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25–879 PDF 2006

S. HRG. 109–317

THE IMPACT OF DIRECT-TO-CONSUMER DRUG

ADVERTISING ON SENIORS’ HEALTH AND HEALTH

CARE COSTS

HEARING

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

WASHINGTON, DC

SEPTEMBER 29, 2005

Serial No. 109–14

Printed for the use of the Special Committee on Aging

(

SPECIAL COMMITTEE ON AGING 

GORDON SMITH, Oregon, Chairman 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

JAMES M. TALENT, Missouri 

ELIZABETH DOLE, North Carolina 

MEL MARTINEZ, Florida 

LARRY E. CRAIG, Idaho 

RICK SANTORUM, Pennsylvania 

CONRAD BURNS, Montana 

LAMAR ALEXANDER, Tennessee 

JIM DEMINT, South Carolina 

HERB KOHL, Wisconsin 

JAMES M. JEFFORDS, Vermont 

RUSSELL D. FEINGOLD, Wisconsin 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

BILL NELSON, Florida 

HILLARY RODHAM CLINTON, New York 

CATHERINE FINLEY, Staff Director 

JULIE COHEN, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Herb Kohl ............................................................. 1

Opening Statement of Senator Gordon Smith ....................................................... 3

Opening Statement of Senator Ron Wyden ........................................................... 4

PANEL OF WITNESSES

Rachel E. Behrman, MD, MPH, deputy director, Office of Medical Policy, 

Center for Drug Evaluation and Research, and director, Cross-Centers Initiatives Task Force, Office of the Commissioner, U.S. Food and Drug Administration, Department of Health and Human Services ............................... 6

Paul Antony, MD, MPH, chief medical officer, Pharmaceutical Research and 

Manufacturers of America (PhRMA), Washington, DC .................................... 58

Donna Sweet, MD, FACP, chair, Board of Regents, American College of 

Physicians, Washington, DC ............................................................................... 80

Peter Lurie, MD, MPH, deputy director, Health Research Group, Public Citizen, Washington, DC .......................................................................................... 87

Richard L. Kravitz, MD, MSPH, director, Center for Health Services Research 

in Primary Care, University of California, David Medical Center, Sacramento, CA .......................................................................................................... 100

(III) 

(1)

THE IMPACT OF DIRECT-TO-CONSUMER DRUG 

ADVERTISING ON SENIORS’ HEALTH AND 

HEALTH CARE COSTS 

THURSDAY, SEPTEMBER 29, 2005 

U.S. SENATE, 

SPECIAL COMMITTEE ON AGING, 

Washington, DC. 

The committee met, pursuant to notice, at 10 a.m., in room SH–

216, Hart Senate Office Building, Hon. Herb Kohl, presiding. 

Present: Senators Smith, Talent, Kohl, and Wyden. 

OPENING STATEMENT OF SENATOR HERB KOHL 

Senator KOHL [presiding.] Good morning and we welcome everyone to this hearing where we will examine today the effects of direct-to-consumer advertising of prescription drugs on patients, doctors, and health care spending. As always, we thank our Chairman, 

Gordon Smith, for working with us in a bipartisan manner to examine this important issue affecting seniors. 

We all know that Americans pay the highest prices in the world 

for medicines that are largely researched and manufactured here 

in our own country. Starting in January, the American taxpayers 

will pay hundreds of billions of dollars for drugs through the new 

Medicare benefit. So now, more than ever, we have a responsibility 

to ensure that those dollars are being spent wisely. 

As we look to the reasons why drug costs are so high, one contributing factor is the widespread advertising of drugs directly to 

consumers. Spending on advertising of prescription drugs more 

than quadrupled between 1996 and 2003 in this country. Companies have the right to spend as much as they choose to promote 

their products, although it should be noted that, aside from New 

Zealand, the United States is the only country in the world that 

allows direct advertising of drugs to consumers. We should consider 

whether there is a message there that we should think seriously 

about. 

But as the largest payer of prescription drug costs, the Federal 

Government has an obligation to examine the impact of these 

drugs on drug choices and health care spending. Today’s ads often 

steer consumers toward newer, costlier drugs when older, less expensive drugs may be more appropriate. This leads to higher 

health care spending as patients demand and doctors prescribe 

more expensive medicines. 

The reason that these ads are so powerful is because they often 

are the only source of information that patients have about a drug. 

2

The ads paint a picture of a healthy life that can be theirs only if 

they just ‘‘ask their doctor.’’ Unfortunately for consumers, this is 

not always the complete picture as most patients have no idea 

whether the new drug is better than the older one that they have 

been taking for years. 

It should not be left solely to the drug industry to educate patients and doctors about new medicines. We need more unbiased 

research, perhaps through the NIH, that will compare new and old 

drugs to help doctors and patients determine which is the best, 

most cost-effective medicine for them. 

We also need to give doctors time to fully understand the benefits and risks of a new drug once it reaches a market. Ads for 

newly approved drugs hit the airwaves immediately, sending patients to their doctors to request what they have seen. We should 

consider a moratorium on advertising for newly approved drugs to 

provide doctors enough time to fully understand their effects. 

Finally, we also know the FDA has limited enforcement measures at their disposal to crack down on misleading advertising. Providing stronger enforcement tools to the FDA will help prevent unnecessary utilization costs and potentially harmful outcomes to patients. 

I am working on legislation to address some of these issues, and 

I know that other Senators, including Senator Wyden, who is here 

today, have also begun working on legislative answers. I have also 

joined with Senator Frist to ask the GAO to study the effect of 

DTC advertising on drug costs and utilization. I look forward to 

working with all of my colleagues on this important issue. Clearly, 

companies have the right to advertise their products, but with the 

new Medicare drug benefit starting soon, taxpayers are about to 

foot the bill for billions of dollars in drug costs. They deserve to 

know that doctors and patients have the best information available 

to choose the most appropriate and the most cost-effective medicines. 

We thank everybody for their participation here today. Before we 

turn to Senator Smith, I want to mention that we have a roll call 

vote at 11:30 which requires all Senators to be in the chamber. I 

hope we can move forward with this hearing and maybe conclude 

so that we will not have to recess for an extended period of time 

and return. 

So now we turn to our esteemed chairman, Gordon Smith, for his 

opening remarks.

3

OPENING STATEMENT OF SENATOR GORDON H. SMITH, 

CHAIRMAN 

The CHAIRMAN. Thank you, Senator Kohl. It is a pleasure to 

work with you. This hearing is very appropriate, very timely, and 

it was your idea, and we thank you for your leadership. 

Also, my colleague in the Senate, Senator Wyden, thank you for 

your service on this committee as well. Ron Wyden’s commitment 

to seniors and the elderly is legendary in my State, and appropriately so. 

We welcome all of you and wish you a good morning. While national health care spending has slowed in recent years, it is projected that total national spending on health care goods and services will reach 18.4 percent of the Nation’s gross domestic product 

by 2014. How the Government and individual citizens spend their 

health care dollars will continue to be an important policy discussion on Capitol Hill. 

One area of health care in which spending is projected to increase significantly in coming years is prescription drugs. Advances 

in pharmaceutical sciences have provided millions of Americans 

with the opportunity to live longer, healthier lives, but often at a 

significant cost. 

Over the last several decades, the pharmaceutical industry has 

spent billions of dollars to promote new prescription drugs to both 

doctors and consumers. Direct-to-consumer advertising is just one 

component of a larger marketing effort. But given that spending on 

such ads has quadrupled since 1998, it is an area that deserves 

further exploration, especially in connection to how it affects consumer safety and overall prescription drug consumption. 

From a positive standpoint, direct-to-consumer drug advertising 

may encourage individuals who might otherwise not seek health 

services to see their doctors. This is especially true for individuals 

who may be suffering from a mental illness, such as depression or 

bipolar disorder. 

A 2003 study showed that approximately 25 percent of surveyed 

individuals who had discussed an advertised drug with their physicians reported receiving a new diagnosis. Evidence would suggest 

that advertising can encourage individuals to learn more about 

symptoms they might suffer from and get treatment for 

undiagnosed conditions. 

Beyond advertising’s ability to prompt individuals to seek out 

health care, there are many other issues that should be explored 

further by policymakers, industry representatives, and health care 

advocates. For instance, does the content of direct-to-consumer 

advertisements appropriately inform individuals of the benefits and 

risks of new prescription drugs, or are they aimed more at building 

product loyalty? This is an especially important question to ask in 

regard to new products entering the market, whose effect on the 

general population may not be fully known. I am hopeful some of 

the discussion today can address this concern, as well as other 

issues relating to better informing consumers through direct-to-consumer ads. 

In terms of physician prescribing behavior, it is still unclear how 

direct-to-consumer advertising affects the decision to prescribe a 

certain type or brand of prescription drug. We will hear today 

4

about recent research that suggests patient requests for specific 

drugs may influence doctors’ prescribing behavior. However, while 

such findings highlight an interesting dynamic of the patient-physician relationship, it may be more difficult to explicitly link drug requests to direct-to-consumer advertising. 

I should also note that in considering the issue of prescribing behavior, we should not ignore other types of promotional activities, 

especially those targeted towards physicians and their office staffs. 

I invite all witnesses to share their thoughts on the relationship 

between direct-to-consumer advertising and overall health care consumption. Additionally, I would appreciate any suggestions witnesses might have to offer that improve the process by which information regarding prescription drugs is communicated to the public. 

I look forward to a thoughtful exchange today, and I hope this 

hearing will prompt a broader discussion of the steps interested 

parties can take to further ensure a more consistent balance between promotional and education content in all forms of prescription drug advertising. Ultimately, we should all be working toward 

the goal of keeping consumers well informed of important developments in pharmaceutical science so that they can improve their 

overall health and well-being. 

Thank you, Senator Kohl. 

