing can be expanded to
evaluate whether the advertisements are conveying medical information
clearly and effectively, and to assure that the advertisement is not
creating any misimpressions.
L6. Industry should develop consumer-friendly versions of the
current professional ``Brief Summaries.'' Not only has the FDA allowed
industry to revise this material, they have encouraged industry to do
so. From a best practice perspective, there is no reason why industry
cannot revise the Brief Summaries of each and every product that is
promoted through DTC by the end of 2002. These revisions should also be
tested to assure that they are understandable to the average consumer.
L7. Recommendations for DTC Content Design
La. Content accuracy is more than just lack of factual errors.
Often materials can be misleading by omission of information that can
provide objectivity and balance. The review process established by
industry should include outside independent advice from medical experts
to look for such important omissions or potential areas of confusion.
Lb. Responsible DTC should include information about behavioral
and non-pharmacologic approaches to treatment and/or prevention. In
many common diseases and conditions, such as hypertension and Type II
diabetes, diet and exercise are the first-line therapy. DTC materials
have the responsibility to inform patients of these important public
health measures.
Lc. The use of statistics or data in DTC advertisement can be
inherently misleading and, if used, must be presented in a manner that
assures accurate understanding by the target audience. For example,
stating that a drug reduces risk of a disease by 50% may be factually
correct. But, that benefit may only be a reduction from 2% risk to 1%
risk. To simply state a ``50% reduction'' is inherently misleading
unless accompanied by a full and understandable disclosure of the
meaning of the data.
Ld. Industry typically assesses DTC advertising materials by
means of field tests and focus groups. These tests should be expanded
beyond just marketing efficacy to include questions that measure
whether the content is understandable to consumers and to assure that
the content does not create misimpressions. That data should be made
available to the internal DTC reviewers and should be available for
submission if requested by the FDA.
L8. Recommendations For DTC Design and Visual Presentation
La. Industry must recognize that patients, especially those
with serious or chronic medical conditions, may be emotionally
vulnerable to information that can be interpreted as suggesting
unrealistic hope for improvement.
Lb. Print advertisements and broadcast commercials are
expensive to develop and disseminate. Obviously, industry has the right
to make these materials visually attractive so that consumers will pay
attention. However, there is a point where the application of visual
design that appeals to consumers' ``inner self'' and ``inner desires''
may become misleading to consumers by creating unrealistic hope. While
this area is admittedly subjective, the main area of concern relates to
the selection and portrayal of ``role model'' patients and the
activities they are represented as performing.
Lc. Industry should establish a process for including outside
medical advice regarding the selection and characterization of actors
cast to depict patients suffering from a condition or disease. Every
effort should be made to assure that actors portraying patients are
appropriate in age, sex, race, national origin, body habitus, and
physical characteristics. Actors portraying patients become ``role
models'' for how patients see themselves. They should be shown with
performance and activities that represent realistic expectations for
individuals who suffer from the respective disease or condition.
Part 3
EthicAd'
EthicAd' is non-profit organization dedicated to helping
to promote increased public health benefits from DTC information about
prescription pharmaceutical products. EthicAd' is a
coalition of leaders from academic medicine and the healthcare
community who are committed to working as a neutral and impartial body
in collaboration with regulatory agencies, professional organizations,
consumer groups, advertising agencies, and the pharmaceutical industry.
Dr. Michael E. DeBakey is Chairman Emeritus of EthicAd'.
Our goal is to maximize the public health benefits of DTC
information by providing the consumer with substantive, understandable
and reliable information about pharmaceutical products. We will achieve
this goal through the development and continuous improvement of
``Ethical DTC Standards'' for the development of DTC material.
EthicAd' will focus upon the educational quality of DTC
material, while taking into account the concerns of manufacturers and
regulators. The role of EthicAd' is not to judge or evaluate
individual products, but to promote high ethical standards and
effective educational techniques for communicating information about
those products. In addition, EthicAd' will review DTC
materials and provide an ``EthicAd' Seal'' for DTC
pharmaceutical information that demonstrates use of the Ethical DTC
Standards.
