[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
DIRECT-TO-CONSUMER ADVERTISING: MARKETING, EDUCATION, OR DECEPTION?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
----------
MAY 8, 2008
----------
Serial No. 110-114
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
DIRECT-TO-CONSUMER ADVERTISING: MARKETING, EDUCATION, OR DECEPTION?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
MAY 8, 2008
__________
Serial No. 110-114
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
U.S. GOVERNMENT PRINTING OFFICE
54-104 PDF WASHINGTON : 2008
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20402-0001
COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
BART STUPAK, Michigan JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico
ALBERT R. WYNN, Maryland JOHN B. SHADEGG, Arizona
GENE GREEN, Texas CHARLES W. ``CHIP'' PICKERING,
DIANA DeGETTE, Colorado Mississippi
Vice Chairman VITO FOSSELLA, New York
LOIS CAPPS, California STEVE BUYER, Indiana
MICHAEL F. DOYLE, Pennsylvania GEORGE RADANOVICH, California
JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MARY BONO MACK, California
JAN SCHAKOWSKY, Illinois GREG WALDEN, Oregon
HILDA L. SOLIS, California LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas MIKE FERGUSON, New Jersey
JAY INSLEE, Washington MIKE ROGERS, Michigan
TAMMY BALDWIN, Wisconsin SUE WILKINS MYRICK, North Carolina
MIKE ROSS, Arkansas JOHN SULLIVAN, Oklahoma
DARLENE HOOLEY, Oregon TIM MURPHY, Pennsylvania
ANTHONY D. WEINER, New York MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah MARSHA BLACKBURN, Tennessee
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David L. Cavicke, Minority Staff Director
_____
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman GREG WALDEN, Oregon
HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex
officio)
(ii)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 4
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 6
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 7
Prepared statement........................................... 8
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 9
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 10
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 88
Witnesses
Ruth S. Day, Ph.D., director, Medical Cognition Laboratory, Duke
University..................................................... 11
Prepared statement........................................... 19
Nancy H. Nielsen, M.D., Ph.D., President-Elect, American Medical
Association.................................................... 28
Prepared statement........................................... 30
Mollyann Brodie, Ph.D., vice president and director, Public
Opinion and Media Research, Kaiser Family Foundation........... 51
Prepared statement........................................... 53
Marcia G. Crosse, Ph.D., Director, Healthcare, Government
Accountability Office.......................................... 70
Prepared statement........................................... 72
James Sage, senior director and team leader, Lipitor, Pfizer,
Inc............................................................ 104
Prepared statement........................................... 106
Deepak Khanna, senior vice president and general manager, Merck/
Schering-Plough Pharmaceuticals................................ 111
Prepared statement........................................... 113
Kim Taylor, president, Ortho Biotech, Inc........................ 118
Prepared statement........................................... 119
Submitted Material
Slides accompanying Ms. Day's presentation....................... 145
Subcommittee exhibit binder...................................... 211
DIRECT-TO-CONSUMER ADVERTISING: MARKETING, EDUCATION, OR DECEPTION?
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THURSDAY, MAY 8, 2008
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, D.C.
The subcommittee met, pursuant to call, at 10:05 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Bart
Stupak [chairman of the subcommittee] presiding.
Members present: Representatives Dingell (Ex Officio),
Stupak, Waxman, Green, Shimkus, Whitfield, Walden, Burgess,
Barton (ex officio), and Ferguson.
Staff present: John Sopko, Scott Schloegel, Paul Jung,
Joanne Royce, David Nelson, Kyle Chapman, Alan Slobodin, Karen
Christian, and Whitney Drew.
Mr. Stupak. This hearing will come to order. Today we have
a hearing entitled ``Direct to Consumer Advertising: Marketing,
Education, or Deception?'' Each member will be recognized for a
5-minute opening statement. I will begin.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. Nearly 10 years ago, the U.S. Food and Drug
Administration relaxed its rules relating to direct-to-consumer
advertisements for prescription pharmaceutical products. Since
then, spending on DTC ads has increased from about $1.1 billion
in 1997 to about $4.2 billion in 2005. This nearly 300 percent
increase in DTC ad spending dwarfs the 86 percent spending
increase in advertisements to physicians and the 103 percent
spending increase in research and development over the same
period of time.
The pharmaceutical industry insists than DTC ads are mainly
an educational endeavor designed to educate consumers about new
products. Research shows that some DTC advertising results in
patients seeing their doctors and discussing previously
undiagnosed conditions.
We must acknowledge that direct-to-consumer ads are also
designed to market and sell these products. Research has shown
that DTC advertising may result in advertised drugs being
prescribed when a similar, less-expensive drug may have been
just as appropriate. Every $1 spent on direct-to-consumer
advertising results in up to a $6 increase in sales. One study
demonstrated that every $1,000 spent on direct-to-consumer
advertisements resulted in 24 new prescriptions.
The purpose of the hearing is to examine the potentially
misleading and deception tactics used in direct-to-consumer
advertisements for prescription pharmaceutical products. Our
hearing today will examine three specific television
advertisements: ads for Lipitor featuring Mr. Robert Jarvik,
``Food and Family'' ads for Vytorin, and ``cancer fatigue'' or
``quality of life'' ads for Procrit.
Pfizer's Lipitor ads featured Robert Jarvik, an individual
who has never held a license to practice medicine and has never
been allowed to prescribe a medication. For his participation
in these ads, he was paid $1.35 million; however, none of his
ads indicates that he was compensated for his appearance. In
addition, Mr. Jarvik states in one of these ads that he himself
takes Lipitor. Yet, he admitted in an interview that he did not
begin taking Lipitor until a few months after he began filming
his commercials. These ads are in violation of the American
Medical Association guidelines concerning the involvement of
health professionals in DTC advertisements. Mr. Jarvik's ads
help maintain Lipitor's position as the most prescribed anti-
cholesterol ``statin'' drug.
[Video shown.]
Merck and Schering-Plough's ads for Vytorin resulted in $5
billion in sales in 2007. However, while these ads appeared on
the airwaves, the release of an important study examining
Vytorin's ability to stop cholesterol build-up was delayed and
suppressed by the companies. Significant and valuable results
from this study were delayed for 2 years, while Vytorin was
continuously marketed to consumers.
We now know that Vytorin has no effect on cholesterol
build-up; however, this information came to us about 2 years
too late. Many consumers may not have taken Vytorin had they
been aware of the study results, especially since a less
expensive, equally effective generic drug, Zocor, was readily
available. In addition, taxpayer dollars may have been
needlessly spent of Vytorin through Medicare Part D as the drug
was marketed to consumers while the company sat on its study
results.
[Video shown.]
Johnson & Johnson's Procrit was approved by the FDA to
treat chemotherapy- and dialysis-induced anemia. Yet for 7
years, it was marketed directly to consumers for the treatment
of ``cancer fatigue'' in order to improve the ``quality of
life'' for patients. This was clearly an instance of off-label
marketing, a practice that is prohibited by the FDA. No only
did the company advertise the drug, but the FDA did very little
to stop them.
[Video shown.]
These are three examples of drug companies acting
improperly. Our goal today is to expose the deceptive and
misleading aspects of each of these television ad campaigns,
but also those of DTC ads in general. We also intend to explore
better practices for direct-to-consumer marketing.
Both the Lipitor ads with Mr. Jarvik and the Vytorin ``food
and family'' ads were voluntarily withdrawn shortly after our
subcommittee began investigating direct-to-consumer ads in
January of this year. However, American consumers should not
have to rely on the oversight function of Congress to make sure
drug companies tell the truth in their advertisements. It is
likely that direct-to-consumer ads will continue, and
pharmaceutical companies may continue using these same
questionable practices that were used in these three ad
campaigns.
The FDA Division of Drug Marketing, Advertising and
Communication, DDMAC, is responsible for regulating direct-to-
consumer ads. Drug companies are required to submit copies of
their ads at the same time that they are disseminated, but no
pre-clearance is yet required. If a direct-to-consumer ad is
found to be in violation of FDA regulations, FDA can issue
warning letters for serious violations, which may lead to
regulatory action by the FDA. However, if a company refuses to
comply, the FDA cannot impose fines, except through
administrative hearings. In other words, the FDA is toothless.
Today we will hear from several witnesses, including the
three pharmaceutical companies responsible for the Jarvik
``food and family'' and ``cancer fatigue'' campaigns. We will
also hear from Kaiser Family Foundation about the effects of
direct-to-consumer ads, the American Medical Association,
regarding their policy on the portrayal of health professionals
in DTC ads, and the Government Accountability Office concerning
FDA's rules in regulating direct-to-consumer ads. We will also
hear from Dr. Ruth Day from Duke University, who will provide
an overview of research on how people understand and remember
information in drug ads and how to improve their ability to do
so. We will learn some of the techniques used in broadcast
advertisements that affect how consumers process the
information in direct-to-consumer ads. This information may
reveal that it is not simply a matter of what is said in a
direct-to-consumer ad, but more importantly, what people take
away from it.
The United States is only one of the two countries that
allows direct-to-consumer ads. Pharmaceutical companies should
consider it a privilege to be allowed to air direct-to-consumer
ads in this country. As with all privileges, there are
responsibilities, and we should make sure that pharmaceutical
companies conduct themselves responsibly. The Food and Drug
Administration shares the responsibility to make certain that
drugs are marketed responsibly to consumers. I also believe
that Congress shares the responsibility, and I intend to make
certain that our committee ensures the pharmaceuticals market
their products properly. I believe that Congress needs to
decide whether the U.S. should continue to be one of only two
countries in the world that allows direct-to-consumer ads, and
if we continue to allow such advertising, whether any further
limits on direct-to-consumer ads should be required. The three
ads that we will discuss today are indicative of typical
direct-to-consumer ad campaigns. It appears that we need to
enforce significant restrictions on direct-to-consumer ads to
protect American consumers from manipulative commercials
designed to mislead and deceive for the profit of
pharmaceutical companies.
I look forward to the testimony of each witness today, and
it is my sincere hope that today's hearing will lead to a
better understanding of the effects of direct-to-consumer
advertisements and their proper role in our health care system.
Mr. Stupak. I will next turn to my friend for an opening
statement, Mr. Shimkus of Illinois.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman.
Today, this subcommittee will conduct oversight on direct-
to-consumer advertising by drug companies. This topic has long
been a controversial one. I think part of the frustration on
our side is that some of the premises are not correct, because
last fall, when the Subcommittee on Health and then the full
committee passed the FDA Amendments Act of 2007, we created a
new standard that statements in drug ads must be clear,
conspicuous, and neutral. We had to weigh concerns about First
Amendment and commercial speech rights of companies against
concerns that drug ads were misleading and confusing.
And before we get started, I think we need to be clear
about FDA's authority with respect to drug ads. Contrary to the
statement in the Majority staff memo for this hearing that
states, and I quote, ``If a company refuses to comply with FDA
or untitled or warning letters, the FDA cannot impose fines or
other punishments, but must instead pursue an injunction from
the courts.'' The FDA Amendments Act specifically gave the FDA
power to impose civil fines on companies. Section 104 of the
Act amends Section 303 of the Food and Drug and Cosmetic Act
and provides that FDA may impose civil fines on companies when
the direct-to-consumer ads are identified as being false and
misleading. Granted, the FDA has only had this authority since
the Act was passed last fall, and the Act just went into effect
1 month ago, but they do have the power to impose these civil
fines.
And that is part of the frustration. We strengthened the
law. We gave the FDA power to act, and we haven't really given
them time to really impose the civil fines on false and
misleading ads. This leads me to my concern about the timing of
this hearing. This is a hearing of the Subcommittee on
Oversight and Investigation. Our job is to uncover facts and
see where the facts take us. While I believe that oversight of
the drug advertising is important and necessary, I wonder if
this is the appropriate time to be debating these issues, at
least for some of the topics we will be discussing today.
As I mentioned earlier, the FDA Amendments Act, which was
signed into law last fall, created a new standard for
statements in broadcast drug ads. The regulations to interpret
this standard are still being drafted. We have given FDA new
power to impose fines on companies that make false and
misleading statements in ads. Yet today we are reviewing three
ad campaigns that were in place before the new law was enacted,
and they are now off the air. Pfizer pulled its ads for
Lipitor, and Merck/Schering-Plough pulled its ads for Vytorin
in January. Johnson & Johnson's Procrit ads have been off the
air for 3 years.
There have been a number of suggestions in the media and
elsewhere about why these ads were pulled. Some have concluded
that the fact that they were pulled is an admission that the
ads were misleading or deceptive. Before we make any conclusion
about these ads, I think we need to take a careful look at the
evidence. So far the companies have produced thousands of pages
of documents, perhaps even hundreds of thousands of pages about
these ads. These documents show how they were drafted, the
rough draft of the ads, the companies' communications with
advertising campaigns and with FDA's Division of Drug
Marketing, Advertising, and Communications. We need to
determine what the companies knew about the science supporting
these advertising at the time they created the ads. In the case
of Vytorin and Procrit, the Committee is still investigating
the issue of what the companies and knew, and in particular,
when they knew it. This is a long way between finding that
language in an ad may be confusing or not as clear as possible
and concluding that there was an intent to deceive. We need to
be careful about drawing conclusions before we have had a
chance to review all of the evidence before us.
I also think it is important to take a step back and put
these ads into perspective. Americans see these ads all of the
time, maybe even every day. Research from the Kaiser Family
Foundation and a representative from the foundation that is
testifying today shows that two-thirds of Americans believe
that these ads helped educate them about diseases that they may
not have been aware of and about available treatment. With
regard to what people did after seeing the ad, the foundation's
research shows that the vast majority of people, almost 70
percent, have not talked to their doctors about drug ads they
have seen. Of those who did, the doctors responded in a variety
of ways, including recommending lifestyle changes, recommending
another prescription, recommending the drug in the ad, or
recommending the over-the-counter drug. In this sense, an
argument could be made that ads for drugs prompt a conversation
that needs to happen between doctors and patients about
patients' health and about how a patient should be treated.
In addition to balancing these benefits, we need to
remember that there is a First Amendment concern at play here.
The case law consistently supports the right of companies to
engage in commercial speech. Of course, that speech cannot be
misleading or false, and it is the FDA's job to ensure that
this does not happen. We need to take a look at FDA's review of
these ads, whether their system is designed to pinpoint the ads
that contain false or misleading statements, and whether the
Agency is taking action. Again, this is an unusual time to be
looking at this issue, when Congress just changed the standard
to require a clear, conspicuous, and neutral statement about
the side effects, and this standard did not apply to the ads
before us today.
I also look forward to the testimony of the American
Medical Association and its thoughts about the role of these
ads and the appropriateness of physicians serving as
spokespeople. And once again, I welcome Marcia Crosse of GAO,
and I am interested to see what developments have taken place
since GAO issued its report in 2006 on direct-to-consumer
advertising of drugs. If the purpose of this hearing is to
improve the accuracy and the clarity of drug advertising, I am
happy to work with Chairman Stupak and the subcommittee members
on this issue in a constructive way.
Again, I thank Chairman Stupak for convening this important
hearing, and I yield back my time.
Mr. Stupak. I thank the gentleman. Mr. Green for an opening
statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman. I thank you for holding
the hearing today on direct-to-consumer advertising.
From 1997 to 2007, spending on DTC advertising increased by
almost 300 percent, to $4.2 billion from $1.1 billion. Research
has shown that for every dollar spent on DTC advertisements,
companies gain $6 in increased sales. In my opinion, when
discussing DTC advertising, we only have to say one word, and
that is Vioxx. When it became painfully clear that the effect
of direct-to-consumer advertising on the demand for the drug.
Upon its approval, Vioxx was indicated for a small subset of
the population who experienced pain and arthritis, but who
couldn't tolerate other drugs. Vioxx was never intended for the
vast number of Americans who suffer from arthritis and joint
pain, and yet the drug's advertisement painted a picture of
pain-free life, as if Vioxx was the next best thing since
sliced bread. Soon enough, patients were asking doctors for
Vioxx and sales began to skyrocket. The ads were so persuasive
that it became unclear to many Americans, including some in our
own families, that Vioxx wasn't readily available to the public
without a prescription, and maybe a prescription was actually
needed. We know from the example of Vioxx that not all products
are safe, even after the approval of the FDA. And post-market
studies are necessary to ensure the patients' safety.
However, many drugs are heavily marketed through DTC
advertisements and consequently, a large number of patients are
exposed to a significant number of health risks. In this
hearing, we will look at several different issues with DTC
advertisements. Pfizer's Dr. Jarvik advertisement and the
misleading information it contained when patients see an
advertisements with a world-renown inventor, who they think is
a doctor or celebrity, they believe the product is safe, and
yet we soon discover that Dr. Jarvik was not a licensed
physician. We will also be discussing the Procrit
advertisements which show cancer patients having increased
energy after Procrit. The FDA never approved Procrit for
treatment of fatigue. In fact, Procrit was approved to prevent
the need for blood transfusion in a very specific group of
patients. The Committee will also look at the Vytorin ads and
the fact that they were still being broadcast when the study on
it effectiveness was delayed for 2 years. The FDA determined
the ads violated policy by not including a disclaimer on the
effectiveness of Vytorin.
We should remember there is no way we can determine the
full range of risk based on clinical trial alone, and in
essence, once the drug is in the marketplace, it becomes the
new clinical trial, and DTC does increase the number of
individuals who go to their physician, but at the same time, it
increases the likelihood that more people will be exposed to
any number of negative effects of these drugs before they are
thoroughly tested.
Mr. Chairman, again, I thank you for holding the hearing. I
will yield back my time.
Mr. Stupak. I thank the gentleman. Mr. Burgess for an
opening statement, please? We have five votes on the floor, but
we are going to try to get as many openings in as we can before
we leave.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Dr. Burgess. Thank you, Mr. Chairman. I appreciate your
courtesy, and thank you for holding today's subcommittee
hearing on the issue of direct-to-consumer advertising. It is
an important aspect of one of the things that we are obligated
to have under our study here at our committee.
One of the things that concerns me greatly is the issue,
and we just heard Mr. Green talk about Vioxx, of aftermarket
surveillance, Mr. Chairman. This committee did a great deal of
work with the FDA reauthorization last summer, and the Reagan-
Udall language in that legislation, which was to allow for
post-market surveillance, which was to allow the exact same of
surveillance to which Mr. Green just alluded, was unfortunately
not funded in the USDA appropriations bill last summer, for
reasons, quite frankly, I don't understand. We managed to do
several earmarks in that appropriations bill, but can't seem to
find the money to fund the very critical aftermarket
surveillance, which would answer some of the questions that we
have here in front of us today.
I will just say in my years as a practicing physician, I
wasn't a great fan of direct-to-consumer advertising, but I
recognize it does have a function in patient education.
Certainly, the Vytorin commercial that you aired for us just a
few moments ago has never been my favorite commercial. I have
sometimes wondered about the actual content of that commercial,
but it does provide a bit of patient education in that there
are two sources for elevated cholesterol, and it is important
for patients to understand that if they are going to play an
active role in the maintenance of their health and the ability
to lower their cholesterol function overall.
Dr. Jarvik's appearance on the other commercial that you
aired, I am trying to see where the inappropriateness of that
occurred. I have reviewed the criteria that was laid out for us
by the president of the AMA. I will confess to you that I don't
see the problem that was in that ad. There is no question that
the introduction of statins into the armamentarium of the
average primary care physician has made a big impact on the
reduction of hearth disease in this country, and as a
consequence, I think it is 800,000 premature deaths from
cardiac disease have been prevented by the introduction of
those types of medicines, so there has been significant savings
to the Medicare program because of the introduction of these
types of medications, so it is, to me, a little bit of a
mystery why we are including that in the body of evidence that
we are studying today.
Mr. Chairman, there are a variety of things that go into
the decisionmaking process between a doctor and a patient when
the decision time comes for prescribing a medication. This is
something that came home to me when we were undergoing the
process of rewriting the FDA Reauthorization Bill last summer,
and the enormous responsibility that is laid upon each of us on
this committee to do the correct thing so that the practice of
medicine is not compromised in this country. I want us to be
very, very careful as we proceed down this road, because
honestly, I can see that we could make some decisions that
would be not in the best interest in allowing the physician and
the patient to have all of the information before them when
they make decisions. I mean, after all, we want there to be
more transparency in the practice of medicine today. We want
our patients to become more active participants in not just the
maintenance of their health but the treatment of their disease,
and this is yet one additional tool that is available to them.
And one other thing I would just say, and I will be
interested when we hear from the GAO testifying today, the bar
graphs that show the increase in the amount of direct-to-
consumer advertising that has occurred since 2004, and I just
am curious as to whether or not we subtracted the public-
service-type announcements like for the PPA bus that Montel
Williams takes around the country, if that type of advertising
is included in that block of data shows an increase. I am
curious about that because the amount of time and effort that
was spent of marketing drugs to treat erectile dysfunction
seemed to me to be disproportionate. And I have always
considered that the companies would do themselves a great favor
by increasing the public-service part of their announcements
and not just the marketing of lifestyle drugs.
But it is an interesting topic, Mr. Chairman. It is a
timely topic, and I will yield back the balance of my time.
[The prepared statement of Mr. Burgess follows:]
Statement of Hon. Michael C. Burgess
Thank you Mr. Chairman and Ranking Member Shimkus.
Today the Health Subcommittee is also holding a hearing on
the issue of stem cells; therefore, unfortunately, I will be
splitting my time today between these two hearings. I apologize
in advance for my attendance.
Mr. Chairman, as the only member of this subcommittee to
have actually had a patient come to them after watching a
direct-to-consumer advertisement, I'd like to offer my
perspective. At times, I did have patients that came to me and
asked for a certain medication because they saw the proposed
benefits of a drug that was advertised and had self-diagnosed
themselves. This is a reality, it does occur. However, as the
physician, it was my responsibility to diagnose the patient,
and it was my responsibility to write the prescription for the
medicine. This responsibility isn't abdicated just because a
patient watches an ad on TV.
While direct-to-consumer ads are made for the benefit of
marketing specific drugs, in my opinion, the true benefit is
that they make people stop and think about their health
problems and then seek medical attention. Mr. Chairman, I think
we can all agree that society in general benefits when people
are proactive with the healthcare needs.
However, I clearly don't believe that direct to consumer
advertisements should ever be misleading or deceitful. That's
one of the reasons that I supported, along with the bipartisan
leadership of this Committee, H.R. 3580, The FDA Amendments Act
of 2007. This legislation, which was just signed into law on
September 27, 2007, addressed this very issue. HR 3580 amended
the Food, Drug and Cosmetic Act to 1) require that the major
statement about side effects be clear, conspicuous and neutral,
and 2) that the FDA has the power to impose civil fines when
ads have false or misleading statements.
Mr. Chairman, this newly enacted legislation deals with
this very issue we are discussing today. Couple this with the
fact that the Food and Drug Administration, the Agency that has
the power to enforce this law wasn't asked to testify, I'm not
really sure of the purpose of this hearing.
I yield back the remainder of my time.
----------
Mr. Stupak. I thank the gentleman, and as a member of this
committee, and a physician, I hope you will stay at least
through our first panel. I think you will find it very
educational from a perspective of a physician and also a member
of this subcommittee.
Dr. Burgess. If the chairman will yield, just as a
housekeeping issue, we do have the other hearing going on as
stem cells.
Mr. Stupak. Right, I realize that. That is why I said that.
You have been an active member. I just want to give you a
double opportunity to get educated today.
Mr. Waxman?