Senator KOHL. We thank you, Mr. Chairman, and now we would 

like to hear from the very fine Senator from Oregon, Ron Wyden. 

OPENING STATEMENT OF SENATOR RON WYDEN 

Senator WYDEN. Well, thank you, and I guess I should thank all 

the chairmen that are here today, and I think it is terrific, Senator 

Kohl, that you developed this idea, but these hearings don’t just 

happen by osmosis. They happen because the Chair wants them to, 

and I commend Senator Smith, and I very much share his view 

about the need to educate consumers as well. 

I have come to the conclusion on this that the people of this 

country think prescription drug advertising has just gotten completely out of hand, and that much of the advertising—not all of 

it, but much of it goes way beyond the legitimate interest in educating the consumer and is primarily used to increase demand and 

increase profits for the pharmaceutical companies. I have been 

struck and have actually asked the pharmaceutical representatives 

why it is that if education is the primary interest here, why is it 

that only the blockbuster drugs seem to be the ones that get advertised. You don’t seem to see the ones, the orphans that can’t generate much profit. They don’t seem to be the ones that get advertised. 

So the question then becomes: What would be an appropriate approach to deal with this issue that particularly is consistent with 

the Constitution? There is a First Amendment right to communicate, and certainly the companies have asserted it. The companies also get a tax break for using that First Amendment right, so 

when those purple pills dance across somebody’s television set, 

there is already a taxpayer subsidy for that particular activity. But 

in fairness to the companies, it is also correct that if somebody advertises for their pizza parlor or some other business, they get a 

tax break for that as well. 

5

So the question that I have said at least ought to be the start 

of this debate is: Should there be a double subsidy for these prescription drug ads? The pharmaceutical people already get one subsidy. Should they get a second one? Senator Sununu of New Hampshire and I have concluded that that is where we would draw the 

line. We would say let us now take the advertising expenses out 

of the costs at least of Government programs like Medicaid. 

Senator Smith in particular has done extraordinary work on the 

Medicaid program. It is clear that there are going to have to be reforms. The Congressional Budget Office has told us that given the 

fact that we are going to spend $4 billion a year on prescription 

drug ads—not my figure; that is from the Wall Street Journal. According to the figures from the Congressional Budget Office, we 

could get close to half of the savings that are needed for the Medicaid budget target just if we stop the companies from getting a 

double subsidy and took advertising expenses out of the cost of 

Government health programs like Medicaid. 

So Senator Sununu and I are going to continue to work on that 

legislation. It is S. 1128, the Pharmaceutical Advertising and Prudent Purchasing Act. It was introduced in May. I want to wrap up 

just by giving a couple of comments on some charts that we have 

developed. We have put together some charts that outline the advertising situation. 

The first shows the most advertised drugs in our country as of 

2003, and you can see many drugs that the consumer and the public is familiar with. 

The second chart is the one that I think is particularly troubling. 

It shows the drugs that are most used by the Medicaid program. 

These are the top ten drugs that Medicaid pays for with taxpayer 

dollars for low-income people at a time when the Medicaid program 

faces the draconian cuts. You can see that of the ten most commonly used drugs in the Medicaid program, four of them are paid 

for with this double subsidy that I think is so troubling. 

The last chart I brought is an indication that highlights the point 

Senator Kohl made of what is to come. We, of course, are starting 

very shortly a Medicare prescription drug benefit. We are now talking here about the ten most commonly used drugs in the Medicare 

program, and virtually all of them are advertised. So, once again, 

Medicare, like the other programs—the VA, the Public Health 

Service, and other programs—Government health programs will 

pay a double subsidy. It seems to me that if the companies get to 

exercise their First Amendment rights, they get a tax break for exercising their First Amendment rights, at some point you ought to 

draw the line and say we are not just going to subsidize them 

again and again and again. Senator Sununu and I have drawn that 

line in S. 1128 where we would take the advertising expenses out 

of the cost of government health programs. 

I thank the two Chairs, and particularly for giving me a little 

extra time to walk through our legislation, and I look forward to 

working with both of them and thank them both for their kind 

words. 

Senator KOHL. Thank you, Senator Wyden. 

At this time we will call our first witness, Dr. Rachel Behrman. 

Dr. Behrman comes from the Food and Drug Administration. She 

6

is the deputy director of FDA’s Office of Medical Policy, which oversees the Division of Drug Markets, Advertising, and Communications. 

Dr. Behrman, we are very pleased that you are here today, and 

we welcome your testimony. 

STATEMENT OF RACHEL E. BEHRMAN, MD, MPH, DEPUTY 

DIRECTOR, OFFICE OF MEDICAL POLICY, CENTER FOR 

DRUG EVALUATION AND RESEARCH, AND DIRECTOR, 

CROSS-CENTERS INITIATIVES TASK FORCE, OFFICE OF THE 

COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION, 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. BEHRMAN. Thank you, Senator Kohl, Senator Smith, and 

Senator Wyden. Good morning. As you mentioned, I am Dr. Rachel 

Behrman, deputy director of the Office of Medical Policy and director of the agency’s Cross-Centers Initiatives Task Force. 

Thank you for this opportunity to discuss FDA’s role and experience in overseeing the promotion of prescription drugs to consumers. Today I will briefly discuss some of the issues behind the 

ongoing debate about DTC advertising, many of which have just 

been touched upon, and then summarize several agency initiatives. 

One of our top priorities is ensuring that Americans are educated 

about their health and treatment options with clear and accurate 

information. We have all been exposed to DTC ads in print and on 

television, for example, and perhaps have felt that although DTC 

advertising has the primary intent of promoting a product, it also 

has the potential to promote awareness of undiagnosed or undertreated diseases, to promote an understanding of possible treatments, and to foster health-related discussions with physicians. In 

other words, it is an opportunity for two different interests to align. 

But this can only happen if the promotion is done properly if, in 

addition to being truthful and not misleading, the promotion is 

clear and accessible to consumers. 

Direct-to-consumer advertising has always been legal in this 

country, although historically it was aimed primarily at physicians, 

and our regulations do not distinguish between the two audiences. 

DTC advertising remains a small percentage of all prescription 

drug promotion, but it has increased sharply since the mid–1990’s 

as broadcast DTC has become more prevalent. This increase has 

sparked an intense debate about the impact of DTC and about the 

role of regulation. 

Monitoring DTC advertising is a top priority for us, but truthful 

advertising cannot be achieved unless it accurately communicates 

and balances the benefit and risk information about a prescription 

drug. Thus, FDA has undertaken a number of important initiatives 

to improve the communication of prescription drug information to 

consumers. 

In 2004, we issued two draft guidance documents aimed at improving the quality and usefulness of DTC advertising. The first 

addressed alternative ways of disclosing risk information in consumer-directed print advertisements. The goal of the guidance is to 

encourage manufacturers to abandon the dense, tiny-type presentation of risk information and replace it with clear, comprehensible, 

succinct, and visually accessible paper that can serve as an eduVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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cational tool and can stimulate discussion between patients and 

their health care providers. 

The other guidance addresses and encourages what are common 

called help-seeking advertisements. These are ads that do not mention a particular product but are intended to raise awareness of a 

particular disease or condition. 

In addition, FDA is finalizing a regulation that will completely 

overhaul the information required to be distributed with prescription drugs. Known as ‘‘the package insert,’’ it is the long, complicated, tiny-print label that is tucked into prescription drug packages. When this regulation issues, it will require that a high-level 

summary of the most important information precede the detailed 

prescribing information contained in the package insert. This summary, which will be reviewed and approved by the FDA, will enable us and the industry we regulate to more rapidly and easily 

identify the risk information that should be included in advertising. 

This regulation, once issued, will also support the agency’s electronic health initiatives, for example, ultimately making it possible 

for FDA to provide concise, reliable, and up-to-date medical product 

information available immediately and free of charge on the Internet and in an easily searchable format. 

The key issue in the DTC debate is whether it helps or harms 

Americans. Answering this question requires data. We must know 

what consumers understand, how they perceive risk information, 

and what helps them make informed choices, to name just a few 

of the questions facing us. Therefore, FDA continues to conduct research and last fall published a comprehensive report on patient 

and physician attitudes and behaviors associated with DTC advertising of prescription drugs. 

Our data demonstrate that DTC advertising clearly provides an 

opportunity to inform. This number will not be a surprise: 81 percent of patients responding to our surveys have been exposed to 

DTC advertising, and many of them went on to seek more information, usually about the drug but sometimes about their health condition. 

On the other hand, our data also show that approximately 60 

percent of patients and physicians believe that DTC advertisements overstate the benefits of the product and almost as many believe that the ads understate the risks. This is a problem that must 

be addressed by the industry we regulate, and so we welcome 

PhRMA’s recent announcement of voluntary guidelines to improve 

the quality of DTC advertising. These guidelines in particular emphasize compliance with FDA regulations and require advertising 

to be neither false nor misleading, to make claims only when supported by substantial evidence or substantial clinical experience, 

and to appropriately balance the risk and benefit information. 

Another recent initiative involves the re-evaluation of our regulations. Are these regulations, implemented in the 1960’s and without a consumer audience in mind, effective for DTC advertising? To 

help answer that question and many others surrounding DTC, we 

have scheduled a public hearing on November 1 and 2 of this year, 

and we hope to hear a broad range of opinions. 

DTC advertising is advertising, but it is also an opportunity—an 

opportunity to help Americans become better informed about their 

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health and to reach Americans who may be unaware of or ignoring 

important health problems. This opportunity should not be missed. 

Therefore, the agency will continue our research to better understand the effects of DTC advertising and how best to communicate 

the important information about risks and benefits. We will also 

continue to closely monitor DTC advertising while working within 

industry to ensure that all promotion is fully compliant with applicable laws and regulations; and when it is not, we will take appropriate enforcement action. 