Senator Dorgan. Dr. Shaw, thank you very much.
Dr. Dolinar.
STATEMENT OF RICHARD DOLINAR, M.D., ENDOCRINOLOGIST,
ENDOCRINOLOGIST ASSOCIATES
Dr. Dolinar. Senator Dorgan, Senator Fitzgerald: Thank you
for allowing me to testify today. I am an endocrinologist in
private practice in Phoenix, Arizona. I specialize in the
treatment of diabetes. I received my undergraduate degree at
SUNY College in Albany, New York, I went to medical school at
State University of New York at Buffalo, and I did my training
in diabetes and endocrinology at Duke University down in North
Carolina.
I am also a retired Air Force colonel, Vietnam veteran,
former flight surgeon. I mention my flying experience for the
following reason: I want to use it as an example to make the
case for direct-to-consumer advertising and to show you the
value thereof.
When you are flying in an airplane and you smell smoke in
the cockpit, you have got to address that issue immediately and
aggressively. Otherwise that plane is going to come down sooner
than you planned, at a location other than an airport, and the
wheels are not going to be the first thing to touch the ground.
Likewise with diabetes. High blood sugars indicate the
smoke of diabetes in a patient. If that is not treated
immediately and aggressively, that patient is going to crash,
and the crash is going to be in the form of a heart attack, a
stroke, kidney failure, amputation, blindness. What direct-to-
consumer advertising is doing is bringing patients into my
office early so that I can treat them, can intervene.
We know that by treating diabetes, bringing the blood
sugars under control, we can decrease the complications down
the road. When you look at diabetes, it is the complications
that really cost. For example, if you do not treat the sugars
and they get a heart attack, then they come into the hospital
with a heart attack or stroke, very expensive.
In fact, your diabetes patients, they represent 6 percent
of the population; they consume 15 percent of the health care
dollar. On the other hand, if we can get them early and treat
them, I am confident we can decrease the amount of dollars
spent on the diabetes patient.
Direct-to-consumer advertising brings these people in for
treatment. The other thing it does, it helps to reach out to
those who are not diagnosed. The ADA estimates there are 6
million people out there with diabetes that do not realize it.
By getting the word out to them and reaching out to those
people and bringing them in, we can significantly help them.
They really represent smoke in the cockpit of our health care
system. There is an avalanche of diabetes that is now affecting
our population.
I also think direct-to-consumer advertising is critically
important today, especially in light of managed care. Managed
care has changed the doctor-patient relationship. I started
medical school in 1968 and over the last 30 years I have seen
the changes. The doctor is now often faced with the problem of
attempting to meet the needs of two masters: on the one hand
the patient, on the other hand the managed care plan, the HMO,
the insurance company.
On the one hand, he is trying to provide care. On the other
hand, incentives and disincentives are set up to withhold care.
In a situation like this, the doctor-patient relationship
becomes an adversarial one. We have drugs available to treat
diabetes that can save money down the road, but unfortunately
many of the managed care plans have incentives in place not to
treat these patients. So consequently the patient is in a very
difficult situation, in a situation where you are in an
adversarial relationship with your physician, you need
everything you can to help you. Information is critical. DTC
provides information to those patients.
I personally do not think that advertising burdens the
physicians or negatively impacts on the doctor-patient
relationship. In fact, I find that patients who have seen these
ads on diabetes, hypertension, etcetera, are easier to work
with. They know the seriousness of the disease, they know there
are treatments out there, and they come asking for help. So I
have found it to be a benefit actually.
I do not think it puts pressure on me to order drugs that
are not necessary. If that patient does not require the drug, I
do not order it.
