[Senate Hearing 110-830]
[From the U.S. Government Publishing Office]
S. Hrg. 110-830
MARKETING OR MEDICINE: ARE DIRECT-TO-CONSUMER DEVICE ADS PLAYING
DOCTOR?
=======================================================================
HEARING
before the
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
WASHINGTON, DC
__________
SEPTEMBER 17, 2008
__________
Serial No. 110-36
Printed for the use of the Special Committee on Aging
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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SPECIAL COMMITTEE ON AGING
HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon GORDON H. SMITH, Oregon
BLANCHE L. LINCOLN, Arkansas RICHARD SHELBY, Alabama
EVAN BAYH, Indiana SUSAN COLLINS, Maine
THOMAS R. CARPER, Delaware MEL MARTINEZ, Florida
BILL NELSON, Florida LARRY E. CRAIG, Idaho
HILLARY RODHAM CLINTON, New York ELIZABETH DOLE, North Carolina
KEN SALAZAR, Colorado NORM COLEMAN, Minnesota
ROBERT P. CASEY, Jr., Pennsylvania DAVID VITTER, Louisiana
CLAIRE McCASKILL, Missouri BOB CORKER, Tennessee
SHELDON WHITEHOUSE, Rhode Island ARLEN SPECTER, Pennsylvania
Debra Whitman, Majority Staff Director
Catherine Finley, Ranking Member Staff Director
(ii)
C O N T E N T S
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Page
Opening Statement of Senator Herb Kohl........................... 1
Statement of Senator Ken Salazar................................. 59
Panel I
Statement of Kevin J. Bozic, M.D., Professor of Orthopedic
Surgery, University of California at San Francisco, Ca......... 3
Statement of William E. Boden, M.D., Professor of Medicine and
Public Health, University of Buffalo, Buffalo, NY.............. 18
Statement of George A. Diamond, M.D., F.A.C.C., Senior Research
Scientist, Emeritus, Cedars Sinai Medical Center, Los Angeles,
CA............................................................. 39
Statement of Ruth S. Day, Ph.D., Director, Medical Cognition
Laboratory, Senior Fellow, Duke Aging Center, Durham, NC....... 40
Statement of Ami Gadhia, Policy Counsel, Consumers Union,
Washington, DC................................................. 46
Panel II
Statement of Dr. Daniel Schultz, Director, Center for Devices and
Radiological Health, Food & Drug Administration, Washington, DC 62
Statement of Stephen Ubl, President and Chief Executive Officer,
AdvaMed, Washington, DC........................................ 82
APPENDIX
Prepared Statement of Senator Robert P. Casey, Jr................ 95
Mr. Ubl's Response to Senator Kohl's Question.................... 95
Statement of the Sudden Cardiac Arrest Association............... 97
(iii)
MARKETING OR MEDICINE: ARE DIRECT-TO-CONSUMER MEDICAL DEVICE ADS
PLAYING DOCTOR?
---------- --
WEDNESDAY, SEPTEMBER 17, 2008
U.S. Senate
Special Committee on Aging
Washington, DC.
The committee met, pursuant to notice, at 10:29 a.m. in
room SD-562, Dirksen Senate Office Building, Hon. Herb Kohl
(chairman of the committee) presiding.
Present: Senators Kohl [presiding], and Salazar.
OPENING STATEMENT OF SENATOR HERB KOHL
The Chairman. Good morning to one and all. We'll commence
our hearing at this time. We thank our witnesses for being with
us today.
Today we're examining issues related to direct to consumer
advertising for restricted medical devices that are regulated
by the Food and Drug Administration. This is part of an ongoing
15 month series of oversight hearings we have held on medical
device and pharmaceutical marketing. Unlike direct-to-consumer
advertising of drugs, direct-to-consumer advertising of medical
devices has not yet been highly scrutinized.
Since the mid-1990's when the Federal Government changed
rules regulating such advertising the drug industry has spent
billions of dollars advertising their products directly to
consumers. The FDA has devoted considerable resources to the
oversight of direct-to-consumer pharmaceutical advertising.
There have been several Congressional hearings held on this
practice.
However, the medical device industry is just beginning to
get into the game. Over the past four or five years their use
of DTC ads is growing on television, in print and on the
internet. Hundreds of millions of dollars have been spent on
them according to the Congressional Research Service.
While their spending on direct-to-consumer ads is still
only a fraction of drug industry spending, this marketing
practice is growing. In recent years a number of DTC ad
campaigns have been launched in an effort to market specific
and often complex medical device products, some of which
require surgery to obtain. As with DTC drug ads the FDA has
raised concerns about advertising restricted medical devices,
specifically about whether appropriate risk and safety
information is provided to consumers including seniors and the
elderly.
Today we'll hear from a variety of medical, advertising and
consumer experts. They will detail for the Committee perceived
shortcomings in DTC advertisements for medical devices and how
these ads can influence consumers and patients. Our witnesses
also will outline recommendations on how we might improve the
review and the oversight of these ads.
We will hear from the head of the FDA's medical device
center about how the Agency oversees these DTC medical device
ads. As well as how those methods differ from the more
extensive FDA efforts to track and analyze DTC drug ads.
We've also invited AdvaMed to testify this morning. AdvaMed
is the largest medical device industry organization and will
weigh in on the question of regulating DTC medical device ads.
We should note that in 2006 the American Medical
Association announced its support for enhanced regulation of
DTC ads by the FDA and went so far as to call for a moratorium
on all new DTC ads until physicians have been appropriately
educated about the drug or the medical device.
Based on what we hear here today we are prepared to work
with Chairman Dingell in the House to consider similar
legislative measures. We want to acknowledge that DTC
advertising may have some benefits. Responsible DTC advertising
can encourage consumers and patients to become proactive in
their own treatment plan and encourage a wide audience to
consider preventive medicine. These are positive and
potentially valuable aspects of DTC advertising.
So we thank our witnesses. We welcome them here today.
Introducing the members of the first panel.
Our first witness will be Dr. Kevin Bozic. Dr. Bozic is an
Associate Professor in residence in both the Department of
Orthopedic Surgery and the Institute for Health Policy Studies
at the University of California in San Francisco. He's
conducted studies on how direct-to-consumer advertising of
restricted medical devices does have the potential to adversely
impact the doctor/patient relationship, patient education,
health care costs as well as health care quality. He's speaking
today on behalf of the American Association of Orthopedic
Surgeons.
Our next two witnesses will share their time jointly. Dr.
William Boden is Director of Cardiovascular services at Kaleida
Health System in Western New York and Chief of Cardiology at
Buffalo General and Millard Fillmore Hospitals in Buffalo.
Dr. George Diamond is a 2004 recipient of the Distinguished
Service Award of the American College of Cardiology and is the
author of hundreds of peer reviewed publications. Dr. Boden and
Dr. Diamond are the authors of a recent article in the New
England Journal of Medicine which offers a detailed critique of
a particular heart stent advertisement that was broadcast to
millions of Americans.
Also joining us here today is Professor Ruth Day, the
Director of the Medical Cognition Laboratory at Duke University
and a Senior Fellow at the Duke Aging Center. Dr. Day has
served on many FDA Advisory Committees and was also a Fellow at
the Center for Advanced Study in the Behavioral Sciences. Her
research is on comprehension and memory for medical
information, especially drugs and medical devices.
Our last witness on our first panel will be Ami Gadhia who
is a Policy Counsel for Consumers Union, a non-profit publisher
for Consumer Reports magazine. Consumers Union is an
independent, non-profit organization that advocates on behalf
of consumers in many fields of industry including healthcare.
We welcome you all here today. Dr. Bozic, you may testify.
STATEMENT OF KEVIN BOZIC, M.D., PROFESSOR OF ORTHOPEDIC
SURGERY, UNIVERSITY OF CALIFORNIA AT SAN FRANCISCO, CA
Dr. Bozic. Thank you. Good morning, Chairman Kohl and other
distinguished members of the Committee. My name is Dr. Kevin
Bozic and I speak to you today as a practicing orthopedic
surgeon and health care services researcher from the University
of California, San Francisco and a member of the Board of
Directors of the American Association of Orthopedic Surgeons.
On behalf of the AAOS, I thank you for providing me the
opportunity to testify to you today on the issue of direct-to-
consumer advertising of restricted medical products.