Finally, we look forward to beginning a thorough evaluation of 

the regulations that govern promotion, and DTC promotion in particular. 

Thank you, and I will be happy to answer any questions. 

[The prepared statement of Dr. Behrman follows:]

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Senator KOHL. Thank you, Dr. Behrman. 

Dr. Behrman, in the last year, I understand that FDA has issued 

17 warning letters to drug companies regarding misleading advertising. While this may not seem like a lot, it is considerably more 

than in the past two years. 

Dr. BEHRMAN. Yes. 

Senator KOHL. To what do you attribute this increase? Is it a 

push for greater scrutiny from your agency? Is it that more drugs 

are on the air than ever before or more misleading drugs on the 

air? 

Dr. BEHRMAN. There are two parts to the answer to that question. One, I believe, part of what you are asking me is are the ads 

getting worse, and the other is why this shift in more warning letters as compared to what we call untitled letters, which are lesser 

violations. In part, we have, because of resource constraints, made 

a very conscious and determined effort to focus on the most egregious violations and, therefore, focus more on the kinds of ads that 

might prompt a warning letter. That is part of the answer, and, 

again, part of the answer might be that it appears to us—and, 

again, we tend to see the worst—that there has been somewhat of 

a trend to ads we consider more violative. 

Now, just in the last few months, we have been encouraged in 

that we have seen a couple of ads that really have broken a new 

mold and actually have done what we have all been talking about 

a little bit this morning, which is take more of an opportunity to 

inform and educate at the same time promoting the product. 

Senator KOHL. Dr. Behrman, as you know, spending on DTC advertising of prescription drugs more than quadrupled between 1996 

and 2003, yet there has not been a comparable increase in your 

staff and budget at the FDA to police all of these ads. PhRMA’s 

new guidelines are calling for companies to submit all new TV ads 

to the FDA before they air. Does the FDA have the resources to 

do their job? What additional tools would you need? 

Dr. BEHRMAN. Well, I am not here asking for resources, although 

asking a manager if they want more resources, I think, is very 

much like asking a child if they want another cookie. It is always 

very hard to say no. 

We are very proud of our efforts. We prioritize. We target. We 

have not increased to the same extent, obviously, that advertising 

has. As you said, it is a program, if you will, the promotions are 

over $20 billion a year. DDMAC, the Division of Drug Marketing, 

Advertising, and Communications, is staffed by a staff of 40, a very 

dedicated and capable staff, but a staff of 40. So we prioritize, and 

we believe that we have a vibrant program. 

Senator KOHL. As you, of course, know, Bristol-Myers Squibb recently announced a 1-year moratorium on ads for all newly approved drugs in an effort to allow physicians enough time to fully 

understand the appropriate use of their medicines. Would the FDA 

support a similar moratorium on all newly approved drugs? 

Dr. BEHRMAN. Again, there are two parts to the answer. One, 

under our regulations and under our law and under our Constitution, DTC advertising is legal. I think what is of keen interest to 

the agency, which I tried to point out, are our other efforts to make 

sure that physicians and patients and consumers have other aveVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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nues of access to information. We as an agency are extremely good 

at analyzing data. We have not been as good in the past about providing that data, improving our website, improving the package insert, which, when our content and format reg is finalized, will revolutionize package insert information and make it accessible in 

hand-held and make it accessible over the Internet. So we are focused very much on other avenues of information. 

Senator KOHL. Thank you, Dr. Behrman. 

Mr. Chairman. 

The CHAIRMAN. Thank you, Senator Kohl. 

Dr. Behrman, I am going to ask this question just for my own 

interest about your relationship with PhRMA and drug companies 

when you work out disclaimers. I always get a chuckle out of their 

ads, frankly, because they claim hypothetically if you take this, it 

will cure your hemorrhoids, but you are going to have a heart attack. What kind of dynamic is there between you? Is it contentious, 

or do the companies see these tag lines, these disclaimers, these 

warnings, as protecting them against liability? They certainly 

would cause me not to take the drugs. 

Dr. BEHRMAN. I cannot speculate on what PhRMA thinks or 

what actually any individual company thinks because, remember, 

the ads are developed by the company, not by PhRMA. 

The CHAIRMAN. Right. 

Dr. BEHRMAN. It is also worth pointing out, as I am sure you 

know, that our enforcement process is post hoc. Companies are not, 

except in very rare circumstances, obligated to show us an ad before it airs. They are obligated to show us the ad at the time it airs, 

and then we are in this post hoc enforcement mode. 

Just of note, there have been ads for certain conditions where the 

side effect profile is so unappealing—and this is for some of the 

obesity drugs—that DTC advertising was, I believe, deemed by the 

companies as, again, not sensible. But we are very interested in 

how to properly communicate risk information and to do it in such 

a way that it doesn’t—you know, the hemorrhoid/heart attack example is an example, but what if you truly have a serious condition 

such as diabetes, but you find the recitation of whatever frightening? This is not what we want. We want clear, accurate communication of information and in a balanced way in the ad. That is 

what we believe the regulations demand, and that is what we are 

doing research to better understand how to accomplish. 

The CHAIRMAN. Well, I think it is important that accurate appear 

in ads, frankly, because while there is a First Amendment right, 

we don’t live in a snake-oil age. They need to have information regarding risks. 

Dr. BEHRMAN. Exactly. One question we are bringing to this public meeting, this Part 15 hearing in November, is given that it is 

to a consumer audience, what is the bare minimum, if you will, of 

contextual information about the disease, about the condition, 

about other therapies that must be provided so that it is truthful 

and not misleading? You have the hemorrhoid and heart attack. 

Ours is the risk information is in Italian and the ad is in English. 

Is that permissible? 

The CHAIRMAN. Yes. Well, I just think you are performing very 

important work for consumers. If the companies, are going to exerVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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cise their right to advertise directly to consumers, it is important 

that people know whether the cure is worse than the disease. 

Dr. BEHRMAN. Worse, or inappropriate for them and they should 

not even bring it up. 

The CHAIRMAN. There really does need to be an educational component that may be at cross purposes with building brand loyalty. 

But that is the world we live in. 

Thank you. 

Senator KOHL. Thank you, Mr. Chairman. 

Senator Wyden. 

Senator WYDEN. Thank you, Mr. Chairman. Both of you have 

asked good questions. I just have a couple of quick follow-ups. 

What do you do by way of defining when a company goes over 

the line? You said that you try to deal with the most egregious 

kinds of claims, which certainly is in the public interest. But how 

do you define that? How do you, in effect, go about the task of saying this one is over the line and we are going to send them a warning letter, we are going after them, this one is within bounds? How 

do you go about that? 

Dr. BEHRMAN. It is a very good question. It is a very difficult decision. Anything, obviously, that requires that kind of judgment is 

not black and white and cannot be clearly articulated, although we 

try very hard to set standards that are easily understood by the industry we regulate in terms of, for example, developing more guidance because, in part, they need to produce quality ads, but in part, 

if we haven’t made it clear to them what the standards are, it becomes harder for them to do. It also is a question sometimes of 

what comes to our attention. Remember, we are inundated with advertising, as we have all discussed. It is a $20 billion a year expenditure. So we don’t look at every ad. It could be a complaint. 

It could be we see one at home. It could be a family member brings 

it to our attention. But then we have to make an assessment of 

whether indeed it is violative or not. 

Senator WYDEN. You said $20 billion. I have been using this Wall 

Street Journal figure of direct-to-consumer advertising as $4 billion. 

Dr. BEHRMAN. I am sorry, $4 billion for—yes, I am thinking of 

the entire mission of the division. 

Senator WYDEN. OK. With respect to what is ahead, have you all 

given some thought to including cost-effectiveness as part of the 

whole debate about what goes into one of these ads? Because I 

think that as people look in the future—and we are certainly going 

to see more of this—that is one of the things they really want to 

know. 

Dr. BEHRMAN. Cost-effectiveness of the therapy? 

Senator WYDEN. Yes, and data that points to this drug that is 

being advertised as being more cost-effective than what is out 

there. 

Dr. BEHRMAN. Well, our standard for putting a claim in an ad 

is that it be supported by substantial evidence, and if there was to 

be a cost claim, it would have to be supported by evidence that 

would be adequate. 

Senator WYDEN. I am asking about whether you all are looking 

at requiring something like that or asking for it. 

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Dr. BEHRMAN. Asking for cost-effectiveness data, no, we are not. 

Senator WYDEN. Do you think that would be in the public interest? 

Dr. BEHRMAN. To ask FDA to evaluate cost information? 

Senator WYDEN. No, no. To say that that should be included in 

the claim. No, you wouldn’t be suddenly out there trying to make 

those assessments, but that that should be required as part of an 

ad. 

Dr. BEHRMAN. Again, I am not an attorney. I think it would be 

very difficult for us to require certain types of speech or claims in 

any ad. We are required to evaluate the ads that come before us 

to see whether they are compliant with regulations. But other 

than, for example, requiring that it be consistent with labeling, we 

are not required to have certain types of information in the advertisement. 

Senator WYDEN. So where do you look then on the label? If labeling is going to be the sort of lodestar here, you know, what do you 

look at in terms of labeling? Because I think that is something that 

the public wants to know. I mean, the public wants to know about 

whether it is going to be effective for them from the standpoint of 

their health, and the public wants to know if it is going to be costeffective. 

Dr. BEHRMAN. Well, again, whether it is going to be effective for 

them is a discussion they have to have with their health care provider. Whether it is going to be cost-effective for them, I am still 

at a loss of quite how to understand how to evaluate that. I can 

understand how to balance as a physician the risks and benefits for 

a particular patient, but I am not quite sure how I would understand how to balance how much it costs them. 