If any of us were to go out and buy a house or buy a car or
buy a stereo set, would we not get information from various
sources before we made that decision? Yet when it comes to
health care we seem to keep the patient in the dark. I think
knowledge is power. I think it is critically important that
patients have that knowledge, have that power, because
currently they are trapped in their health care systems. They
do not have choice. They have to take their employer's health
care system. So we have limited choice, and now if we limit
direct-to-consumer advertising we limit knowledge, and if we
limit choice and limit knowledge how is that patient going to
work their way through the health care maze to get the care
that they need?
Direct-to-consumer advertising provides information that is
filtered through the FDA. It is regulated by the FDA. It is a
better source of information than on the unregulated Internet
or whatever hearsay the patient picks up from somebody down the
street.
For the sake of the patients, I would ask you to vote
against ignorance. I think anyone against direct-to-consumer
advertising is really in favor of ignorance. I would ask you to
vote against ignorance. I would ask you not to place any
further constraints on direct-to-consumer advertising.
Thank you. I would be happy to take any questions.
[The prepared statement of Dr. Dolinar follows:]
Prepared Statement of Richard Dolinar, M.D., Endocrinologist,
Endocrinologist Associates
Mr. Chairman and Members of the Committee:
I am Dr. Richard Dolinar, an endocrinologist in private practice in
Phoenix, Arizona, specializing in the treatment of diabetes. I earned
my undergraduate degree at Siena College in Albany, New York, and my
medical degree from the State University of New York at Buffalo. I did
a fellowship in endocrinology and diabetes at Duke University. I am co-
author, with Betty Breckenridge, of a book entitled Diabetes 101, a
patient-oriented guide to this disease. It is in its 3rd edition and
has been published in several languages. I am also a retired Air Force
Colonel, a Vietnam veteran, and a former flight surgeon.
I mention my flight experience because I want to use an airplane
analogy to make the case for the value of direct to consumer
advertising of prescription drugs.
When you're flying and you smell smoke in the cockpit, you know
that this is something that has to be addressed immediately and
aggressively. If this problem is not addressed, the plane is likely to
come down sooner than planned, at a place other than an airport, and
the wheels are not going to be the first things that touch the ground.
If a patient's blood sugar is high, that's the smoke that warns of
diabetes. Unless the problem is addressed immediately and aggressively,
there will certainly be a crash--in the form of a heart attack, a
stroke, kidney failure, amputation or blindness, all of which are
complications of diabetes.
In my experience as an endocrinologist, direct to consumer
advertising of prescription medicines is getting patients with diabetes
into my office sooner, so they can be treated with effective medicines
and avoid the dire complications of this disease. According to the
American Diabetes Association, an estimated six million Americans have
undiagnosed diabetes. This constitutes smoke in the cockpit of our
health care system that, unless addressed, will lead to deadly, and
costly, crashes.
People with diabetes make up about 6 percent of the U.S. population
but account for 15 percent of health care costs--15 cents out of every
health care dollar. For Medicare, the percentage is even higher because
1 out of 5 people over age 65 has diabetes. Twenty-five percent of
Medicare costs go toward diabetes. The majority of this expenditure
goes to the complications of diabetes, complications that put patients
in the hospital or on the surgery table and can make them disabled for
life.
If we can get diabetes under control, we can avoid these
complications, saving lives and money. That's why it's critical to
diagnose diabetes promptly and treat it aggressively. Direct to
consumer advertising is helping us reach this important goal.
Direct to consumer advertising is bringing diabetes to the
attention of people who might have it. It's pointing out the
seriousness and possible complications of the disease. It's prompting
people who may have diabetes in the family or may be feeling unusually
tired, to see their doctors and be checked out. For people who are
already diagnosed, the ads reinforce the fact that this is a chronic
disease and that patients need to stay on their medicines.
Direct to consumer advertising is particularly critical in this era
of managed care. Sadly, in many cases, the physician can no longer act
as the patient's advocate. In health maintenance organizations, or
HMOs, the physician is often forced into the uncomfortable position of
being an adversary rather than an advocate. The way the system works,
the physician makes more money if he or she provides less care.