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman. Both the good doctor
and I are involved in both subcommittees, so we are going to be
doubly educated on two different topics today, but I appreciate
the fact that you are holding this hearing, because the United
States is one of only two countries in the world that permits
direct-to-consumer advertising of prescription drugs. After
all, these are not over-the-counter drugs. A doctor has to give
a prescription. And yet the billions of dollars in advertising
directed to consumers pays off, because there is an increase in
the purchase of drugs.
Now, if we look at an ideal world, one would hope that the
FDA would be approving a drug, and we would know that it is
going to be absolutely safe and effective. That is what their
objective is supposed to be, but we don't live in a perfect or
ideal world, and when a drug first goes on the market, we don't
have every confidence about its safety. Sometimes we have to
wait for a greater population to use the drug before safety
problems do occur. Now, if FDA has no other choice but to
approve drugs based on this imperfect knowledge, they have to
wait, then, because their preapproval is much smaller. So we
look to what the Institute of Medicine has to say about this
matter, because they have studied it carefully.
In 2006 they had a groundbreaking study, and they expressed
some serious reservations about direct-to-consumer advertising.
In their report, they cited the distortion of drug usage
practices caused by DTC ads, in which the use of more expensive
drugs are increased, but there may be effective drugs that are
less costly, especially if they are lower-cost generics, that
are not being used because of the heavy advertisement steering
consumers to the more expensive drugs. The IOM also described
the mixed effects that DTC has as an education tool. It
conceded that consumers might learn about conditions or disease
through a DTC ad that they might not otherwise have been aware
about. On the other hand, the report cited that many ads
overstate the benefits of a drug while understating the risks.
Well, that is the commercial advantage of the drug
manufacturer, and the IOM said that the DTC ads have an impact
when people don't get the full information.
Physicians themselves provide evidence that DTC ads do
work. Surveys vary but roughly half of the physicians report
that when a patient asks them for a specific drug, they
prescribe it. Well, the IOM recommended that FDA be given some
new authorities aimed at DTC advertising, specifically out of a
concern about that rapid uptake of new drugs with unknown risks
caused by DTC ads. The IOM thought Congress should give FDA the
authority to restrict advertising on a case-by-case basis
during the first 2 years when a drug is on the market. When we
considered FDA amendments last year, we tried to include that
kind of provision. The original bill would have given the FDA
the authority to limit the advertisements to consumers of newly
approved drugs, while the Agency is still reviewing the safety
concerns of the drug for a period of up to three years. FDA
could have restricted DTC ads, only if it determined on a case-
by-case basis that additional data about serious risks needed
to be compiled after approval and that the public health could
not be protected by less restrictive means, like a disclosures
statement. This authority fell clearly within the bounds of the
first amendment, and I was disappointed that we didn't
ultimately hold onto it. The final legislation only included
some extremely limited provision and some very loss civil
monetary penalties for false and misleading ads. They simply
would not give the FDA the tools it needs to address what I
think is a very concerning practice.
I want to mention briefly another concern that I have. DTA
advertising is a critical issue. It actually represents a
relatively small fraction of all drug promotion activities. In
fact, I am more concerned about the practice of advertising to
physicians. That form of promotion occurs much more frequently
and outside of the public view, so it receives less scrutiny by
the American public. We know, though, that it is inside the
doctors offices where the most persuasive and effective
advertising really goes on. Their promotional documents are
accompanied by meals for the entire staff, tickets to sporting
events, personalized gifts. Obviously, this is a topic for
another day, but I do hope that we will have an opportunity to
address it soon.
Mr. Chairman, I look forward to the haring. I thank you
again for convening us, and I hope this will be a beneficial
education for everyone involved.
Mr. Stupak. Thank you, Mr. Waxman.
We have five votes on the floor. One is a motion to
recommit, which will be intervened by a 15-minute vote, so we
are going to recess for one hour. Mr. Whitfield said that he
will graciously hold his opening statement until then, and we
will come back and have Mr. Whitfield's opening statement, and
we will have a couple of hours to get through this hearing. So
we will be in recess for one hour.
[Recess.]
Mr. Stupak. The hearing will come to order. When we left
for our extended recess, Mr. Whitfield was waiting patiently
for his opening statement, and the gentleman will now be
recognized for his opening statement.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Mr. Chairman, I thank you and I certainly
want to thank the witnesses today, and we apologize for the
delay, which seems to be not uncommon here in the House.
This obviously is quiet an important hearing that we are
having here today, and I do think it is important to reiterate
what some other members have said that there is a basic legal
principle in the United States about free commercial speech.
And I, for one, do not really have a problem with advertisement
of medical products on televisions, because I genuinely believe
that one of the problems in our healthcare system today is a
lack of information, and I know that one of the members
mentioned the fact that for every $1 of advertising that drug
companies do on television, there is $6 of revenue for that
product, and I think Dr. Burgess touched on the fact we do not
know, however, what healthcare dollars have been saved by
patients using medicines that may have been advertised on
television.
So I think to have just sort of a blanket criticism of
advertisement by drug companies is not really accurate, or is
not correct. Obviously, we cannot stand for misleading
advertising, deliberately misleading the American people, and
we do have rules in effect relating to the FDA and ads that are
put on television relating to medical care for patients, but as
we have this hearing, and we have had others on this subject
matter, we will value the input that the witnesses have today
because I think the bottom line is the more we have patients
talking to their doctors and the more information that patients
have, I think that gives us the best opportunity to provide
good healthcare. That is, I want to reiterate, once again, we
certainly are not going to stand for or put up with or allow
misleading advertisement or advertisement that is blatantly
incorrect.
So with that, I look forward to our hearing today, Mr.
Chairman, and I think this is a very important area for us to
continue to look at. Thank you.
Mr. Stupak. Thank you, Mr. Whitfield. Mr. Barton and Mr.
Dingell are going to try to make it. If they do come, we will
have them give their opening statements at that time.
But that should conclude the opening statements of the
members. Members are back and forth between the health
subcommittee, so we will begin with our first panel. Now, the
first panel is Dr. Ruth Day, who is director of medical
cognition laboratory at Duke University. Dr. Day, would you
please come forward? And Dr. Day, it is the policy of this
subcommittee to take all testimony under oath. Please be
advised that you have the right, under the rules of the House,
to be represented by counsel during your testimony. Do you wish
to be represented by counsel, Dr. Day?
Ms. Day. No.
[Witness sworn.]
Mr. Stupak. Let the record reflect the witness replied in
the affirmative. You are now under oath.
By the agreement of both parties, Dr Day is going to have a
little extra time for her opening statement. So Dr. Day, we
traditionally keep it at 5 minutes, but we are going to extend
you a courtesy of a little extra time because of the expertise
in which you want to explain to the Committee. So I will let
you begin your testimony, doctor.
TESTIMONY OF RUTH S. DAY, PH.D, DIRECTOR, MEDICAL COGNITION
LABORATORY, DUKE UNIVERSITY
Ms. Day. Thank you and good afternoon. My name is Ruth Day.
I am a faculty member at Duke University and director of the
medical cognition laboratory there. My expertise is in
cognitive science, how people understand, remember and use
information. I recommend that everyone consult the screen. I am
going to be showing visual displays throughout my testimony.
I am not here today as a naysayer. I am not here to say
that direct-to-consumer adverting is bad and should be
withdrawn from the market. I am also not here as a yea-sayer. I
am not here to say that direct-to-consumer adverting of
prescription drugs is good and should be retained. Instead, I
am here to report research on how people understand and
remember information from these drug ads.
This research was not funded by any drug company, ad
agency, advocacy group, or government agency. So the basic
question is how do people understand information about drugs.
And the answer is with difficulty. And there are many possible
reasons for this. There is a very heavy information load. There
can be complex and technical information and so forth; however,
I am going to focus on the problem of cognitive accessibility.
Cognitive accessibility is the ease with which people can
find, understand, remember, and use drug information, and
hopefully in a safe and effective manner. Cognitive
inaccessibility occurs whenever people have trouble doing any
one or more of these things. Research in my lab looks at drug
information from a variety of sources, from television to the
Internet to hardcopy, and here are just some of the types of
information sources that we do study. DTC, or direct-to-
consumer, advertising does take place in all of these areas,
but today, I am focusing just on our research on the
prescription drug ads on television.
Our basic approach and research has three parts. We begin
with a cognitive analysis of the ads, so wherever they have
come from, in this case television, we obtain quantitative
measures of cognitive accessibility and calculate various
scores, put them together, and then we compare the cognitive
accessibility in the presentation methods for benefits versus
risks in particular, and other things as well. We then develop
an enhanced version if we think there is a problem, where we
enhance the type of information that is disadvantaged, and we
retain exactly the same information, but just present it in a
way that people are more likely to get it. Then we perform
cognitive experiments to test for the effects on attention,
comprehension, memory, problem solving, decisionmaking
behavior, and when we can, ultimately, health outcomes.
Many cognitive principles underlie this research that are
well-known and documented. I have time to only address a few of
them today as shown on the screen.
[Slide shown.]
Language difficulty or level, chunking, location, speed,
and attention, which I will be describing shortly.
So how do we get these TV ads that we analyze? We have been
collecting them since the year 2000, continuously, through
today and beyond, and we essentially use the broadcast-capture
method. We record on a daily basis, and capture the ads that
are embedded in the various programs. Therefore, we do not
target specific health conditions or specific drugs; we study
all of them.
I am going to start with some of our research from the
early years, 2000-2001, and we continue on these today, but
just to get us started what our original findings were. Here is
the way a typical experiment goes. We show people a TV ad, and
then afterwards, we test them on their knowledge about the
benefits and the risks and other types of information. We use a
variety of cognitive tasks. I will only have time to, really,
tell you about one type of task today. So when we ask people,
``well, what is this drug used for,'' we then plot percent
correct, as a function of what drug ad they saw, and here are
some early results for three drugs: Paxil, Nasonex, and
Orthotricyclen. And the results are good. People know what the
drug is used for, ranging from about 70 to 90-plus percent
correct. That is good. When we asked for the same ads, and what
are the possible side effects that were presented in the ad,
performance goes way down. So here we have benefits; here we
have risks. So people are not getting this information well at
all. Averaging over many experiments on many ads, on average,
we were getting about 80 correct on the benefits and about 20
percent on the side effects, with variations across specific
ones, of course.
So how are these benefits being presented that enable
people to understand and remember them? Well, here is an
example where you are told something about a foot-long frank
and your grandpop Frank and so on, and so this ad does bring
forth the idea of two sources of cholesterol: food and family.
And the way the benefits are handled is very effective. Here is
a case for Wellbutrin XL, and there are two main messages in
the ad, that it treats depression with a low risk of sexual
effects. And we find that they repeat the low risk of sexual
effects so often that that is almost a stronger message than
what the drug is for. Here are other cases where there is great
care taken in presenting the benefits. For example in Crestor,
the mantra ``down with the bad; up with the good'' type of
cholesterol is very effective. And the others are all effective
as well in presenting two concepts, many of which are difficult
to understand, and they are getting across and people
understand them.
What about the risks? Well, before I show you how the risks
are presented and what the consequences are, let us raise this
question: why should the public know about risks? Here is a
quote. ``Drug information should be provided only in such
medical terms as are unlikely to be understood by the ordinary
individual.'' And that came out in the U.S. Code of
Regulations, 1938, and that was a view that prevailed at that
time.
Today, there are people who have viewpoints, both pro and
con, as to what and how much consumers should know about the
potential risks of drugs. Those on the pro side cite it is
important for patients to have informed consent about what they
are taking, and understand what it is and then participate in
decisionmaking with their physicians. For example, they might
try lifestyle changes before going to a medication, or just go
forward on the medication. And one I find particularly
convincing is that then they would have a better idea of what
appropriate action to take should any of these side effects
occur. On the con side, some people say if you tell people too
much about the risks they will be scared, they can't understand
them anyway, maybe they won't comply, and so on. So there are
these differing views today, but the balance has swung, very
considerably toward the pro side.
So now going back to the original finding that people know
a lot about the benefits after an ad and not much about the
side effects, why is this so hard? There are many possible
reasons, such as this fear idea, their motivation, education,
health literacy, and so on.
So let's see how we look at what is going on here. When we
capture an ad, one of the first things that we do is to get a
transcript, and by this, I mean the soundtrack, the spoken
transcript by the voiceover or the characters on the screen,
and we look at all of it, but we focus primarily on the
benefits and the risks. So let's look at the language level
that is used. There are many linguist measures that we use in
our research, some of them complex, from word selection and
grammatical structure, logical structure, cohesion, readability
measure, and so on, but all of them speak to comprehensibility,
how easy would it be to understand.
Here is one of our first studies from 2001, 29 drug ads,
and if you look, averaging across all of them, what grade level
of comprehension would a person need in order to understand the
benefits is about a sixth-grade grade level. That is pretty
good for a general population. What grade level of
comprehension would they need in order to understand the side
effects is about a ninth-grade level, so that is three grade
levels higher in order to understand the side effects as
opposed to the benefits, so that is what part of the problem
is. And this is an average across many ads. Some are even more
extreme than shown here. One we collected that you had to have
eight grade levels higher to understand the side effects, but
of course not all of them show this pattern, and some are more
equally balanced.
So now, let's look at a speaker timeline for a drug.
[Slide shown.]
The yellow boxes show when someone is speaking and just the
straight black lines are when there is some silence, and there
is time going from left to right. All right, this is a
particular ad for Allegra, and it started out in the first
yellow box, and it said it is allergy season or Allegra season.
And then there was a pause, and then there was a message, again
a positive message, and a pause, and then there was a long
block where it started by talking about what the side effects
were and went immediately into other information, so the point
about this display is that for the first blocks of information,
there is what we call chunking. You put together a set of
information, and then you separate it from surrounding
information, in this case with silence, and that helps mental
digestion, so to speak. Whereas, in the long block, after you
say the side effects, if you keep talking, there is less
opportunity for that to happen. So that is a case where the
side effects are being disadvantaged in that criterion.
Let us talk about location of information. There is a well-
known phenomenon in the memory literature about what happens if
you present a list of things for people to remember, whether
they are words or number of whatever, when you then plot
percent correct as a function of the location of the items in
the list, this typical finding comes out, and this has been
repeated time and time again. This is a well-known phenomenon.
People remember the information better at the end of the list
and the beginning of the list and have trouble with the
information in the middle, and it is in the middle and a little
bit past the middle, so on the screen, in the middle and toward
the right, so to speak.
So now, let us use this to ask the question, where is the
location of side effects in, say, this group of ads that we
captured? We are going to look, for each ad, where, in time,
were the side effects presented. So we are looking at location
as a function of elapsed time. And there are the results. The
pink bars are just for each drug, and I have put a box around
to show that it is approximately 60 to 85 percent of the time
elapsed when the side effects come in. When we combine all
risks, and risks include not only side effects, but
contraindications, who should not take a drug, interactions
with other drugs, and so forth, you will see that exactly the
worst location is being used for this negative information
about the possible risks of the drugs. So clearly, the risks
are being presented in an unfavorable location, but you might
say what effect does location have on cognition? For mental
processing we need evidence.
So we produced our own little TV ad for a hypothetical drug
called Flu-Aid, and its structure and content is exactly like
typical drug ads, and our purpose is to vary specific factors
to observe effects on cognition. And so people would see the
ad, and on a random basis, half of them would hear the side
effects in the usual unfavorable location and/or in a more
favorable location with the exact same visual and auditory
information. They differ only in the location of where the side
effects are presented.
We are now going to plot percent-correct side effects for
those two locations, and people who received the information in
the unfavorable location did not do well. People who received
it in a more favorable location did very well. In fact, there
is a 100 percent increase in what they knew right after the ad.
There were still some people who were unable to report any side
effects at all, but virtually of them, nearly all of them, had
had the ad with the information in the unfavorable location--a
big difference there.
Let us now talk about speed. There are two interesting ads
from 2005, both for sleep medications Ambien and Lunesta, where
there were some interesting variations in speed of speaking
during the ad, so we counted the speed of speaking, in terms of
syllables per second, and here for the Ambien ad, there was a
speed up when the information came for the side effects,
whereas the Lunesta, there was no speed up. And so we did an
experiment with both of these ads. We are focusing just on the
speed, now, of the side effects, which Ambien being twice as
fast, approximately, than Lunesta. And you could still say, so
what? Just because it speeds up, does speed effect knowledge
that people take away, and the answer is, yes, indeed. So the
faster they spoke, the less that people took away.
The final one is about attention, and for this I am going
to be relying on an ad campaign that started in 2005 and
continues today for Nasonex. This is the Nasonex bee, a very
charming character with a foreign accent, very appealing. And
we were testing this in the laboratory, and we found people
weren't remembering the side effects at all. And we were
wondering about this. It only had five side effects, and the
limits of short-term memory are approximately seven, plus or
minus two, so it is well within that, but it was particularly
low. And when we analyzed the ad, we found that there was some
interesting visual effects going on during the speaking of the
side effects. So instead of showing you the video, I have some
stop-action shots of what the bee does here. So if you will fix
your attention on where the red arrows are on his wings, I will
now show you some screenshots, and watch what happens.
[Slide shown.]
Did you see how the wings moved and also flashed? That was
going on during the side effects. Right afterwards, there was a
section on benefits, and during this point, this part, the bee
was hovering, and you could barely see his wings at all, during
the expression of the benefits at the end of the ad. So we
counted the number of wing flaps per second for the benefits
section versus the side effects that I have described and found
that there were many more wing flaps going on during the side
effects section, and there were also some flashing effects
going on--might have been graphic art effects--and these were
all going on during the side effects and very little light
during the benefits. So all of these wing flaps and wing
flashes and sparkly things essentially divided the attention of
the viewers. Instead of concentrating on the auditory channel
where the side effects were being presented, they were pulled
away to the visual channel, and thus led to decreased
knowledge, and there were many more comments from this
particular ad that there weren't any side effects. People
actually denied--they didn't say any.
And I first presented these results at an FDA public
meeting on direct-to-consumer advertising in November of '05,
and early in '06, there were new versions of this ad. In one,
during the side effects, the bee had soft, black wings. In
another, he was just hovering, and you couldn't see any wing
action much at all. In another there was no bee at all. And so
we did a head-to-head comparison in a laboratory experiment
between the original wing flap ad and the hover ad and looked
at how much people knew about the side effects, and as you can
see, everything else was the same, the side effects and so on,
but they got much more of a take-away message about the side
effects from the hover ad. So this is an example of visual
distraction, only one of many techniques that can be used.
So to go back to the original question, why is it hard for
people to get the information about risks, and particularly
side effects, many of these cognitive principals, only few of
which I have been able to talk with you about today, are indeed
responsible, and we have tested them experimentally in the lab.
So here are some conclusions. There is currently, and has
been for a long time, an unfair balance between the
presentation of the risks and the benefits in these ads. Now,
when I say unfair balance, I mean in terms of the cognitive
accessibility, the presentation techniques that make it easier
or harder for people to get the information. I am not talking
about fair balance, as the FDA does, as to what is in the ad.
The business of what is in the ad is the company's and the FDA.
What I am talking about is given what is in the ad, how
cognitively accessible is it to the viewer. So since the year
2000, as we reported many of the results, there have been
changes, and many of them have been addressed to our particular
results in some ads, but there certainly need to be many more.
Otherwise, we are in the following situation: that the ads
are pressing risk information, they are physically present, but
functionally absent. What is the good of having information
that is physically present versus functionally absent? It
fulfills certain legal requirements, but it is not communicated
to the intended audience.
So some recommendations: we need to have an evidence-based
approach in evaluating these ads, to be used by industry and
the regulators as well, using the same criteria. So say for
example, for location and speed and other things, to have a
checklist with the same quantities measure, and make sure that
the treatment of benefits is as good as the treatment for the
risks--they are roughly balanced, and then we can get into fair
balance of the cognitive accessibility of both types of
information. Otherwise, here is the final point, risks go like
this: we send them out the viewer, and they go up over their
head and gone. But I think we can this information into the
head, and in order to do it, we need to increase cognitive
accessibility.
This concludes the formal presentation of my testimony. But
Mr. Chairman, I would like to comment that at the House
request, I have examined ads for the hearing, and if you would
like that commentary now, I will do it.
Mr. Stupak. If you would, do so quickly.
Ms. Day. OK, very quickly, we were able to conduct full
experiments on two of the ads, and I will show you. For the
Lipitor ad, here is the same set of results for how well they
did in getting the benefits versus the risks, the same kind of
pattern. For the benefits, one benefit came across much better,
the lowering of the cholesterol, than of reducing the risk of
heart attack, and for the side effects, neither came across
well, that there could be muscle pain or weakness. And I do not
think it is the fault of this ad. I think it is the problem
with the statins in general. This is a very serious side effect
that can occur with the statin drugs, but when you say muscle
pain and weakness, these are things that the public has
experienced many times, and they don't understand how serious,
taken together, they can be.
And there was another thing in here that all of the statin
ads tend to have something like: you need simple blood tests to
check for liver problems. And we asked people are there any
medical tests you should have, and they did pretty well. Most
said yes, but when we asked what are they for, they really
didn't know. Most said they didn't know; some said liver tests,
and then I didn't even list all of the others. They are all
over the place.
So when we asked people when should these tests take place,
nearly all of them said before you take the drug. It qualifies
you to take the drug. So there is no sense that certain drugs
can effect liver function and other function while taking them
or that the test might be a monitoring later on, so that is
general thing where we need some public education about what it
means when these statements are made.
The other one that we were able to do testing on is
Procrit, and there is its profile in terms of what people could
report about the benefits and risks, a little bit more in
balance here, and both of the messages came across strongly,
that it does something for red blood cells and also your energy
level and so forth. And there was something interesting about
side effects, that one they got, the one about diarrhea, but
not the other one because it was called edema, and I don't
think the general public knows that edema means swelling. So
this is just a simple case that had they used the term
swelling, they probably would have done much better.
That concludes my review of those ads.
[The prepared statement of Ms. Day follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. I thank you, doctor. Before we go to questions,
Mr. Dingell, would you wish to make an opening statement, sir?
Mr. Dingell. Mr. Chairman, I won't impose upon the
Committee by submitting an opening statement in so many words.
I will ask unanimous consent that I be permitted to insert that
in the record in the appropriate place and fashion, and I thank
you again for your courtesy, but also commend you for your
vigor and your energy in conducting this. And while I am at it,
to the witness, Dr. Day, thank you for your very fine
presentation.
[The prepared statement of Mr. Dingell follows:]
Statement of Hon. John D. Dingell
Mr. Chairman, thank you for holding this important hearing
on the risks of direct-to-consumer advertising of drugs.
In the wake of revelations concerning the safety problems
surrounding widely advertised drugs such as Vioxx and Ketek, we
must ask how well the policies that govern direct-to-consumer
advertising are serving the American people. Direct-to-consumer
or "DTC" advertising of new drugs has been particularly
problematic for new drugs that may lack a broad safety record.
About 10 years ago, the Food and Drug Administration (FDA)
relaxed its rules for direct-to-consumer advertisements of
prescription drugs, making the U.S. one of only two countries
in the world that allow such marketing. Since then, Americans
have witnessed a flood of DTC ads, particularly on television.
In fact, spending by drug companies on DTC ads has grown
exponentially since 1999. And it is no wonder-research shows
that for every $1 spent on DTC advertising, up to a $6 increase
in drug sales result.
The drug industry asserts that these drug ads benefit the
public health by educating both consumers and physicians about
disease and potential drug therapies. As we explore the risks
and benefits of DTC advertising, however, it is worth noting
the words of a former New England Journal of Medicine editor
who said drug companies were "no more in the business of
educating the public than a beer company is in the business of
educating people about alcoholism."