Senator WYDEN. I guess what I am saying is I think this is something the Government ought to look into, because what we are seeing is enormous amounts of money spent on drugs that incrementally better than what is out there, but are much more expensive, 

and it just continues this spiral of cost. 

I thank you, Doctor. I would only ask, Mr. Chairman, when I 

cited the Congressional Budget Office, I probably low-balled the 

number in terms of the amount of advertising, and I would just ask 

that that full discussion with Douglas Holtz-Eakin be put into the 

record, because essentially when I have said that if you take advertising out of the expenses of Medicaid, you could come close to half 

of the target. I used the Wall Street Journal figure, the $4 billion 

figure. I probably could have gone higher with Douglas HoltzEakin. In fairness and so that the committee has the accurate 

record, I would ask that Douglas Holtz-Eakin’s entire set of remarks on that point be put into the record. 

Senator KOHL. It will be done. 

[The information referred to follows:]

Senator WYDEN. I wanted to also explore with you a topic you 

and I have talked about. Senator Sununu and I have been concerned about the fact that public programs, programs like Medicaid, the Public Health Service, the VA, are paying for prescription 

costs, you know, advertising. In effect, those programs end up getting shellacked, you know, twice. There are tax breaks for the 

pharmaceutical folks to advertise on TV. Nobody is quarreling with 

55

that, trying to take it away. But after that expenditure is made 

with taxpayer money, then more money gets spent for in effect like 

Medicaid to pay for all those purple pills, you know, dancing across 

everybody’s television set. So we are trying to address this, you 

know, issue and, you know, obviously advertising increases utilization of prescription drugs and, or course, the program. 

Let me ask it this way: The official sources on drug advertising 

seems to be that the country spends between $3 billion and $5 billion a year on prescription drug advertising. According to the bipartisan experts, after the Medicare drug benefit kicks in, Medicaid is 

expected to be about 10 percent of the prescription drug market. 

That seems to be a kind of consensus recommendation. 

So Senator Sununu and I are interested and working on the language of this and would very much like your counsel so as to focus 

on utilization and focus on market share. It is our sense that if we 

do that, the government could save about $300 million to $500 million a year on Medicaid, in effect over a billion dollars over a 5-

year period. 

Do you feel that that is essentially a reasonable kind of analysis? 

Mr. HOLTZ-EAKIN. Yes. You know given that the language was 

tight enough that could find a way to actually recoup the costs and 

that we can, you know, get a sense that the numbers are on the 

mark. They certainly seem reasonable. Yes. 

Senator WYDEN. Well, I appreciate that, and I would like to work 

with you on the language because I know that the way it is framed 

so as to focus on utilization and market share is really, really key, 

and if we could follow up with your technical folks. They have been 

very helpful to us already. This is a bipartisan bill, and I just point 

it out because we have Chairman Smith here, and he has done excellent work on the Medicaid program. He is trying to get $10 billion worth of savings without hurting people on Medicaid, and I 

would just like to, you know, make it clear, you know, for the 

record that Dr. Holtz-Eakin has said we could get more than a 10 

percent of the savings in the target that Chairman Smith is looking 

at by the advertising, you know, provisions along the lines of what 

Senator Sununu and I have been talking about. So we will be anxious to follow up with you, and we got to figure out how to save 

$10 billion on Medicaid, and we all want to do it without hurting 

people. We just on the record a way to in the ballpark to get 10 

percent of the money. That is what we ought to be trying to do is 

sharpen our pencils.

Senator KOHL. Thank you, Senator Wyden. 

Senator Talent is here. 

Senator TALENT. I want to thank the Senator from Wisconsin 

and the chairman for sponsoring this hearing, which I think is an 

important one, and it is a subject that has troubled me and I have 

done a lot of thinking about it, because, on the one hand—I am not 

going to make a long statement, I promise. But I imagine you all 

sort of have these conflicting feelings. On the one hand, I don’t like 

to interrupt the flow of information or treat seniors like they can’t 

analyze this information and make useful decisions. On the other 

hand, there sure are a lot more of these ads than there used to be, 

and I have some concerns also. 

56

I think it is probably more appropriate to reserve most of my 

questions for the second panel, but, Dr. Behrman, if you would 

just—I will follow up on something that I think the chairman 

raised when I was not here. I watch these ads, and they talk about 

how great the drugs are, and I would expect that they would do 

that. There is this little voice as the end that mentioned, you know, 

‘‘not for people who have had liver problems.’’ I think you went into 

this a little bit, but are we doing enough to warn people about the 

potential negative side effects of this? Particularly I wonder if you 

all have done as an agency any work in an area that was raised 

in another hearing. Let me just give you that, and then you can 

answer it in light of that. 

When we had the hearing on scams that are directed at seniors, 

one of the witnesses represented a group that had done a lot of 

work on how seniors get information and how they perceive it. In 

other words, if you remember, Mr. Chairman, they made the point 

that when you do bullet points to seniors, because as our memories 

begin to change as we get older, there are ways of communicating 

so that it really hits, and then ways of communicating so that they 

don’t remember it. I wonder if, considering whether this is false 

and misleading, you have taken that into account, these ads that 

are aimed at particular parts of the population, if you guys have 

studied that to make certain that this information about potentially harmful side effects isn’t being slipped in in a way that they 

know people are less likely to absorb. So if you would comment on 

that, I would appreciate it. 

Dr. BEHRMAN. Sure. You have actually raised several different 

points, all of which are worth commenting on. 

First, in terms of—we call it ‘‘minimization of risk information,’’ 

not adequate presentation of risk information. It is one of the most 

common reasons we cite an ad for violation. We are very concerned. 

It can be buried in tiny print in a broadcast ad. It can be buried 

with loud music. There are many ways to bury it. That is why we 

have—either in print or broadcast, that is why we have started increasingly to do research on what we call the brief summary, the 

presentation of risk information, and issue guidance, and that is 

part of what we hope to hear at our public hearing. 

You are referring a little bit, I believe, to chunking of information, that you can access the information better if it is chunked. It 

is not just seniors. It is everybody. That is why we—and it was 

based on those principles that we are revamping the package insert. Once the package insert is revamped, it will be much easier 

for industry, we hope and we believe, to better pull out the risks 

because, yes, we want to see ads that incorporate the risk information into the entire ad, not leave it for the end, not bury it, and 

not make it hard to understand. 

Senator TALENT. You just may want to look at—and we can get 

this information to you—some interesting studies about how people 

absorb information in different ways as they get older. It has nothing to do with any disability or anything. 

Dr. BEHRMAN. Right, sure. 

Senator TALENT. It is just as your memory changes. So ads that 

are directed particularly at older parts of the population may be 

able to slip information through in that fashion. 

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Dr. BEHRMAN. It would be good to see that. 

Senator TALENT. But I am glad to know that is a priority, and 

I appreciate your being here. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you, Senator Talent. 

Mr. Chairman. 

The CHAIRMAN. Doctor, both Senator Wyden and I do town halls 

all over Oregon, and sometimes we do them together. One of the 

complaints that he and I invariably hear at every stop is about 

direct-to-consumer advertising. Obviously you are telling us your 

workload has gone up. The use of advertising has increased. Have 

the companies ever shared with you the pluses and minuses of 

what they are doing? Because there is clearly a backlash among 

seniors to these ads as expressed. This claim is not supported by 

data, but it is an overwhelming complaint that we hear constantly. 

Can we get cheaper drugs and stop these ads? Give us the money 

in savings and cost; these ads are driving us crazy. These are folks 

who are coming out of assisted living facilities to hear a couple 

Senators talk, and this is what is on their minds. 

Do they ever share with you the tradeoffs that they go through? 

Dr. BEHRMAN. No, but—and, again, you will have the opportunity to speak with them on the next panel, but they have put out 

voluntary guidelines, and the guidelines do talk about appropriateness of the audience, if you will, in terms of air time. So I would—

and this is a guess on my part. I would assume it is on their minds, 

and I would also just add that it is not just seniors, it is parents 

of growing children like myself who also would appreciate it if 

things were——

The CHAIRMAN. You don’t like the Levitra ads during a football 

game? 

Dr. BEHRMAN. At a very young age, my boys had me explain 

erectile dysfunction to them. 

The CHAIRMAN. OK. 

Senator KOHL. Thank you very much, Dr. Behrman. Your testimony has been good, and your responses to questions have been 

very helpful. 

Dr. BEHRMAN. Thank you. 

Senator KOHL. We have four panelists for our second presentation. The first witness will be Dr. Paul Antony of the Pharmaceutical Research and Manufacturers of America. Dr. Antony is 

PhRMA’s chief medical officer. In this role, he serves as PhRMA’s 

principal advocate on all health care and medical policy issues. 

Our second witness will be Dr. Donna Sweet of the American 

College of Physicians. Dr. Sweet is chair of the Board of Regents 

of ACP, and she is director of Internal Medicine Education at Via 

Christi Regional Medical Center-St. Francis Campus in Wichita, 

KS. ACP is the Nation’s largest medical specialty society, and Dr. 

Sweet is here to share with us ACP’s position on direct-to-consumer 

advertising of prescription drugs. 

Next we will have Dr. Peter Lurie of Public Citizen. Dr. Lurie 

is deputy director of Public Citizen’s Health Research Group, a consumer advocacy group located here in Washington. Dr. Lurie has 

worked on a myriad of issues related to the cost and safety of prescription drugs. 

58

Finally, we have Dr. Richard Kravitz. Dr. Kravitz is professor of 

Internal Medicine and director of the UC Davis Medical Center, 

Center for Health Services Research in Primary Care. His research 

is focused on understanding social influences on clinical practice. 

He is here to discuss his recent research on DTC advertising of prescription drugs. 

We welcome you all here today, and, Dr. Antony, we will take 

your testimony. 