Although medicines, by helping avoid complications from diabetes, can
save money in the long run, HMOs, unfortunately, focus on the short
run, the bottom line for the current quarter. And, since patients tend
to change insurers every two or three years, there is always the hope
that when the patient crashes, it will be on another HMO's watch.
In this environment, the patient needs all the help he or she can
get. Specifically, the patient needs information about disease and
possible treatments. Armed with such information, a patient may be able
to successfully navigate the HMO maze and get needed treatment. Direct
to consumer advertising is an excellent source of information. Since
it's regulated by the Food and Drug Administration, it's a far better
source of information than the neighbor down the street or the
unregulated Internet.
I dispute the notion that direct to consumer advertising burdens
physicians. I find that patients who have seen ads for diabetes
medicines are informed and easier to work with. They are aware of the
disease, and they know that it can be treated. Perhaps more important,
they know that treating the disease now can make a difference down the
road. They're ahead of the game and willing to take new medicines that
can help them avoid the complications of diabetes.
Nor do I feel that direct to consumer advertising puts pressure on
doctors to prescribe unnecessary medicines. Quite often, patients with
Type 1, or insulindependent, diabetes come in with an advertisement for
a pill they hope will enable them to stop insulin injections. I simply
level with these patients and tell them that these new medicines work
only for Type 2 diabetes. They are disappointed, but accept the reality
that these pills are not appropriate for them. I do not consider taking
the time to explain this to patients an inconvenience, and I resent any
implication that I would allow pressure from direct-to-consumer
advertising to influence my prescribing decisions.
If any of the Members of this Committee were buying a car or a
house or even a television, I'm sure you would gather information about
the purchase from a variety of sources. When it comes to health care, a
much more critical decision, however, we seem to want to keep consumers
in the dark. We need educated and informed consumers of health care.
It's not right to withhold information about health care from patients.
Direct-to-consumer advertising is an easily accessible, user-friendly,
and FDA-regulated source of information about diseases and possible
treatments.
To be against direct to consumer advertising is, in my mind, to be
in favor of ignorance. Knowledge is power. That's why we're at this
hearing, so we'll gain the knowledge to make the right decisions. Don't
take knowledge away from them, too. How are patients to defend
themselves and get the best care possible, if we limit both choice and
knowledge?
For the sake of patients, I ask that you vote against ignorance and
refrain from placing further restrictions on direct to consumer
advertising of prescription medicines.
Thank you very much. I would be happy to take any questions.
Senator Dorgan. Thank you very much. You have provided
interesting and in some cases different testimony about the
same issue.
I recall an ad that has been on television for some long
while about a young man what lost I think 140 pounds eating
Subway sandwiches. Do you recall that ad?
Dr. Dolinar. I do not recall that one, no.
Senator Dorgan. Well, do you recall it? Some guy walking
around holding up the pants he used to wear. He dropped I think
100, 140 pounds by eating a certain deli sandwich at a
franchise store.
I was thinking about advertising. You know, I am smart
enough to understand that the proper weight loss program does
not include going to a fast food store. But it seems to me in
advertising it is kind of let the buyer beware, you make
whatever claims you can make and let people assess those
claims.
It is different, however, with respect to prescription
drugs. I expect or I would expect that all of you would agree
that there are risks that one must be cognizant of, and that is
the reason we have a regulatory regime with respect to
prescription drug advertising. We want to make sure that what
people are representing about the drugs is accurate, number
one, and number two that we are giving some basic information
about the risk of the drugs and so on.
There has been testimony today that the regulatory
responsibility is not being met, not sufficient resources exist
at the FDA. You have heard some of that discussion. Mr.
Cloutier, what is your impression of that?
Mr. Cloutier. I would echo the support of Sidney Wolfe and
others saying that, given the volume and the rate of increase,
we have not seen a commensurate increase in staff and resources
at the FDA to oversee and regulate this.