Nevertheless, drug advertising can indeed serve an
educational role, provided drug companies scrupulously adhere
to FDA guidelines for DTC ads. FDA guidelines and regulations
require that direct-to-consumer ads must:
be accurate and not misleading;
make claims only when supported by substantial
evidence;
reflect balance between risks and benefits; and
be consistent with FDA-approved labeling.
Regrettably, investigations by this Committee have revealed
systematic violations of these principles by a number of drug
companies. Some ad campaigns have been misleading and others
appear downright deceptive.
DTC advertisements may well serve an educational purpose,
but they are primarily designed to sell products.
The Food and Drug Administration shares the responsibility
with pharmaceutical companies to ensure that drugs are
accurately marketed to consumers. And Congress must ensure FDA
has the authority and resources to effectively monitor whether
drug companies are properly marketing their products in
compliance with the law.
Mr. Chairman, I commend you and your Subcommittee for
today's hearing on direct-to-consumer advertisements and I look
forward to the testimony of each witness.
----------
Ms. Day. Thank you.
Mr. Stupak. Thank you, Mr. Dingell.
OK, we will start with questions, and I will begin the
questioning. Doctor, the techniques you described, did you get
them from any psychology textbook or from an advertising
manual?
Ms. Day. All of them are from textbooks in cognitive
psychology and cognitive science. That is where the research
has been conducted. I don't know if they are in the marketing.
I do know many of them are in marketing textbooks, but not all
of them.
Mr. Stupak. OK, does the actual number of benefits and the
number of side effects affect your research? For example, if a
drug has two benefits but seven side effects, wouldn't there be
more side effects to forget?
Ms. Day. Yes, that is a good point. We take care of that by
the following. If you recall the first slide that I showed,
which were for three drugs, and I showed how poor the recall
was for all of the side effects, they vary widely in terms of
the number of side effects, three, seven, or nine, and the
results were all the same, so in that experiment, there was no
difference. In the two studies that I just mentioned now for
Lipitor and Procrit, they were equally balanced. Each had two
benefits, each had two side effects, and as you can see, the
results showed the same pattern.
I would just comment on the Lipitor ad if I might, it says
that there are the two side effects. You might consider liver
problems as an implicit side effect, but it is not explicitly
stated as such, so we do study memory load and find that is not
driving our results.
Mr. Stupak. You study all commercials, not direct-to-
consumer ads, right?
Ms. Day. No, we are not an advertising outfit. We study all
drug information. We will study pharmacy leaflets. We will
study medication guides. We will study the full prescribing
information that the physicians use and that is the approval
document----
Mr. Stupak. Well, let me ask you this. If you do all of
these studies on pamphlets and ads and anything else, are there
good ads? I mean ones that do a good job of both presenting the
risks and benefits in a way that people truly understand and
remember them?
Ms. Day. I would not do a categorical statement that some
ads are good and some ads are bad or wrong, but I can speak to
some ads that are particularly good in certain features.
For example, in connection with the speed-up ads, when I
first saw the recent campaign on Enablex, for bladder problems,
I was absolutely stunned at how slowly the entire ad is spoken,
and there is absolutely no speed up for the side effects, and
we have recently tested that ad and people do very well with
it.
Mr. Stupak. Well, let me ask you this: if an ad agency or
drug company wanted to make sure that the consumers actually
receive the information they are supposed to receive from an
ad, is there a way to test for it?
Ms. Day. Absolutely. Just as we have done here, it could be
included in their market research that they do. Market research
is usually designed to find out if there is brand awareness and
the messages and appeal of the people speaking, but some of
ours are full experiments that I haven't talked about here
today, but some of the simple things that we do can easily be
combined in their market research endeavors.
Mr. Stupak. Have you or your group there at Duke University
ever been approached by a drug company or an ad agency or the
FDA to assist them in analyzing ads to make sure they are fair?
Ms. Day. Well, I have never been approached by an ad
agency, period. I have been approached by drug companies to
help them with their campaigns, and I have not done so. I have
been approached by the FDA to give public testimony in various
hearings on direct-to-consumer advertising, and I have done
that. And in those meetings and in other professional meetings,
such as the Drug Information Association, there is a wide
variety of stakeholders, and I have spoken informally with
everyone about my research and the techniques, but I have not
consulted on any specific ads or ad campaigns that anyone has.
Mr. Stupak. Well, would testing an ad to make sure that
people actually understood the ad or the information in the ad,
would that take a lot of time and money to do?
Ms. Day. Well, a full battery of what we do on an ad like
this is about 30 to 40 minutes, including the informed consent
and so on. We get a lot more than what I have talked with you
about today. But for just what I have talked with you about
today, it could take about 15 minutes. As for the money, the
money would be very nice to be able to fund this. We would be
able to study a lot more ads. We are doing this ourselves on a
shoestring, but we study a wide variety of individuals of all
educational levels and backgrounds, and we study physicians as
well as the consumers, and we find that the physicians have the
same kind of trouble with the written information about the
risks, as opposed to the benefits, as the consumers do. But we
don't have sufficient funding to do as much as a national look
from our laboratory across many consumer groups, and I think
the companies would have the funding to do that.
Mr. Stupak. Let me ask you another question. There is a lot
of interest of this hearing on the floor from members, and when
we were down voting for over an hour, a number of members
mentioned it, and one member asked me in particular to ask you
this question. Congressman John Hall from New York wanted to
know the affect of these ads on children, the cognitive
accessibility, do you find it different with age? He objects to
the erectile dysfunction ads going during children hour, or the
going problem, and all of these other things are ones that he
pointed out in particular. Do kids pick up on these?
Ms. Day. All of our research is with people age 18 and
over. However, it is interesting that when, after the direct-
to-consumer advertising effects came to the public light,
around the time of the COX2 inhibitor hearings, the Vioxx and
so on, there was attention drawn to direct-to-consumer
advertising, Pharma, the Pharmacological Trade Association, did
draw up a code of operation, and I believe at that time, those
types of ads, for ED, were going to be aired after the 10:00
hour, when the family hour is over. But they are now during the
evening hours, so something there has changed, and I have
anecdotal reports I have heard from colleagues, but we have not
done research about this.
Mr. Stupak. You mentioned that in one of the drugs that you
looked at, it actually revealed that there was an eight grade
level difference between the risks and the benefits. That is a
large swing in your study, and that was for the Flovent
inhaler, wasn't it?
Ms. Day. I did not show that here today. That was a long
time ago, and there were quite a few that had a sixth grade
difference as well. And I believe it is my responsibly to
follow those ads over time and see if those things are
corrected after they are reported, and I have not done that
yet, so I can't answer.
Mr. Stupak. It was Flovent, and it was eventually pulled
from the market.
Ms. Day. Right, it was.
Mr. Stupak. Mr. Whitfield for questions, please.
Mr. Whitfield. Thank you, Mr. Chairman. And Dr. Day, thank
you for being with us today.
The medical cognition laboratory at Duke, how old is that
laboratory?
Ms. Day. Well, this is a part of my own laboratory, and I
have been doing research on this since about the mid-80s. The
first published account was in 1988.
Mr. Whitfield. You said part of your laboratory?
Ms. Day. Yes, my laboratory also looks at courtroom
cognition, how judges and jurors understand and remember
information about laws and apply them to decisionmaking. So
most of the laboratory now is devoted to medical cognition, but
we do have other projects as well.
Mr. Whitfield. And you are part of Duke University and you
are the director of that laboratory?
Ms. Day. Yes, I am.
Mr. Whitfield. And the only funding is through Duke
University.
Ms. Day. That is correct, and my own pocket and my own
time. I have received no funding, personally, for this.
Mr. Whitfield. And I know, in your opening statement, you
said that you are not saying that direct-to-consumer ads are
bad and should be withdrawn. Is that correct?
Ms. Day. That is correct, and I am not saying they are good
and should be retained.
Mr. Whitfield. And you are not saying they are good and
should not be withdrawn.
Ms. Day. Right, I am looking at what people get from the
information and how we can do things to enable them to get
more.
Mr. Whitfield. And I agree with you. I mean I think the
more information patients have, the better. One part of your
cognitive accessibility study which seems to be missing to me,
which is a vital and very important part, and I don't know if
you have studied it or not, but obviously before any patient
can use any of these medicines that we are talking about, they
have to have a prescription, and they have to have a
consultation with their physicians, and I am assuming that the
physician also has the responsibility to talk about benefits
and side effects.
Ms. Day. That is correct.
Mr. Whitfield. Have you ever studied that aspect to take
this one step further?
Ms. Day. And by the way, pharmacists also have a
responsibility to discuss this with the patients as well. I
have studied physicians, not for the direct-to-consumer ads,
because they tend not to like those anyway. But I have studied
them in the written information from company Web sites, so I
have taken exactly the side effects section from drugs and
shown them to physicians, either in the original form or in an
enhanced version that I have developed for showing side
effects, and they have studied them and then reported. And in
his particular case that I am thinking of now, it was for a
drug that they all regularly prescribed, because this was at a
medical convention or meeting where I knew what their specialty
was. And they did a very poor job in reporting what those side
effects were afterwards when the information was presented in a
traditional way with sentences and bullets. However, when I
presented it in a way that is more graphic in design, that
emphasizes severity of the different side effects, they
improved dramatically. There was no difference between the
physicians and the laypersons in this.
Mr. Whitfield. I think that is an important part to the
point that we need to make. I think many of us would be really
concerned about ad if patients looked at those ads and then
they went to the drug store and said I want this. But they
can't it without a prescription.
The second point I would like to make, have you ever
submitted your research studies that you discussed in your
testimony to a peer-reviewed journal?
Ms. Day. Yes, I have. A related work, not the details of
today, was in the Psychology of Learning and Motivation, the
first one in this line. And another was to the American
Association for Artificial Intelligence. That was a juried
selection.
Mr. Whitfield. And how many other laboratories similar to
yours are there with other universities around the country?
Ms. Day. I am not really sure. I know of clusters of people
who do research on all of this, and sometimes they have a wider
or narrower focus on certain issues.
Mr. Whitfield. And do you all get together periodically
for----
Ms. Day. No, I think we should, but we wind up together at
different meetings, and I am thinking of convening a conference
to bring people together to talk about these issues.
Mr. Whitfield. Drug companies are required to include
information about risks as well as benefits. How does a drug
company or the FDA draw the line when communicating risk
information? Is there a point when an ad can include too much
information on risk and viewers begin to tune out the
information?
Ms. Day. Two answers to that: first of all, it is not for
me to say how many can or should be there based on the
available information about the drugs, and I commented on that
before. That is the business of the FDA and the companies. But
I think your question is about how much information is too
much. You are talking about information load. And we have found
that it is not how much information is presented, but how it is
presented. So to go back to this last example with the
physician looking for Avandia and as we took it off the company
Web site for the patient information section. There were 26
side effects. No one can remember all 26, obviously, but when
we gave them to people and they tried to recall, they could get
very few, six or seven, when we gave the original form of the
information. But when we gave it to them in the enhanced
version, they went up dramatically, and it depended upon what
cognitive task we used. When we asked them a number estimation
task about how many were there, people went up to perfect
performance. So it isn't how much information you give. It is
how you give it.
Mr. Whitfield. I would just ask one brief question. Does
anyone purchase your test results from the laboratory?
Ms. Day. No one, not from me. I do not earn any money.
Mr. Whitfield. So no one really has access to it. You don't
give to any groups?
Ms. Day. No, no one has ever requested it. We have found
that somebody came as a test subject, and we found out later
works for one of the companies, but no.
Mr. Stupak. If I may, just a little follow-up on Mr.
Whitfield's questions. The most important part of your
testimony, if I could summarize it, it is not so much what is
presented in the ad but what people take away from the ad.
Ms. Day. Well, I would say there is an intervening step. It
is no so much what is in it, but how it is presented benefits
what they will take away, so that you can be in legal
compliance with FDA regulations as to what needs to be in
there, but if you present it in a certain way, you are really
decreasing the chances that people are going to walk away with
it, and conversely.
Mr. Stupak. So conversely is presentation will determine
what people take away from the ad?
Ms. Day. Yes, and I am saying not presentation in terms of
cutesy things going on and so forth, but taking into account
well-known and well-documented cognitive principles.
Mr. Stupak. Any further questions? Having no further
questions, thank you, and thank you Dr. Day for your testimony.
I would now call up our second panel of witnesses. On our
second panel, we have Dr. Edward Langston, who is chair of the
American Medical Association's Board of Trustees, Dr. Mollyann
Brodie, who is Vice President and Director of Public Opinion
and Media Research at the Kaiser Family Foundation, and Dr.
Marcia Crosse, who is Director of the Health Care Division at
the Government Accountability Office. All right, I guess there
is a change in the lineup here. Instead of Dr. Ed Langston, we
have Dr. Nancy Nielsen who is President-Elect of the American
Medical Association. It is the policy of this committee to take
all testimony under oath. Please be advised witnesses have the
right under the Rules of the House to be represented by
counsel. Do any of our three witnesses, our three doctors here,
wish to be represented by counsel? OK, you all are shaking your
head, so therefore, I will ask you to stand and raise your
right hand and take the oath.
[Witnesses sworn.]
Each witness is now under oath. We will now hear a prepared
five-minute opening statement from each witness. You may submit
a longer statement for inclusion in the hearing record.
Dr. Nielsen, shall we start with you, please, from the
American Medical Association. Thank you for being here. If you
would, start your testimony.
STATEMENT OF NANCY H. NIELSEN, M.D., PH.D., PRESIDENT-ELECT,
AMERICAN MEDICAL ASSOCIATION
Dr. Nielsen. Thank you, Chairman Stupak and Representative
Whitfield, and to the rest of the Committee, thank you for
holding this hearing. My name is Nancy Nielsen, and I am
clinical professor of medicine and senior associate dean at the
University of Buffalo School of Medicine. I am here today as
president-elect of the American Medical Association. The AMA
welcomes the opportunity to share our policy as well as the
House of Medicine's perspective on DTCA's impact on the
patient-physician relationship, on its adequacy as a source of
information for patients, and its role in driving healthcare
costs.
DTCA has become ubiquitous over a very short period of
time. According to a recent consumer survey, almost 91 percent
of Americans have seen or heard DCTA. The sheer volume that now
appears on television in particular, including ads for drugs to
treat conditions like erectile dysfunction, raises questions
about the timing and the appropriateness of these
advertisements for some consumers such as children. Just before
9:00 a.m. this past Easter Sunday morning, while home with a
sick grandchild, an ad appeared on TV advertising one of the
drugs for erectile dysfunction. I quickly made hot chocolate.
Equally troubling, there is mounting evidence that many of
the television direct-to-consumer ads lack fair balance and
include claims of benefits that overwhelm risk information, and
you just heard a very erudite testimony on that regard. Also,
intense advertising for newly approved drugs can exacerbate
significant safety problems. The Vioxx case is illustrative of
that issue.
The AMA has been and continues to be concerned about the
possible negative impact of DTCA on the patient-physician
relationship and on patient safety. We are also increasingly
concerned about the role the DTCA plays in fueling the increase
in healthcare costs. It is all the more urgent now, as Congress
grapples with escalating costs, and the need to prioritize
limited healthcare dollars.
DTCA has been a lightening rod of concern of our member
physicians for over 20 years. Our policy on DTCA has evolved
over this period, and the current policy we have submitted to
you was adopted in 2006. Product-specific advertisements are
considered acceptable if they satisfy the AMA's guidelines, and
key points from these guidelines are seven. First, the DTCA
should be indication specific and enhance consumer education
about both a drug and a disease. Two, should provide a clear,
accurate, and responsible educational message. The information
about benefits should reflect the true efficacy of a drug as
determined by clinical trials leading to FDA approval. Three,
it should not encourage self-diagnosis or self-treatment, which
of course is not the same as encouraging patients to report
symptoms. That we obviously favor. Four, it should exhibit a
fair balance between benefit and risk, and again, you have just
heard a better analysis of that than I can give you. We
certainly believe that the time and space devoted to the
benefit and risk information and the ease with which people can
find, understand, remember, and use the information about
benefits and risks should be comparable. Five, it should
present risk information that will be understood by a majority
of consumers without using strategies designed to minimize
risks or distract from them, as you have just seen. Six, it
should not use an actor who portrays a physician or an actual
physician to endorse the drug product, unless there is a
prominent disclaimer or disclosure. And seven, it should be
targeted for placement so as to avoid audiences, like my
grandson, that are not age appropriate for the messages
presented.
In addition to those guidelines, the following key points
from our policy deserve mention. Our AMA supports both FDA pre-
review and pre-approval of DTCA prior to broadcast or
publication. DTCA for new drugs should not be run until
physicians have been appropriately educated about the drug. The
length of this moratorium on DTCA could vary from drug to drug
and should be determined by the FDA in negotiations with the
manufacturer. AMA encourages further research on the effects of
DTCA, and we support Congress authorizing ARC to perform
periodic, evidence-based reviews to determine the impact on
health outcomes and public health. If DTCA is found to have a
negative impact on either of these, then Congress should
consider legislation to increase DTCA regulation or possibly
ban it in some or all media.
In conclusion, recent events have heightened our concern,
and the AMA looks forward to working with you to ensure that
consumers receive information that is accurate, informative,
promotes communication between patients and physician and does
not drive inappropriate costs. Thank you very much for the
opportunity to be here.
[The prepared statement of Dr. Nielsen follows:]
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Mr. Stupak. Thank you, Doctor. And Dr. Brodie, for your
opening statement. If you would, push that button right there
on that mic, and you might have to pull that up a little bit.
STATEMENT OF MOLLYANN BRODIE, PH.D., VICE PRESIDENT AND
DIRECTOR, PUBLIC OPINION AND MEDIA RESEARCH, KAISER FAMILY
FOUNDATION
Ms. Brodie. Mr. Chairman, and member of the Oversight and
Investigations Subcommittee, thank you for the opportunity to
testify today on the public's views of direct-to-consumer
prescription drug advertising. I am Mollyann Brodie, vice
president and director of public opinion and medical research
at the Kaiser Family Foundation. Despite the fact that they
account for just 10 percent of healthcare spending over all
prescription drugs and their costs have become a central
healthcare affordability and access issue in the views of the
American public, mainly because they touch almost everyone.
More than half of Americans regularly take perception drugs,
and four in ten report some serious problem paying for their
medications, including having to skip doses because of the
cost.
The public has mixed views of prescription drugs and the
companies that make them. On the positive side, they appreciate
the benefits for the drugs themselves and most people agree
that medications have had a positive impact on their own lives
and the lives of Americans in general. However, on the negative
side, they are very concerned about high drug prices, which
nearly eight in ten say are unreasonable, and which, in the
public's views are largely driven by high company profits.
Prescription drug advertisements have become ubiquitous, and
nine in ten adults report having seen or heard advertisements
for medications. Americans have mixed views about the relative
benefits and costs associated with these ads. On the one hand,
most Americans agree with the proponents of the drug ads, who
say that they raise awareness, help educate the public, and
reduce stigma. On the other hand, most people agree with the
critics of the ads, who say they raise prescription drug prices
and induce unnecessary demand.
Further, the public's views are mixed about how well the
drug ads present specific information about the medicines they
advertise. While the majority say they do a good job explaining
the potential benefits and what condition the drug is designed
to treat, more than half say they do only a fair or poor job
explaining the potential side effects. The survey data strongly
suggests that the drug advertisements are doing what they were
designed to do: prompting people to talk to their doctors and
to get prescriptions. About a third of Americans report that
they have talked to a doctor about a specific drug after seeing
an ad, and about eight in ten of that group said that the
doctor recommended a prescription as a result, either for the
drug they asked about or for another medication. People report
that these discussions led to other actions as well. For
example, more than half of those who talked to their doctor
about a specific drug say the physician recommended lifestyle
or behavioral changes, while about three in ten said the doctor
recommended an over-the-counter drug.
Now, these findings are echoed in surveys we have done with
physicians who are involved in direct patient care, a large
majority of whom report both getting inquires from patients
based on drug ads, and at least sometimes recommending a
prescription drug as a result. Eight in ten physicians say that
patients asked them about specific diseases or treatments that
they had heard about from ads, at least sometimes, including
nearly three in ten who say they frequently get such inquiries.
When asked what actions they usually take when the patients ask
them about mediations, the most common response is recommending
a lifestyle or behavioral change, which half of doctors say
they do so frequently. Doctors are less likely to day they
frequently give a prescription for the requested drug. However,
about three-quarters say they at sometimes recommend a
different medication, and more than half said that they at
least sometimes give the patient a prescription for the drug
they asked about.
What the survey data can't tell us is whether this
advertising induced demand is good or bad from a health
perceptive. It is mostly encouraging people who might not
otherwise get treatment to seek needed medication, or is it
mostly leading to demand for unnecessary medications? These are
questions that go beyond the scope of what the public can tell
us in a survey. Given that ultimately the doctor must decide
whether or not to write the prescription, it is helpful to
recognize that the majority of the physicians do not seem to
think that these inquiries from patients are negatively
impacting their doctor-patient relationship, although about one
in five say that they do.
The data also shows that the public prioritizes
affordability of prescription drugs, and while government
regulation in many areas is unpopular, there is an appetite
among many for increased government regulation when it comes to
reining in prescription drug prices. Furthermore, typical
arguments against such actions do not substantially erode this
public support. To a lesser degree, some, about four in ten,
are supportive of more regulation in terms of making sure
advertising claims are not misleading, although many believe
that there is already enough regulation in this area. However,
since the public has both become more skeptical of drug ads
over time, and gives these ads low scores on their ability to
effectively communicate about potential side effects, the
public would likely welcome efforts that may lead to
improvements in prescription drug advertising practices.
Thank you for the opportunity to testify today and for your
attention to the public's views on this important matter. I
welcome your questions.
[The prepared statement of Ms. Brodie follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you. Dr. Crosse from the Government
Accountability Office, your testimony, please.
STATEMENT OF MARCIA G. CROSSE, PH.D., DIRECTOR, HEALTHCARE,
GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Crosse. Thank you. Mr. Chairman and members of the
subcommittee, I am pleased to be here as you examined the
practice of direct-to-consumer advertising of prescription
drugs. My remarks today are primarily based on our November
2006 report on trends in FDA's oversight of direct-to-consumer
advertising.
As we have heard, FDA regulates the promotion and
advertising of prescription drugs, including television,
magazine, and Internet materials, to ensure they are not false
or misleading. Drug companies do not have to obtain FDA's
review of consumer advertising materials before they are
disseminated. Companies sometimes voluntarily choose to submit
draft versions of the materials to FDA for advisory comments in
advance of public distribution. However, except in limited
cases, companies are only required to submit final materials to
FDA at the same time as they begin dissemination to the public.
We found that FDA reviews only a small portion of the
materials it receives, and the Agency cannot ensure that
identifies for review the materials it considers to be highest
priority. This has occurred at a time when the number of
materials for consumers has more than doubled in 5 years, to
over 21,000 items in 2007. Previously, FDA officials told us
that the Agency prioritizes the review of materials with the
greatest potential to negatively affect public health, but
there were no documented criteria for making this
determination. FDA tells us that it now has developed criteria
to prioritize reviews, as we recommended in 2006. However, just
as we previously reported, FDA still does not systematically
apply these criteria to identify the highest priority materials
for review.
So what happens if the reviewers find a problem with an ad?
If FDA identifies a violation, the Agency may issue a
regulatory letter, asking the drug company to pull the ad or
take other actions. However, since the 2002 policy change
requiring internal legal review by FDA's Office of Chief
Counsel of all draft regulatory letters, FDA's process for
drafting and issuing letters has taken longer, and the Agency
has issued fewer letters per year. Prior to this policy change,
from 1997 to 2001, it took FDA an average of 2 weeks to issue a
letter. By 2007, the time had increased to over 6 months. FDA
officials told us that the policy change was the primary factor
contributing to the longer time.