STATEMENT OF PAUL ANTONY, MD, MPH, CHIEF MEDICAL 

OFFICER, PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PHRMA), WASHINGTON, DC 

Dr. ANTONY. Mr. Chairman, Ranking Member Kohl, and members of the committee, on behalf of the Pharmaceutical Research 

and Manufacturers of America, I want to thank you for allowing 

us to participate in this hearing today on direct-to-consumer advertising. I am Dr. Paul Antony, the chief medical officer of PhRMA. 

Patients are increasingly demanding more information about 

their health and treatment options, not less, and they are getting 

this information from a wide variety of sources, including newspapers, television, and the Internet. Direct-to-consumer advertising 

is one of the many sources patients use to obtain health information. 

DTC advertising can be a powerful tool in educating millions of 

people and improving health. DTC advertising provides value to 

patients by making them aware of the risks and benefits of new 

drugs. It can empower patients and enhance public health. It plays 

a vital role in addressing a major problem in this country of undertreatment and under-diagnosis of disease. It encourages patients to 

discuss medical problems with their health care provider that 

might otherwise not be discussed due to a stigma being attached 

to the disease. It encourages patient compliance with physician-directed treatment regimens. 

Despite the very positive role that DTC advertising can play in 

educating patients about health issues and options, over the years 

there have been concerns expressed about direct-to-consumer 

advertising. In order to ensure that direct-to-consumer advertising 

remains an important and powerful tool to educate patients, on 

July 29 of this year, PhRMA’s Board of Directors unanimously approved a set of guiding principles on direct-to-consumer advertisements about prescription medicines. 

Our principles recognize that at the heart of our companies’ DTC 

communications efforts should be patient education. This means 

that DTC communications designed to market a medicine should 

responsibly educate patients about a medicine, including the conditions for which it may be prescribed. DTC advertising should also 

foster responsible communications between patients and health 

care professionals to help the patient achieve better health and a 

better appreciation of the medicine’s known benefits and risks. 

Our guiding principles recognize that companies should spend an 

appropriate amount of time educating health care professionals 

about a new medicine before it is advertised to patients. 

Companies that sign on to these guiding principles agree to submit all DTC television ads to the FDA before releasing these ads 

59

for broadcast, giving the agency an opportunity to review them consistent with its priorities and resources. Should new information 

concerning a previously unknown safety risk be discovered, companies commit to work with the FDA to responsibly alter or discontinue a DTC advertising campaign. 

In addition, the principles encourage companies to include, where 

feasible, information about help for the uninsured and underinsured in their DTC communications. Our companies offer a host 

of programs that can assist needy patients with their medicines. 

The principles also recognize that ads should respect the seriousness of the health condition and medicine being advertised and 

that ads employing humor or entertainment may not be appropriate in all instances. 

As a result of concerns that certain prescription drug ads may 

not be suitable for all viewing audiences, the guiding principles 

state that, ‘‘DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved.’’ 

PhRMA’s Board also unanimously approved the creation of an 

Office of Accountability to ensure the public has an opportunity to 

comment on companies’ compliance with these principles. Periodic 

reports will be issued by the PhRMA Office of Accountability to the 

public regarding the nature of the comments it receives, and each 

report will also be submitted to the Food and Drug Administration. 

PhRMA’s Board also agreed to select an independent panel of 

outside experts and individuals to review reports from the Office of 

Accountability after one year and to evaluate overall trends in the 

industry as they relate to these principles. These principles will go 

into effect in January 2006. 

We believe these principles will help patients and health care 

professionals get the information they need to make informed 

health care decisions. 

Given the progress that continues to be made in society’s battle 

against disease, patients are seeking more information about medical problems and potential treatments. The purpose of DTC advertising is to foster and inform conversations about health, disease, 

and treatments between patients and their health care practitioners. Our guiding principles are an important step in ensuring 

that patients and health care professionals get the information 

they need to make informed health care decisions. 

This concludes my oral testimony. I would be happy to answer 

any questions or supply any additional material requested by members or committee staff. 

[The prepared statement of Dr. Antony follows:]

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Senator KOHL. Thank you very much, Dr. Antony. 

Dr. Sweet. 

STATEMENT OF DONNA SWEET, MD, FACP, CHAIR, BOARD OF 

REGENTS, AMERICAN COLLEGE OF PHYSICIANS, WASHINGTON, DC 

Dr. SWEET. Thank you, Senator Kohl, Senator Smith, Senator 

Talent, and Senator Wyden. I am, as stated, Donna Sweet, chair 

of the Board of Regents of the American College of Physicians, the 

nation’s largest medical specialty society representing over 119,000 

doctors of internal medicine. ACP appreciates the opportunity to 

testify on the subject of direct-to-consumer advertising of prescription drugs. 

Internists typically provide primary and subspecialty care to 

large numbers of patients who are Medicare-eligible and have multiple medical problems. It is these patients who are most adversely 

affected by DTC advertising. 

Since 1998, ACP has been opposed to the practice of DTC advertising, which often leaves our patients confused and misinformed 

about medications. It undermines the patient-physician relationship and impedes the practice of medicine by challenging the individual physician’s medical judgment. 

ACP recognizes the value of consumer education. The medical 

community has an obligation to empower consumers by educating 

them about health conditions and possible treatments. A healthy 

physician-patient relationship can lead to better health outcomes 

through appropriate use of safe and effective medications. The College also acknowledges the need for the pharmaceutical industry to 

market its products, but believes public education programs that do 

not promote a particular drug product and are financially supported by pharmaceutical companies are a better approach. 

The pharmaceutical industry spends millions of dollars to support the efforts of non-profit organizations, including the ACP, to 

educate the public through unrestricted educational grants that do 

not promote a specific product. As an example, the ACP and the 

ACP Foundation recently received a multi-million-dollar unrestricted educational grant from Novo Nordisk to create and disseminate educational tools and information for physicians, patients, 

and other members of the health care team to raise awareness and 

teach best practices in diabetes care, not branded in any way with 

Novo Nordisk. That is how the industry can help both patients and 

physicians. 

ACP also appreciates the PhRMA-issued voluntary guidelines to 

regulate the industry’s use of DTC ads and that some companies 

have even gone beyond the PhRMA guidelines by voluntarily agreeing to delay advertising of new drugs to consumers until their safety and effectiveness have been tested. However, voluntary guidelines in our opinion are not a substitute for an effective regulatory 

approach to DTC advertising. 

The power of media broadcast is huge. Pharmaceutical companies and ad agencies know that. That is why DTC advertising is 

done. But it does put an adversarial element into the physician-patient relationship. Even in a practice like mine, where I have the 

luxury of being the medical home for some of my seniors for the 

81

last 15 to 20 years, when I have to say no to something that the 

healthy-looking person on television says is good for them and will 

make them feel better, it takes some work. Most of the major drugs 

seen on DTC ads target our seniors. Thick, ugly toenails, erectile 

dysfunction, urinary incontinence, osteoporosis—all things that 

need to be discussed, but not necessarily secondary to an ad that 

says, ‘‘This product is best.’’ 

Consider the toenail ad, my personal favorite. While I am trying 

to tell a senior that it is not life-threatening; that there really 

aren’t little creatures with horns, legs, and arms under their toenails, living in sofas and chairs; that the drug is quite expensive; 

and that the risks of toxicity are significant and that it may not 

work, I lose valuable time that could have been directed at the underlying reason they have those toenails—their diabetes, their vascular disease, their cholesterol, their overall health. 

Some ads, like those that tell people that there is help for embarrassing problems—urinary incontinence as an example—have 

opened dialog, but the ads promote the more expensive brand 

names when generics often work equally as well. 

Last, some of the ads are just embarrassing. I was talking to a 

senior last week from Arkansas who was watching sports on TV 

with his grandkids, and he was not really paying any attention to 

the ads until his 7-year-old grandson pulled on his shirt sleeve and 

said, ‘‘Grandpa, what is a 4-hour erection?’’ 

ACP would prefer to see Congress ban DTC advertising because 

it does not constitute appropriate patient education. In the absence 

of a prohibition, which we understand is probably not possible, the 

College calls on Congress, the FDA, and the industry to take actions to minimize the deleterious effects of DTC advertising, and 

we would recommend the following: 

Federal regulations and guidelines must be expeditiously 

strengthened to make drug advertising as honest and useful as 

possible. The FDA’s retrospective regulatory process should be replaced with a mandatory pre-release screening of all pharmaceutical advertising. Marketing should be directed at providing clinicians with accurate information on new drug products. Physicians and pharmaceutical companies should continue to work together to create effective advertising and educational initiatives. 

Finally, the Federal Government should continue to fund studies to 

further define and measure the impact of DTC ads. 

Just as fast-food advertising to our kids is leading to an epidemic 

of obesity, I have to believe that DTC advertising to our seniors 

leads to an overconsumption of medications and sometimes outright doctor shopping if they really feel they have to have those 

medicines. 

ACP thanks the Aging Committee for addressing this subject and 

for considering the views of the American College of Physicians, 

and I would take any questions or provide additional information 

as needed. 

[The prepared statement of Dr. Sweet follows:]

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Senator KOHL. Thank you very much, Dr. Sweet. 

Dr. Lurie. 

STATEMENT OF PETER LURIE, MD, MPH, DEPUTY DIRECTOR, 

HEALTH RESEARCH GROUP, PUBLIC CITIZEN, WASHINGTON, 

DC 

Dr. LURIE. Thank you. Like all interventions in health care, DTC 

advertising should be evaluated by comparing risks and benefits in 

the context of available or potentially available alternatives. On 

balance, we believe that the clearly demonstrated adverse effects of 

DTC advertising outweigh the still undemonstrated effects that 

might be beneficial. Where there is any hint of a beneficial effect, 

we find that there are better ways of accomplishing it. 

