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ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

MAY 8, 2008 

Serial No. 110–114 

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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 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

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 

CHARLIE MELANCON, Louisiana 

Vice Chairman 

HENRY A. WAXMAN, California 

GENE GREEN, Texas 

MIKE DOYLE, Pennsylvania 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

JOHN D. DINGELL, Michigan (ex officio) 

ED WHITFIELD, Kentucky 

Ranking Member 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(II) 

(III) 

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/ScheringPlough 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 

(1) 

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. 

2 

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-toconsumer 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-conVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
3 

sumer 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. 

4 

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 

5 

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. 

6 

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. 

7 

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 

8 

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. 

9 

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 

10 

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 

11 

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 recVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
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ommend 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 wellknown 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 typVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
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ical 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, 

14 

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. 

15 

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, 

16 

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 functionVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
17 

ally 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, 

18 

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:] 

19 

20 

21 

22 

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 conVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
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ducted. 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? 

24 

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? 

25 

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 

26 

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 

27 

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 wellknown 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. 

28 

STATEMENT OF NANCY H. NIELSEN, M.D., PH.D., PRESIDENTELECT, 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 deVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
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signed to minimize risks or distract from them, as you have just 

seen. Six, it should not use an actor who portrays a physician or 

an actual physician to endorse the drug product, unless there is a 

prominent disclaimer or disclosure. And seven, it should be targeted for placement so as to avoid audiences, like my grandson, 

that are not age appropriate for the messages presented. 

In addition to those guidelines, the following key points from our 

policy deserve mention. Our AMA supports both FDA pre-review 

and pre-approval of DTCA prior to broadcast or publication. DTCA 

for new drugs should not be run until physicians have been appropriately educated about the drug. The length of this moratorium on 

DTCA could vary from drug to drug and should be determined by 

the FDA in negotiations with the manufacturer. AMA encourages 

further research on the effects of DTCA, and we support Congress 

authorizing ARC to perform periodic, evidence-based reviews to determine the impact on health outcomes and public health. If DTCA 

is found to have a negative impact on either of these, then Congress should consider legislation to increase DTCA regulation or 

possibly ban it in some or all media. 

In conclusion, recent events have heightened our concern, and 

the AMA looks forward to working with you to ensure that consumers receive information that is accurate, informative, promotes 

communication between patients and physician and does not drive 

inappropriate costs. Thank you very much for the opportunity to be 

here. 

[The prepared statement of Dr. Nielsen follows:] 

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Mr. STUPAK. Thank you, Doctor. And Dr. Brodie, for your opening statement. If you would, push that button right there on that 

mic, and you might have to pull that up a little bit. 

STATEMENT OF MOLLYANN BRODIE, PH.D., VICE PRESIDENT 

AND DIRECTOR, PUBLIC OPINION AND MEDIA RESEARCH, 

KAISER FAMILY FOUNDATION 

Ms. BRODIE. Mr. Chairman, and member of the Oversight and 

Investigations Subcommittee, thank you for the opportunity to testify today on the public’s views of direct-to-consumer prescription 

drug advertising. I am Mollyann Brodie, vice president and director 

of public opinion and medical research at the Kaiser Family Foundation. Despite the fact that they account for just 10 percent of 

healthcare spending over all prescription drugs and their costs 

have become a central healthcare affordability and access issue in 

the views of the American public, mainly because they touch almost everyone. More than half of Americans regularly take perception drugs, and four in ten report some serious problem paying for 

their medications, including having to skip doses because of the 

cost. 

The public has mixed views of prescription drugs and the companies that make them. On the positive side, they appreciate the benefits for the drugs themselves and most people agree that medications have had a positive impact on their own lives and the lives 

of Americans in general. However, on the negative side, they are 

very concerned about high drug prices, which nearly eight in ten 

say are unreasonable, and which, in the public’s views are largely 

driven by high company profits. Prescription drug advertisements 

have become ubiquitous, and nine in ten adults report having seen 

or heard advertisements for medications. Americans have mixed 

views about the relative benefits and costs associated with these 

ads. On the one hand, most Americans agree with the proponents 

of the drug ads, who say that they raise awareness, help educate 

the public, and reduce stigma. On the other hand, most people 

agree with the critics of the ads, who say they raise prescription 

drug prices and induce unnecessary demand. 

Further, the public’s views are mixed about how well the drug 

ads present specific information about the medicines they advertise. While the majority say they do a good job explaining the potential benefits and what condition the drug is designed to treat, 

more than half say they do only a fair or poor job explaining the 

potential side effects. The survey data strongly suggests that the 

drug advertisements are doing what they were designed to do: 

prompting people to talk to their doctors and to get prescriptions. 

About a third of Americans report that they have talked to a doctor 

about a specific drug after seeing an ad, and about eight in ten of 

that group said that the doctor recommended a prescription as a 

result, either for the drug they asked about or for another medication. People report that these discussions led to other actions as 

well. For example, more than half of those who talked to their doctor about a specific drug say the physician recommended lifestyle 

or behavioral changes, while about three in ten said the doctor recommended an over-the-counter drug. 

52 

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:] 

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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, compaVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
71 

nies 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:] 

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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. 

92 

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. 

93 

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 directto-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 phyVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
94 

sicians 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? 

95 

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 directto-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 

96 

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 overutilization 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—— 

97 

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-thecounter 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. 

98 

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. 

99 

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 directto-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. 

100 

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 evidencebased 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 

101 

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 

102 

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 directto-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 

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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 whollyowned 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 

104 

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 cardioVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
105 

vascular 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:] 

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107 

108 

109 

110 

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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. 

112 

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/ScheringPlough 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:] 

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114 

115 

116 

117 

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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 chemotherapyrelated 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 paVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00124 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
119 

tients, 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 parVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00125 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
120 

*Procrit (epoetin alfa) is a registered trademark of Ortho Biotech Products, L.P. 

ticular, the broadcast television advertisements of Ortho Biotech’s medicine 

Procrit *, which the company stopped airing 3 years ago. 

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 

121 

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 chemotherapyinduced 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 

122 

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—— 

123 

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. 

124 

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-toconsumer 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. 

125 

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? 

126 

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 changeof-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 

127 

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. 

128 

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? 

129 

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. 

130 

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? 

131 

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 chemotherapyinduced 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. 

132 

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 offlabel 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 offlabel 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 MedWatch. 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. 

133 

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 

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tured 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? 

135 

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? 

136 

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 

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entists 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 

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ing 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 

139 

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 

140 

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 

141 

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? 

142 

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 inforVerDate Nov 24 2008 10:20 Jan 12, 2010 Jkt 037690 PO 00000 Frm 00148 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-114 SCOM1 PsN: JIMC
143 

mation 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-tohead 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. 

144 

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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