Not only did the policy change create delays, but after the
policy change FDA issued many fewer of these regulatory
letters. The agency issued 15 to 25 letters per year before the
policy change, but only issued two such letters in 2007. FDA
officials told us that the Agency does not issue letters for
all violative materials that it identifies. Instead, it focuses
on those that it considers the most serious and most likely to
negatively affect consumers' health. At the time of our 2006
report, we found that the effectiveness of FDA's regulatory
letters at halting violative ads had been limited. By the time
these regulatory letters were issued, drug companies had
already discontinued more than half of these ads. Generally,
companies have complied with FDA requests and regulatory
letters. They have removed cited materials that were still
being disseminated, and those companies requested to issue
corrective materials did so.
However, FDA's issuance of regulatory letters did not
always prevent similar violations for the same drugs. We found
that almost one-third of drugs cited had received multiple
regulatory letters, sometimes for similar types of violations.
In conclusion, given substantial growth in direct-to-
consumer advertising in recent years, FDA's role in limiting
the dissemination of false or misleading advertising to the
American public has become increasingly important. Fulfilling
this responsibility requires that the Agency, among other
things, review those advertising materials that are high
priority and take timely action to limit the dissemination of
those that are false or misleading. FDA's development of
documented criteria to prioritize its reviews is a step in the
right direction. However, as we recommended in 2006, we believe
that FDA should take the next step of systematically applying
those criteria to the materials it receives.
Finally, despite FDA agreeing with an earlier GAO
recommendation in 2002 to issue regulatory letters more
quickly, the amount of time it takes to draft and issue letters
has continued to lengthen. We believe that delays in issuing
regulatory letters limit FDA's effectiveness in overseeing
direct-to-consumer ads and in reducing consumers' exposure to
false and misleading ads. Mr. Chairman, this completes my
prepared remarks. I would be happy to respond to any questions
you or other members of the subcommittee may have.
[The prepared statement of Ms. Crosse follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Well, thank you, and thank you to all of our
witnesses for your testimony. We will begin questions. Dr.
Nielsen, why does the AMA have policies on direct-to-consumer
advertising?
Dr. Nielsen. We have policy because physicians have been
concerned about this for 20 years. We have seen a change in the
legal environment. This, apparently, is protected under the
First Amendment, and therefore it is unlikely that the clock
will be turned back to a ban. However, as was pointed out,
there are only two countries in the world that allow this kind
of advertising, the other being New Zealand.
So it has been a concern, and doctors, frankly, are not
real fond of direct-to-consumer advertising, not because we
don't want patients to come in and talk about their symptoms.
We do value the educational aspects, but it is frankly fairly
clear that that the majority of what is happening has a
marketing effect rather than an educational effect, and it is
troubling when a patient comes in with a demand for a
particular drug, and that sometimes results in what you have
heard described from the Kaiser Family Foundation.
Mr. Stupak. Would you believe that because a doctor appears
in an ad the general public are more apt to believe the
credibility of that ad? Is that the AMA's position?
Dr. Nielsen. It is our position that we strongly discourage
physicians from appearing in ads.
Mr. Stupak. Why do you strongly discourage?
Dr. Nielsen. Because we think that, frankly, they don't
know the patients that they are talking to and it does lend an
air of credibility. We discourage it. We say that if it does
happen, then there should be a disclaimer indication that the
physician has been compensated.
Mr. Stupak. OK, so there has to be a disclaimer about
compensation.
Let me talk about the Lipitor ad there with Dr. Jarvik. He
is not a license doctor, right?
Dr. Nielsen. No, but it is my understanding he does have an
M.D. degree, so he would be appropriately referred to as Dr.
Jarvik, although it is also my understanding he has never been
licensed.
Mr. Stupak. So he is not licensed to write a prescription
for Lipitor, is he?
Dr. Nielsen. That is correct, but once he graduated from
medical school, he is a doctor.
Mr. Stupak. OK, is he a cardiologist?
Dr. Nielsen. It is my understanding that he is not, no. He
is certainly an expert in matters involving the heart, as we
all know, in terms of the device.
Mr. Stupak. Is he a cardiac surgeon?
Dr. Nielsen. No, sir.
Mr. Stupak. Is it AMA's position, like when they had that
person rowing in the Lipitor ad, that they should disclose that
was not Dr. Jarvik?
Dr. Nielsen. Well, actually, when I saw the ad, I didn't
know it was supposed to be Dr. Jarvik. Sorry, I think that went
right past me.
Mr. Stupak. Everyone assumed it was. Sorry. What is a heart
expert? They use that word in that ad. What is a heart expert?
Dr. Nielsen. Well, there are lots of heart experts. We have
physiologists at my medical school who teach cardiac
physiology. They certainly are heart experts. That is very
different than being a cardiologist.
Mr. Stupak. So it could be a full-fledged cardiologist to a
consumer advocate?
Dr. Nielsen. I am sorry, I don't understand.
Mr. Stupak. Well, it could mean almost anything then,
right? Heart expert could mean almost anything. By using it in
an ad, you don't know how I am referencing it.
Dr. Nielsen. I guess that is correct. There are many people
with many different kinds of expertise that could be referred
to in that manner.
Mr. Stupak. Dr. Brodie, if I may, can you tell us whether
the public is interested in seeing more regulation or less
regulation based upon your studies?
Ms. Brodie. In our latest study, definitely, there is an
interest from some for more regulation in this area. We found
about 43 percent felt that there was a need for more
regulation. About 48 percent said that there was already about
the right amount.
Mr. Stupak. Your latest study, is this the one that was in
January?
Ms. Brodie. Yes.
Mr. Stupak. It was in USA Today. I think Kaiser had it in
USA Today in early January, right?
Ms. Brodie. Yes, it was a partnership with us, the USA
Today and the Harvard School of Public Health, and the data was
collected in January of 2008.
Mr. Stupak. And if I remember correctly that data basically
said that we would like to see the regulation on pricing of
drugs come down, right?
Ms. Brodie. The real complaint that the public has is not
so much as the ads themselves, but it is their perceived impact
that the ads have on prices. The real concern the public has
about prescription drugs right now is the price of drugs.
Certainly, we saw about two-thirds of people interested in
seeing more regulation when it came to prices, but my take-away
message from the public is that because they have become more
skeptical of drug ads over time, because they are concerned
about the relationship between ads and prices, and because they
also give them low scores on their ability to communicate side
effects, I think that regulation in this area would be welcome.
I think any or any other efforts would be welcome in trying to
help improve prescription drug advertising.
Mr. Stupak. Right. In fact if I take away something from
your study there, it was like, well, we think they do a decent
job of advertising but the thing they sort of fall off on or
don't tell us about are the side effects.
Ms. Brodie. Yes. They gave good scores when it came to
being able to communicate what the drug was for and the basic
benefits of the drug. The public feels like that information is
communicated well but they feel like they do a less good job
talking about the side effects.
Mr. Stupak. Dr. Nielsen mentioned that when she was taking
care of her grandchild, about the inappropriateness of the ad
when she was helping her grandchild. Did the public have any
sentiment like that, as Congressman Hall mentioned to me
earlier today on the floor. Do they think there is
appropriateness when an ad should be shown and when it should
not be shown?
Ms. Brodie. Our research didn't ask exactly about the
appropriateness of the timing of ads, but we did ask whether
they felt like ads were too sexually explicit, and about 40
percent felt that they were, these direct-to-consumer ads could
be too sexually explicit. On the other hand, this wasn't
something that bothered people very much. Only about 20 percent
said that that bothered them a lot. So I think that it
certainly bothers some people out here, but I wouldn't say it
is a general impression. But we didn't ask specifically about
the timing of ads.
Mr. Stupak. And I am sure your group had to be at least 18
or older to answer your questions.
Ms. Brodie. Yes, it is a national random adult sample.
Mr. Stupak. I would be interested if we could go to a
preschool and see what they are saying.
Questions, Mr. Shimkus?
Mr. Shimkus. Thank you, Mr. Chairman. I will tell you all
and the folks in the audience here that I have a major concern
on the timing of these ads. Dr. Nielsen, I would concur with
you, and I think my positions here over the many years support
a family hour, support the appropriateness of what is
broadcast. And I am just putting that out for the record
because I have been in that same position, although it has not
been with my grandchildren, it is with my children, since I am
a late bloomer. And Dr. Day, I apologize for not being here but
I would like to just publicly say I would like to have you come
by and visit with me. I would like to visit the flapping of
wings and the peer review issue of research. So if you could do
that, I would appreciate it.
Dr. Nielsen, are you aware of the Food and Drug
Administration study proposed experimental evaluation and
impact distraction on consumer understanding of risk and
benefit information in direct-to-consumer prescription drug
broadcast advertisements published in the Federal Register on
August 22, 2007?
Dr. Nielsen. I have not read that, sir.
Mr. Shimkus. The purpose of the study is, in part, part of
this debate, so I would encourage you to look at that, and we
add that into the toolbox of understanding about this whole
approach. I think it would be helpful.
Dr. Nielsen. If I could just comment, we certainly support
the FDA, as I have stated.
Mr. Shimkus. Do you support the provision that we increase
the authority of the FDA to do civil penalties and the like
with the understanding that we have done that and it has only
been a short term that it has been in play.
Dr. Nielsen. Yes, sir. And in fact, our policy goes further
than what has been passed by Congress and it encourages that
pre-approval, as you know.
Mr. Shimkus. Do you concur with the statements from my
friend from California that made the assumption that we can't
trust physicians because they are bought off by the
pharmaceutical companies?
Dr. Nielsen. Well, I think what you heard from Dr. Day is
physicians are people like everybody else, and the way things
are presented to them is just as important as the way it is
presented to consumers.
Mr. Shimkus. So you agree with him?
Dr. Nielsen. I agree that physicians are people. I do not
agree that physicians are bought off by drug companies.
Mr. Shimkus. Well, I mean that is the assertion made.
Dr. Nielsen. I heard that, sir. I was in the audience. We
have an ethical position about that that we would be happy to
discuss with you.
Mr. Shimkus. I'm fine with your position. I think I would
address it with my colleague from California. I think that is
who made the assertion. I appreciate your profession. I
appreciate the Hippocratic Oath. I think part of this problem
is the prescriber of the drug is whom?
Dr. Nielsen. Drugs are prescribed by physicians. They can
also be prescribed, in some states, by other health
professionals.
Mr. Shimkus. So the health professionals do the prescribing
and part of the Kaiser Foundation research said that one of the
benefits is it helps create information for people to go to
physicians. And really, in the Kaiser study, it said that on
the most part that doctors directed these patients who came for
information to other drugs or lifestyle changes. You would
think that that would beneficial, wouldn't you?
Dr. Nielsen. Indeed. And in fact, when a patient comes in
discussing symptoms, that can only be a good thing.
Mr. Shimkus. And I think, again, that is the debate,
especially with the First Amendment issues. Again, my caveat is
this family hour provision and the timeliness of advertising,
which might claim that I am schizophrenic on this, but I think
when it comes to the kids and what is aired over the air, I am
willing to really push that issue.
Dr. Nielsen. The ethical tenets of our profession are very
clear, that one should, in prescribing a drug, do what is best
for that patient. There is no question about that.
Mr. Shimkus. Dr. Crosse, you are aware that the Congress
increased spending on staff assigned to review ads to $6.25
million a year from the previous high of just over $1 million?
Ms. Crosse. Yes, I believe under the amendments act.
Mr. Shimkus. Have you staffed up?
Ms. Crosse. The FDA has increased the staff assigned to the
division to review these ads.
Mr. Shimkus. So we have new law and we have increased
staffing, so we are moving in the right direction if we are
concerned about direct-to-consumer marketing.
Ms. Crosse. I would believe that there are number of steps
that are positive in this area.
Mr. Shimkus. You mentioned a change in policy with regard
to review of regulatory letters so that the chief counsel's
office reviews them for legal sufficiency. Why was this change
made?
Ms. Crosse. We don't really have a clear understanding of
why this specific change was made. We reported on it in 2002
and again in 2006. I think there was a concern that came down
from HHS from the General Counsel's office direction that this
change be made to review the letters for sufficiency.
Mr. Shimkus. Thank you. Mr. Chairman.
Mr. Stupak. Mr. Barton for questions. Do you want to do an
opening statement?
Mr. Barton. I shall just take five minutes and going to do
a little of both since I have been delayed.
I apologize for not being here for a good part of the
hearing. As we all know, there have been a lot of votes on the
floor and things like that, but you know, last year, the
committee, on a bipartisan basis, adopted an amendment to give
the FDA some new authority in terms of making sure that drug
ads are done properly. I don't know if there have been any
questions about that. But we are in a situation today--this is
not, in my opinion, Sinclair Lewis of the early 1900s when we
had buyer-beware drugs and food products being sold to the
American people. One of the drugs that is under review today I
take: Lipitor. I have taken it for 2 years since I had a heart
attack. I go see my cardiologist every 6 months, and according
to him, it is working fine, and I am working fine.
So I guess I would ask our AMA witness, Dr. Nielsen, do you
consider some of these drug ads to be so misleading that we
should consider changing the current laws we have for reviewing
them at the FDA?
Dr. Nielsen. Yes, sir. As I stated in my testimony, it is
AMA policy that the FDA be given authority, and of course by
that we mean effective authority to not only do the kind of
sanctioning that has already been granted to them, but also to
give them the authority and the resources to carry out the
mission to pre-approved direct-to-consumer ads.
Mr. Barton. So you think this is a more important problem
than plants in China that are putting poison into heparin?
Dr. Nielsen. No, sir, that is not at all what we mean. The
FDA has wide authority. But as long as it is legal to do
direct-to-consumer drug advertisements, then it is very
important that it not be misleading to the public. So as long
as we have it, there has to be regulation.
Mr. Barton. These ads that we are reviewing today were
aired before the new law that we passed last year and the new
regulation had actually been implemented. And as I understand
it, most of the ads that are in question today have been
voluntarily pulled from television. So I just want to make sure
I understand, it is the American Medical Association position
that current law that has yet to have the regulations
implemented is not strong enough.
Dr. Nielsen. That is our policy, and it is not targeted
against any specific ads.
Mr. Barton. Mr. Chairman, I respectfully disagree with the
AMA's position, but I respect the American Medical Association.
I will be happy to look at the issue in greater detail. I don't
consider this to be the most pressing issue that is before the
subcommittee. And as you know, since I used to chair this
subcommittee, I am a strong supporter of aggressive oversight
and investigation, and I will support you and Chairman Dingell
procedurally in almost anything that you wish to investigate.
But I would hope that some of the other issues that were
ongoing, including our foreign food inspections, would perhaps
take a little bit higher priority. With that, I yield back.
Mr. Stupak. I thank the gentleman. While it is true there
are new rules, which some of us think are very weak provisions,
but they are new provisions, and I hope that these hearings not
only highlight the fact there are some new rules that will be
implemented, but maybe FDA will take it seriously, Number one.
Number two, apply pressure on the FDA to quickly enact these
new rules and not take years to do it, and take actions against
violators. So those are some of the reason why we are doing
this. On a lighter note, I notice that you have been taking
Lipitor for 2 years, do we expect to see you on the Potomac
rowing?
Mr. Barton. Well, I have got as much experience doing that
as the person that was in the ad.
Mr. Stupak. I think you have more experience. But on a
serious note, I think it is the first time we have had an
opportunity to take note of your portrait, and I would like to
congratulate you on having that addition of your portrait in
the hearing room as former chair, so thank you and thank you
for being here.
Mr. Whitfield, I guess, for question. And we will go
another round. I have questions, and we will go another round.
Mr. Whitfield. Thank you, Mr. Chairman, and I thank the
panel for being here. I am sorry I missed your testimony, but I
am a little bit familiar with what your testimony was.
Dr. Nielsen, recognizing that the AMA's position is pre-
clearance of these ads, it is my understanding that you have
made some reference that direct-to-consumer ads may cause or
contribute to over-utilization of prescription drugs. Is that
your position or is that correct?
Dr. Nielsen. That is our concern. We respectfully request
studies to look at that.
Mr. Whitfield. OK, but there have been no studies on that?
Dr. Nielsen. There have been some, as you have heard, that
have approached it in other ways, but it is a concern, as
everyone is worried about healthcare costs, particularly if the
advertising is for drugs that are under patent, which may be no
more effective than a drug that is available that is
considerably cheaper.
Mr. Whitfield. Well, the thing that puzzles me about all of
this, and I talked a little bit about this in my opening
statement is the fact that the doctor prescribes the medicine,
and that is what they are trained to do, to diagnose and
prescribe the medicine. So are you saying that doctors are
actually influenced by their patients because of what patients
see on television about ads?
Dr. Nielsen. I think there is no question that that is the
case, and it causes some problematic moments in the office. I
can tell you, absolutely, from my own 23 years in practice that
it happened periodically. It happened several times a week.
Patients came in, essentially convinced because, particularly a
television ad convinced them that they needed a specific drug.
So the conversation, then, was not about the symptoms so much
as it was about why that drug or some alternative was going to
be----
Mr. Whitfield. So what is the responsibility of the doctor
in that instance?
Dr. Nielsen. The responsibility is very clear. The doctor's
ethical responsibility is to do what he or she thinks is the
best thing for that patient. When there are alternatives, it
is, in fact, quite possible that the physician may be persuaded
by the patient's increased demand that as one of the
alternatives be prescribed, but it always has to be in the
patient's best interest.
Mr. Whitfield. I know that it is difficult to speak
categorically in every instance, but generally speaking, it has
been my experience that when I go to a doctor or when family
members go to a doctor, and when I served on the health
subcommittee, that generally speaking, patients listen to their
doctors, and generally speaking, they are pretty comfortable
with the physician's opinion. They may go out and get a second
opinion or a third opinion, which I think is good, but I would
just be shocked, myself, to think that physicians would be so
intimidated or pressured by patients to prescribe a particular
drug because of someone seeing it on television. And maybe I am
being naive, but I just feel like one of the problems in our
healthcare system, in my view, is that patients, generally,
almost categorically do what the doctor says and that they
should get a second opinion or so. Do you think I am off base
in that belief or not?
Dr. Nielsen. No, not completely, but let me offer a couple
of things. First, you heard from the Kaiser Family Foundation,
and I will defer to my colleague to give us the statistics, but
you heard that about half of the time the physician will
prescribe something else or recommend an alternative, or
sometimes an over-the-counter approach. On the other hand,
there are other studies which show that a patient may leave a
physician if they do not get the drug that they are seeking,
and every doctor will tell you about that. That doesn't mean
that they give them the drug so they don't leave, but they have
had patients leave them, so think it is not quite true that all
patients do what their doctors recommend. Would that it were so
and would that we had better communication between patients and
doctors about their symptoms.
Mr. Whitfield. In this information age in which we live
today, with the Internet and people go online and put in drugs
and all sorts of information is available, I don't have any
scientific evidence to support this, but I would imagine that
people can go on the Internet and get all sorts of information
about drugs that maybe they are getting as much information
from that source as they are from direct ads. Is that any
concern to you about all of the information that is out there
on the Internet?
Dr. Nielsen. In my experience, most of the time the
Internet research done is more disease-specific than drug-
specific. It does lead people, sometimes, to the drug-specific
information. However, what we are really talking about today is
the ads, primarily on television, because that has been
relatively new over the past 11 years. The print ads tend to be
a little more balanced, but the TV ads are the ones that are of
more concern, and that is different than a patient searching
for information about diabetes on the Internet. You are
absolutely right you can get good and bad information on the
Internet as well.
Mr. Whitfield. Dr. Crosse, two of the three ad campaigns we
are discussing with the next panel involve direct-to-consumer
advertising on treatment options for high cholesterol. Did your
November 2006 report on direct-to-consumer ads recognize any
beneficial relationship between those direct-to-consumer ads
and treating high cholesterol?
Ms. Crosse. Yes, we talked in that report about the
research that is out there that talks about the role of these
ads in informing and educating patients as well as some of the
same concerns that we have just heard from Dr. Nielsen. There
has been research on both sides of this issue, and there
certainly is some evidence that it can play a positive role in
informing patients about treatment options they may not have
been aware of before.
Mr. Whitfield. I see my time has expired, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Whitfield. Mr. Walden for
questions please.
Mr. Walden. Thank you, Mr. Chairman.
Mr. Chairman, one question for you before I ask the
witnesses. Did the FDA not want to testify at this hearing, or
were they invited or they refused? I know we have had problems
in the past, sometimes, getting them here.
Mr. Stupak. It was decided not to have them at this
hearing.
Mr. Walden. OK, I hope at a future hearing they are here,
because I think it would be good to pose some of these
questions to them, and I am disappointed we are not going to
have that chance.
Dr. Crosse, let me go to you then. As you mentioned in
footnote 2 in your written testimony, the FDA Amendments Act of
2007 gave this new authority to the FDA. The act authorized the
FDA to require submission of any draft TV ad for review up to
45 days before it is scheduled to be aired. It gave the FDA the
power to impose civil money penalties if statements and drug
ads are false or misleading. Is that adequate authority for the
FDA?
Ms. Crosse. I think we don't know yet. These new
authorities have not yet been implemented by FDA, and I think
it is too soon to see how that will play out. The civil
monetary penalties would be a step, in general, beyond what
they have been doing with untitled letters and warning letters,
the kind of regulatory actions they have been taking. Since in
2007, they only issued two such enforcement letters, I think we
are talking about a potentially very small number of actions
that would ever arise to the level of civil monetary penalties
because in general----
Mr. Walden. Is that because most ads aren't false or
misleading?
Ms. Crosse. I can't speak to how many ads have false or
misleading content. FDA has not identified that many ads that
rose to the level of taking regulatory action, and when they
have, the companies have in general been responsive to pull
those ads.
Mr. Walden. Are you aware of any ads or any companies that
have refused to pull an ad?
Ms. Crosse. I am not aware of any, no, and the increasing
number of companies had already voluntarily been submitting
broadcast television ads to FDA for advisory opinions prior to
broadcast. This new authority will allow FDA to call for
companies to do that across the board for the television ads,
not the other materials which comprise the bulk of the DTC
advertising.
Mr. Walden. Let me ask you this question. We have dealt in
this oversight subcommittee before on some of the products that
are not regulated by the FDA but claim incredible benefit for
their usage, and the FDA has really no regulatory authority. I
am talking about supplements here. Does the FDA have any
authority regarding those advertisements and claims?
Ms. Crosse. They can take action to ask the companies for
support, but they do not have the same authority in this area
as they do in the area of prescription drugs and in fact the
Federal Trade Commission has been the primary actor in
regulating advertising by dietary supplements.
Mr. Walden. I know some of the discussion my colleagues
were having about the family hour and some of these ads that
run, we were having a little chat back here about trying to
explain to a teenager about a lot of things, whether it is a
Victoria's Secret ad, or feminine products, or some of the
supplements that claim incredible, well, you know what I mean.
And none of those would really fall under this issue either.
And I think we have to be careful in this country to go down a
slippery slope when the court has clearly said there is a right
to commercial speech for a legal product. Correct? Hasn't the
Supreme Court ruled that on commercial speech in this area?