As you've indicated, over the past decade the United States
has experienced a dramatic increase in direct-to-consumer
advertising from medical device and pharmaceutical
manufacturers, health plans, hospitals and physicians, all
attempting to increase their market share by advertising their
products and services directly to patients. The internet has
created a new generation of technologically savvy and empowered
health care consumers who are taking a more active role in
finding the best solutions for wellness and health. We
encourage our patients and their families to obtain and
understand evidenced based health care information. We
encourage patients to work with their healthcare practitioners
to develop shared decisionmaking for treatments that promote
cost effective healthcare.
We believe that direct-to-consumer advertising of
restricted medical products has the potential for both positive
and negative consequences. Direct-to-consumer advertising may
encourage patients to seek treatment for previously undiagnosed
disease, and may de-stigmatize certain diseases or health
conditions, help create more informed patients and foster true
shared decisionmaking between patients and their physicians.
However, we're also aware of the potential negative
consequences of DTCA related to medical products. Product
specific advertisements which exaggerate the benefits and
downplay the risks of a medical device may strain the doctor/
patient relationship by creating unrealistic patient
expectations, thus diminishing the role of the physician in
clinical decisionmaking. Furthermore, patient pressure in
response to direct-to-consumer ads may lead to over utilization
of costly, at times unproven, medical devices and may lead
physicians to venture outside their comfort zone in order to
satisfy inappropriate patient requests for specific treatments
or devices.
In the course of today's discussion, we would note that
disease awareness or help seeking advertising, which seeks to
raise awareness amongst patients regarding a specific disease
state or health condition should be differentiated from product
specific advertising. The AAOS holds patient education as one
its most important objectives. We believe that help seeking
advertising may stimulate patients to research their health
conditions and discuss all available options with their
healthcare practitioners. We recognize that delayed diagnosis
and treatment of certain chronic disease conditions such as
arthritis and osteoporosis are serious health concerns in the
U.S., and disease awareness advertisements may play a vital
role in bringing needed therapies to patients with chronic
diseases.
Although the effects of direct-to-consumer advertising
related to pharmaceutical drugs have been studied extensively,
there are substantial differences between pharmaceutical
products and medical devices which make extrapolating the
findings or conclusions from studies regarding the effects of
DTCA related to drugs to the potential impact of advertising
that is used to promote regulated medical devices inappropriate
and misleading.
First, there's a substantial cost differential between
medical devices and prescription drugs.
Second, medical devices are usually sold to hospitals,
although physicians are the primary decisionmakers and end
users. Unlike prescription drugs, early adopters of new medical
technologies, including physicians and hospitals, often promote
their use of these technologies in an attempt to differentiate
themselves in a competitive marketplace. However, when a
physician decides to use a new device in their practice
additional training is often recommended and the potential
adverse consequences to the patient and the physician are
considerable if an inappropriate or unfamiliar device is used.
Finally, unlike prescription drugs, the choice of implant
or procedure cannot easily be substituted if the result of the
procedure is undesirable.
We're concerned about the lack of fair balance and risk
information in direct-to-consumer ads related to medical
devices. Potential benefit information is typically presented
in layman's terms whereas risk information is down played by
using medical jargon, using a very small font size or
increasing the speed of delivery of information in a voice over
announcement. Therefore risk information is often not read, not
comprehended nor sometimes even reasonably visible.
In a 2007 published study on the impact of direct-to-
consumer advertising in orthopedics, my colleagues and I
evaluated the influence of DTCA in orthopedics by surveying
practicing orthopedic surgeons who perform hip and knee
replacement procedures and patients who were scheduled to
undergo these procedures. The goals of our study were to
evaluate the impact of DTCA on consumer demand, healthcare
services, resource utilization and the doctor/patient
relationship. We found that although direct-to-consumer ads had
a substantial influence on both patient and surgeon
decisionmaking, patients and surgeons differed considerably
with respect to their opinions of the value of DTCA as a source
of information regarding hip and knee replacement surgery.
The majority of surgeons surveyed believed patients who
were exposed to DTCA were confused or misinformed about the
appropriate treatment for their condition, had unrealistic
expectation regarding the benefits of the specific type of
surgery or implant and requested types of surgeries or implants
that were not appropriate for their conditions.
In contrast, the majority of patient respondents believed
that advertisements educated them about their medical
conditions and treatment options. Only 18 percent of patients
thought advertisements confused them about the appropriate
treatment for their condition.
The findings of our study underscore the need to improve
the quality and accuracy of information available to patients
regarding their health conditions and treatment options.
As surgeons, we applaud efforts by our patients to educate
themselves regarding their health conditions and their
potential treatment options. However, we believe it is
important for patients to evaluate the source and accuracy of
the information on which they base their opinions.
Reliable healthcare information that is supported by
scientific evidence has the potential to enhance the dialog
between patients and their physicians, and to improve patient
satisfaction and the overall quality and efficiency of the care
we deliver. However, as our research has shown biased
information contained in direct-to-consumer advertisements
promoting specific regulated medical devices which are not
supported by scientific evidence has the potential to cause
tremendous harm to the doctor/patient relationship, to create
unrealistic patient expectations and to lead to inappropriate
over utilization of costly, unproven medical technologies which
could have dire public health consequences.
In closing we offer the following specific recommendations
to the Committee as it examines the consequences of direct-to-
consumer advertising of restricted medical products.
We believe that direct-to-consumer advertising of medical
devices has the potential to create distorted markets and have
adverse public health consequences, and therefore we support
greater restraint from the medical device industry and greater
oversight from the FDA.
We support ongoing research into the effects of direct-to-
consumer advertising on the physician/patient relationship,
healthcare services resource utilization and spending, public
safety and cognitive science.
We support disease awareness and help seeking
advertisements which seek to educate patients about their
health conditions and the treatment options available to them
rather than product specific advertising. Claims made in
product specific advertisements related to medical devices are
often biased, not supported by scientific evidence and
contribute to unrealistic patient expectations and
inappropriate requests for specific procedures or implants
which could have great public health consequences.
We support the presentation of fair, balanced and risk and
benefit information in direct-to-consumer ads of regulated
medical devices. We recommend that healthcare stakeholders work
together to improve the quality and accuracy of information
contained in consumer directed advertisements related to
medical products.
We support increased resources for the FDA in the area of
medical device advertising and increased oversight from the
FDA's Center for Devices and Radiological Health advertising
review staff on the DTCA of medical devices.
Finally, we support a prohibition of direct-to- consumer
advertising and marketing on restricted medical products to
children.
I appreciate the opportunity to share our views with the
Committee on the issues related to direct-to-consumer
advertising of restricted medical devices. I look forward to
answering any questions you may have.
[The prepared statement of Dr. Bozic follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The Chairman. Thank you. We'll move on to Dr. Boden.
Dr. Diamond, please hold your testimony to 5 minutes.
STATEMENT OF WILLIAM E. BODEN, M.D., PROFESSOR OF MEDICINE AND
PUBLIC HEALTH, UNIVERSITY OF BUFFALO, BUFFALO, NY
Dr. Boden. Thank you, Senator. Beg your pardon.
Before we testify we'd like to ask your permission to play
a copy of the broadcast advertisement that is the subject of
the article that we recently published in the New England
Journal of Medicine and which explains the dangers associated
with the type of direct-to-consumer advertisements for the
restricted medical devices that we are discussing here today.
May we see the DVD?
[Audience watching DVD advertisement.]
Dr. Boden. Thank you, Mr. Chairman and honored members of
the Committee. We appreciate the opportunity to come before you
this morning. To express our concerns relating to this direct-
to-consumer advertising or DTCA of the intra-coronary stent to
the lay public and to healthcare consumers.
This advertisement appeared 10 months ago during the Dallas
Cowboys/New York Jets nationally televised Thanksgiving Day NFL
game. It was the first direct-to-consumer advertising campaign
of a drug eluting coronary stent that was launched by a device
manufacturer, that is to say Cordis, Johnson and Johnson. Their
initial 60 second advertisement featured in this segment, which
was boldly entitled, ``The life wide open'' on the surface is
quite provocative, as we will maintain. We believe that this
initial medical advertisement has crossed the line in promoting
a particular coronary device to millions of individuals who are
unable to discern many of the subtle and complex therapeutic
issues that even we cardiac specialists continue to debate.
The distinction between drug and device DTCA is
significant. Unlike drugs that merely require a physician
office visit and an explicit prescription by a physician or
provider than can be then filled by a patient at the pharmacy.