Senator Dorgan. Dr. Shaw?
Dr. Shaw. We actually have a very good relationship with
the FDA and it is interesting that a lot of times there is
internal pressure placed on them not to come to the Hill and
ask for additional funding. But I think that if one took the
individuals aside within FDA they would almost uniformly say
that they are in desperate need of additional funding and
staff.
Senator Dorgan. Dr. Dolinar, as a practicing physician you
may not deal with that question day to day, but what is your
impression of that?
Dr. Dolinar. I would be happy to respond to it. First of
all, the Subway sandwiches, I will have to get the reference on
that so I can start using it in my practice.
But think about it. If we had the same constraints on
advertising for Subway sandwiches and hamburgers, probably at
the end of the advertisement there would be a disclaimer: This
food could cause obesity, heart attack, high cholesterol, et
cetera.
Senator Fitzgerald I thought made a very good point earlier
when he said he had a nine year old boy who saw an
advertisement and wanted something. But actually Senator
Fitzgerald, being the parent, had control over whether that
child was going to get that or not. I have a nine year old boy,
Mark, and Mark came to me. He wanted me to build him a
pipeline. I said, a pipeline? That is one of those things where
you go flying on your skateboard, you go up in the air and flip
around. I am the parent. I am not going to do that.
But my point is these are prescription drugs. What DTC
does, it brings the patient in, it starts the process. Then the
physician evaluates, is this an appropriate drug, is it not
appropriate, is there something else we should be using. So I
think that is important.
Also, just to share with you, as I have been sitting here
listening to the proceedings I just could not help but think
back to the 1950's. I was a child in the 1950's and at that
time polio was a very big problem, in the early 1950's. Then
the vaccine came out. I wonder, if this were the 1950's,
whether we would be sitting here today pointing out that the
amount of money spent on vaccines is skyrocketing and that this
is a very bad thing and that we should not be advertising about
polio because it is bringing all these people in to ask for
this vaccine, when in reality there would be another chart with
the number of iron lungs going in the opposite direction.
I think drugs are the solution, not the problem. I think
when it comes to the world of diabetes, high blood pressure,
heart attack, and stroke, it is not as obvious as that polio
example I just gave you, but I can assure you by using these
drugs I can decrease blood pressure, blood sugars, cholesterol.
I can decrease the chance of complications coming down the
road.
So I find this to be very important.
Senator Dorgan. I would just observe that in the 1950's
they could not advertise prescription drugs, and of course in
the 1950's when Dr. Salk gave us the vaccine it became a matter
of public health for us to deliver that vaccine to virtually
everyone, especially all children in this country.
Yes, Dr. Shaw.
Dr. Shaw. Mr. Chairman, if I could follow up on your Subway
sandwich analogy, as long as you have offered it. I think that
what I have heard here is almost universal agreement that DTC
has the potential to do great good and the pharmaceutical
industry in the United States and globally is one of the best
assets for health care that exists, period. It is just a
question of a squandered opportunity.
With your Subway analogy, there is an opportunity to talk
to the American people, not just about which lipid-lowering
drug is best, but the fact that if you went back to Subway and
started using their low-fat sandwiches or other modifications
that in fact you could reduce or eliminate the potential for
heart disease or atherosclerotic that two-thirds of the
American citizens are going to die from, approximately, and
two-thirds of the world's population does not have this entity.
Why can this opportunity be used also, not just to promote
drugs, but to promote public health?
Senator Dorgan. Let me just make one quick comment. I do
not dispute at all that there is good that can be achieved by
direct-to-consumer advertising. The issue we have not discussed
in great detail because that is not what the hearing is about
is the substantial increased cost and pricing of prescription
drugs, which I think one could have a hearing or several
hearings just on the question of pricing and whether that
pricing is fair.
But let me call on my colleague Senator Fitzgerald.
Senator Fitzgerald. Thank you, Mr. Chairman.