Ms. Crosse. I am not qualified to speak to that for the
direct-to-consumer advertising of prescription drugs, but that
certainly is the concern that has been raised about
controlling----
Mr. Walden. I thought there was a court decision that
validated. There certainly have been court decisions that have
overturned prohibitions on some liquor advertising. It seems to
me that there has to be an overriding public interest issue
here, and I am not sure I see it. I hear a lot from my
constituents, but the physicians who hate getting this rush of
people coming in saying what about this drug. I understand
that, and given their time commitments to each patient, that
has got to be difficult to manage, but I have always been a
believer that more information is better than less, and more
freedom of disclosure of information is better than a
government censor of information, and that an open and free
marketplace, when we are advertising legal drugs that have been
approved, I may not like all of those ads, but I guess I have
just a little different philosophy about it. Dr. Nielsen, do
you have a comment?
Dr. Nielsen. I do. I think we would absolutely agree with
you, and that is why we have been very careful to say that ads
that are educational can in fact be beneficial. You will hear
things on television and on the radio like know your numbers.
That could refer to your blood pressure. It could refer to your
cholesterol. That is very helpful. That is important. Patients
do need that kind of information. That is really not the
concern. It is some of what you heard earlier, although we
didn't have the sophistication of the glittery bee wings, which
I find very interesting. The risks and benefits, one has to be
very careful, because frankly, the educational mission we would
support. The marketing we would ask to be fair and balanced.
Mr. Walden. All right, and I know my time is expired. I
appreciate the testimony of all of our witnesses today. Thank
you very much.
Mr. Stupak. We will go another round of questions if anyone
has any more questions. Dr. Nielsen, you indicated the AMA
would like the ads to be evidence-based reviewed.
Dr. Nielsen. We want the ads claiming benefits to be
evidence-based and related to what has been presented to the
FDA for the indications for which they were approved, yes.
Mr. Stupak. So evidence-based review would, in a way, work
like Dr. Day did, like not speed up the words, not put them at
the end where you lose meaning, not to put glitter in bee wings
or anything else to distract you, correct?
Dr. Nielsen. And I think that the study that was referred
to earlier that the FDA is proposing to do will look at just
that.
Mr. Stupak. OK, you also mentioned a moratorium so we know
the side effects. Could you explain that?
Dr. Nielsen. It was not quite that. It was when a new
product comes to the market, if it is significantly different,
then hopefully the FDA would have the authority to negotiate
with the manufacturer for a moratorium on DTCA for a period of
time to be sure that the information is adequately communicated
to physicians first who have to prescribe that drug.
Mr. Stupak. Well, like the Vytorin. They say in that ad
there are two ways you get cholesterol, which is educational,
which is good, and it claimed that the drug could address both
of those ways, which it did not. So in that instance, because
Vytorin was something new, would that be the type of drug you
would like to say, well, let's wait a little bit and make sure
it works before we put it out advertising it.
Dr. Nielsen. No, now you are talking about something
different. What that ad calls to mind is the issue of emerging
science. As the science emerges, that the combination is no
more effective than a lesser cost----
Mr. Stupak. Sure, Zocor.
Dr. Nielsen. And if that data were in fact suppressed while
marketing was going on, that is of grave concern and should be
a concern to the country.
Mr. Stupak. So emerging science should not even be
advertised until it is at least proven science.
Dr. Nielsen. Emerging science, it is really important to
recognize the imbalance between what emerges from the
scientific literature and the vast resources committed to
direct-to-consumer advertising, and we value our colleagues who
are in the pharmaceutical industry. We ask them merely to be
ethical and fair and when new science emerges to take that into
consideration with a fair and balanced ad or pull the ad.
Mr. Stupak. OK, and let me ask this question to either one
of you if you would care to answer. I will take Vytorin, a new
drug. It is expensive. I don't have the numbers. It was $8 or
$9 a tablet or something. It was quite a bit, and Zocor is 5
cents. Has anyone ever done a study like that only the most
expensive drugs are the ones being advertised as opposed to
Zocor is just as good as Vytorin, but you don't see it on TV
anymore because the patent is expired? Has anyone ever done
that? Are the drugs we are seeing on the TV the expensive ones
in those areas? Has Kaiser done that? GAO? AMA?
Dr. Nielsen. It is very clear that it is the drugs under
patent that are being advertised.
Mr. Stupak. The most expensive drugs then? You don't know
or you are not in the position to say?
Dr. Nielsen. Well, we think we all know the answer to that.
Mr. Stupak. Yes, I think we all do. All right. Let me ask
this. Dr. Crosse, we talked about the chief counsel office and
there is a change in policy. Was there a problem before that we
had to change the policy so now it takes us so long, like 6
months, to get a letter out to a drug company on advertising?
Was there a problem that they highlighted that they said here
is why it is going to Chief Counsel so it slows the process
down to make sure we do it right? Were there problems?
Ms. Crosse. It is not clear that there was a problem. The
stated purpose for the policy change was to ensure the legal
supportability of the letters that were being issued. The
letters that had previously been issued had not been
challenged, however, on the basis of their legality, so it is
not clear that there was a direct link to that. Having said
that, we don't object to them wanting to ensure the
supportability of the letters they issue. It is the time it has
taken, and they committed to issuing those much more quickly in
2002. They said they were putting in place a process to do
reviews within 15 days and ensure that letters were issued
within 45 days, but every single year, it has continued to
lengthen until 2007, and it is now over 6 months to do the
review of these, and some of these have had over 30 iterations
internally at FDA before a letter has been issued.
Mr. Stupak. My friend Mr. Shimkus pointed out that we have
increased money for the FDA to review these ads. Even with more
people there, you may do other things. You may try to
streamline it, but as long as we have this bottleneck at the
Office of Chief Counsel, it is not going to expedite FDA review
of an ad or enforcement action.
Ms. Crosse. Certainly, we point to that as marking a change
that has greatly reduced the number of regulatory actions FDA
has taken in this area.
Mr. Stupak. My time has expired. Anyone else for questions?
Mr. Shimkus.
Mr. Shimkus. Yes, just real quick, Mr. Chairman. Dr.
Nielsen, when a prescription is written, does the doctor list
the side effects on the prescription itself?
Dr. Nielsen. No, sir. That is normally on what the
pharmacist will hand to the patient.
Mr. Shimkus. Correct. I am just asking the question.
Dr. Nielsen. But there is a discussion----
Mr. Shimkus. See, I really trust my doctor, but we have bad
actors in every organization that disappoint us. But I give the
physicians a lot more credit than I think you are doing today
by them being able to stand up and say I don't care what you
are saying. You are my patient. This is not right for you. And
I believe that they are strong enough in fortitude and
backbone, and I would trust a doctor over an ad any day of the
week because we all know ads are there to sell you things. I
mean Cocoa Puffs. You name it. Americans know that because we
have free, over-the-air TV, you have to support that through
advertising revenue, and advertising is there to sell you
things. So I think that is part of our frustration. We love our
doctors. They are true professionals, and I just think they are
tougher than what is being said here today, and I trust them to
be able to stand up against a large pharmaceutical company that
may be advertising something that is not in their patients'
best interest.
Let me ask you another question. We are going to talk about
specific ads in the next panel. Of the three drugs that we are
going to be addressing, are all three of them not in compliance
based upon evidence? Is there a problem with the evidence
behind the claim?
Dr. Nielsen. I can't comment on those three ads
specifically, but I really do need to comment because if I
implied in any way that physicians are not acting ethically and
they are caving to demands, I really have not conveyed what----
Mr. Shimkus. I am just trying to stand up for my doc who I
know.
Dr. Nielsen. I am here to stand up for the hundreds of
thousands of educated, ethical, dedicated, and hardworking
physicians, but it is true that patients have left physicians
because they would not bend to those kinds of marketing
pressures.
Mr. Shimkus. So then they are going to get the drug from a
doc who is not ethical.
Dr. Nielsen. They will find someone who will prescribe the
drug. There are studies to show that. But indeed, doctors work
very hard to try to do the right thing for their patients.
Mr. Shimkus. That is all I have, Mr. Chairman.
Mr. Stupak. Mr. Whitfield?
Mr. Whitfield. Just one other question, Mr. Chairman, thank
you.
Dr. Brodie, I know you have conducted some polling about
where patients get information about prescription drugs. Where
do direct-to-consumer ads rank for prescription drugs. Would
you go through that briefly?
Ms. Brodie. In the January survey that I talked about
before, we asked people to rank sources of information, about
how much they information they get, and as we just heard,
doctors are right at the top. Seventy-two percent say they get
a lot of information about prescription drugs from their
doctor. Pharmacists ranked second. Information about the
product in the prescription-drug package ranks third. Forty-
three percent say they get a lot of that. Twenty-two percent
say they get a lot from government agencies like the FDA,
families and friends, the Internet, and then at the bottom of
the list is ads for prescription drugs in terms of where people
say they are getting the most information from.
Mr. Whitfield. OK, I yield back the balance of my time.
Mr. Stupak. Mr. Ferguson for questions?
Just one question. Your survey showed, and you went back
and compared it with a survey the Kaiser Foundation did, I
believe, back in 1997, people trusted the ads to be accurate
more, did they not, than they do in your survey here in 2005?
It was almost like a doubling they lost confidence in these
ads.
Ms. Brodie. Yes, in 1997, I think, 33 percent said they
trusted them most of the time, and that was down to 18 percent
now, that they could trust what the drug companies had to say
in their advertisements most of the time, so that has fallen
from 33 percent in 1997 down to 18 percent now. I think that is
reflective of the changes that we have seen in DTC advertising.
In 1997, they were very new. It was something that were just
sort of getting exposed to, and now they are ubiquitous, and
now, I think, are assessing the ads more like they are any ad
in that they are not new anymore. They are just an
advertisement like any other product or service.
Mr. Stupak. Dr. Nielsen, the AMA is concerned, just in
summation in a way, about doctors appearing in ads because of
trustworthiness. They have to disclose if they have a fee, and
they should have because they are considered experts in these
areas. Is that what you are trying to say? I didn't think you
were dumping on doctors.
Dr. Nielsen. Yes, sir. We think doctors should relate to
their patients, and they should not be, frankly, hired
hucksters for a drug company. And I hate to use that
perjorative term, but when one appears in an ad, it implies a
credulity that we think is not seemly, and so we strongly
discourage it. If they do appear, then we strongly insist that
there must be a disclaimer.
Mr. Stupak. In the Lipitor ad, I want to go back to this
just one more time. Dr. Jarvik wasn't licensed to prescribe the
medicine. Underneath your rules, he would be considered a
doctor, and therefore, underneath your guidelines, he should
have disclosed he was a paid consultant. Was that one of the
problems with this ad?
Dr. Nielsen. Well, that would meet our guidelines, yes. You
know, I think most Americans know when a celebrity appears in
an ad that they probably are compensated for that, but we think
with a physician that they should be clear about that.
Mr. Stupak. With Dr. Jarvik's status, went to medical
school, but is not allowed to write a prescription because he
is not licensed, would he have had to follow the AMA
guidelines? He is not a member, right?
Dr. Nielsen. No, he is not.
Mr. Stupak. So there is no requirement on him?
Dr. Nielsen. We have no enforcement arm, but these are what
we strongly recommend.
Mr. Stupak. OK, anything further? It has been a good panel.
We could go on and on, but I think we are going to dismiss you.
Thank you all very much for your testimony today.
I would now like to call up our third panel of witnesses
and invite them to come forward. On our third panel, we have
Mr. James Sage, who is the Senior Director and Team Leader for
Lipitor at Pfizer; Mr. Deepak Khanna, who is the Senior Vice
President and General Manager of Merck and Schering-Plough
Pharmaceuticals; Ms. Kim J. Taylor, who is President of Ortho
Biotech, a wholly-owned subsidiary of Johnson & Johnson.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised each of you have the right under
the rules of the House to be advised by counsel during your
testimony. Do any of you wish to be represented by counsel?
Ms. Taylor. I am here with our company's outside counsel,
Mr. Lenny Brewer.
Mr. Stupak. OK, you may consult with him, but he cannot
testify, so if you want to consult with him if a question is
asked to you, you have a right to do so.
Ms. Taylor. Thank you very much.
[Witnesses sworn]
Mr. Stupak. We will begin with your five-minute opening
statement, and we will start from my left. Mr. Sage, would you
like to begin, please?
STATEMENT OF JAMES SAGE, SENIOR DIRECTOR/TEAM LEADER, LIPITOR,
PFIZER, INC.
Mr. Sage. Good afternoon, Mr. Chairman, Ranking Member
Shimkus and members of the subcommittee. My name is Jim Sage,
and I am the senior director and Lipitor team leader for
Pfizer, which means that I am responsible for the marketing
practices for Lipitor in the U.S. On behalf of Pfizer, I want
to thank you for the opportunity to briefly address a few key
issues relating to Pfizer's television advertisements for
Lipitor, including Pfizer's use of direct-to-consumer
advertising, the value of Lipitor, and Dr. Jarvik's role as a
spokesperson.
Regarding direct-to-consumer television advertising, Pfizer
is committed to responsible advertising that anticipates and
addresses the needs of patients and physicians. Pfizer
developed safe and effective medicines to prevent and treat
some of the world's most serious illnesses. In 2007, we invest
$7.6 billion in research and development, and we use DTC to
increase awareness of our products, to educate consumers about
the conditions that they treat, and to increase patient and
physician discussion about those conditions.
Unlike most other industries, pharmaceutical companies
cannot sell their products directly to the people who use them.
Instead our products must be prescribed by physicians. As a
result, the prescribing doctor's role is indispensable when
considering the DTC issue. DTC ads encourage an active
partnership between patients and their doctors. Millions of
Americans suffer from treatable medical conditions that remain
undiagnosed, untreated, or under-treated.
This is certainly the case with high cholesterol, only half
of those who have this condition have been diagnosed, and of
those who have been diagnosed, only half have received treated.
Elevated LDL cholesterol is one of the most common risk factors
for cardiovascular disease. Heart disease and stroke continue
to be a leading cause of death and disability in the United
States. Statins, including Lipitor, have played an important
role in addressing the risk of heart disease when diet and
exercise alone are not enough.
Lipitor itself has been studied for approximately 15 years,
in over 400 clinical trials, in over 80,000 patients. Lipitor
was in research and development for nearly a decade before
coming to market. Our commitment to research did not stop there
but continued with several landmark trials. These trials helped
form the basis for the current understanding of cardiovascular
risk and for updated cardiovascular disease-prevention
guidelines. In fact, six of these trials have been cited by
independent guideline bodies as impacting current standards of
care.
What we learned from this research is that when diet and
exercise alone are not enough, Lipitor is a safe and effective
medicine to reduce LDL cholesterol by 39 to 60 percent and has
significantly reduced the risk of heart attack and stroke in a
broad range of patients with common risk factors, including
hypertension, diabetes, and preexisting heart disease.
Now, let us turn from the science that has proven Lipitor's
safety and effectiveness to our company's television
advertising campaign for Lipitor featuring Dr. Jarvik. Pfizer
asked Dr. Jarvik to appear in Lipitor advertisements because he
is recognized for his work related to the human heart. Dr.
Jarvik honestly and sincerely embraced our heart health
campaign. He and Pfizer believed that the ad were an effective
way to deliver an important preventative health message to a
large number of patients to encourage them to reduce the risk
of heart disease through diet and exercise, was well as through
consultation with their doctors about the importance of
managing their cholesterol.
Dr. Jarvik received his MD degree from the University of
Utah College on Medicine in 1976. Although not a practicing
physician, he has devoted his entire career to medical science
related to the human heart. He has invented medical devices to
help patients with advanced heart disease, and he has
collaborated with other physicians and scientist on these
activities. As Dr. Jarvik has said publicly, he has the
training, experience, and medical knowledge to understand the
conclusions of the extensive clinical trials that have been
conducted to support the safety and effectiveness of Lipitor.
Both Pfizer and Dr. Jarvik are confident that the statements
included in these ads fairly represent the scientific data of
Lipitor.
Some have asked why Pfizer decided to stop using Dr. Jarvik
in our advertisements. We chose Dr. Jarvik to participate in
these ads because he is nationally prominent expert, with the
knowledge and experience to speak intelligently and sincerely
about the benefits of Lipitor. Unfortunately, the way that Dr
Jarvik was presented in these ads has created misimpressions
and distractions from our primary message which was to
encourage patients and physicians to discuss the leading cause
of death in the world: cardiovascular disease.
Going forward, we are committed to ensuring there is
greater clarity in our advertising regarding the presentation
of spokespeople. In summary, Pfizer believes it is important to
continue to educate consumers about the risks of elevated
cholesterol and the value that Lipitor provides as a potential
treatment option. We believe that DTC ads are an effective way
to accomplish this objective. Thank you, and I look forward to
any questions that you may have.
[The prepared statement of Mr. Sage follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, doctor. Mr. Khanna, your opening
statement please, sir. And for all of the witnesses, if you
have a longer opening statement, we will be happy to include it
in the record. OK, Mr. Khanna.
STATEMENT OF DEEPAK KHANNA, SENIOR VICE PRESIDENT AND GENERAL
MANAGER, MERCK/SCHERING-PLOUGH PHARMACEUTICALS
Mr. Khanna. Mr. Chairman, Ranking Member Shimkus and
members of the committee, I am Deepak Khanna, senior vice
president and general manager of Merck/Schering-Plough
Pharmaceuticals. Like many Americans, I try to control my
cholesterol through diet and exercise. Merck and Schering
Plough formed Merck/Schering-Plough Pharmaceuticals in 2000 to
make available important treatment choices for patients, who
unlike me, cannot maintain a healthy cholesterol level through
diet and exercise alone.
As early as 1961, scientists identified elevated levels of
cholesterols as among the risk factors for coronary heart
disease, the leading killer of Americans. Lowering LDL
cholesterol through diet, exercise, and if necessary,
pharmaceutical treatment is the cornerstone of heart disease
prevention. Mr. Chairman, despite our advances in the
understanding of the role of high cholesterol in heart disease
in and in the development of effective treatment, the toll of
heart disease remains too high, and the level of understanding
and treatment remain too low.
Approximately 46 million adults in the U.S. have been
diagnosed with high cholesterol and might benefit from
pharmaceutical treatment. However, just 14.5 million adults are
currently being treated with a cholesterol-lowering medication.
Of those treated, more than 4 million, or nearly one-third, are
not attaining the desired cholesterol goals established by the
NIH's National Cholesterol Education program. The result is
unnecessary disease and suffering.
It is against this backdrop that Merck/Schering-Plough
Pharmaceuticals approached the decision to create and broadcast
advertisements for Vytorin, which is combination of two
medicines, Zetia, which limits the absorption of cholesterol
from food, and simvastatin, a statin medicine that moderates
the body's inherited, natural production of cholesterol.
High cholesterol alone has no symptoms. Advertising can be
especially helpful in informing people about the need to
address this important condition as well as reminding them to
fill their prescriptions and take their medicines as directed
by their physician. As we developed our advertising, we learned
that the vast majority of people understood the role of diet
and exercise in cholesterol control but did not appreciate the
genetic causes. This leads to them disproportionately blaming
themselves for a condition that is often inherited. The
advertising that Merck/Schering-Plough broadcast from September
2004 until January of this year used a unique, memorable,
effective approach to educate about the importance of lowering
cholesterol, the two sources of cholesterol, the importance of
diet, and the additional LDL lowering that can come from drug
therapy when a healthy diet is not enough.
Our food and family advertisements were entertaining. This
approach kept consumers engaged while we delivered a serious
educational message, and our consumer research has consistently
shown that the information about the two sources of cholesterol
is getting through. We commissioned a Harris survey that found
that prior to our advertising, just 16 percent of people were
aware that there two sources of cholesterol. In the year
following our advertising, we found a full 54 percent of people
now understood this. We also learned that our advertising had
helped relieved the guild people often carry when they are
unable to control their high cholesterol with diet and exercise
and encouraged them to have discussions with their physicians
about additional options for controlling their cholesterol.
In developing the advertising campaign, we sought advice
from the Food and Drug Administration on the proposed content
of our advertisements and revised our advertisements in
response to those comments. These advertisements only made
claims that were supported by research that were evaluated by
the FDA and that were consistent with our FDA-approved
labeling. Merck/Schering-Plough Pharmaceuticals suspended our
Vytorin food and family broadcast advertising in January. We
took this action in anticipation of the confusion that could be
created by our release of the results of the enhanced trial.
Mr. Chairman, the enhanced trial was a relatively small
study of a unique patient population that was genetically
predisposed to very high levels of LDL cholesterol. Enhanced
compared the impact of Vytorin versus simvastatin on a
surrogate market fro heart disease, reduction in the thickness
of the carotid arterial wall. While there was no difference on
this measurement between the two treatments, Vytorin did
demonstrate superior LDL lowering compared to simvastatin.
Merck/Schering-Plough Pharmaceuticals stands behind the
benefits of Vytorin in lowering LDL cholesterol. We will
continue to responsibly inform patients and prescribers about
LDL cholesterol, the importance of diet and exercise, and
Vytorin. As we move forward, we will continue to consult with
physicians, patients, and the FDA to ensure that the
information we provide will continue to educate and motivate
patients to improve their health. I appreciate the opportunity
to appear before you and welcome your questions.
[The prepared statement of Mr. Khanna follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you. Ms. Taylor, your opening statement
please.
STATEMENT OF KIM TAYLOR, PRESIDENT, ORTHO BIOTECH, INC.
Ms. Taylor. Chairman Stupak, Ranking Member Shimkus, and
members the subcommittee, good afternoon. I am Kim Taylor, the
president of Ortho Biotech. I am pleased to be here today to
speak with you about direct-to-consumer advertising, and in
particular, the broadcast television advertisements of Ortho
Biotech's medicine Procrit, which the company stopped airing 3
years ago. Because the subcommittee expressed interest in our
history of Procrit television advertisements, which focused on
the treatment of anemia associated with cancer chemotherapy, I
will focus my testimony on this indication.
When the FDA approved Procrit for the treatment of
chemotherapy-induced anemia, it premised the approval on the
ability of ESAs to treat anemia by increasing a patient's
hemoglobin, reducing the likelihood that a chemotherapy patient
would require a transfusion of red blood cells and reduced the
amount of blood that would be needed in the case of a
transfusion. ESAs are very effective at reducing a chemotherapy
patient's need for transfusion. As the FDA stated in its March
2008 briefing at the Oncologic Drugs advisory committee review
of ESAs, across several studies, approximately 50 percent of
anemia patients receiving chemotherapy required transfusions,
as compared to approximately 20 to 25 percent of patients who
received ESAs concurrently with chemotherapy.
The development of a product that could reduce
chemotherapy-related transfusions was important to patients.
Before Procrit and other ESAs became available, anemic
chemotherapy patients faced the choice of living with anemia
and the significant impact on even the most basic activities of
daily living, or that could require interrupting chemotherapy
treatment, or accepting the discomfort and medical risks
associated with multiple transfusions.
I would like to describe for the subcommittee my
understanding of the process by which Ortho Biotech undertook
direct-to-consumer advertisements for Procrit. I should note at
the outset that I was not employed with Ortho Biotech at the
time, so I have no firsthand knowledge of these events. I have,
however, endeavored over the past several weeks to gather and
become familiar with the history of Ortho Biotech's Procrit
advertisements.
During the middle 1990s, cancer doctors began to have a
greater awareness of a practice that is generally called
supportive care. Consistent with an increased focus on
supportive care, researchers investigated the use of Procrit to
address chemotherapy patients' anemia and decrease the need for
transfusion. Studies validated the use of Procrit in this way.
At the same time, any patients with chemotherapy-include anemia
were under-diagnosed for this condition, and some patients were
even unaware that anemia could cause fatigue and tiredness.
Others were not candid about their fatigue for fear that their
doctor could possibly interrupt their lifesaving chemotherapy
treatment.