A specialized medical device such as the Cypher Stent requires
a very sophisticated medical understanding that few individuals
in the lay public could realistically expect to gain from such
a short 30 to 60 second TV ad campaign.
During a diagnostic coronary angiogram during which we
would detect the blockages or narrowings that might result in a
potential stent procedure, a cardiac patient may be in
significant pain, medicated with sedatives or analgesics,
potentially acutely overwhelmed with the recent disclosure of
obstructive coronary artery disease. Thus unable to fully
comprehend all of the therapeutic implications of which type of
stent would be best for him or her in the setting of an
impending operative procedure. It seems difficult if not
impossible to imagine that a patient would in the above
clinical context attempt to challenge the interventional
cardiologist's judgment and clinical acumen by calling into
question which particular stent type, for example, the Cypher
Stent, should be used for that procedure.
It seems equally plausible that an interventional
cardiologist would exceed to a patient's request for a
particular stent type based solely on a patient's very limited
information derived from a DTCA that touts that one particular
stent over another. This makes it very difficult to understand
what impact, if any, direct-to-consumer advertising directed at
the lay public could in a meaningful way influence Cypher Stent
usage at the patient level. The statutory authority for the
current regulation of DTCA by the Food and Drug Administration
actually goes back 70 years ago to 1938 when the Federal Food,
Drug and Cosmetic Act outlined the requirements for
pharmaceutical products for which companies sought U.S.
marketing approval.
Several years later in 1962, Congress specifically granted
the FDA statutory authority to require prescription drug
labeling in advertising including direct-to-consumer
advertising. In 1969 the Agency issued final regulations
governing drug advertising stipulating that advertisements must
not be false or misleading, must present a fair balance of
information about both the risks and the benefits of using a
given drug, must contain facts that are material to the
product's advertised uses and must include a brief summary
mentioning every risk described in the product's approved
labeling. Current Agency regulations differentiate between
print and broadcast direct-to-consumer advertising.
In the former print medium all information about associated
risks including major side effects, contraindications and
precautions contained in the drug's FDA label must be
explicitly divulged. By contrast in the broadcast
advertisements, only so called major risk information must be
stated. But such broadcast ads must direct viewers to other
accessible sources containing complete risk information. This
distinction reflected a pragmatic recognition of the time
limitations, typically 30 to 60 seconds of broadcast ads. By
the way in this particular ad that we saw, if you go to the
website shown on the ad it provided no explicit safety
information when one attempted to elicit that.
About 10 years ago in 1997, the FDA issued a preliminary
guidance for industry that re-interpreted FDA regulations
without actually changing the regulations. They reiterated that
the advertising be non-deceptive and must present a fair
balance between information about effectiveness and information
about risk, include a thorough major statement conveying all
the product's most important risk information in consumer
friendly language and must communicate all information relevant
to the product's indication including limitations to use in
consumer friendly language.
The Chairman. Mr. Boden? Dr. Boden?
Dr. Boden. Yes?
The Chairman. Your time. Could you summarize your
statement?
Dr. Boden. Yes, sir. So in what I would like to actually
state then is that there are several recommendations that we
would like the Committee to consider.
First, that the FDA should place drugs and devices on the
same regulatory footing. DTCA should be required to reflect the
evidenced based clinical data that have demonstrated only the
proven clinical benefit of the drug or device before being
advertised. Unsubstantiated therapeutic claims or expert
consensus are not evidentiary and should not constitute an
approved basis for advertising to the lay public.
Congress should authorize the FDA to adopt the model used
to promote DTCAs used in New Zealand by establishing an
advisory panel under the Federal Advisory Committee Act that
would vet and discuss all advertising prior to final
publication. This could comprise a multidisciplinary Committee
with representative membership that would include the drug or
device industry, physician specialists and consumer union
representatives. The FDA should consider establishing a fund in
which a certain percentage of product claim advertising revenue
would be tithed and redirected to help seeking ads that promote
public health education and heighten public awareness of a
particular disease state. This would create a methodology for
promoting fair, objective and balanced consumer health
education to the lay public devoid of potential commercial
bias.
Last, the Committee might consider enacting a ban for the
first two years on all DTCA of drugs or devices that have been
FDA approved in order to assure that post marketing
surveillance and phase four clinical data acquisition have
established an appropriate safety record and profile before
they are advertised broadly to the public. Thank you very much.
Now I'd also like Dr. Diamond to also add some comments please.
[The prepared statement of Dr. Boden follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
STATEMENT OF GEORGE A. DIAMOND, M.D., F.A.C.C., SENIOR RESEARCH
SCIENTIST, EMERITUS, CEDARS SINAI MEDICAL CENTER, LOS ANGELES,
CA
Dr. Diamond. Mr. Chairman, thank you for inviting me to
contribute to these deliberations. I concur completely with the
comments of my colleague, Dr. Boden and would simply like to
make one additional point.
Direct-to-consumer medical advertising stands at the end of
a long chain of regulatory processes by a series of agencies.
Each of these agencies has its own relatively narrow aims and
none of them communicate very well with one another.
First, the FDA determines the treatment's safety and
efficacy. CMS then determines if the treatment is reasonable
and necessary. Individual payers then determine that
reimbursement is usual and customary. Professional
organizations, such as the American College of Cardiology,
issue consensus guidelines to the effect the treatment that is
useful and effective. Finally the courts decide that treatment
is prudent and cautious.
At no point in this chain is there any direct focus on the
ultimate goal of healthcare, the provision of clinical benefit.
The goal of medicine is not to provide prudent, usual or
reasonable treatments. It is to improve longevity or quality of
life.
The direct-to-consumer ad serves this higher goal no better
than the average political ad serves the ideals of the
Democratic process. It simply introduces another myopic link in
the chain, consumer opinion. The direct-to-consumer problem is
therefore best approached by deconstructing this chain and
developing a coordinated, stream lined, regulatory approach
designed to serve the dual goals of safety and benefit.
From this perspective the question to be addressed by this
Committee is not how direct-to-consumer ads be regulated. But
at what point along the stream lined, regulatory chain, in our
free market society, do such ads appropriately, effectively
serve these goals. My answer, only when two conditions are
satisfied.
First, the treatment should target an issue of material,
clinical importance. There is little need to regulate ads
regarding the latest cold remedy.
Second, the claim should be supported by rigorous,
scientific evidence. That would be news we can use, so to
speak.
But advertisements are not the only way to get this news.
CMS's new Chartered Value Exchange network, Secretary Leavitt's
most significant legacy to quality improvement could become the
vehicle for transforming policy into practice by translating
the various regulatory and clinical findings into information
that the public can understand and trust. We will thereby
empower them to be informed partners in their healthcare, a
worthwhile goal to be sure.
We will know we have succeeded in reaching this goal when
direct-to-consumer advertising becomes completely superfluous,
if not unseemly. Thank you.
The Chairman. Thank you, Dr. Diamond. Professor Day.
STATEMENT OF RUTH S. DAY, PH.D., DIRECTOR, MEDICAL COGNITION
LABORATORY, SENIOR FELLOW, DUKE AGING CENTER, DURHAM, NC
Dr. Day. Good morning. My name is Ruth Day. I'm the
Director of the Medical Cognition Laboratory at Duke University
and Senior Fellow at the Duke Center for the Study of Aging.
I'd like to direct everyone's attention to the screens, as
I will be showing slides throughout my testimony.
I'm not here today to argue for or against direct-to-
consumer advertising of medical devices. Instead I'm here to
report research on how people understand and remember
information in these ads. This research was not funded by any
medical device company, ad agency, advocacy group or government
agency.
The basic question is, how do people understand medical
device information? The answer is, with difficulty. There are
many possible reasons for this. There's a heavy information
load, complex and technical information and so on.
But today I would like to focus on ``cognitive
accessibility.'' Cognitive accessibility is the ease of which
people can find, understand, remember and use medical device
information, and hopefully in a safe and effective manner. We
look at a variety of information sources for these ads. Today
I'll be focusing just on the ads that air on television and on
the internet.
We've been collecting ads for a long time, since the year
2000. Most of our research has been on prescription drugs, but
also medical devices.
We use two basic approaches, at least, in this research.
First of all we perform cognitive analyses of the ads. We
obtain quantitative measures and calculate cognitive
accessibility as I'll show you in a bit. Then compare the
accessibility of the benefits vs the risks. Then we perform
cognitive experiments to test the effects of all of these
measures on attention, comprehension, memory, problem solving,
decisionmaking, behavior and ultimately health outcomes.