Thank you, all of you, for your testimony. It is all very
good. I wondered really if our tort system in your opinion does
not provide a sufficient check on rogue behavior on the part of
prescription drug advertisers. I do not know if either of the
first two witnesses had any particular ads that they have seen
for prescription drugs that they thought went too far. If you
do, I would be interested, if there are any specific ads that
you could cite that you thought went too far.
But also, does not our legal system in this country present
some liability for any advertiser of pharmaceuticals or, for
that matter, anything else that goes too far? Either of you,
Mr. Cloutier and Dr. Shaw?
Mr. Cloutier. I would just actually draw your attention to
the ads that the chairman showed at the beginning. Our concern
is about the amount of risk information and the availability of
that in terms of comprehension relative to other information
that is being presented. I think it is a complicated picture.
We are about to release some research next week on use of
drugs in the over 65 population. One of the things that we have
found is that 10 percent of people over 65 use 8 therapeutic
classes or more. That means that they are treating eight
separate conditions simultaneously. What we know about that is
there is a 100 percent probability of polypharmacy, in other
words some adverse health consequence of using all those drugs.
As we see direct-to-consumer advertising driving up volume
and usage, some of which is very appropriate, some of which is
less clear, that consumers as we empower them to seek these
prescription drugs need to have the information available to
them. We believe that it is lacking and the voluntary
regulations that are in place do not require appropriate
disclosure of those risks.
Senator Fitzgerald. Dr. Shaw.
Dr. Shaw. Well, in our opinion the overwhelming majority of
pharmaceutical companies are extremely responsible in the way
they approach direct-to-consumer advertising. It is sort of the
80-20 rule, that perhaps 20 percent of the companies are
causing 80 percent of the problems.
Earlier testimony by Dr. Wolfe cited the fact that in some
instances companies have been cited 13 and 14 different times
for essentially the same violation, with little or no
consequences, and it has just become sort of a cost of doing
business. In the mean time, it provides incremental revenue.
Senator Fitzgerald. How is this really any different than
just about any other area? You have ads out there all over the
place, say, to invest in a mutual fund and you are not going to
have all the information you really need in the ad, which will
probably show their last year's return or something like that,
just as you are not going to have all the information on both
sides of the story in an ad for a prescription drug. Why is
this any different than any other area?
The consumers out there who undertake research on their
own, try to get educated as best as possible, and view a
variety of sources are always going to come out better,
whatever the area.
Dr. Shaw. Senator, I think from our perspective the key is
this: through direct-to-consumer advertising the pharmaceutical
industry has become a de factor health care information
provider. Frankly, I think the health care providers----
Senator Fitzgerald. What is wrong with that?
Dr. Shaw. Nothing necessarily. The issue is the essence of
standards and are they going to assume the same ethical levels
of behavior that we expect from other health care
professionals. We think that they are capable of that, but we
think that there is a need to push in that dimension.
Senator Fitzgerald. Back to my liability question, do they
not have liability if they are misleading people?
Dr. Shaw. What behaviors would you expect from your
physician? Would you expect your physician to merely act within
the bounds of the law or do you expect something different?
With due respect----
Senator Fitzgerald. I think they have a fiduciary duty. I
expect them to take extra care, a physician. But they are
always worried about their own liability for medical
malpractice. I would think that there would be many potential
tort causes of action for misleading advertising for a
prescription drug manufacturer. That is kind of a free market
check on the whole system.
Mr. Cloutier. I would like to respond to that. I think
there is a dimension of public health protection here that is
being missed. To go back to my example of eight therapeutic
classes being used by 10 percent of the over 65 population,
there simply is no evidence of what three drugs or more does
when someone is taking them. So part of it is that we actually
lack the science, that the science is out of pace with the
promotional activity of loading on all these pharmacologic
agents in one person, that we need to pay attention to and that
we need to be cautious about.