In this environment, Ortho Biotech undertook a
comprehensive educational campaign that included programs of
outreach to patients, patient educational campaigns, and
direct-to-consumer advertising. Ortho Biotech believed that
direct-to-consumer advertising as one part of a comprehensive
educational effort was an effective way to raise awareness
about chemotherapy-induced anemia. The Procrit broadcast
advertisements ran from 1998 to 2005. All of the ads
communicated the same general theme: chemotherapy-induced
anemia can cause fatigue and weakness, and Procrit may
alleviate those symptoms by addressing the chemotherapy-induced
anemia. A central message of each and every advertisement was
to encourage the patient to talk to his or her doctor about the
symptoms of anemia. Only through discussing these symptoms with
a doctor could the doctor then make the medical determination
of whether that patient would benefit from Procrit.
As the committee reviews Ortho Biotech's direct-to-consumer
broadcast advertisements for Procrit, I would like to stress
four fundamental points. First, the statements in the
advertisements regarding the benefits of Procrit were true,
responsible, and substantiated by clinical studies, showing
that the administration of Procrit led to significant
improvements in the symptoms of anemia in chemotherapy
patients. Second, the advertisements were consistent with the
FDA-approved indication for Procrit, in this case, the
treatment of chemotherapy-induced anemia. The advertisements,
therefore, discussed the symptoms of chemotherapy-induced
anemia, such as fatigue and weakness, and very carefully made
clear that Procrit treats chemotherapy-induced anemia or
increases red blood cells. Third, the advertisements began 5
years after Procrit was approved for the treatment of
chemotherapy-induced anemia, well beyond the current
pharmaceutical industry's and Johnson & Johnson's own internal
guidelines on the waiting period for direct-to-consumer
advertising. And finally, the advertisements were submitted to
the FDA, as required by regulations, and Ortho Biotech had
extensive and ongoing discussions with appropriate FDA
officials about the content of the advertisements.
As the state of the medical knowledge evolved over time,
Ortho Biotech has worked closely with the FDA to ensure that
new and relevant information was included in the label and
raised as appropriate in the advertisements. In 2005, Ortho
Biotech ended its Procrit direct-to-consumer broadcast
advertising. Ortho Biotech believed that patients suffering
from chemotherapy-induced anemia were aware of Procrit as a
treatment option to discuss with their physicians and that ESAs
were established as within the standard of care for
chemotherapy-induced anemia. We have no current plans to resume
Procrit direct-to-consumer television advertisements.
Procrit remains an important medicine for its approved
indications. Procrit and other ESAs continue to provide
significant benefits to patients with chemotherapy-induced
anemia, and I would be happy to answer any questions that you
have.
[The prepared statement of Ms. Taylor follows:]
Statement of Kim Taylor
Chairman Stupak, Ranking Member Shimkus, and Members of the
Subcommittee, good morning. I am Kim Taylor, the President of
Ortho Biotech, and I am pleased to be here today to speak with
you about direct-to-consumer advertising, and in particular,
the broadcast television advertisements of Ortho Biotech's
medicine Procrit \*\, which the company stopped airing 3 years
ago.
---------------------------------------------------------------------------
\*\ Procrit (epoetin alfa) is a registered trademark of Ortho
Biotech Products, L.P.
---------------------------------------------------------------------------
Ortho Biotech, a member of the Johnson & Johnson family of
companies, is a leading biopharmaceutical company that provides
innovative products and services designed to help enhance the
lives of individuals with serious chronic illnesses. Ortho
Biotech is a leader in the research and treatment of anemia,
which is a blood condition identified by a deficiency of
hemoglobin sufficient to cause symptoms. Hemoglobin is a
component of red blood cells, and its purpose is to transport
oxygen from the lungs to all tissues of the body. Symptoms of
anemia include weakness and fatigue because the tissues of the
body are not getting enough oxygen to function properly.
A class of medicines known as erythropoiesis-stimulating
agents (ESAs) can treat anemia because they are biologically
similar to the naturally occurring protein erythropoietin,
which stimulates red blood cell production. The first ESA
approved in the United States was epoetin alfa, the medicine
that is marketed by Ortho Biotech under the brand name Procrit.
Ortho Biotech distributes Procrit under an agreement with
Amgen, the initial developer of epoetin alfa. Under that
agreement, Ortho Biotech distributes the medicine for patients
not on dialysis. The FDA granted the first approved indication
for the medicine, the treatment of chronic renal failure, in
1989. Since then, the FDA has approved three additional
indications: In 1991, it was approved for the treatment of
anemia in zidovudine (AZT) therapy in HIV-infected patients. In
1993, the medicine was approved for the treatment of anemia
associated with cancer chemotherapy. And in 1996, the FDA
approved the medicine for administration before surgery as a
means to reduce transfusions.
Because the Subcommittee expressed interest in our history
of Procrit television advertisements, which focused on the
treatment of anemia associated with cancer chemotherapy, I will
focus my testimony on this indication.
When the FDA approved Procrit for the treatment of
chemotherapy-induced anemia, it premised the approval on the
ability of ESAs to treat anemia by increasing a patient's
hemoglobin, reducing the likelihood that a chemotherapy patient
would require a transfusion of red blood cells, and reducing
the amount of blood that would be needed in the case of
transfusion. ESAs are very effective at reducing a chemotherapy
patient's need for transfusions. As the FDA stated in its March
2008 briefing for the Oncologic Drugs Advisory Committee review
of ESAs, ``[a]cross several studies, approximately 50% of
anemic patients receiving chemotherapy required transfusions as
compared to approximately 20-25% of patients who received ESAs
concurrently with chemotherapy.''
The development of a product that could reduce
chemotherapy-related transfusions was important to patients.
Before Procrit and other ESAs became available, anemic
chemotherapy patients faced the choice of living with anemia,
which could require interrupting chemotherapy treatment, or
accepting the discomfort and medical risks associated with
transfusions, including HIV, Hepatitis B and C, bacterial
infection, and transfusion-related acute lung injury, each of
which can be fatal. Avoidable transfusions also burden the
blood supply. Because the only source of blood is the voluntary
donation by individuals, the blood supply is under constant
pressure.
I would like to describe for the Subcommittee my
understanding of the process by which Ortho Biotech undertook
direct-to-consumer advertisements for Procrit. I should note,
at the outset, that I was not employed with Ortho Biotech at
the time, so I have no first hand knowledge of these events. I
have, however, endeavored over the past several weeks to gather
and become familiar with the history of Ortho Biotech's Procrit
advertisements.
During the middle 1990s, cancer doctors began to have a
greater awareness of a practice that is generally called
"supportive care." Supportive care is treatment given to
prevent, control, or relieve complications and side effects of
an illness or its treatment. Management of chronic cancer pain
is perhaps the most well known supportive care measure, and the
treatment of chemotherapy-induced anemia is another example.
Consistent with an increased focus on supportive care,
researchers investigated the use of Procrit to address
chemotherapy patients' anemia and decrease the need for
transfusions. Studies validated the use of Procrit in this way.
At the same time, many patients with chemotherapy-induced
anemia were underdiagnosed for the condition. Some patients
were even unaware that anemia could cause fatigue and
tiredness. Others were not candid about their fatigue for fear
that their doctor could possibly interrupt their lifesaving
chemotherapy treatment. Indeed, cancer patients described
fatigue as having a significant impact on their daily lives,
yet there was low awareness that chemotherapy related fatigue
may be caused by anemia and that there were treatments for
chemotherapy-induced anemia. In this environment, Ortho Biotech
undertook a comprehensive educational campaign that included
programs of outreach to doctors, patient educational campaigns,
and direct-to-consumer advertising. Ortho Biotech believed that
direct-to-consumer advertising, as one part of a broader
comprehensive educational effort, was an effective way to raise
awareness about chemotherapy-induced anemia.
I should pause here to note that our parent company,
Johnson & Johnson, was a key player in the development of
industry guidelines for direct-to-consumer advertising. In
addition to adhering to the industry-wide guidelines, Johnson &
Johnson adopted its own internal guiding principles that are
even more rigorous than the industry guidelines. Although the
development of the Procrit advertisements preceded these
guidelines, the creative development process for the Procrit
advertisements was carefully reviewed by Ortho Biotech's
Promotional Review Committee. This group is composed of
individuals from the legal, regulatory, medical, clinical, and
health care compliance departments of the company. Through
consultation and review of the activities of the Procrit
marketing group, the Promotional Review Committee ensured that
the advertisements complied with FDA regulations and were
consistent with the approved indications.
Our development of the Procrit ads began with an assessment
of the patient audience that would be viewing the ads,
including extensive individual interviews with chemotherapy
patients. Our goal was to understand the patients, their needs,
and the most effective way to reach those who may be suffering
from chemotherapy-induced anemia.
The Procrit broadcast advertisements ran from 1998 until
2005. All of the ads communicated the same general theme:
chemotherapy-induced anemia can cause fatigue and weakness, and
Procrit may alleviate those symptoms by addressing the
chemotherapy-induced anemia. A central message of each and
every advertisement was to encourage the patient to talk with
his or her doctor about the symptoms of anemia. Only through
discussing these symptoms with a doctor could the doctor then
make the medical determination of whether that patient would
benefit from Procrit.
As the Committee reviews Ortho Biotech's direct to consumer
broadcast advertisements for Procrit, I would like to stress
four fundamental points. First, the statements in the
advertisements regarding the benefits of Procrit were true,
responsible, and substantiated by scientific studies showing
that administration of Procrit led to significant improvements
in the symptoms of anemia in chemotherapy patients. Second, the
advertisements were consistent with the FDA-approved indication
for Procrit--in this case, the treatment of chemotherapy-
induced anemia. The advertisements, therefore, discussed the
symptoms of chemotherapy-induced anemia - such as fatigue and
weakness--and very carefully made clear that Procrit treats
chemotherapy-induced anemia or increases red blood cells.
Third, the advertisements began five years after Procrit was
approved for treatment of chemotherapy-induced anemia, well
beyond the pharmaceutical industry's and Johnson & Johnson's
own internal guidelines on direct-to-consumer advertising.
Fourth, the advertisements were submitted to the FDA as
required by regulations, and Ortho Biotech had extensive and
ongoing discussions with appropriate FDA officials about the
content of the advertisements. As the state of the medical
knowledge evolved over time, Ortho Biotech has worked
collaboratively with the FDA to ensure that new and relevant
information was included in the label and raised as appropriate
in the advertisements.
In mid-2005, Ortho Biotech ended its Procrit direct-to-
consumer broadcast advertising. Ortho Biotech's decision to
conclude the Procrit broadcast advertisements was related in
part to the reason that we began the ads in 1998--the awareness
in the doctor and patient community about the symptoms and
treatment of chemotherapy-induced anemia. By the early 2000s,
Ortho Biotech believed that patients suffering from
chemotherapy-induced anemia were aware of Procrit as a
treatment option to discuss with their physicians, and that
ESAs were established as within the standard of care for
chemotherapy-induced anemia. Given this heightened awareness
and other business considerations, Ortho Biotech concluded that
further investment in Procrit direct-to-consumer advertising
was no longer warranted. We have no current plans to resume
Procrit direct-to-consumer television advertisements.
Procrit remains an important medicine for its approved
indications. Procrit and other ESAs continue to provide
significant benefits to patients with chemotherapy-induced
anemia, particularly when an ESA is the only available means to
reduce the need for blood transfusions. Procrit is safe and
effective for the treatment of chemotherapy-induced anemia when
it is used in accordance with its FDA-approved prescribing
information.
I would be happy to answer any questions that you might
have.
----------
Mr. Stupak. Thank you, and thank you to each of you for
being here today. We will probably go a couple of rounds of
questions, so let us start with Mr. Sage. Mr. Sage, in that
binder right there, I want to go to a couple of exhibits. I am
looking at exhibit 10 and exhibit 11, page 8. This is your
marketing research, and it is basically a report on the
research of having Dr. Jarvik in there. There are a lot of
things like, ``he is an expert in cardiology. His resume and
his background speaks for itself. I cannot conceive a man that
would be out there selling a product with that type of
background, integrity. I don't think he is doing it for the
money. I think he is doing it because he has found something
that helps. Jarvik knows the heart. He is not a paid actor, not
a fly-by-night.'' It doesn't really show that people who viewed
the Jarvik ads were likely to believe that Dr. Jarvik was not
being paid to do the commercials.
Mr. Sage. So your question was whether or not it was clear
that he wasn't being paid?
Mr. Stupak. Well, it is the perception of the people there,
according to your two marketing reports, right?
Mr. Sage. Just to clarify, these reports are 2 out of 30
reports that we have done with consumers on Lipitor. These
reports are qualitative in nature. The one report is a study
done with about----
Mr. Stupak. My question, and I know there are a lot more of
those reports, that is why I went to specifically page 8. I was
talking about how the people perceived Dr. Jarvik as not being
a paid spokesperson, but yet, in fact, he was paid, right?
Mr. Sage. He was paid. Just to clarify, that is quote from
a single physician in a study of 20 physicians.
Mr. Stupak. You are on exhibit 10 and exhibit 11, right?
Mr. Sage. Yes, sir.
Mr. Stupak. All right. Page 11, Pfizer, Mindy Goldberg
Association, Lipitor, generic defense, consumer qualitative
research, page 8 has all of these individuals' statements on
there. That is not a one-pager from some doctor.
Mr. Sage. Just to clarify, Mr. Chairman, this is a study
that was done with an outside vendor.
Mr. Stupak. For Pfizer.
Mr. Sage. For Pfizer.
Mr. Stupak. For you, and the impact that the Jarvik ads
were having.
Mr. Sage. Yes, with----
Mr. Stupak. And how people were perceiving it. On page 8,
there it tells how people are perceiving it, right?
Mr. Sage. It is one physician's opinion of Dr. Jarvik. It
is a study of 20 physicians.
Mr. Shimkus. Mr. Chairman, we may be on different--I want
to make sure we are on the same--I don't know if we are on the
same----
Mr. Stupak. Exhibit 11. It is about----
Mr. Shimkus. They are tabs, so----
Mr. Stupak. It is about 14 pages, Mindy Goldberg Associates
Incorporated, Lipitor generic defense, consumer qualitative
research, right?
Mr. Sage. Yes, we are looking at the same thing, sir.
Mr. Stupak. OK. So how can you say that is one physician?
Mr. Sage. Just to clarify, we have done over 30 studies
with consumers on Lipitor. The overwhelming----
Mr. Stupak. Right, I know, but I am asking about this
study, about----
Mr. Sage. Sure, it is one study with 20 physicians. What
she is quoting is a quote from one physician of those 20. It is
not a projectable----
Mr. Stupak. So even this one physician, if you believe it
is-- so you say it is one physician. ``He is an expert. He
knows the heart. He is not a paid actor and not even a fly-by-
night guy.'' Right. That is what the----
Mr. Sage. That is what it says, yes, sir.
Mr. Stupak. OK, and then on the other one, page 10,
basically it says the same thing: ``I like the Dr. Jarvik ads
best of all because in my mind, he is not being paid. He is a
real person. He is not a sterile doctor. He is an expert. He
invented the artificial heart. He is an expert in cardiology.''
So----
Mr. Shimkus. These are from tab 10 now.
Mr. Stupak. Right, these are tab 10, right?
Mr. Sage. I am with you, sir, yes.
Mr. Stupak. So, and you never disclosed that Dr. Jarvik was
paid?
Mr. Sage. We did not.
Mr. Stupak. This person might have had a different review
or comments for you if he would have known Dr. Jarvik was paid,
right?
Mr. Sage. It is possible, yes, sir.
Mr. Stupak. And are you aware of the AMA guidelines that if
a health professional appears in ads, it is recommended that it
be disclosed that they are being paid?
Mr. Sage. I am, Chairman, yes.
Mr. Stupak. OK, well, why didn't you do that then?
Mr. Sage. As I understand, the decision at the time, we
consulted what we thought were the appropriate guidelines,
which were the Pharma code, our own internal guidelines on DTC,
as well as the FDA through pre-clearance. The reason we didn't
look at the AMA guidelines is because we didn't consider Dr.
Jarvik a prescribing physician.
Mr. Stupak. But you represented him as a physician, right?
Mr. Sage. We represented him very clearly as the inventor
of the artificial heart, which was disclosed----
Mr. Stupak. Well that brings me to my next question. Go to
exhibit 6, tab 6 there. Dr. Jarvik's own colleagues write that,
``Dr. Jarvik is not the inventor of the artificial heart.'' And
they requested that the Lipitor ads be corrected to accurately
describe Dr. Jarvik's contribution as one of the designers of
the artificial heart. He is not the inventor of the artificial
heart. Is that what it says?
Mr. Sage. That is what it says, yes, sir.
Mr. Stupak. OK, so if you are not portraying him as a
prescribing physician, and he is not the inventor of the
artificial heart, then how are you portraying Dr. Jarvik then?
Mr. Sage. We actually took corrective measures based on
this feedback. We clarified the communication. We pointed out
that he is the inventor of the Jarvik artificial heart, so this
was taken into account, Mr. Chairman.
Mr. Stupak. All right, let me ask you this one. Exhibit 14
and 15, based on this document, it appears that Pfizer was
about to embark upon a Doctors for Lipitor campaign, right?
Mr. Sage. It was an idea that was under consideration.
Mr. Stupak. And that was based on the success of the Jarvik
campaign, right, exhibit 10 and 11 that we showed you earlier?
Mr. Sage. It was, in part, influenced by our prior
experience, yes, Mr. Chairman.
Mr. Stupak. And a couple of doctors have agreed to do ads
for Lipitor? Dr. Robert Cloner and Dr. Lori Mosca?
Mr. Sage. At the time, two physicians had expressed some
interest. I might point out, though, that this is a campaign
that we are not moving forward with.
Mr. Stupak. Right. Do you think that the use of Dr. Jarvik
and the way it was misrepresented in your ads could have
alienated health professionals from being willing to
participate in direct-to-consumer ads, as Dr. Nielsen sort of
testified to in the first panel? Not specific to Lipitor, but
if we misrepresent the healthcare professions, they are going
to be less likely to appear in ads, and they didn't want that
taint, if you will, on the medical profession. Is that fair to
say?
Mr. Sage. I think it is fair to say that no physician wants
to taint the medical profession, nor does Pfizer.
Mr. Stupak. OK, my time is up. I think we will go more than
one round. I didn't get to the other witnesses yet.
Mr. Shimkus, questions?
Mr. Shimkus. Thank you, Mr. Chairman. A couple questions:
in your own particular processes when you are moving to market
a drug, do you all have a promotional review committee? Is
there a doctor-based review committee on the advertising?
Mr. Sage. Sure, all of the promotional materials that we
develop, whether they are for professionals or consumers, go
through an internal review process. It includes review from
lawyers, regulatory people, as well as physicians, and then all
of those materials are filed with FDA.
Mr. Shimkus. Mr. Khanna?
Mr. Khanna. Sure, yes, we have a very extensive review
process that includes not only physicians, people familiar with
the regulator process, as well as legal folks, and in addition,
these ads are pre-submitted to the FDA.
Mr. Shimkus. I am going to get to the FDA in a moment. Ms.
Taylor?
Ms. Taylor. Yes, we also have a protocol review committee
that is comprised of medical, regulatory, legal experts, and so
on, and they all review all of the materials prior to them
being finished.
Mr. Shimkus. And the follow-up question is, these doctors,
are they licensed physicians? And I guess a more clarifying
question would be in the specialty of the drug.
Mr. Sage. It depends. You have a mix of physicians on the
Lipitor team, some of whom are licensed, some of whom are not,
all of whom have spent a lot of time on the Lipitor clinical
programs, so they are very familiar with the data.
Mr. Shimkus. Mr. Khanna?
Mr. Khanna. They are licensed, and they are familiar with
the data.
Mr. Shimkus. And Ms. Taylor?
Ms. Taylor. Also, for us they are licensed and board
certified.
Mr. Shimkus. A follow-up question to all three, are they
paid by you all as part of this committee? I would imagine that
a stipend would have to be paid just to encourage them to come
and spend a day or two to do the review, but I am asking the
question because I really don't know.
Mr. Sage. Congressman, in Pfizer's case these are employees
of Pfizer.
Mr. Shimkus. Thank you.
Mr. Khanna. These are employees of Merck/Schering-Plough.
Ms. Taylor. And also in the case of Ortho Biotech, they are
employees.
Mr. Shimkus. OK, in all of the opening statements, we
talked about the FDA process. I probably could have talked to
the chairman. He is a good friend of mine. And if I would have
done a better review, I might have said why don't we have
someone from the FDA? We didn't. But the more I hear the
testimony, based upon submissions and consultations, in all of
these cases, you have done some of that, have you not, Mr.
Sage?
Mr. Sage. Correct. The ad in question and future ads in the
Jarvik campaign were submitted to FDA for comments.
Mr. Shimkus. And did they return comments?
Mr. Sage. They did.
Mr. Shimkus. Were they anything earth shattering?
Mr. Sage. All of the FDA comments were taken into
consideration.
Mr. Shimkus. Did you change anything because of the
comments?
Mr. Sage. We did, sir.
Mr. Shimkus. I used to teach high school. I am not going to
let you get away with just a yes or no. I need more
information. Can you give me an example of something you
changed?
Mr. Sage. Sure. One of the claims that the FDA had a
question about or a concern about was an efficacy claim that we
made against other LDL-lowering medicines, about our ability to
lower cholesterol, and we narrowed that claim to be more
precise to existing data.
Mr. Shimkus. Mr. Khanna, same line please.
Mr. Khanna. Yes, we did pre-submit our ads to the FDA. We
did receive comments from the FDA, and we did incorporate those
comments. A specific example is they asked us to strengthen the
importance of diet in our ads and we did receive those
comments.
Mr. Shimkus. Ms. Taylor?
Ms. Taylor. Yes, we did submit our ads in accordance with
the regulations, to the FDA. On occasion, we did receive
comments, which we addressed with the FDA and had an ongoing
dialogue with them. To give you a specific example of something
that we had changed, one word in particular, non-myeloid
cancers, which referred to the indication, was felt to be
unclear to the consumers, and so this was adjusted to refer to
patients with many types of cancer.
Mr. Shimkus. Was this an advisory opinion, or were these
responses after the ads were already run?
Ms. Taylor. These were responses after the ads were run.
Mr. Shimkus. Mr. Chairman, I think that is all I have right
now.
Mr. Stupak. Mr. Whitfield for questions.
Mr. Whitfield. Thank you, Mr. Chairman.
Mr. Khanna, the phrase or term ``enhanced'' is used to
identify the clinical trials as it related to Vytorin. Is that
correct?
Mr. Khanna. Yes, that is a specific trial for Vytorin.
Mr. Whitfield. And my understanding that the ad that Merck/
Schering-Plough used relating to Vytorin, there was never any
question about the truthfulness relating to the LDL cholesterol
being lowered. Was that ever in dispute about the truthfulness
of that aspect?
Mr. Khanna. No, that was confirmed in our FDA-approved
label and also confirmed in the enhanced study.
Mr. Whitfield. But the part of the ad that was in dispute
related to cardiovascular outcomes. Is that correct or am I
wrong there? What part of the ad was in dispute? Did it relate
to the cardiovascular outcomes of using the drug?
Mr. Khanna. Are you referring to the most recent letter
that we received from the FDA?
Mr. Whitfield. Yes.