Senator Kohl, you are correct that New Zealand has permitted 

direct-to-consumer advertising, but actually now there is a moratorium on it, and they are planning on making that moratorium 

final. The only country that has tried it has turned its back on it. 

I will make seven points. 

First, direct-to-consumer advertisements bear little relationship 

to public health needs. New and expensive drugs, those for diseases 

that are bothersome and incurable, are the ones that we see advertised. Only 14 percent of sales for the top 50 DTC-advertised drugs 

are for acute conditions, and only one of the top 50 DTC-advertised 

drugs was an antibiotic, presumably because people are quickly 

cured and there is no need for a refill. We see shouldered aside advertisements for generic drugs, such as those that might prevent 

heart attack or stroke, and, of course, any non-drug interventions, 

like behavioral smoking cessation, weight loss or exercise programs. 

Second, many DTC advertisements are misleading or dangerous. 

Part, I think, of the reason we have this hearing is because of what 

happened with Vioxx. We should remember that Vioxx was the No. 

1 DTC-advertised drug in 2000, and at $160 million was larger 

than the campaigns that year for either Pepsi or Budweiser. So 

that is one well-known example. 

I have attached to my testimony a second example, which is a 

DTC ad which might be considered a direct-to-children ad. It is an 

ad for Differin, an acne medication, and if you look at my testimony, you will see that teenagers are exhorted—those at Acne 

High are exhorted to take a course called ‘‘Zit 101.’’ Of course, they 

need to talk to their parents because children don’t usually go to 

their doctors without their parents. If you can get your parent to 

help you out, you get to qualify for one of the three levels of ‘‘cool.’’ 

If you sign up, you get two free music downloads. If you get and 

refill a Differin prescription, you get seven free music downloads. 

If you get your parent to help you refill it, you get ten. This is turning children into the agents of the pharmaceutical industry in a 

way to get around doctors. I think that is really inappropriate. 

A third example, very briefly, is AstraZeneca’s Crestor, a drug in 

which the industry actually managed to misrepresent the FDA 

itself by saying that the FDA had few concerns about the safety of 

the drug, when, in fact, they were on record saying that they did. 

Point three, consumers are being misled. Sixty percent of people 

surveyed by the FDA thought that the advertisements provide inVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00091 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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sufficient information about drug risks, and 44 percent felt similarly about the benefits. Consumer support for DTC advertisement, 

as all of you have hinted, is, in fact, declining. There are data from 

the FDA’s own survey comparing the 1999 to 2002 survey that 

show that more and more people are getting fed up with these ads 

and fewer ‘‘liked seeing’’ the advertisements, a decline from 52 percent down to 32 percent. 

Point four, doctors are being coerced. Dr. Kravitz will talk, I am 

sure, in great detail about his landmark study, but I will point to 

one part of it, which is that patients with adjustment disorder, only 

10 percent of whom would otherwise have gotten a prescription for 

an antidepressant drug, 55 percent of those did when they went to 

a physician mentioning an ad for Paxil that they had seen on TV. 

So this is a clear increasing of prescribing when it probably is not 

justified. 

Point five, the price of health care is being driven up. Patients 

are being induced to request new, more expensive medications instead of equally effective, older generic ones. The GAO concluded 

that, ‘‘DTC advertising appears to increase prescription drug 

spending and utilization.’’ I am sure that their next study that you 

have requested will come to the same conclusion, and most of that 

is because of increased utilization, not prices. 

Point six, potential benefits of DTC advertising. There is a comprehensive review study referenced in my testimony of the data on 

this issue. They conclude: ‘‘The onus is on those who might support 

[DTC advertising] to produce evidence of benefit and, in the absence of this evidence, we must assume that the likely disbenefits. 

. . outweigh the as yet unproven benefits.’’ 

I go on to talk about Dr Kravitz’s study in which he shows that 

if you want people to get prescribed more antidepressants—and I 

shan’t comment on whether that is a good idea or not. But if one 

did, in fact, general entreaties to physicians are more effective than 

direct-to-consumer advertisements. 

My seventh and final point is that FDA enforcement is lackadaisical. I have attached some data for enforcement actions at the 

FDA dating back to 1997. These are all enforcement actions. There 

may be a small increase recently, but the overall trend is down and 

has been consistently so, in fact, going back to 1998. But there is 

a big drop-off after 2001, at which point all warning letters and 

regulatory letters needed to go through the Office of the Chief 

Counsel at the FDA, which resulted in a decreased number of regulatory letters being released, which the GAO said had adversely affected FDA’s oversight. 

So, in conclusion, then, we believe that the benefits have not 

been demonstrated, and to the extent that there are any they can 

be secured through other less dangerous routes, but the dangers 

are quite clear. 

Our recommendations are: Firstly, the industry, the guidelines—

PhRMA has been aroused to produce them only because of criticism. The guidelines are voluntary, and are they recommend, for 

example, if the company should wait ‘‘an appropriate amount of 

time’’—whatever that is—after launching a new drug before initiating a DTC advertisement. Senator Frist has recommended a 2-

year waiting period. Growth of DTC advertising didn’t happen 

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magically. It is because of deregulation by the FDA. It means the 

genie can be put back in the bottle. 

We would recommend that FDA provide proper patient information. The best way to do this is through medication guides, which 

the agency developed an interest in 1995. But there are only about 

75 of those, and that is part of the reason the industry can get 

away with it—because the FDA has failed to provide this kind of 

information. 

Federal agencies should be doing more to educate patients, and 

I refer to the FDA, of course. The NIH and the Agency for Health 

Care Research and Quality could also be doing more. The FDA has 

yet to publish any regulations regarding DTC advertisements. You 

heard Dr. Behrman talk about how they use the prescription drug 

advertising rules to apply to DTC. There are some guidances, but 

they are voluntary. They have little ability to enforce them. They 

are understaffed. There is no pre-review of television advertising, 

and we also think there should be a ban on celebrity endorsements. 

Most fundamentally, the agency still does not have the ability to 

level civil monetary penalties. 

In conclusion, health care observers have long noted that health 

care is unlike other markets in that patients typically do not purchase services directly. Rather, because of the complexity of the decisions involved and the potentially life-threatening nature of poor 

choices, the physician acts as a ‘‘learned intermediary’’ on the patients’ behalf. DTC advertising is nothing less than an end run 

around the doctor-patient relationship, an attempt to turn patients 

into the agents of the pharmaceutical industry as they pressure 

physicians for medications that they may not need. 

Thank you. 

[The prepared statement of Dr. Lurie follows:]

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Senator KOHL. Thank you, Dr. Lurie. 

Dr. KRAVITZ.

STATEMENT OF RICHARD L. KRAVITZ, MD, MSPH, DIRECTOR, 

CENTER FOR HEALTH SERVICES RESEARCH IN PRIMARY 

CARE, UNIVERSITY OF CALIFORNIA, DAVID MEDICAL CENTER, SACRAMENTO, CA 

Dr. KRAVITZ. Chairman Smith, Senator Kohl, distinguished members, thank you for inviting my testimony today. 

Spending on direct-to-consumer advertising has increased every 

year since the early 1990’s and, as we have heard, in 2003 totaled 

$3.2 billion, perhaps edging up to as much as $4 billion today. 

Much of the spending is for drugs used to treat conditions that affect the elderly, including high blood cholesterol, stomach ulcers, 

degenerative arthritis, strokes, and depression. As you have heard 

in testimony already, the debate on the proper role of DTC advertising is highly contentious. 

While all the signs are that older Americans, just like their 

younger counterparts, are responding to DTC ads, in a telephone 

survey of Sacramento residents several years ago, more than half 

the respondents had read a DTC ad from cover to cover, and in a 

more recent survey conducted by Prevention magazine, 27 percent 

of seniors had asked their physicians about advertised medicines. 

The question is: Is there anything wrong with that? 

Proponents of DTC advertising argue that ads educate patients 

and encourage appropriate care-seeking, while critics charge, as we 

have heard, that ads lead to overprescribing of unnecessary, expensive, and potentially harmful medications. 

To shed some light on this controversy, we conducted a study 

that was published in the April 27th issue of the Journal of the 

American Medical Association. The study was designed as an experiment using standardized patients, or SPs. SPs are actors 

trained to portray the clinical and biographical features of a role 

and to do so accurately and reliably. The use of SPs allowed us to 

control very precisely for patient demographic characteristics and 

symptoms, allowing us to ascribe any differences in doctor behaviors to the kinds of requests the SPs made. 

We enrolled 152 physicians in three U.S. cities. Most physicians 

saw two unannounced standardized patients, for a total of 298 visits. We used 18 white, middle-aged actresses who were trained to 

portray six roles, which we created by crossing two clinical conditions with three request types. The clinical conditions were major 

depression and adjustment disorder. Major depression is serious 

and needs to be treated promptly. Adjustment disorder represents 

an exaggerated reaction to life events and can usually be treated 

with watchful waiting. 

As you will see in one of your handouts, the first one, with the 

little picture up in the upper right-hand corner, actresses portraying ‘‘Louise Parker,’’ the major depression role, complained of 

depressed mood for a month, worse in the past two weeks. Actresses portraying ‘‘Susan Fairly,’’ the adjustment disorder role, 

noted some sleep problems and low energy for a few weeks, but 

nothing that interfered significantly with function. 

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The SPs were further assigned to one of three request groups, 

and that is laid out in the next handout. A third of the standardized patients mentioned seeing a television ad and made a brandspecific request for Paxil. Another third told of watching a TV documentary and made a general request for medication that might 

help. The last third made no request at all. 

We thereby created six cells, six separate conditions, with about 

50 standardized patient visits in each one. The first cell, for example, contained visits in which the SP portrayed major depression 

and made a brand-specific request for Paxil, then major depression 

with a general request, no request, and so on. 