Many cognitive principles underlie this work such as the
time spent on certain types of information, repetition,
language complexity, speaking speed and other things as well.
We study a wide variety of device ads, such as hip replacement,
stents, cosmetic procedures and devices for weight reduction.
Across all of these, the benefits generally have very high
cognitive accessibility, with a lot of time spent on them.
There's also repetition of the messages, simple language,
normal speaking speed, chunking, put together what goes
together, but separate it with pauses on either side for
``mental digestion,'' few other distractions and good locations
for the information.
What about the risks? Sometimes they're absent. Quite often
they are absent. Other times they're non specific. There will
be nonspecific things said such as, ``there are potential
risks''. Risks are sometimes present and when they are, they
are generally of lower cognitive accessibility. So all those
features we talked about before, are lower in cognitive
accessibility for risks relative to the benefits.
Now let's focus on one type of device, joint replacement
since it is of special interest to older people. In one ad
there's an arthritic woman and there are no risks presented at
all. In another there are some lovely cartoon women and all
that's said is, ``there are potential risks.'' One with a home
nurse; just ``potential risks.'' Basketball coach; ``potential
risks.'' Woman walking across the United States: ``potential
risks.'' There's one with a gymnast and potential risks are
flushed out. They include a ``loosening, dislocation, fracture
and wear, any of which could require additional surgery.'' So
only one in six joint replacement ads has any specific risks.
So let's do a cognitive experiment to test the consequences
of these presentation practices. We've selected a weight-loss
device where a band is put around the upper part of the stomach
and can be adjusted to control the flow of food. Participants
in our experiment saw the ad. Then we tested their knowledge
about the benefits and the risks using multiple tasks.
A very simple thing we do is to ask, what is the name of
the medical device? As you can see on the slide, just about
everyone knows. When we ask, what is it used for, performance
is excellent, 96 percent correct. They know it's for weight
loss. That's the indication, what it is used for.
When asked about the contra indications who should not use
it, their performance is much worse. They just don't get this
information. So the indication is a benefit and performance is
excellent, while contra indications are a type of risk and
performance is poor.
In a free report task we asked, what were the benefits in
the ad? Later we asked, what were the risks in the ad? Here are
the results for the benefits vs. the risks. As you can see on
the slide, knowledge of benefits was twice as good as risks.
Here's the breakdown for the specific benefits and risks. One
of the risks is fatality or death and just about no one gets
that.
In a recognition task, we basically give one benefit at a
time and participants decide whether each it was in the ad or
it was not in the ad. Then we do the same thing for risks.
Chance now is 50 percent correct, because they're just saying
yes or no.
For the benefits, there is very high performance. For the
risks, just about chance. People just don't know the risks. We
can break this down into those benefits that actually were in
the ad, 90 percent correct vs. those that were not in the ad.
Can they correctly say no, those are not possible risks? Still
very good performance, 70 percent correct.
When we look at the risks, it doesn't matter whether the
risks we give are in the ad or not--just about chance
performance for all of them. Very different performance for
risks relatives to benefits. Why? We can trace it to
differences in their cognitive accessibility.
So there is an unfair balance in the presentation of risks
vs. benefits, in terms of cognitive accessibility.
Here are some recommendations. We need an evidenced-based
approach in developing and reviewing ads. We should have these
quantitative measures of cognitive accessibility for the
benefits, such as location, speed, competing information and so
forth. But we should have it for the risks as well. Then we can
get both types of information into fair balance.
Otherwise we will be presenting risk information that may
be physically present, but functionally absent. Physically
present, but functionally absent. People can't get the risks.
So to conclude, risks can go this way, as shown in this
animation--toward the person, but over the head and away.
However, there is a way to get risk information into the heads
of people. That is to increase its cognitive accessibility.
Thank you.
[The prepared statement of Dr. Day follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The Chairman. Thank you. Ms. Gadhia?
STATEMENT OF AMI GADHIA, POLICY COUNSEL, CONSUMERS UNION,
WASHINGTON, DC
Ms. Gadhia. Good morning, Chairman Kohl, Ranking Member
Smith and members of the Committee. My name is Ami Gadhia. I'm
policy counsel with Consumers Union, the non-profit publisher
of Consumer Reports magazine. I'm here today to testify about
DTCA for implantable medical devices and the safety and health
concerns related thereto.
Consumers Union commends the Committee for holding today's
hearing on this critical consumer safety issue. In addition to
our testimony today, CU has registered its concerns about this
issue through a petition we submitted to FDA in December of
2007. The petition makes the same recommendations that I make
today to the Special Committee.
Most people are familiar with DTC ads for prescription
drugs. Now DTC ads for implantable medical devices such as knee
and hip replacement hardware and heart valves are also
appearing on our televisions. Unfortunately injuries and deaths
related to medical devices are also manifesting themselves.
In a December 2007 article entitled, ``Medical Devices,
Problems on the Rise,'' our publication, Consumer Reports noted
that ``reports of deaths linked to medical devices are at an
all time high with 2,712 fatality reports in 2006, more than
double the number in 1997.'' This article also notes that in
September 2007, FDA issued its own report for its Fiscal Year
2006 saying it had seen a 25 percent increase in adverse events
linked to medical devices over fiscal year 2005 including 2,830
deaths, over 116,000 injuries and over 96,000 device
malfunctions. A number of studies show significant injury
including healthcare acquired infections following implant
surgeries.
Both healthcare acquired infections and device failure can
and do cause death or serious morbidity and expense. These
statistics point to the need for regulation of the claims made
in and the warning information transmitted through the
advertising of the devices. While FDA review and regulation of
DTC prescription drug ads are still in their infancy the Agency
currently conducts almost no oversight of DTC ads for
implantable medical devices. Consumers Union thus strongly
urges Congress to require FDA to conduct the same oversight and
regulation of DTC ads for implantable medical devices as the
Agency is now authorized to do for DTC drug ads and to expand
their review of all of these ads.
In June 2006, Consumer Reports published an article in
which we noted that ``five percent of survey respondents
reported getting an infection shortly after surgery, a
significantly higher rate than reported in some major
studies.'' The CDC's National Nosocomicomial Infections
Surveillance System report clearly shows hip and knee
prosthesis surgery to be a serious source of infection. In some
of the NNIS reporting hospitals, the infection rate may run as
high as 5 percent or more.
The Agency for Healthcare Research and Quality notes that
complication of device, implant or graph was the third most
common of the principle diagnosis for hospital stays with MRSA
infection in 2004. While this category includes skin graphs,
devices and implants contribute to the total of 23,500 reported
stays with MRSA infection in 2004. A 2007 Health Affairs
article stated, more than 600,000 total knee replacements are
performed worldwide each year. This number will likely rise
because of the aging population and the expanding clinical
indications. The surgery carries risks of potentially life
threatening complications including anesthesia related
problems, wound and joint infections, deep venous thromboses,
injury to nerves and blood vessels around the knee and the
potential for future surgical revision.
A Wall Street Journal article published April 10, 2007
described the growth of medical device DTC ads. The warnings of
side effects are generally non-existence or minimal, as Dr. Day
related. Saying such things as ``there are potential risks,''
potential for complications. We found no ads that advised the
consumers of the very real possibility of deadly infection or
to urge them to seek out surgical facilities with low infection
rates. Examples of websites that offer relatively little or no
warnings that we could easily see in clicking through the sites
are contained within our written testimony.
It is also important that the ads carry a warning of the
potential for infection, morbidity and mortality as a result of
surgery and implantation because the system of payments between
many device companies and surgeons creates financial incentives
to conduct the surgery. These same incentives to use various
devices may well have the effect of minimizing the warnings and
advice cautioning patients about other solutions such as weight
loss, pain medication, physical therapy, etc. A 2007 Wall
Street Journal health blog posting reported that nationally
``more than 40 surgeons or groups each received at least one
million dollars in payments'' in 2007.
We raise the issue of industry consulting fees. Because it
calls into question the objectivity of a physician as a learned
intermediary to fully inform patients of the downsides of such
surgeries. This potential problem is another reason to require
ads to carry robust warnings.
Given these significant concerns we believe that oversight
and regulation could improve consumer safety and outcomes.
Specifically CU makes the following recommendations.
FDA should be required to mandate that all print and
electronic ads including internet ads for implantable devices
warn consumers about one, the very real danger of healthcare
acquired infections that can and do result from surgery and
follow up care.
Two, the expected life span of the device before failure
occurs.