Mr. Khanna. We initially sent our ads to the FDA. We got
comments from the FDA on our ads, made those changes based on
the FDA comments, and we ran those ads. Most recently, on
January 23 of this year, we received a change of opinion from
the FDA, so they have changed their opinion on some of the
comments that they have, and would like us to consider putting
a disclaimer about outcomes, that Vytorin does not have
outcomes above simvastatin, which is a component of Vytorin. So
we have just received those comments, and now we are working
with the FDA to try to address those comments.
Mr. Whitfield. I don't remember the details of this, but
wasn't there some issue relating to the relating to the release
date of information of the enhanced study, and did that affect
the change-of-opinion letter?
Mr. Khanna. Sir, I am not sure what prompted the FDA's
change of opinion letter. The letter came to us this year on
January 23, so we are going to work with them to accommodate
those changes.
Mr. Whitfield. But did your company delay the release of
the enhanced study?
Mr. Khanna. No, sir. I can tell you that the main debate
that occurred around the Enhance study was around the quality
of the data, and there was a significant scientific debate
about the quality of the data. I witnessed some of that debate.
There were pros and cons to that debate. Ultimately, Merck/
Schering-Plough did take steps to ensure that the quality of
the data was there and to ensure that the data was meaningfully
analyzed prior to it being presented, and that did take longer
than we anticipated.
Mr. Whitfield. Now, Mr. Sage, on the Lipitor ad, I know
that Lipitor has been studied for many, many years and has gone
through hundreds of clinical trials, including use of thousands
of patients, so your ad, there was never any questions about
the truthfulness of the comments relating to the LDL--lowering
of it, right?
Mr. Sage. That is correct.
Mr. Whitfield. So the only issue relating to your ad was
about Dr. Jarvik being in the ad, is that correct?
Mr. Sage. That is correct, Mr. Congressman.
Mr. Whitfield. And the only issue there was that, one, he
was paid, and two, he was not a practicing physician. Is that
correct?
Mr. Sage. Correct.
Mr. Whitfield. And your company made the decision to just
pull the ad, is that correct?
Mr. Sage. We ultimately made the decision to pull the ad.
Our intent was never to misportray Dr. Jarvik. We took steps
notto do that, but ultimately, there were misimpressions, so we
decided to pull the ad.
Mr. Whitfield. But Lipitor is clinically proven to reduce
the risk of heart attack?
Mr. Sage. Yes, that is one of our indications: heart attack
and stroke.
Mr. Whitfield. And do more cardiologists prescribe Lipitor
than any other medication?
Mr. Sage. They do, yes, sir.
Mr. Whitfield. OK, I have no further questions.
Mr. Stupak. Is Mr. Walden not here? Mr. Ferguson.
Mr. Ferguson. Thank you, Mr. Chairman. I appreciate your
courtesy in allowing me to sit in here. I have been a longtime
member of this subcommittee until recently, so it is nice to be
back, and thank you for your courtesy in bringing me back.
Mr. Sage, was the Ford F150 truck the best-selling truck in
the world before they started advertising? I am kidding. I
thought a little levity might help. I am sorry. Thank you and
our witnesses for being here. I appreciate it. I wanted to
start with Ms. Taylor. Thanks for being here to discuss Procrit
and the advertisements for Procrit. I am an open book. I just
want to be clear up front. I am biased when it comes to
Procrit. I lost my mother about 5 years ago to bone marrow
cancer. She had cancer for about 6 years, and when she was
first diagnosed, they gave her about a year to live. She ended
up living 6 years. She got to meet three of her grandchildren
over the course of that time. It was a great miracle in our
family. But obviously, through extensive chemo and other cancer
treatments, she was also someone who took Procrit, and some of
the best days we had with my mom was when she was benefitting
from the benefits of Procrit, so first of all, thanks for
producing the product. No drug is perfect, but certainly in our
family's case, it did a lot of good.
So just with that full disclosure, I understand the ads for
Procrit changed over the time that you had them on the air. And
I am not sure that some of the ads that we have heard about
today give a full picture of the ads that aired over the course
of time. Can you very briefly just talk about the reasoning
that you had, over time, for changing the ads as you did?
Ms. Taylor. Most of the changes that were made in the ads
were specifically, I believe, to clarify the condition for the
consumer. So chemotherapy-induced anemia, as a term, is very
difficult for a consumer to understand. Anemia, in fact, can be
very difficult for a consumer to understand. The key symptoms
of anemia, however, such as fatigue and weakness, are very
apparent to them, so advertisements, then, tended to focus
towards these key symptoms representing anemia, that would
allow a patient to recognize them, and in consequence, then,
seek guidance from his physician to talk about the symptoms.
In fact, not having seen the study from Dr. Day before, it
was, I think, very reassuring and gave us a degree of
confidence that these ads did talk and represent anemia in a
definition that patients would understand and were well
represented.
Mr. Ferguson. So I know some of the criticism of your ads
have been because of the discussion of symptoms. I am not a
doctor. I am not a medical expert, but I know that,
particularly in the case of anemia, as we saw in my mother's
case, it is diagnosed, in part, by the presence of the
symptoms, and a lot of folks, particularly patients who are
just tired. I think back to my mom's situation. She was just
tired. She didn't want to complain about just being tired when
she was a cancer patient, so I would imagine that educating
people like my mom or others about symptoms that might come
with a more serious medical condition, rather than the fact
that maybe they were just up late talking to kids or grandkids
the night before would have something to do with whether or not
they are getting the proper medical treatment. Is that correct?
Ms. Taylor. That is correct. And I think we need to be
careful about what we are talking about here, because these
were not correcting their anemia so that they could perform
strenuous exercise. These were, in many cases, everyday acts of
living that enabled them to carry on just a normal life while
they are going through one of the most traumatic and invasive
experiences in their life, which is to undergo chemotherapy.
Mr. Ferguson. As far as you know, did your ads raise the
awareness in the patient community that their symptoms might be
caused by anemia?
Ms. Taylor. Yes, we believe it did. In fact, that is why we
discontinued our ads in 2005. From our research, we believed
that there was a sufficient understanding of these symptoms and
recognition of them as being related to anemia. Roughly 6 to 7
out of 10 patients with chemotherapy will suffer from
debilitating anemia through the course of treatment.
Mr. Ferguson. Thanks, Mr. Chairman. I look forward to round
two.
Mr. Stupak. Thanks to the gentleman. Mr. Dingell for
questions?
Mr. Dingell. These are questions to our witness from Merck/
Schering-Plough. Mr. Khanna, is it true that the enhanced study
ended in April 2006?
Mr. Khanna. Sir, the study was clinically completed in
April 2006.
Mr. Dingell. And is it also true that the Enhanced results
were not released until January 2008. Is that correct?
Mr. Khanna. Sir, there was a significant scientific debate
about the quality of the data.
Mr. Dingell. Now, the Enhance study showed no difference
between Vytorin and Zocor in cholesterol build-up. Is that
correct?
Mr. Khanna. It showed no difference in the thickness of the
carotid artery as measured by imaging, and we are talking about
fractions of a millimeter difference here, which in part was
some of the reason for the some of the quality questions, to
really go through a better understanding of this data, and that
was a significant scientific debate.
Mr. Dingell. Now, between April 2006 and January 2008,
Vytorin was advertised to the public in television ads. Is that
correct?
Mr. Khanna. It was advertised between September of 2004
through January of this year.
Mr. Dingell. Now, in that period of time, Vytorin reached
$5 billion in sales. Is that correct?
Mr. Khanna. That is correct.
Mr. Dingell. So Vytorin was marketed to the public while an
important study showed that it was no more effective at
cholesterol buildup than a generic drug that was delayed by the
company for nearly 2 years, is that correct?
Mr. Khanna. Sir, the study showed no difference in
thickness of the carotid artery as measured by imaging. It did
show that we lowered cholesterol more than simvastatin,
consistent with our label, and it also showed that our drug was
safe and well tolerated, consistent with our label.
Mr. Dingell. So now, it is also true that FDA ultimately
decided that these Vytorin DTC ads needed to be changed because
they were misleading. Is that not so?
Mr. Khanna. Sir, we did receive a change-of-opinion letter
from FDA on January 23 of this year. Our FDA ads have all been
reviewed by the FDA. We have received comments from the FDA and
incorporated those comments into our ad.
Mr. Dingell. But it is true, is it not, that FDA decided
that these Vytorin ads needed to be changed because they were
misleading. Yes or no?
Mr. Khanna. We received a change-of-opinion letter from the
FDA on January 23.
Mr. Dingell. Now, Ms. Taylor, on March 9 of 2007, FDA
issued a black box warning on the Procrit label, did it not?
Ms. Taylor. That is correct.
Mr. Dingell. Along with the warning, FDA amended the
Procrit label, removing all efforts to the improvements of
quality of life in the cancer setting, did it not?
Ms. Taylor. I believe that is correct, yes.
Mr. Dingell. On November 8, 2007, FDA once again
strengthened the black box warning on the Procrit label. Is
that correct?
Ms. Taylor. That is correct, yes.
Mr. Dingell. Are you familiar with the findings in the
February 27, 2008, issue of the Journal of the American Medical
Association, concerning the risks of Procrit?
Ms. Taylor. I believe I am, yes.
Mr. Dingell. Now, isn't it true that study researchers
reported findings which demonstrated that even when used as
directed, Procrit and other erythropoeisis-stimulating agents,
or ESAs, put cancer patients at nearly 57 percent increased
risk of blood clots? Yes or no?
Ms. Taylor. I don't have the article in front of me. I am
sorry. I am not aware of that specific reference.
Mr. Dingell. Well, are you saying yes or no or you don't
know?
Ms. Taylor. I am saying I don't know.
Mr. Dingell. Now, isn't it true that study researchers also
found that Procrit and other ESA increased the death risk in
cancer patients by about 10 percent? Is that true or not?
Ms. Taylor. I would have to check on that for you, sir.
Mr. Dingell. All right, and they also found that Procrit
and other ESAs could actually enhance cancer growth at the same
doctors were using other drugs to control the disease. Is that
not true?
Ms. Taylor. I would have to check that as well, sir.
Mr. Dingell. Are you prepared to state under oath that
Johnson & Johnson's national DTC advertising campaign, touting
Procrit for fatigue relief, was unrelated to overuse or
medically unnecessary use of Procrit in the years 1998 to 2005?
Ms. Taylor. Yes, sir, I am.
Mr. Dingell. In your testimony, you stated that Procrit ads
all communicated the same theme, essentially that anemia can
cause fatigue and weakness, and Procrit may alleviate these
symptoms. Is that correct?
Ms. Taylor. What we did talk about was that anemia was a
key side effect of chemotherapy and that fatigue and weakness
are key symptoms of anemia that are recognized by patients.
Mr. Dingell. So then the Procrit ads promoted the notion
that Procrit improves the problem of fatigue and the quality of
life. Is that not so?
Ms. Taylor. What they did do was ask patients who were
undergoing chemotherapy and who experienced fatigue and
weakness to seek advice from their doctor about their symptoms
and allow the doctor to make a decision at that point.
Mr. Dingell. Now, these ads all featured weary, tired caner
victims who regained their looks, energy and zest for life
after using Procrit. Isn't that so, yes or no?
Ms. Taylor. I believe the ads accurately represented the
community that was being treated by the product.
Mr. Dingell. The tagline for these TV was ``strength for
living.'' Is that correct?
Ms. Taylor. That is correct.
Mr. Dingell. Now, the FDA has repeatedly denied your
company's application for a quality of life indication. Is that
not true?
Ms. Taylor. The FDA has not approved a quality of life
indication from Procrit. That is correct.
Mr. Dingell. Now, Procrit was not an FDA-approved device to
treat weakness or fatigue. It was approved for the treatment of
anemia. Is that not true?
Ms. Taylor. It is approved for the treatment of
chemotherapy-induced anemia. That is correct.
Mr. Dingell. Now, is J&J or Ortho Biotech considering
voluntarily removing Procrit from the market due to all of the
controversy surrounding the safety of the drug?
Ms. Taylor. No, sir, we are not.
Mr. Dingell. You are not considering that. Now, some final
questions for the panel. Ladies and gentlemen, just to each of
you, and we will start on your right and on my left. Will you
agree to follow the AMA guidelines regarding the use of actors
and health professionals in DTC ads? Sir?
Mr. Sage. Mr. Congressman, I am not in a position to decide
policy for Pfizer. That being said, as the team leader for
Lipitor, if we were going to do this ad again, which we are not
planning to do, I certainly would recommend it.
Mr. Dingell. Sir?
Mr. Khanna. Our ads are consistent with Pharma guidelines,
and I believe Pharma guidelines are very similar in many cases
to the AMA guidelines.
Mr. Dingell. And ma'am?
Ms. Taylor. Yes, sir. Our guidelines as well are very
consistent with the Pharma guidelines, and we would follow
those explicitly.
Mr. Dingell. So you are telling me that you are not going
to follow AMA guidelines?
Ms. Taylor. No, our guidelines are consistent with the
Pharma guidelines, and the Pharma guidelines are consistent, I
believe, with the AMA recommendations.
Mr. Dingell. Now, yes or no, starting again on your right
on my left. Will your company agree not to market products in
DTC ads until the completion of a valid outcome study? Yes or
no?
Mr. Sage. Mr. Congressman, in the case of Lipitor, which is
what I am here to speak about today, we have well-validated
outcome studies, so for Lipitor, yes.
Mr. Dingell. Sir?
Mr. Khanna. Sir, our ads focus on the points of lowering
bad cholesterol, focus on the importance of diet, and focus on
the fact that Vytorin does lower bad cholesterol. We believe
that these are important, not only from a public health
perspective, but lowering bad cholesterol, this is the
cornerstone of heart disease prevention, and we believe it is
important to continue to do that in a balanced an appropriate
way and we will review what we----
Mr. Dingell. I don't understand. Is that a yes or a no.
Mr. Khanna. Sir, we believe it is important to continue to
communicate the importance of lowering bad cholesterol.
Mr. Dingell. I am still trying to understand. Is that a yes
or no?
Mr. Khanna. Sir, we are going to continue to communicate
the importance of lowering bad cholesterol, as well as diet,
and Vytorin as an option.
Mr. Dingell. Now, ma'am, will your company agree not to
market products in DTC ads until completion of a valid outcome
study, yes or no?
Ms. Taylor. In speaking for Ortho Biotech, sir, we would be
unlikely to be doing DTC advertising without valid clinical
outcome studies. That is correct.
Mr. Dingell. Now, this should be a fairly simple question.
Pharma has issued guidelines on this subject which require a
moratorium on DTC ad until physicians are adequately educated
about the risks and benefits of the new drug. Starting on your
right and my left, sir, will you follow the Pharma guidelines,
yes or no?
Mr. Sage. Pfizer does follow the Pharma guidelines and has
its own more stringent internal guidelines, so yes, sir.
Mr. Dingell. Sir?
Mr. Khanna. We do feel it is important that physicians have
experience with the drugs before we advertise, and in the case
of Vytorin, physicians have experience with both Zetia as well
as simvastatin.
Mr. Dingell. All right. Ma'am?
Ms. Taylor. We did not advertise Procrit in DTC for a 5-
year period after it was first approved, but for future
products, we believe an adequate period, which may depend on
the product and the condition being treated, but an adequate
waiting period is most necessary, yes, sir.
Mr. Dingell. These are simple yes-or-no questions again. If
you please, sir, will your company market products in DTC ads
for off-label uses, yes or no?
Mr. Sage. Pfizer's position is that we market claims that
are consistent with our label. Our new ads are pre-cleared.
They are reviewed, and it is our belief that it should be
within our label. Yes, sir.
Mr. Dingell. Are you telling me yes, or are you telling me
no?
Mr. Sage. I am telling you yes.
Mr. Dingell. You are telling me no. How about you, sir?
Mr. Sage. No, sir. I said yes, to clarify.
Mr. Dingell. You are saying yes. Sir?
Mr. Khanna. If I may just ask you to repeat the question.
There was a little confusion between the answer and the
question.
Mr. Dingell. Ma'am, yes or no?
Ms. Taylor. I was asking for clarity around the question as
well. Would you mind repeating the question sir?
Mr. Dingell. The question: will you agree not to market
products in DTC ads for off-label uses?
Ms. Taylor. Yes, sir. We agree not to market products for
off-label uses.
Mr. Khanna. I agree. We will not market products for off-
label use. Our promotion will be consistent with our FDA-
approved label.
Mr. Dingell. All right, now, FDA has a phone number of Med-
Watch. Will your company add to the ads that you are putting
the notation that FDA has this 1-800-MED-WATCH phone number to
be included in your DTC ads?
Mr. Sage. Mr. Congressman, as I said, I am not in a
position to decide that policy for Pfizer. I would certainly
take that recommendation back.
Mr. Dingell. Sir?
Mr. Khanna. I will take that recommendation back for
consideration.
Mr. Dingell. Ma'am?
Ms. Taylor. Again, I am not in a position to qualify that
for the entire company, but we most certainly would look at it.
Mr. Dingell. So I haven't got any yesses. I have we will
take it under advisement. Is that what I am being told here?
Mr. Sage. Yes.
Mr. Khanna. Yes.
Ms. Taylor. Yes.
Mr. Dingell. Maybe you would like to select one of your
number to tell me what would be your objection to adding that
to your ads? What would be the objection to that, starting on
your right? You obviously have a concern which says that this
is not something that we want to do. What is it?
Mr. Sage. My only concern is personal, Mr. Congressman. As
I said, I am not in a position to make that decision for the
company. It is not a question of whether or not we take adverse
events seriously.
Mr. Dingell. Sir?
Mr. Khanna. Sir, it is something we want to evaluate. For
me, but what is most important is that we promote what is
consistent with our label, that it is accurate information, and
what motivates patients to take an action to see their
physician, so we are going to do that in the appropriate,
balanced manner.
Mr. Dingell. Ma'am?
Ms. Taylor. Yes. I am not in a position to be able to make
that position here, but from a personal perspective, what is
important is that patients have access to report that, and all
of your current ads do have patient reporting number to report
many adverse effects. So in the meantime, there is a mechanism
with our advertising to follow that.
Mr. Dingell. Thank you. Mr. Chairman, the thought occurs to
me that maybe we need somebody who can really speak on behalf
of the companies and just, perhaps, this committee should have
a proper hearing in which we bring back the presidents of the
companies, because I think that they could probably respond to
these questions in a little more helpful fashion. And I thank
you, Mr. Chairman for your courtesy, and if I have any time
left, I will certainly yield to my good friend.
Mr. Shimkus. Just as you address that, a lot of things have
been debated about the FDA did in this process because a lot of
this stuff ran through their process and the question was why
they weren't here. If we are going to do that, I would think
the FDA would be another group to bring back to see what they
knew and when they knew it and how they knew it and the like.
Mr. Stupak. We are going to have votes here pretty quick.
Let us shoot around a couple more questions if we can. I know I
have some more questions.
Mr. Sage, just so there is no misunderstanding here, the
issue with the Lipitor ad is not whether it was indicated that
Mr. Jarvik was compensated, but more importantly it was that
people had a hard time remembering the side effects and the way
that you structured the ad so they did not know what it was. In
fact, Dr. Day showed that people wildly misrepresented the need
for blood test while taking Lipitor. Don't you think the
serious side effects of these drugs should also have equal
airing with the benefits of these drugs in the ads?
Mr. Sage. Mr. Chairman, I think it is obviously important
to communicate the side effects as well as the benefits in
these ads. I also want to point out----
Mr. Stupak. In an equal manner? Dr. Day sort of destroyed
your ad in the way you placed your side effects.
Mr. Sage. Mr. Chairman, all of our ads are reviewed
internally. Many of those ads were reviewed by the FDA. They
are accurately balanced.
Mr. Stupak. Did you ever have a cognitive assessment made
on your ads.
Mr. Sage. No, we did not. I was not aware of the cognitive
assessment. It was very enlightening. Thank you.
Mr. Stupak. Mr. Khanna, today there is a news report that
is running in the Wall Street Journal, stating that Schering-
Plough has been asked to submit documents to the Justice
Department on your Enhance study. Is that correct?
Mr. Khanna. I am not aware, sir.
Mr. Stupak. OK, it just hit today. So I guess I am kind of
wondering if it was on Enhance study or on the stock sales. You
don't know anything about it?
Mr. Khanna. I don't know.
Mr. Stupak. All right. Let me ask this question to you. In
Vytorin, it appears that this is what we were talking about
earlier about as an emerging science. You were going for a rare
population that you were targeting, were you not?
Mr. Khanna. No, sir, all people have cholesterol that you
inherit as well as----
Mr. Stupak. Right, but what about your Enhance study?
Wasn't that targeted at people who not only have cholesterol
but whose family history would suggest they have cholesterol
problems?
Mr. Khanna. No, sir.
Mr. Stupak. Well, why the hot dog and Uncle Frank, then?
Mr. Khanna. No, sir, the Enhance study was a very specific
patient population called heterozygous FH who was predisposed
to having very high levels of cholesterol.
Mr. Stupak. Because of family history?
Mr. Khanna. Well, they have very high levels of
cholesterol, but everybody gets cholesterol from family.
Mr. Stupak. I don't disagree with you. You make two claims.
Number one, you are going to fight cholesterol. Number two, you
are going to go after those folks whose family history produces
cholesterol, correct? That is your Enhance study, right?
Mr. Khanna. What we are saying is that you get cholesterol
from two sources. You get it from food that is high in
cholesterol, and inheritance.
Mr. Stupak. Right, and it was a small study, and you
conducted the Enhance trial because of this, for those who have
a very high level of LDL cholesterol, right?
Mr. Khanna. No, sir, we got approved based on our ability
to lower bad cholesterol. That is the way that the FDA approves
drugs in this marketplace.
Mr. Stupak. OK, so it is just bad cholesterol, so why are
you having the frank hot dog and Uncle Frank or Virginia and
Virginia ham?
Mr. Khanna. We are tying to do a few things. One, we are
trying to say that lowering bad cholesterol is important. Two,
we are trying to reinforce diet. Three is we are tying to say
you get bad cholesterol from food that is high in cholesterol,
such as a hot dog, or your mom and dad, because what we found
is that if we can educate people that you get high
cholesterol----
Mr. Stupak. So your Enhance study wasn't meant to reduce
cholesterol but also to reduce the blockages. Wasn't that the
purpose of your Enhance study?
Mr. Khanna. Sir, the purpose of the Enhance study was to
look at the effect on the carotid artery and compare Vytorin to
simvastatin, and what we found in there was that there was no
difference in these images.
Mr. Stupak. So that part wasn't proven, and that is why the
study is in question here, right? The results of your study,
what you thought it would be, and what it ended up being, was
two different things.
Mr. Khanna. We did plan for a range of options.
Mr. Stupak. What you thought the study was going to show,
it did not show that. In fact, it took you 2 years to release
that study, did it not?
Mr. Khanna. Sir, there was a very rigorous scientific
debate about the quality of the data.
Mr. Stupak. OK, it took you 2 years to release it, right?
Mr. Khanna. I am not a scientist, but I witnessed that
debate, and there were pros and cons about that debate.
Mr. Stupak. Why don't you go to the exhibit book. We have
several emails from Merck/Schering-Plough as well as from
coordinators of the Enhance study that shows the results were
delayed. That is exhibit 22. It shows that the results were
delayed several times, even against the wishes of the principal
investigator. Do you know what the delays were in the Enhance
trial?
Mr. Khanna. Sir, I know that there were significant steps
taken to look at the quality of the data, and I know that that
process around the quality of the data and to ensure that the
data could be analyzed meaningfully did take longer than
anticipated.