The next slide shows the major results. Among SPs portraying 

major depression, antidepressant prescribing was highest when a 

general request was made, 76 percent of visits; middling when a 

brand-specific request was made, 53 percent; and lowest when no 

request was made, 31 percent. These are among SPs who, by all 

rights, should well have been treated at the first visit. 

In adjustment disorder, prescribing occurred in 55 percent of 

brand-specific visits, 39 percent of general request visits, and only 

10 percent of no request visits. 

We went on to define——

Senator TALENT. Mr. Chairman, can I just ask a question to clarify this? It is just a factual thing. 

When the drug was prescribed and when they made a brand-specific request, did the physician prescribe the brand they asked for, 

or was there another drug, or did you keep track of that? 

Dr. KRAVITZ. We did, and, in fact, Paxil, the brand-specific drug, 

was prescribed about half the time when that specific drug was——

Senator TALENT. So when they made——

Dr. KRAVITZ. The other half the time another antidepressant 

was——

Senator TALENT. One more—was there a difference between how 

often the Paxil was prescribed between the control groups when 

they asked for it specifically or when they just said we have got a 

problem, maybe there is a drug that will help us? 

Dr. KRAVITZ. Very interestingly, Paxil was almost never prescribed in the major depression condition unless it was asked for 

specifically. It was prescribed about 20 percent of the time in the 

adjustment disorder condition when it wasn’t asked for. 

Senator TALENT. OK. So half the time when asked specifically 

and they prescribed something——

Dr. KRAVITZ. Less than 20 percent otherwise. 

Senator TALENT. OK. Thank you. I am sorry, Mr. Chairman. 

Dr. KRAVITZ. We went on to define ‘‘minimally acceptable initial 

care’’ for depression as any combination of an antidepressant prescription, a referral to a mental health professional, or a follow-up 

appointment within two weeks. The next slide in your handout 

shows how minimally acceptable care was much higher for SPs 

making any kind of request, either brand-specific or general, than 

for those making no request, over 90 percent versus 56 percent. 

So, in summary, patients’ antidepressant requests are a powerful 

influence on physicians’ prescribing decisions. While such requests 

clearly improve quality of care for patients in actual need of immeVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00105 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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diate treatment, they also lower the prescribing threshold when an 

immediate prescription may not be in the patient’s best interest. 

To the extent that these results hold true for other conditions 

and therapies, DTC advertising is a two-edged sword, capable of reducing underuse of necessary treatment and increased overuse of 

unnecessary treatment both at the same time. 

Thank you. 

[The prepared statement of Dr. Kravitz follows:]

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Senator KOHL. Thank you very much, Dr. Kravitz. 

We can stay here until about 11:20. Let’s see how far we can get. 

I would like to ask the whole panel, the question is: Do you think 

that if we either rein in or even possibly eliminate DTC advertising 

and also provide more comparative studies about the effectiveness 

of drugs, we will then be able to move toward a goal of providing 

the best drugs at the best prices to the American people? I will 

start with you, Dr. Antony. 

Dr. ANTONY. Senator, let me start by saying the industry also 

wants to make sure we get the best drugs to the right patient at 

the right time, so we are committed to doing that. 

On the issue of whether direct-to-consumer advertising will affect 

the price and cost of medicines, I am going to refer to a study that 

was actually done by the Federal Trade Commission where they 

studied that and reported back to the FDA. From their own study 

in 2003, they state that direct-to-consumer advertising accounts for 

a relatively small proportion of the total cost of drugs, which reinforces the view that advertising would have a limited, if any, effect 

on price. The reason that is important is everyone talks about the 

$4 billion that is spent on advertising, which is a large amount. 

But more than 10 times that amount is spent on research and development, more than $40 billion a year. So, in the overall picture, 

it is unclear whether reining in direct-to-consumer advertising 

would actually lower the price of medicines. 

Senator KOHL. Dr. Sweet. 

Dr. SWEET. I would agree. I think there is little evidence that it 

would decrease the cost of medications. But my concern is the overall health care costs that I know Senator Wyden is concerned 

about. Every time a physician has to see a patient back for toxicity, 

every time there is a drug prescribed when there might have been 

a lower-cost alternative drug because of DTC, you are increasing 

the overall health care cost. So, yes, I would agree that taking care 

of DTC advertising is not going to lower the overall cost of most 

medications. I am concerned about the overutilization, and as I 

stated in my testimony, we at the ACP believe that the pharmaceutical industry is a tremendous resource, and we would like to 

see them put those resources into the kinds of things that we know 

do help patients: non-branded, public relations kinds of messages 

that address things like depression and incontinence and even erectile dysfunction, but without specifically branding a given drug. 

In answer to the first part of your question, we always need more 

data, and, yes, there is a real lack of data that looks at these 

newer, more costly agents, especially in classes where there are 

older, already sometimes generically available medications. It 

would be wonderful to have more data on truly head-to-head analyses of the overall effectiveness. 

That is probably not going to happen just because of the way industry drives clinical research. But anything we could have as better data to suggest to our seniors that a generic drug for urinary 

incontinence works just as well as what they saw being carried behind the car and the outhouse would be helpful to us as clinicians 

with our patients. 

Senator KOHL. Thank you. 

Dr. Lurie. 

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Dr. LURIE. While it is true that direct-to-consumer advertising 

isn’t the largest fraction of all advertising for drugs in this country, 

but it is substantial, about 20 percent, and growing. So I do think 

it would make a difference. 

DTC ads, as I said, for the 25 largest therapeutic classes, accounted for 12 percent of drug sales growth between 1999 and 

2000, and the estimate was that it would cost $2.6 billion as a result, just in those 25 therapeutic classes. So I think emphatically 

it would lead to an increase in the overall cost of drugs. Be careful 

to distinguish between drug prices and costs. I don’t think that the 

prices would go up, but I think that the overall costs go up because 

people get driven away from non-drug interventions or generic 

drugs interventions to newly patented drug interventions which are 

more expensive. 

The GAO estimated that a 10-percent increase in DTC advertising translated into a 1-percent increase in sales for that class of 

drugs, which is an enormous increase when you think about these 

drug classes that are selling in the billions of dollars. 

So I think absolutely it makes a difference. It may or may not 

be the most important thing. Certainly if the committee can pay attention to the gifts and handouts that are being given to physicians 

and where most of the pharmaceutical company advertising does 

go, I have no objection to that. But in the meantime, before us we 

have DTC advertising and emphatically it does contribute to the 

overall cost of drugs. 

Senator KOHL. Thank you. 

Dr. Kravitz. 

Dr. KRAVITZ. Well, asking a researcher whether there should be 

more comparative studies is kind of back to that cookie situation 

that Dr. Behrman mentioned. But, yes, I think there should be 

more comparative studies of two types. First, there is a desperate 

lack of head-to-head comparisons between individual drugs within 

a class, so that not only consumers but physicians have little basis 

to distinguish between drugs within a category. Second, the moratorium on DTC advertising for a period of time that has been proposed in several quarters should be extended to place a greater emphasis on more rigorous post-marketing surveillance so that we can 

use that period of time to actually collect some systematic, useful 

information. 

As far as reining in DTC, I think indeed much more could be 

done to raise the rigor of the education that is provided to patients, 

but my own view is that DTC should not, in fact, be banned, and 

that, in fact, in some situations we need not less DTC but more. 

For example, patients who are discharged from the hospital having 

suffered a heart attack should be on medicines called beta blockers 

as well as aspirin. I would be highly supportive of a DTC campaign 

to encourage patients who have had a heart attack to go on these 

two medications, which have been associated with a 30-percent reduction in mortality. We see study after study showing that somewhere between 60 and 90 percent of patients receive these drugs, 

where the figure should really be closer to 100. 

Senator KOHL. Thank you. 

Mr. Chairman. 

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The CHAIRMAN. Senator Kohl, I am tempted to ask Dr. Sweet, 

How did Grandpa answer his grandson about the 4-hour issue? 

When my son asked me that, I told him if he ever has that problem, we need to talk. [Laughter.] 

Dr. SWEET. He similarly dodged the issue. 

The CHAIRMAN. OK. On a more serious issue—and in fairness, I 

probably should have asked this to Dr. Behrman. But if I am not 

mistaken, wasn’t Vioxx an arthritis drug broadly advertised? If it 

was broadly advertised, wasn’t it later pulled from the market or 

had substantial warnings placed on it because in fact, it did highly 

elevate the risk of heart attack. 

What does that say about all of this? Am I right in my recollection, and what does it say about all of this? 

Dr. SWEET. I will start. You are very right in your recollection, 

and as testimony has said, in 2000 Vioxx was the most advertised 

directly-to-consumer drug in our nation. I think that is what has 

led all of us to believe that some sort of a moratorium on these new 

drugs prior to direct-to-consumer advertising so that the drug can 

be looked at in a larger group of people would be useful. When you 

do clinical studies, you have a very limited group of people that you 

look at, and generally, they are well selected. The pharmaceutical 

industry wants to make sure that their drug gets approved. It is 

only when you then put a drug into a much larger population at 

all ends of the spectrum of disease states and clinical conditions, 

liver and kidney problems, that you really see what goes on. I 

think that is exactly what happened to Vioxx. 

In my opinion, Vioxx is not a bad drug. Vioxx is a drug that was 

overused in many people who it had not been studied in and for 

which we had no data. As a result, we now have this real—what 

many people would consider a debacle in the industry. It is too bad 

because there were many people who were helped by Vioxx. But 

there were too many people that got it, often as a result of bringing 

that ad in, and it happened to me more than one time where somebody brings the ad in or writes it down from the television, and 

they are hurting and they want something to help, and, ‘‘Doctor, 

this one will work this time. I have got to have it.’’ So, yes, I do 

believe that actually some of the—and perhaps Dr. Antony wants 

to comment, but I do think some of the decrease in direct-to-consumer advertising that we are seeing now is a result of the industry seeing what happened. It is one of the reasons that the ACP 

certainly would like to see very much more data on efficacy and 

safety prior to broad-range direct-to-consumer advertising so that 

we know more about what our seniors and others are asking about. 