CU supports better oversight of medical device ads as we do
for drug ads including an FDA review process before the ads are
issued. FDA needs more resources for reviewing DTC ads and
taking enforcement action when ads are unlawfully misleading,
deceptive or unbalanced. Often FDA does not issue a warning
letter until months after a deceptive or misleading ad has been
widely aired.
Section 503b of the FDA Amendment Act of 2007 includes
stronger authorities for the FDA to require pre-review and
specific disclosures to ensure that consumers are warned in DTC
ads about potential dangers and side effects. We urge FDA to
use these authorities as well as its existing authorities to
review device implant advertisements and require that they warn
of the specific dangers of infection. Advise patients to ask
questions about infection rates and anti-infection practices at
the facility where the implantation will take place.
In conclusion there is no question that many implantable
medical devices can restore high quality of life for patients
who have been suffering. But we do believe that unintended side
effects and deaths can be minimized if the public is better
educated about the risks involved and about facilities that are
not demonstrating the highest level of anti-infection
practices. The law requires that for all DTC ads for
prescription drugs the claimed benefits must be accompanied by
balanced warnings of the risks of using the drug. The same
requirement should be applied to devices.
Thank you.
[The prepared statement of Ms. Gadhia follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The Chairman. Thank you. Senator Salazar, would you like to
comment, questions?
OPENING STATEMENT OF SENATOR KEN SALAZAR
Senator Salazar. Thank you very much, Chairman Kohl.
I have an opening statement that I will submit for the
record.
Senator Salazar. I have some questions and comments.
Let me first of all say that this is a very important
hearing and I very much appreciate your leadership in bringing
this matter to the attention of the Committee and to the
attention of the U.S. Senate. A question that I would have for
any of you, but Ami, starting with you since you were the one
who came up with the recommendations. You essentially are
telling us that we ought to have the same kind of oversight and
regulation with respect to implantation devices as we now do
with the FDA and prescription drugs.
Miss, my question to you is whether or not you think the
kind of oversight and regulation that we have from FDA with
respect to prescription drugs is working. In all sense what I
hear from people as I travel around my state as I did during
the month of August where I had 31 hearings on healthcare in 31
counties, is that people think that much of what we are hearing
from the pharmaceutical companies with 30 second ads is in fact
a huge part of our healthcare problem in America today. So my
question is, are we being effective in terms of the kind of
regulation that we have with respect to advertising on
pharmaceutical drugs? If we're not, why should we simply import
that system over to dealing with the kinds of devices that
we're dealing with here today?
Ms. Gadhia. You're correct that there's still a lot of work
to be done to protect consumers with regards to drug DTC ads.
The FDAAA Section 503b does do a lot to try to improve that
regulation oversight. It's still relatively new. It's only
about a year old.
So I think we're still seeing whether FDA is implementing
it or not. As everyone knows they're obviously very strapped
for resources. So it's sort of a question of even getting
device DTC ads up to the same level.
Senator Salazar. Let me ask you this. If, may I compare, I
see what we do here in the United States verses what other
countries do. Other countries simply prohibit it. I see Dr.
Bozic's statement here, it's titled, Marketing or Medicine, Are
Direct-to-Consumer Medical Device Ads Playing Doctor?
When you look at the 30 second ads that we see so many of
from the pharmaceutical industry, when we look at the devices
we're talking about today, why not just adopt the kinds of
prohibitions that have been adopted in other countries? Why do
we let these 30 second ads essentially be the ones that are
playing doctor to a patient?
Ms. Gadhia. I don't disagree with that. It's--
Senator Salazar. Then why don't you make that as part of
your recommendation instead of just saying apply what is
probably not a very workable program with pharmaceuticals to
put it into the implantable device industry.
Ms. Gadhia. Just to make sure I understand your question.
So why not just prohibit these ads?
Senator Salazar. In the way they do in other countries.
Ms. Gadhia. Well, I guess the question is whether the
wherewithal exists with the FDA and with the medical device
industry being as large as it is in this country whether that
exists as a real possibility. The suggestions in my testimony
are meant to posit real immediate solutions that we feel could
begin to regulate a largely unregulated area.
Senator Salazar. On the other hand, are there benefits that
come from the kind of advertising that does take place where
consumers are made much more informed about the kinds of
remedies that might be out there with respect to joint
replacements or heart stents or other kinds of things we're
talking about here? Other benefits that come from the type of
advertising that we see on television today?
Ms. Gadhia. You know I would concur with, I believe it was
Dr. Boden, who talked about, I apologize if it was Dr. Diamond,
who talked about the confusion and the fact that patients are
coming to doctors not knowing a whole lot about these
particular devices and what they do. So I think it's
questionable whether whatever positive benefits or information
are coming from these ads are actually correct.
Senator Salazar. Ok. Ms. Day or anybody else want to
comment on the question?
Dr. Day. I do have a comment about potential benefits of
these types of ads, since we've been collecting them for over 8
years and been testing them all along. We have seen a growth in
what consumers understand about potential side effects for any
treatment.
When you ask them, what are possible side effects, they're
able to generate more now. So there's more awareness of
potential side effects. If you compare our society with the UK,
it's a very interesting comparison--similar culture, same
language.
I was giving a presentation in the UK recently and
afterwards I spoke with colleagues. I asked them, how do you
get information about potential side effects for drugs and
devices? They said, ``side effects?'' I said, ``well does your
physician tell you?'' They said, ``well, it doesn't come up.''
That society is less aware that there are always potential side
effects with treatments such as drugs and devices, as well as
potential benefits. So I--
Senator Salazar. Ruth, would you concur with Ami's
recommendations in terms of additional FDA resources to
regulate as well as regulation extended?
Dr. Day. Yes. I know some of what goes on in the DDMAC
group, that's the Division of Drug Marketing Advertising and
Communication. They do a lot of very good work. They are
responsible not only for the drug ads we're talking about now,
but all the promotional materials, industry websites, the print
ads and the promotional materials that go to the physicians. If
you look at the total number of pieces of promotional material
they're responsible for and divide by the number of staff
people who review--I think it's about 25 people.
Senator Salazar. So you'd say they have a good program, but
they're just very understaffed?
Dr. Day. Absolutely. I would like to see medical devices
come up as Ami Gadhia also said, to at least that standard as
well.
Senator Salazar. Right.
Dr. Day. Then consider going beyond that level.
Senator Salazar. My time is up. I thank you, Chairman Kohl.
The Chairman. Thank you very much, Senator Salazar. I just
want to follow up, maybe to some conclusion among all five of
you. Would you all agree that we need to do a much better job
of regulating this advertising, DTC advertising in this area?
Anybody disagree on that?
Dr. Day. No.
The Chairman. Do you all see it as a very important issue
if we're going to continue to advertise these devices and even
increase the advertising on these devices that regulation not
only should occur, but must occur? Anybody disagree?
Dr. Day. No.
Dr. Bozic. Not at all.
The Chairman. We thank you so much. Does anybody want to
make a comment before we go on to the next panel?
Dr. Diamond. Well if I could just add one more statement
with respect to the last comment you made. In the end we have
to do more than just regulate. We have to link the claims to
the evidence.
We eventually have to link the evidence to reimbursement.
Because there needs to be an incentive chain throughout the
entire process that encourages the right behavior.
Dr. Bozic. I'd just like to add as we've discussed, I think
there's an important distinction between help seeking or
disease awareness advertisements which can have some positive
health effects, from product specific ads. I do believe that
increased resources for the FDA could lead to increased
oversight and therefore allow us to have some of this fair
balance that we're trying to achieve that we're clearly not
achieving under the current system.
Dr. Boden. I'd just add also that if we could perhaps model
a system after what New Zealand has undertaken, a therapeutic,
advertising preventing service, that might include
multidisciplinary representatives of physicians, specialists,
consumer advocates and other regulatory agencies. I think that
this might help to go a long way toward ensuring that the
content and balance is fair and appropriate for what consumers
can expect to understand.
Thank you.
Senator Salazar. Mr. Chairman, may I ask one more question?
The Chairman. Certainly. Go ahead.
Senator Salazar. Would any members of the panel take the
position that we ought to try to ban these kinds of ads in the
way that other industrialized nations have done so? I'm not
sure we could do it under the First Amendment. But would any of
you take the position that we ought to follow the same pathway
that other industrialized nations have taken to ban these kinds
of ads?