Mr. Stupak. Let us go to exhibit 19. This is a print ad for
Vytorin, submitted to the FDA. Each fact is annotated to a
reference verifying its truthfulness. This paragraph about the
two sources of cholesterol is attributed to a Web site called
aboutyourcholesterol.com. That Web site actually advertises for
a mail-order dietary supplement to lower cholesterol, so it
seems to me that two sources of cholesterol is the cornerstone
of Vytorin's ad, and yet you reference a commercial dietary
supplement Web site to support the FDA application. Why not
publish a scientific study or an internal research document?
Mr. Khanna. Mr. Chairman, the reference to this Web site
was clearly an error, but Vytorin does treat the two sources of
cholesterol.
Mr. Stupak. All right, so that was a mistake you made.
You submit your ad to the FDA, but yet it takes you 2 years
to release the study. So why wouldn't you just release the
study when it was completed to the FDA like you did your ad?
What is more important? The ad or the results of your study?
Mr. Khanna. Sir, this was a scientific issue and it may----
Mr. Stupak. Well, wait a minute, submitting something to
the FDA is not a scientific issue. In fact, you are required to
submit your studies to the FDA. That is a legal requirement.
Mr. Khanna. This is a question of the quality of the data
and to ensure that that data can be analyzed. It was the
details of the science around the enhanced study and making
sure that quality is there. Ultimately, MSP did take steps to
ensure the quality of the data and to make sure that it could
be analyzed meaningfully prior to unblinding the data, and that
did take longer than we anticipated.
Mr. Stupak. My time is up. Mr. Shimkus? I still want to get
to Ms. Taylor. I have still got a number of questions for Ms.
Taylor. But go ahead, I have gone a little bit over my time.
Mr. Shimkus. Yes, Mr. Chairman, I am going to yield to Mr.
Ferguson. We are having competing hearings, and he would like
to get upstairs if that is OK.
Mr. Ferguson. Thank you very much for your courtesies, both
of you. Mr. Khanna, just to continue on this line of
questioning, I understand that there have obviously been some
questions about what enhanced actually showed. My understanding
is that while enhanced showed no significant difference in the
impact on the artery wall thickness between Vytorin and the
simvastatin, the study also showed what you already knew, which
was that Vytorin lowers LDL bad cholesterol better than a
statin alone. Is that correct?
Mr. Khanna. That is correct.
Mr. Ferguson. And was enhanced designed to study or to
measure the effect that Vytorin has on cardiovascular outcomes?
Mr. Khanna. No, sir, it wasn't designed or intended to look
at heart attacks or strokes.
Mr. Ferguson. So the last patient visit for the Enhance
study was in April 2006. The results were released earlier this
year, so a little less than 2 years. With any clinical trial,
we know that immediately following the last patient visit,
there is a process of quality control, analysis of the data, to
ensure that the data is reliable. You have unblinded the
results. You have to analyze the results. My understanding is
that for a number of reasons, with enhanced in particular, with
regard to the data, including the methodology that was used to
measuring, that quality-control process took a little longer
than expected.
Mr. Khanna. That is correct.
Mr. Ferguson. How much longer?
Mr. Khanna. I can't give the exact amount of time, but the
scientists did feel that getting the quality-control questions
right was very important, and there was a robust debate among
many scientists about the quality issues, and untimely MSP did
take steps to ensure that quality.
Mr. Ferguson. Do you think you would have come under some
heat if you released the study more quickly, and you found out
later that the methodology or the data were insufficient or
wrong somehow?
Mr. Khanna. You know I can't comment on that.
Mr. Ferguson. I could probably answer that question. I am
going to say you are going to be damned if you did and damned
if you didn't. Let me just be clear, did you know the results
of the enhanced study while your ad for Vytorin was on the air?
Mr. Khanna. No, sir, I was not made aware of the results of
the Enhance trial until January the 8 of this year.
Mr. Ferguson. And at that point, Vytorin ads were off the
air. You had already chosen to take them off the air.
Mr. Khanna. We took them off the air on January the 14th,
but I was made aware of the study results on January 8 of this
year.
Mr. Ferguson. So you made the decision about the ads before
you even had the results of the enhanced study?
Mr. Khanna. I made the decision about the ads. It was on
January the 14th, essentially the same date that we released
the primary end-point results of the enhanced trial, via a
press release. The reason I made the decision to stop the ads
was mainly because there was already a lot of science
discussion about enhance, as well as speculation about the
results. Since we were releasing the primary end-point results,
I didn't want the ad at the same time because I thought that
there would potentially be confusion out in the marketplace, so
I chose to stop the ad at that time.
Mr. Ferguson. So just to be clear and backing up for a
minute. I went through with my doc, my good cholesterol/bad
cholesterol numbers, and essentially if your bad cholesterol
number is high, it could be from what you eat, or it could be
genetic, right?
Mr. Khanna. That is correct.
Mr. Ferguson. So it is possible that someone who has a
great diet, someone who eats all of the right things still has
a high level of bad cholesterol because of genetics. Is that
possible?
Mr. Khanna. That is absolutely correct, and that is part of
the reason we wanted to educate on two sources, because if you
have got a high diet----
Mr. Ferguson. So even a person who thinks they are totally
responsible--I only eat salad, I don't eat anything with any
cholesterol in it, there is no reason that I should have a high
level of bad cholesterol--could still be at risk for health
consequences because they have a high level of bad cholesterol.
That is possible, isn't it?
Mr. Khanna. That is correct.
Mr. Ferguson. And that person would probably benefit from
knowing that high levels of bad cholesterol could come from
more than the source of a diet.
Mr. Khanna. That is correct.
Mr. Ferguson. Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Ferguson. Mr. Shimkus for
questions?
Mr. Shimkus. I think just a brief one. My friends on the
majority have issued a number of letters about all of these
studies, requesting information from you all. Are you still in
the process of providing documents in response to these
requests?
Mr. Sage. We have complied with the Committee's request and
continue to provide information as needed.
Mr. Shimkus. I mean we, as a committee, are still receiving
information from you?
Mr. Sage. If there is any new information to be had, you
are going to receive it, yes.
Mr. Shimkus. Mr. Khanna?
Mr. Khanna. Yes, we continue to comply with the Committee,
and we are in an ongoing process of sending them information.
Mr. Shimkus. So is there any outstanding information that
we still have yet to get to the Committee, based upon your
product, that we are in the process of getting, or are you
waiting for more requests from us?
Mr. Khanna. No, we are just responding to the various
requests that we are receiving.
Mr. Shimkus. Ms. Taylor?
Ms. Taylor. We have provided everything. That is my
understanding.
Mr. Shimkus. In the last 4 months, give me an idea of how
many documents you may have sent here. I will start with Mr.
Sage. Do you have any idea of the number of documents?
Mr. Sage. Two hundred and ninety thousand.
Mr. Shimkus. Wait, can you say that again?
Mr. Sage. Two hundred and ninety thousand pages.
Mr. Shimkus. Two hundred and ninety thousand pages. Mr.
Khanna?
Mr. Khanna. I am told that it is in the same vicinity.
Mr. Shimkus. Two hundred and ninety thousand? Ms. Taylor?
Ms. Taylor. I don't have the specific number. I am sorry.
My own understanding is that is a lot less.
Mr. Shimkus. Maybe a hundred thousand? I am just joking.
Ms. Taylor. I really don't know.
Mr. Shimkus. I mean that is a lot less than 290,000.
Ms. Taylor. I can find out for you, though, as soon as
possible.
Mr. Shimkus. Do you know if all of the interviews of people
involved in the studies are still being conducted, Mr. Sage?
Mr. Sage. I am not sure I quite understand your question.
In our case, we are not speaking about a study, so if you could
clarify, that would be helpful.
Mr. Shimkus. Let me just go to Mr. Khanna, same question.
Do I need to repeat it?
Mr. Khanna. We believe there are still more interviews that
are going to need to be conducted.
Mr. Shimkus. The chairman is saying there is going to be a
lot more, so I am probably getting ready for 290,000 more
pages.
Is it your understanding that this investigation is
ongoing, Mr. Khanna?
Mr. Khanna. Yes, that is my understanding.
Mr. Shimkus. I think just part of the concern on this side
is that I think there is still information to be had, and I
said this in my opening statement, but it is tough to do
oversight and investigation when not all of the stats are in,
not all of the documents. We don't have the FDA here. I am new
at this business, but that is part of this side's concerns
about the process that we have today, but I think we have
learned a lot, and I will probably learn more, so I am going to
yield back my time, Mr. Chairman.
Mr. Stupak. Thanks. In those 290,000 pages was there
anything in there in which you looked at consumers to see if
they understood the side effects of Lipitor, Mr. Sage, since
that was one of Dr. Day's criticisms of your ads?
Mr. Sage. We look comprehensively at what consumers took
away from our advertisements, Mr. Chairman.
Mr. Stupak. Right, and there was nothing in there about the
adverse side effects, if they understood it, was there?
Mr. Sage. There are no specific studies on that.
Mr. Stupak. Ms. Taylor, I said I would get to you. I have a
couple of questions for you. A year ago a public FDA advisory
committee, Dr. Richard Hauser, FDA's chief oncologist, remarked
that the FDA and the Office of Chief Counsel owed the American
people an explanation why Procrit TV ads were allowed to run
for 7 years. Ms. Taylor, are you aware that many of the experts
inside and outside of the FDA consider the 7-year Procrit TV ad
campaign to have been false and misleading because it
constituted off-label advertising for the treatment of fatigue,
which it is not approved for by the FDA.
Ms. Taylor. No, sir. In fact, my understanding is that we
had a reassurance that during the period concerned, the FDA was
satisfied that we complied with regulations.
Mr. Stupak. I am talking about your advisement for fatigue.
That is an off-label use of Procrit, isn't it?
Ms. Taylor. Our approved use for Procrit is chemotherapy-
induced anemia.
Mr. Stupak. Right, not for fatigue, right?
Ms. Taylor. And the symptoms of fatigue and weakness, which
are cardinal symptoms of anemia were used to describe that for
patient DTC.
Mr. Stupak. In that exhibit book there, go to exhibit 39.
Isn't it true that Ortho Biotech and Johnson & Johnson were
repeatedly cited by the FDA for false and misleading
advertising in connection with direct-to-consumer advertising
of Procrit as a treatment for fatigue: exhibit 39, November 6,
1998 letter from the FDA to Johnson & Johnson, exhibit 44, June
30, 2000 letter from the FDA to Johnson & Johnson, in reference
to promotional campaign for Procrit? The FDA wrote that the
claims made throughout the promotional materials are in
violation of Food, Drug, and Cosmetic Act and implemented
regulations due to expanding the use of a product as a
treatment for fatigue. Exhibit 50, dated 12/21/01, letter from
the FDA to Johnson & Johnson, detailed ``false and misleading
aspects of Procrit advertising, including two direct-to-
consumer broadcast TV ads Auntie Em and Big Boy Bed,'' and
requested that Johnson & Johnson revise the advertising
materials accordingly. ``Claims or implications that Procrit
treats weakness and fatigue or that Procrit increases strength
are misleading. Procrit is indicative for the treatment of
anemia for patients receiving chemotherapy for cancer.'' So how
can you say that was not false and misleading, and you kept
within the FDA guidelines when you have exhibit 39, 44, and 50
that say just the opposite?
Ms. Taylor. These were all, my understanding is, part of an
ongoing discussion that went on with the FDA, and after each of
these letters there was further discussion, and we complied or
agreed with the FDA----
Mr. Stupak. Let me ask you this one. If you were receiving
chemotherapy, you lose your hair, right?
Ms. Taylor. You can, right.
Mr. Stupak. How come your ads don't have anyone in there
that lost their hair to chemotherapy? I mean that is a real
simple thing you could comply with to have a fair ad. In fact,
I believe it is exhibit 50, the FDA said the models you were
showing in your ads were not accurate because you had people
who still had hair, and we know in chemotherapy you lose your
hair. It is number two, December 21, 2001, exhibit 50, ``The
presentations are misleading because the patient models
depicted are not representative of the general population of
chemotherapy patients who would appear weaker and have hair
loss among other side effects.'' That doesn't sound like a
discussion to me. That is sort of a directive on how you should
be doing your ad, and you never presented an ad with a person
without hair.
Ms. Taylor. No, we didn't. I don't have the follow-up
discussion, but I do believe that subsequent ads, which were
agreed with FDA, and which did not have patients who had hair
loss were accepted by FDA in a subsequent period.
Mr. Stupak. Let me ask you this. You said you are pleased
with your ads because people started to understand what edema
was, in response to Mr. Ferguson.
Ms. Taylor. Anemia.
Mr. Stupak. Anemia, not edema, OK. And you were here when
Dr. Day showed that people didn't remember and understand
edema.
Ms. Taylor. Yes, edema.
Mr. Stupak. So why did you use a medical term like edema
instead of using something people would understand like body
swelling?
Ms. Taylor. Actually, we were pleased to see the very high
level of recognition of the risks that we have----
Mr. Stupak. Did you run your ads by anyone like Dr. Day for
cognitive assessment? Anywhere in your company did you ever
look to see if people understood the side effects of these
drugs that you were promoting?
Ms. Taylor. I am not aware of specific research that was
done to determine that, but in seeing Dr. Day's comments, it
certainly gave us pause to look at specific expressions like
edema in future advertisements.
Mr. Stupak Anywhere in your advertising did you say that
use of Procrit for cancer patients who had tumors that Procrit
would be likely to enlarge those tumors and endanger the lives
of those patients?
Ms. Taylor. No, that was not a specific warning in the ads.
Mr. Stupak. But the FDA told you about that, and you didn't
put that in there. Don't you think people should know that
before they take your drug, that in fact, it could worsen their
condition, not make it better, by making the tumor swell more
and shorten their lifespan?
Ms. Taylor. That is a theoretical concern that has been
raised.
Mr. Stupak. Well, it has been documented, right? I mean
they documented how the tumors would swell. In fact, the
greater the Procrit they got, the quicker the tumor swelled.
Ms. Taylor. I don't believe that that is accurate, but what
we did do with the ads was we included all of the side effects
that were significantly different from placebo.
Mr. Stupak. That would be significantly different, wouldn't
it, if you were a cancer patient and the tumors you had in your
body swelled when you took Procrit? Wouldn't that be
significant, especially when it shortens your life?
Ms. Taylor. These are significant results as measured in
clinical studies, so the side effects that were there such as
diarrhea and edema, those were significantly different to
placebo.
Mr. Stupak. Can you point to any of the documents that you
submitted, anywhere, where the FDA approved Procrit for off-
label use for fatigue or weakness in patients? Can you point to
any one document of any use submitted to our committee?
Ms. Taylor. Procrit has been approved for chemotherapy-
induced anemia. Our advertisements were specifically looking at
using language that would be recognizable by a consumer such
as----
Mr. Stupak. So I take it your answer is no because you
cannot point to an exhibit, as the FDA wrote to you in exhibit
39, 44, and 50, telling you not to use your ads for tiredness
and for weakness. Do you have any letter from the FDA in all of
those documents that you provided us that said you could
advertise for that?
Ms. Taylor. In fact, all of the way through, there have
been discussions with the FDA about----
Mr. Stupak. I didn't ask about discussion. I asked about
approval for the way you marketed Procrit for 7 years for an
off-label use that was not approved for Procrit. Do you have
any document that can show me that?
Ms. Taylor. We have consistently, throughout, had
reassurances that the way we were communicating the symptoms of
anemia, such as fatigue and weakness, was appropriate to the
patient group that we were reaching with the DTC.
Mr. Stupak. All right, so you disagree with what the FDA
writes in exhibit 39, 44, and 50? That is all right. Mr.
Shimkus, questions?
Mr. Shimkus. I am going to yield my questions.
Mr. Stupak. Mr. Burgess is here. Questions?
Mr. Burgess. I will on the next round.
Mr. Stupak. We are on three, so Mr. Burgess?
Mr. Burgess. Thank you, Mr. Chairman. I apologize for being
late and coming in at the end of things here. We are also
dealing with stem cells and the Ambassador to Mexico and
Medicare payments, so there is always something going on.
On the issue that you were just discussing with the
chairman, Ms. Taylor, with the studies regarding tumor growth,
when did that come up? When did that become a concern for your
company?
Ms. Taylor. In fact, the theoretical potential for growth
was identified in the original label for Procrit.
Mr. Burgess. Because when I saw the ad that was played at
he beginning of this hearing many, many hours ago, Mr.
Chairman, it was specific that it said that this is for non-
hematologic tumors, is that correct?
Ms. Taylor. It is for non-myeloid.
Mr. Burgess. Non-myeloid. Because there was concern for if
it were a myeloid condition, that it might in fact be
stimulatory. Is that correct?
Ms. Taylor. I am not aware of the exact reason for it, but
it was a theoretical concern when we first had approval for the
product.
Mr. Burgess. Now, is there any indication as to which types
of tumors might be so affected with the theoretic concern of
increased rumor growth?
Ms. Taylor. I am not aware of specific tumor types that
were identified at that point.
Mr. Burgess. Are there, in fact, studies ongoing now to
look into that and answer these questions?
Ms. Taylor. Yes, we are attempting to complete a very large
study. It is very difficult to recruit for because of the very
nature of it. And in trying to do a definitive study, such as a
placebo-controlled study, it is very difficult to do in this
patient population, but we are working closely with the FDA and
believe that we have a design that will meet the needs to
answer some of these questions.
Mr. Burgess. And I realize that a retrospective study is
always fraught with some difficulty, but has there been any
attempt to retrospectively go back and mine the data and look
at that basis?
Ms. Taylor. There is currently underway--a Cochrane
Collaboration is doing a very large review of all of the data
of the years. I think it is roughly about 15,000 patients
experience that is in analysis now, and we should have that in
the coming months.
Mr. Burgess. Very good. On the issue of Procrit itself, was
it ever approved for the indications of treatment of fatigue
and improved quality of life?
Ms. Taylor. Procrit is approved for the treatment of
chemotherapy-induced anemia. For the advertisements that we did
with patients, we use the terms fatigue and tiredness as
representative for patients' understating of the term anemia.
Mr. Burgess. So you were referencing the symptoms of
anemia?
Ms. Taylor. This was referring to the symptoms of anemia,
such as fatigue and tiredness and also the reduction in red
blood cells.
Mr. Burgess. So the indication existed, then, for treating
low red cell mass as a result of chemotherapy, and it really
then kind of strains credulity to think that it's misleading if
you talk about the symptoms of anemia and reduced red call mass
as being those symptoms that you are trying to target with your
treatment of anemia and reduced red cell mass.
Ms. Taylor. That is what we thought, yes.
Mr. Burgess. That is what I would assume as well.
Dr. Khanna, let me just ask you a question, and again, I
apologize to you for being late. On the issue of the Vytorin
controversy that has been discussed today, I referenced in my
opening statement that perhaps there is some good in just
delivering the information that cholesterol comes from two
sources, that the average person with a diagnosis of
hypercholesterolemia may not be aware of the fact that, yes,
there are some things that they do that affects their
cholesterol level, but there may be something thing that are
embedded deep within their cells or their DNA or their family
history that results in high cholesterol, so they may just be a
benefit from even just stating that and providing that
educational information to patients, is that not correct?
Mr. Khanna. That is correct. We know that there are many
patients that are diagnosed, but are untreated, that when you
educate them that your cholesterol comes from two sources, it
takes away one of the barriers, and one of the barriers is
until they know that, they feel it is all their fault, so no
matter how much they exercise and how much they exercise, they
feel it still their fault. Once you educate them, this
motivates them to at least have a conversation with their
doctor about any additional treatments they should consider.
Mr. Burgess. And just on an intuitive basis, to me it
always made sense, the addition of those two compounds to fight
high cholesterol levels. One of the difficulties with statins
is that some people don't tolerate them as well because of side
effects. Is it ever the case that you can use a lower level of
statin by the combination with other medicines to achieve the
desired result of lowering the cholesterol level?
Mr. Khanna. That is correct. What Vytorin provides you is
additional, significantly greater LDL lowering, and we have
head-to-head studies to show that we have got greater LDL
lowering than the three available statins that are on the
market, as well as getting more patients to goal, so you could
use a lower dose of the statin with Zetia to achieve additional
benefits.
Mr. Burgess. And currently, what is the level of LDL which
is the upper limit that you want to be under?
Mr. Khanna. Sir, that varies depending on your risk
factors, but it could be anywhere less than 130, less than 100,
less than 70, depending on your risk factors that you have.
Mr. Burgess. But the overall trend as far as the
recommendation of the medical community has been to recommend a
lower number as the upper limit of normal, over the last 10 or
15 years' time. Is that not correct?
Mr. Khanna. That is correct.
Mr. Burgess. Very well. Mr. Chairman, I will yield back my
time.
Mr. Stupak. Thank you.
Since it came up, let me just ask this. It has come up by
both sides here about the erectile dysfunction and when it
should be adverted. And two of the makers are here of it. Mr.
Sage, Viagra is made by Pfizer. Would you agree that we should
pull those ads until later at night when it is not affecting
young audiences?
Mr. Sage. Pfizer's policy on advertising Viagra is to
advertise it on shows that have at least 90 percent adult
viewership.
Mr. Stupak. OK, it is not a timeline. You do it based on
viewership?
Mr. Sage. It is based on viewership, yes, sir.
Mr. Stupak. And Mr. Khanna? Schering-Plough has Levitra,
right? And so would you agree to move your advertising where
kids would not see it?
Mr. Khanna. Mr. Chairman, I am the general manager of the
joint venture. My responsibilities are solely on Vytorin and
Zetia, so I cannot comment on other products for either parent
organization.
Mr. Stupak. OK, how about as an individual? Do you think we
should be showing those ads during certain hours and there
should be appropriate hours and inappropriate hours to show
Levitra ads?
Mr. Khanna. In my own opinion, I do have two young
children, and I would not like to see ads like that during the
times when kids are watching TV.
Mr. Stupak. Mr. Shimkus.
Mr. Shimkus. Yes, I want to concur with the chairman. I am
a First Amendment guy. I am schizophrenic on this whole debate,
but even the 90-percent viewership, when you have on a major
movie that PG-13, I think we really need to look at some of
these movie channels, and some good stewardship would help go a
long way.
Mr. Ferguson. Mr. Chairman, could I concur on that as well,
but I would also say that, as father of four kids under ten, I
think we have similar concerns about any kind of advertising
that is on TV. Certainly when we are talking about ED drugs,
but we also know that there is a lot of trash on TV, and it is
even tough when you are watching a ball game with you kids on
the weekend, and I have to sit there with the clicker as soon
as any ad comes because some ad for some trashy TV program that
is on later in the week on that same station then comes on, and
you are flipping the channel, and you are muting it, and it is
like a test to see how quickly you can do it. So I absolutely
agree that there are appropriate ads that should be on certain
program or certain times of the day, but it is really, really
tough, and it is certainly not unique to this industry or any
other industry that as ads run that sometimes may be
inappropriate for kids. And I absolutely agree that this is a
problem, but it certain is a broader problem than we are
talking about here. And I would certainly be delighted to work
with you, Mr. Chairman, and the ranking member, and others if
we are going to develop some sort of a proposal for this.
Mr. Stupak. Thanks, and at the request of the minority, we
will have another hearing on direct-to-consumer advertising, so
maybe that could be a part of it.
Well, that concludes all of the questions. I want to thank
all of the witnesses in this panel. They are free to go, and
thank you for testimony today.
I ask unanimous consent that the hearing record remain open
for 30 days for additional questions for the record. Without
objection, the record will remain open. And I ask unanimous
consent that the contents of our document binder be entered
into the record. Without objection, the documents will be
entered into the record. That concludes our hearing. Without
objection, this meeting of the subcommittee is adjourned.
[Whereupon, at 3:50 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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