Senator Fitzgerald. Now, that patient who is taking eight
or more pharmaceuticals at the same time--you said 10 percent
of the seniors are doing that?
Mr. Cloutier. Yes.
Senator Fitzgerald. They are getting those prescriptions
from doctors, are they not?
Mr. Cloutier. They are, and those doctors do not have
information about any more than there of those drugs
interacting with each other. So what will typically happen is
that someone will be taking eight or nine drugs and they will
come in they will have a number of moderate side effects--
dizziness, nausea.
Senator Fitzgerald. That doctor could be liable for
malpractice if he prescribes those conflicting medicines, could
he not?
Mr. Cloutier. There is that potential, yes.
Senator Fitzgerald. I know Dr. Dolinar has been chomping at
the bit. I do not know if I mangled your name there. If I did,
I apologize.
Dr. Dolinar. That is fine.
I am a doctor. I treat patients. Some of them require that
many medications. In fact, in the over age 65 group one out of
five has diabetes and they are taking up 25 percent of the
Medicare budget.
The other point I would like to make, this issue of
empowering the patient I think is critical. I touched on it in
my introductory statement. Many times the doctor is in an
adversarial relationship with the patient. In a setting like
that, you need a patient who is educated.
Let me give you a quick example. A drug came out a few
years ago that was a pill for the treatment of diabetes. It
would allow people who were on insulin who had type 2 diabetes,
it would allow them to come off the insulin shot. They could go
on this pill. Many of them could go on this pill, stop the
insulin.
There was an HMO, I spoke with the physicians there. They
were happy with the drug. They could not use it. They could not
use it because, the way their finances were structured, if the
physician wrote for that drug the patient would get it, but the
cost of that drug would come out of that physician's pay check
that month. So if the drug costs, let us say, $100 for the
month, that doctor's pay check would be $100 less that month.
In a situation like that, I doubt if there would be more
than a handful of physicians who would offer to the patient,
let us try this pill and take you off of insulin. On the other
hand, an empowered patient could go in there and say: I have
seen this drug, I think this could help me; can we try it out.
I cannot emphasize enough how the doctor-patient
relationship has changed. The doctor is in an adversarial role.
Senator Fitzgerald. Well, thank you. Thank you all for your
testimony.
Senator Dorgan. Let me just observe, my colleague raises
the question of tort liability. It is the case, I think,
however, with respect to food safety and safety of prescription
drugs and so on, there is a separate class. I was thinking to
myself as you were asking those questions about Upton
Sinclair's work in Chicago, as a matter of fact, where he was
going into these meatpacking plants, and they had rat problems,
so they were lacing slices of bread with poison and then the
rates would eat the poison and die and they would throw the
bread and the rats right down the same chute where the mystery
meat came out the other end.
He wrote a book about it and of course that led to the Food
and Drug Administration and dramatic standards about food
safety.
There are some things where let the consumer beware and let
the courts respond to it do not work. I think medicine is one
of them, in the sense that you must have standards. I think the
question you raise is important, what kind of standards should
you have with respect to advertising, and that is less--that is
a little less clear.
It is quite clear what standards you ought to have when you
manufacturer prescription drugs in an FDA-approved plant. But
it is a little less clear, and that is one of the reasons for
the hearing, what the standards one must have to deal with
advertising of prescription drugs. It is a most interesting
discussion.
Senator Fitzgerald. By the way, the stockyards are no
longer in Chicago. I think they moved them out West, your way.
Senator Dorgan. That is true.
I want to thank the panel. The testimony we have received
has been most interesting and I think sheds different opinions
and viewpoints on a very interesting question. As the price and
the cost of prescription drugs continues to increase and as new
and exciting prescription drugs are developed to deal with
dread diseases and other conditions, I think all of these
issues will continue to be ones that will be discussed in I
hope a thoughtful and a serious way by the Congress.
This hearing is adjourned.
[Whereupon, at 4:33 p.m., the Subcommittee was adjourned.]