Dr. Boden. Senator, I think most of us would probably
prefer such a ban, but I think that this might trigger court
challenges, you know the First Amendment and commercial speech
protections. So I think if there was a way to navigate that,
you know it would be, I think, worthy of consideration.
Senator Salazar. Ok. Do the rest of you agree with Mr.
Boden's comment?
Dr. Day. I would just like to comment that I do not believe
that they have been ``banned'' in other countries. They have
not been approved. It is allowed in New Zealand. Other
countries are considering it. There's a lot of talk in the UK
that it might happen, or it might not. They go back and forth
on this. But I don't think that the countries have actively
banned the ads. They just have not approved direct-to-consumer
advertising.
Senator Salazar. Ok. Thank you very much.
The Chairman. We thank you so much for being here today.
Your testimony has been very useful. Thanks for being here.
So we've moved off to the second panel. Second panel is Dr.
Daniel Schultz. He's the Director of the FDA Center for Devices
and Radiological Health. That is the office responsible for
among other things, the regulation of direct-to-consumer
advertisements for restricted medical devices.
So Dr. Schultz, what have you got to tell us this morning?
STATEMENT OF DR. DANIEL SCHULTZ, DIRECTOR, CENTER FOR DEVICES
AND RADIOLOGICAL HEALTH, FOOD & DRUG ADMINISTRATION, WASHINGTON
DC
Dr. Schultz. Mr. Chairman, members of the Committee, my
name is Dan Schultz. I'm Director of the Center for Devices and
Radiological Health at the Food and Drug Administration. Thank
you for the opportunity to discuss today the Agency's role in
oversight in direct-to-consumer advertising in promotion of
medical devices.
I will discuss how FDA regulates the promotion in
advertising medical devices. Clarify some important differences
from regulation of drug advertising and promotion. I will also
review the Agency's enforcement actions, outreach and
compliance activities in these areas.
Under the Federal Food, Drug and Cosmetic Act, FDA has
regulatory authority over the labeling of all medical devices.
The Federal Trade Commission regulates the advertising of
medical devices with the exception of restricted devices. A
restricted device is one for which the Agency has issued a
regulation or otherwise imposed requirements restricting the
sale, distribution or use of a device if such restrictions are
necessary for its safe and effective use. FDA therefore
regulates the advertising of restricted medical devices and
FTC, the advertising of non-restrictive medical devices.
Sections 502Q and R of the Act provide that a restricted
device is misbranded if its advertising is false or misleading
and in particular, does not contain a brief statement of the
devices intended use, relevant warnings, precautions, side
effects and contra-indications, excuse me. FDA has issued two
draft guidances pertaining to advertising of restricted
devices. One entitled Draft Guidance for Industry in FDA
Consumer Direct to Broadcast Advertising of Restricted Devices
describes an approach for companies in developing
advertisements that contain a brief statement of intended uses
and relevant warnings, precautions, side effects and
contraindications.
The second, entitled, Help Seeking and Other Disease
Awareness Communications Buyer on Behalf of Drug and Device
Firms assists the drug and device industries in developing such
communications. Generally help seeking and other disease
awareness communications do not constitute labeling or
advertising and so are not regulated by FDA.
Some of the distinctions. Generally speaking there is no
statutory requirement that restricted device or drug
advertisements be submitted to FDA for review prior to
dissemination or broadcast. The main difference between drug
and device promotion occurs at the time of dissemination or
broadcast. Medical device companies are not required to submit
FDA copies of promotional materials at the time of
dissemination. Pharmaceutical companies on the other hand, are
required to submit copies of their promotional materials for
prescription drug products at the time of initial
dissemination.
FDA's drug advertising regulations contain certain specific
requirements regarding the content of prescription drug
advertisements. For example, drug advertisements may not
include false or misleading information or omit material facts
and must present a fair balance between benefit and risk.
Device regulations do not contain specific requirements
regarding the content of advertisements for restricted medical
devices. So regulation comes directly from Sections 502Q and R
of the Act mentioned earlier.
CDRH regulates restricted device advertisements directed to
consumers and physicians, specifically CDRH regulates product
claim and promotional reminder ads, product claim ads include
the name of the product, its indications for use or make a
claim or representation about a specific medical device.
Promotional reminder ads may disclose the name of the medical
device, descriptive information or price information. But do
not provide indications for use or make any claims or
representations. As I previously mentioned help seeking and
other disease awareness ads are not generally regulated.
CDRH's Office of Compliance in conjunction with support
with the rest of the Center is responsible for the surveillance
of advertisements for restricted devices as well as promotional
materials for all medical devices. The Office of Compliance
staff reviewed trade complaints about promotion from
competitors, health care professionals and consumers as well as
promotional activities in the exhibit halls of scientific and
promotional meetings. I just parenthetically would like to say
that we do get a lot of valuable information from competitive
companies. That's actually one of our best sources.
As well we do send a number of our medical officers and
other people around the Center, not just our compliance people
to scientific meetings. They're very helpful as well in getting
us useful information. Some of which we've actually used to
take enforcement actions.
We seek to increase voluntary compliance by industry
through educational programs. These include outreach programs
intended to improve industry's understanding of the statutory
requirements for medical device promotion, website postings and
warning letters which provide examples of violations the Agency
has acted against and helps industry understand what types of
promotion are unacceptable. Guidances to help industry
understand FDA's current thinking, how to comply with the Act.
In addition in 2005, FDA held a public hearing on DTC promotion
to gather input on DTC promotion of regulated medical products.
FDA is using information from that meeting to help guide its
policy on the regulation of DTC promotion.
Last year CDRH undertook a major enforcement initiative in
the area of off label promotion of medical devices directed to
healthcare professionals. In 2007, CDRH met with 20
manufacturers of biliary stents to discuss increased off label
promotion for vascular applications. At that meeting CDRH
identified several instances in which companies were promoting
biliary stent products for uses beyond those cleared by the
Agency.
CDRH requested, I think strongly requested, that firms
review their device's labeling to ensure it was consistent with
cleared indications for use, to stop promoting biliary stents
at vascular meetings, to inform their customers of the risks of
serious adverse events when biliary stents are used off label
and to conduct appropriate clinical trials in support of PMA
applications for the specific vascular indication. CDRH worked
with the companies to ensure that their corrective actions were
fully implemented. Our Office of Compliance continued to
monitor companies and assure continued compliance.
The Agency has issued untitled and warning letters to
companies for violated broadcasting DTC advertising and
promotional labeling. Other enforcement tools that are
available to address misbranded or adulterated devices include
seizures, injunctions, civil money penalties and referrals for
criminal investigation or prosecution. The Agency will maintain
vigilance in this area and continue enforcement practices
necessary to address the unique issues and challenges presented
by consumer directed advertising of restricted medical devices
and to target violations with the greatest public health
impact. That is, maintain a risk based approach.
Thank you.
[The prepared statement of Dr. Schultz follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The Chairman. Thank you, Dr. Schultz. Dr. Schultz, in your
opinion is there any reason why the regulation in the oversight
of medical devices by the FDA shouldn't be at the same level as
it is for pharmaceuticals?
Dr. Schultz. Mr. Chairman, I think that in terms of the
level, I think that the question is really, you know, is it
important, yes, absolutely. The question is how do we go about
it? I think one of the questions that was asked earlier and one
that sort of resonates with me is, how can I use the resources
that I have and that you've provided to us in a most effective
way to ensure the public health?
Obviously we have a number of other priorities including
import safety, product surveillance, good manufacturing, making
sure that we have a review process that gets life saving
devices to the marketplace in a reasonable timeframe. So the
question to me is not is this important? The question is where
do I put it in terms of priority? How can I best achieve the
goals that we all have?
The Chairman. Well, I appreciate that. I think what you're
saying is your not disregarding the importance of it.
Dr. Schultz. Correct.
The Chairman. You're suggesting the argument could easily
be made that it's just as important to regulate medical devices
as it to regulate and oversee pharmaceuticals. But you do not
have the kind of resources to enable you to do that. Is that
what you're saying?
Dr. Schultz. That, well, that's part of what I'm saying.
Yes, that's correct. The other--
The Chairman. It would not be right--
Dr. Schultz. Alright. Sorry.
The Chairman. Correct, or fair for anybody in your opinion
to make the argument that medical device regulation and
oversight is any less important than oversight and regulation
of pharmaceuticals in our society.
Dr. Schultz. I'm a surgeon and I'm a device guy. So
absolutely not. I think medical devices are as important as any
other medical product.
