[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
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                    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

                              ----------                              
                                                                   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?

                              ----------                              


                         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:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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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