The Chairman. In terms of the need for oversight, I'm
saying.
Dr. Schultz. Well, I think, yeah. I mean, I think that they
need to be regulated appropriately for the types of devices
that they are. Again, you know, one of the challenges that we--
The Chairman. Do you think that's important in our society?
Dr. Schultz. Excuse me?
The Chairman. Do you think that that regulation and
oversight of medical devices is an important thing to be
accomplished in our society today?
Dr. Schultz. Absolutely. I've devoted the last 15 years of
my life to that effort. So yes, I obviously think it's very,
very important.
The Chairman. So if we even went to the point of trying to
get some legislation on this to be sure that you're adequately
funded, you would be in agreement?
Dr. Schultz. Again, I think we would have to see and we
would certainly welcome the opportunity to look at whatever
ideas the Committee had and to be able to comment back.
The Chairman. Yeah.
Dr. Schultz. Again, I would like to make sure that we do
what is effective. Not just do something for the sake of doing
something. I think one of the questions that was raised earlier
in terms of how effective some of the drug oversight is. I
think, frankly, that that question and the answers sort of
resonated.
There's a lot of things that could be done. The question
is, what should be done? How could we do it in a way that
effectively achieves its result which is better public health.
The Chairman. As we commented on with the first panel, in
most societies pharmaceuticals and medical devices are not
advertised over television.
Dr. Schultz. Right.
The Chairman. That's for a reason. You know, it's not a
coincidence. That's for a reason.
Dr. Schultz. Yeah.
The Chairman. Now if we're going to have that kind of
advertising allowed in the United States, then isn't it logical
that we need to regulate it to the extent that is necessary to
protect the public?
Dr. Schultz. I think we need to regulate it to the extent
that's necessary to protect the public. I think that's
absolutely a true statement. The question is, excuse me. The
question is how do we do that? How do we do it efficiently?
The Chairman. Sure.
Dr. Schultz. How do we actually address the concerns that
are important and not spend a lot of time, frankly, having seen
the amount of time that we spend looking at labeling and other
promotional activities. You can spend an awful lot of time
wordsmithing things in a way that sometimes I don't think can
be as productive as--
The Chairman. Sure.
Dr. Schultz [continuing]. Some of the other activities that
we're engaged in. So I guess I'm agreeing with you that's it's
an important problem. I would sort of put in a cautionary note
in terms of making sure that whatever we do we think it through
and make sure that it's really going to meet the needs of the
American public.
The Chairman. I couldn't agree more. Just one last
observation that you might want to make.
Dr. Schultz. Sure.
The Chairman. Every last dime that's spent on advertising
is past on to the consumer. The cost of medicine in this
country, the cost of healthcare in this country is something
that we're agitating and concerned about, as you know, at least
as well, if not better than the rest of us. Efforts to try and
contain the cost of medical care in this country is at the
level of being urgent.
As we've said many, many countries don't allow any of this
advertising on television. My guess is that in those countries
people are living to the same age as they are here in this
country. Do you have an observation?
Would you make an observation? Just a matter of what your
long experience has taught you in this field? Is this
advertising network we're spending so much money on and
charging the customer directly for, in terms of the price that
they pay for pharmaceuticals and medical devices?
Is this something that we should be talking about too? Just
a matter of your opinion.
Dr. Schultz. Sure. Yeah. Well, I mean I think it is
obviously an important question. It's one that actually have
been doing some thinking about since receiving your invitation.
You know, again, I haven't seen all of the different ads for
every different product.
But I guess I would sort of comment by way of example.
There are a number of ads that I've seen recently for glucose
monitors for people with diabetes. My sense is, again, opinion,
not data driven. My sense is that reminding diabetics that
monitoring their glucose and making sure that they see their
doctor and control their diabetes is a good thing.
You know, whether how much those ads actually help to do
that, you know, again, I don't have any data. But it seems to
me that those kinds of reminders from whatever source they come
from telling people that they need to take care of their
chronic disease is probably not a bad thing. Some of the other
ads, I think there is a range.
Obviously you saw a number of different ads ranging from
wrinkle fillers to obesity treatments to cardiac stents. I
think that within those products there's a range in terms of
how useful they are in informing people about options and
suggesting that they go see their doctor verses how un-useful
they are in terms of perhaps over promoting and suggesting
treatments that may not be that helpful. At the end of the day,
as far as I'm concerned, you know, the decision in terms of
what the best treatment for an individual patient is rests with
the doctor and with the patient. I can say that as a former
surgeon and as a regulator, I continue to believe that that's
where the decision should be made.
The Chairman. Well, thank you very much. Your testimony has
been extremely helpful. Appreciate your being here, Dr.
Schultz.
Dr. Schultz. Thank you.
The Chairman. We've come down to our last panelist. That is
Stephen Ubl. Mr. Ubl is the President and CEO of the Advanced
Medical Technology Association, normally called AdvaMed.
This is the world's largest medical technology association.
AdvaMed's member companies produce medical devices, diagnostic
products, as well as health information systems. Its members
have produced nearly 90 percent of the healthcare technology
purchased annually in the U.S. and more than 50 percent
purchased annually all around the world.
So we're looking forward to your 5 minute testimony this
morning.
STATEMENT OF STEPHEN UBL, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, ADVAMED, WASHINGTON, DC
Mr. Ubl. Thank you very much, Mr. Chairman. My name is
Steve Ubl. I'm President and CEO of AdvaMed, as you said the
Advanced Technology Association. We welcome the opportunity to
testify this morning on DTC advertising for medical devices.
The medical technology industry is a critical component of
the U.S. health sector. Constant innovation by our member
companies leads to the introduction of new technologies that
prevent illness, allow earlier detection of diseases and treat
patients as effectively as possible.
I've submitted my written statement. But I'd like to focus
on four key points this morning.
First, AdvaMed's member companies believe strongly that
direct-to-consumer advertising of devices must provide truthful
and non-misleading information to consumers. As you are aware,
device manufacturers are generally not heavily engaged in DTC
advertising in comparison to the pharmaceutical industry. Most
of our products are not sold directly to consumers.
In fact according to a Northwestern University report,
medical device manufacturers spent only 116 million on
advertising in 2005 compared to 4.1 billion for pharmaceutical
ads. However, to further reaffirm our commitment we have
guiding principles that will be presented to our board that
strongly support responsible DTC advertising and compliance
with the law. DTC ads should do the following in accordance
with FDA policy: be truthful and not misleading, use consumer
friendly language, disclose relevant risk information,
encourage patients to speak with their doctors in more detail
and follow all FDA and FTC statutes and regulations. I should
also say we support FDA's full enforcement authority against
companies that run ads in violation of the law.
In addition to complying with all relevant, applicable FDA
and FTC policies, our principles go further. For example we
share concerns about inappropriate use of celebrities in ads.
That is why we believe such endorsements must reflect the
honest opinion of the endorser, include statements that are
substantiated as if they were made by the manufacturer and be
representative of a typical patient experience or disclose when
it is not.
Concerns have also been raised that companies should wait
until physicians are trained on a new device before launching
an ad. We support providing appropriate time to educate health
professionals before an ad is launched taking into account the
nature of the product, the risk benefit profile and needed
training. We are also committed to ensuring that ads can
communicate risk information in a way that consumers can best
understand. We would welcome guidance from the FDA on how to
tailor technical language on restricted devices to consumers.
Such guidance should take into account the unique
characteristics of medical technology.
The second point I want to emphasize is that DTC
advertising in the device industry can benefit public health by
informing patients of important potential therapies that they
should discuss with their physicians. A 2005 Rand study found
that patients receive the recommended standard of care only
about half the time. The study found that 80 percent of those
cases were due to under-treatment rather than over treatment.
In May a study published by the Journal of the American
Heart Association found that only 51 percent of patients
eligible for an implantable cardioverter defibrillator or ICD
receive it. As Dr. Bozic mentioned in his testimony, a 2004 NIH
report found that only 9 to 13 percent of patients who could
benefit from joint replacement actually receive it. Whether the
issue is artificial hips and knees, implantable cardiac
technologies or diabetes control, far too many patients do not
receive treatment even when it is clinically indicated and
potentially life saving or life enhancing.
Third, concerns about DTC advertising that have been raised
in the drug context are in many cases, less relevant when
applied to devices. Some have raised concerns that unknown side
effects can appear when a drug is expanded beyond a clinical
trial period. Unknown side effects can appear in devices too,
but they are much less likely because devices, typically, do
not act systemically and because the eligible population for a
particular device is far smaller than for drugs.
In addition, whatever the validity of the concern that DTC
advertising of drugs will cause doctors to ignore their
professional best judgment and write a prescription the patient
does not need or which is inferior to a competing treatment, it
seems misplaced for devices. Unlike drugs, medical device
treatments often entail complex procedures including surgery to
replace body parts like hips and knees, connecting batteries to
the heart or implanting the equivalent of metal scaffolding in
a blood vessel. The idea that a patient would decide to undergo
complex and invasive procedures based on an advertisement or
that a physician would agree to perform them, even when it's
inappropriate for the patient, is difficult to imagine.
My final point is that the FDA and FTC already have ample
legal authority to regulate false or misleading advertising for
medical devices. We believe that manufacturers are responsive
and take action to address any issues raised by the FDA
regarding an ad. For those who violate the law, the FDA has a
broad range of remedies they can bring to bear from issuing a
warning letter to removing a product from the marketplace.
We look forward to taking the feedback from this hearing to
our board and working with you as you continue to explore this
issue. I'd be happy to answer any questions the Committee might
have.
[The prepared statement of Mr. Ubl follows:]
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The Chairman. Thank you, Mr. Ubl. You heard this morning
about some of the shortcomings that are believed to be
associated with DTC ads for restricted medical devices, both
panels. As representative of the largest association of
manufacturers of such devices, how do you respond to such
concerns? What are you intending to do about them?
Mr. Ubl. Well, I mentioned at the outset all the conditions
that we believe should be a part of DTC ads. We've taken the
additional step of developing principles we're presenting to
our board. They go beyond FDA law and regulations in several
respects--notably in the endorser issues that I raised, and the
timeframe for education of practitioners before an ad is
launched. We're open to taking the feedback of the Committee in
terms of additional areas.
I would point out, however, that under-use was not
mentioned in any of the earlier panels. It's a significant
issue in terms of many medical technologies that patients could
benefit from and DTC ads are an important source of that
information.
The Chairman. Mr. Ubl, in your testimony you argue that
manufacturers of the devices being discussed here today should
adopt advertising practices to ensure that commercials
featuring celebrity endorsers are representative of a typical
patient experience. So I'd like to get your opinion of the
following advertisement as we'll run it now. While you watch
it, please keep in mind what we heard from the first panel with
regard to the overly optimistic assumptions patients tend to
form after seeing such advertisements. Let's look at the ad.
[Panel watching video.]
The Chairman. Mr. Ubl, is it typical for hip replacement
patients to be able to play basketball, jump rope and surf as
we saw depicted in this advertisement?
Mr. Ubl. I'm not a physician. I think I would be best if I
refrained from commenting on individual ads. I'd be happy to
restate our views on these types of endorsements.
The Chairman. Go right ahead.
Mr. Ubl. They should reflect the honest opinion of the
endorser. They should include statements that are substantiated
as if they were made by the manufacturer. They should be
representative of a typical patient experience or disclosed
when it is not.
The Chairman. Should medical devices be subject to the same
kind of oversight as pharmaceuticals?
Mr. Ubl. Sir, we believe, if you take a look at the FDA law
regulations and guidance combined with the FTC equivalent that
on the whole, the regulation on the pharmaceutical side
compared to restricted devices is comparable, but for the
exception that Dr. Schultz mentioned earlier in terms of
submitting the ad concurrent with its launch. We will consider
that issue.
But our view is that there are very few medical device and
technology companies who are doing these ads. Those that are,
are trying to do the right thing. We believe that the resources
of the FDA are better trained where the need is most critical,
which is on the enforcement side.
The Chairman. What comment would you be making to Dr.
Schultz if he were sitting at the table and he said we need to
have the same kind of oversight and regulation for medical
devices as we have for pharmaceuticals?
Mr. Ubl. As I said, I think that I found much to agree with
in Dr. Schultz's testimony. In reading it, I believe that,
again, taken on the whole the types of requirements that apply
to restricted devices and pharmaceuticals are quite similar,
but for the exception that I mentioned. So I assume we could
find much common ground in terms of the level of regulation.
I totally agree with his comment in terms of it's not
whether, it's how, and the need to focus the Agency's limited
resources on the most effective use for those resources and in
our view that would be on the enforcement side. I should add
that we're not aware of any company that when an FDA
representative raises a concern with an ad that it's not
addressed in a timely fashion.
The Chairman. Thank you very much, Mr. Ubl. We'd like to
thank you as well as the rest of our witnesses for their
presence here this morning. Clearly we have a subject and an
issue that demands a lot more oversight and thought, ideas
about where we need to go to be sure that people who are
thinking about using medical devices get as much information as
they need from the proper sources and that they're in a
position to make the right decisions.
We're not yet of a mind to propose legislative solutions.
It is not to say that we won't. But clearly this is something
that we need to look at.
I've instructed my Committee staff to be very, very much on
top of the issue. I would expect that we will be putting forth
our opinions and issuing our suggestions so that we can stay on
top of this issue. Thank you so much for being here.
[Whereupon, at 11:50 a.m., the hearing was adjourned.]
A P P E N D I X
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Prepared Statement of Senator Robert P. Casey, Jr.
I would like to thank Chairman Kohl for calling this
important hearing to examine direct to consumer advertising
(DTCA) for restricted medical devices. As this field continues
to grow with advances in science and medical technology, we
must ensure consumers receive the best and most accurate
information available.
The United States is one of two industrialized nations, New
Zealand being the second, allowing direct to consumer
advertising for restricted medical devices. These are devices
that require physician approval for uses such as artificial
knees and hips, heart stents and implantable defibrillators.
Other nations, such as Great Britain, restrict the provision of
treatment information for patients to physicians only. Canada
and the European Union require that advertising be reviewed by
regulating agencies. Indeed, the United States may soon be the
only nation to allow this practice as New Zealand is looking to
strengthen its limitations on direct to consumer advertising
and bring it more into line with Australian law.
In the United States, the Food and Drug Administration
(FDA) has the responsibility of regulating direct to consumer
advertising for restricted medical devices. Under the FDA
guidelines advertising must not be false or misleading, it must
be appropriately balanced between the risks and benefits of the
device, it must include facts that pertain to how the product
is used and it must mention every risk described in the
product's approved labeling. The advertisements do not require
approval by the FDA before being aired and the medical device
section of the Federal Food, Drug and Cosmetic Act states that
no regulations issued under that provision may require the
Secretary to approve an advertisement's content before it is
aired.
All patients should play an active role in their medical
treatment plans and should be able to act as informed consumers
asking questions about specific medical devices and technology.
However, there is a concern that some direct to consumer
advertisements give people false hope and lead them to believe
that with this knee or that heart stent they will be able to
lead a completely changed life and perhaps accomplish things
that had never before seemed possible.
Modern medicine and the human body are both amazing things,
but consumers must have the facts and a realistic prognosis of
the potential that medical devices may offer them individually.
I look forward to hearing the testimony of our witnesses and
working with Chairman Kohl and other members of this committee
on this issue.
In closing, Mr. Chairman, I want to again thank you for
calling this hearing today. I look forward to continuing to
work with you and with our colleagues next year.
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Mr. Ubl's Response to Senator Kohl's Question
Question. Mr. Ubl, at the Committee's September 17 hearing
I played for you a copy of an advertisement for Depuy's
artificial hip product, which features celebrity endorser
basketball coach Mike Krzyzewski of Duke. The advertisement
depicted, among other things, people jumping into rivers,
surfing, and playing basketball. You have represented to the
Committee that AdvaMed is implementing a new policy with
respect to direct-to-consumer advertisements for restricted
medical devices, which include artificial hips. Is the Depuy
advertisement that you viewed at the hearing in compliance with
that new policy?
Answer. I cannot make a judgment about the accuracy of the
ad nor whether the endorsements and testimonials depicted are
representative of a typical patient. Such judgment would depend
on knowledge of the product and patients' experience with the
device, which is why we believe patients should talk to their
physicians about their medical conditions and treatment
options. I can tell you that I know people who have resumed
their lifestyle, active or otherwise, after receiving
artificial hips.
As mentioned at the hearing, we also believe that
``endorsements and testimonials must be representative of a
typical patient experience or the advertisement should contain
a clear and conspicuous disclosure.'' AdvaMed is in the process
of reviewing guiding principles on DTC device advertising and
we will keep the Committee apprised of developments.
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