Dr. ANTONY. Chairman, I would like to respond. Dr. Sweet raises 

this very important issue of what do we do with information about 

medicines and health care as it develops and as we learn more information, because we never have all of the information when we 

originally release a product. 

Dr. Kravitz just mentioned the issue of beta blockers and their 

use after heart attacks, and he actually recommends that we do 

more direct-to-consumer advertising in that area. That is a good 

real-time example of what should we do with more information, because just this week JAMA, the Journal of the American Medical 

Association published a study that said those beta blockers, which 

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we have been really pushing, encouraging physicians to prescribe, 

it looks like that in many patients it doesn’t help them, and in certain patients it may actually harm them. 

So now what do we do? There was no conspiracy to hide this information, and what I will tell you that is interesting about it is 

I am a member of the AMA, I subscribe to that journal. But the 

way I learned about this information was a Bloomberg report that 

summarized that report. I got it on my BlackBerry, and it was even 

before the journal was published. 

So I as a clinician now—and I was telling people to take these 

medicines because that was the best information that was available. Now I have just learned via Bloomberg that apparently there 

is at least one study that says we have to be cautious. 

So in this new information age this issue that you are discussing 

now as a committee is a critical one, and all I would say as an individual clinician and as an industry is that until we sort this out, 

this answer that we can’t share any information, that somehow we 

are not going to disclose information, that that is potentially dangerous, and that a better view is how can we make information 

more reliable, more fair and balanced, not how do we try to hide 

information from people. 

Dr. LURIE. If I may, on Vioxx, I disagree with Dr. Sweet in the 

sense that there was never a study that showed that Vioxx was a 

more effective medication than any nonsteroidal anti-inflammatory 

drug on the market—aspirin, ibuprofen, naproxen, et cetera. There 

was a claim, ultimately allowed by the FDA, that it was less toxic 

to the gastrointestinal tract. So the patients for whom the drug 

made sense were those who had not tolerated the previous drugs 

well. 

However, two-thirds of the increase in drug sales between 1999 

and 2000 was precisely among those who did not have GI toxicity. 

The reason for that in part was DTC advertising, but also because 

of other advertising that the pharmaceutical companies undertake. 

As far as the notion of there being more direct-to-consumer advertising, of course, I don’t agree, but we should be careful about 

what we mean when we talk about that. This conversation has 

been about those DTC ads that have linked drugs and diseases. 

But there is, in fact, a capacity for the pharmaceutical industry to 

engage in disease-only advertising, and those are called help-seeking advertisements. If the industry was that interested in those, we 

would be seeing a massive growth in that kind of advertising rather than the growth in product-related advertising that we do so. 

So as to the beta blocker example, we are never going to see a 

DTC advertisement for those because they have been off patent for 

many years, anyway. 

Senator KOHL. Senator Wyden. 

Senator WYDEN. Thank you, Mr. Chairman. 

Dr. Antony, the heart of the case for PhRMA is that direct-toconsumer advertising is for consumer education. You say that. In 

fact, I guess you use those words, ‘‘The heart of our company’s direct-to-consumer efforts is patient education.’’ But I never see on 

television any drug advertised for which there is a small market, 

which it seems to me undermines the argument this is about patient education. 

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Could you give me an example of a drug that is advertised on 

television for which there really is a need for patient education for 

which there is a small market? 

Dr. ANTONY. Let me respond, again, and I am going to cite a 

study that was conducted by RAND, and I am going to use examples of conditions where there is a need for patient education. This 

RAND study talked about. 

Senator WYDEN. But if I could, because time is short. 

Dr. ANTONY. Sure. 

Senator WYDEN. We see all these ads on TV. Could you give me 

an example of a drug advertised on TV where there is a small market? 

Dr. ANTONY. Senator, I can only address the ones that I am 

aware of, which tend to be diseases that affect a lot of people and 

they may be undertreated. So I don’t—I can’t answer that in terms 

of one that is for a small market because I think that what the 

companies want to go after in a mass marketing or a television ad 

is diseases that affect a lot of people. They may be underused—I 

mean, as opposed to this idea of they are going after things that 

there is already adequate treatment, and I will use asthma as an 

example of something where a lot of people suffer it, it is a chronic 

problem. I would argue it is more than bothersome. It is a real 

issue for people. So, yes, you are going to see advertising in those 

categories. Where with a condition that may only affect a few dozen 

people, I think it is unlikely that you would see television advertising. 

Senator WYDEN. How would you reconcile the idea of voluntary 

guidelines with the fact that people who work for pharmaceutical 

companies get bonuses for increasing sales for drugs that are advertised? I don’t see how you reconcile those two. 

Dr. ANTONY. Senator, I will answer your question, again, both as 

a clinician that was treating patients full-time before joining industry and the industry position. This discussion is on direct-to-consumer advertising. A number of years ago, there was significant 

concern about the direct markets that companies were doing to 

physicians in terms of what the sales reps were doing in the physician offices. The industry came together working with the American Medical Association to develop a code of conduct for how sales 

reps, pharmaceutical sales reps should interact with physicians, 

and it was a voluntary code. But there is no question that physicians saw a dramatic change in the behavior of those sales reps, 

so much so that many of them actually now complain to me and 

say, ‘‘Why can’t I take my wife to these continuing education dinners because I don’t have very much time and I am losing family’’——

Senator WYDEN. That is not what I am asking, Doctor. I am asking how the voluntary guidelines restricting direct-to-consumer advertising can be reconciled with the fact that people who work for 

the companies get bonuses for increasing sales in direct-to-consumer products? 

Dr. ANTONY. Senator, I can’t answer the specific question about 

the bonus. 

Senator WYDEN. OK. Let me ask you one last question, because 

I know Senator Talent wants to get some questions in before the 

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break. Why should Medicaid pay for all of these advertisements on 

television? Your companies already get a tax break for advertising 

on TV. Why should Medicaid pay this double subsidy at a time 

when the program is being cut so dramatically? That is, of course, 

what Senator Sununu and I would stop in our bipartisan bill, but 

I would like to have you tell me why Medicaid should pay for those 

advertising expenses. 

Dr. ANTONY. Senator, I don’t know the details of how much, what 

percentage of the costs are paid by Medicaid or any other payer. 

My understanding is that Medicaid gets—the pricing to different 

groups is very different, and so I don’t know what percentage of 

any cost is actually being picked up by Medicaid. 

Senator WYDEN. But should Medicaid pay for advertising expenses, just as a concept? Is it the position of PhRMA that Medicaid should pay for advertising expenses? 

Dr. ANTONY. Senator, it is my understanding that PhRMA does 

not have a position on that specific question. 

Senator WYDEN. OK. Thank you very much, Mr. Chairman. 

Senator KOHL. Senator Talent. 

Senator TALENT. Thank you, Mr. Chairman, and thanks again 

for this hearing. It has been very useful to me. It has established 

some parameters. When we talk about DTC, we are talking about 

prescription drugs, not over the counter. Is that fair? 

We have referred to—the ranking member referred to the Constitution, and I think you did also, Dr. Lurie. It is your understanding that—I thought you did, that there are restrictions, and 

we really don’t, I guess, have a witness on that question. But I 

think it is everybody’s understanding that there are at least some 

limits on what we can constitutionally do. Is that one of the reasons you guys are not proposing—or some of you are saying a ban 

is something we cannot do? Is it because of your understanding of 

the Constitution? 

Dr. SWEET. Well, I think Dr. Behrman addressed that, and with 

the right to speech and capitalism and all of those things—that is 

why the College’s position is that if we had our druthers, banning 

would be nice. But we realize that in our constitutional arena, it 

is probably not ever going to happen, which is why we then go to 

a greater degree of regulation. 

Senator TALENT. I am not, by the way, trying to make a point 

here. I don’t know that I would agree with that ruling, if that is 

indeed the ruling. 

Is there any evidence or do you all have a good feel, at least 

anecdotally, for how many of the drugs that are advertised in this 

fashion are generally covered by insurance where people have insurance and how many of the people more generally have to pay 

for out-of-pocket? With that affect your opinion on this issue? 

Dr. SWEET. I will answer that as somebody that does this every 

day. The drugs that Senator Wyden had on his list of Medicaid and 

Medicare drugs are absolutely the most popularly prescribed and 

generally needed drugs. 

Again, when you look into—as an example, the number of drugs 

on his list for gastroesophageal reflux disease, the so-called proton 

pump inhibitors, three or four of them were up there. 

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You get into the issue that somebody comes in and they want the 

purple pill, and yet if they have insurance, their formulary says 

they can only get the pink pill. Then you have to either convince 

them that the pink pill works as well, or they want you to pre-authorize the drug which is another layer of paperwork for clinicians. 

But some seniors are very adamant that they want the purple one, 

they don’t want the pink one, the pink one is not going to work as 

well. 

Then you compound that with the fact that one of the drugs that 

was more heavily advertised in 2000 that Senator Wyden had up 

there, Prilosec, is now omeprazole over the counter, which is 68 

cents a day compared to well over $3 a day for the other drug. 

So, again, there is this whole layer of, yes, proton pump inhibitors are wonderful for people who have reflux disease, but if you 

look at the clinical data—Dr. Kravitz and Dr. Lurie look at this all 

the time—in my opinion and in the opinion of most Medicaid programs that have looked at this, there is no clinically significant difference between those drugs in outcomes. Yes, each company’s 

package insert is a little different and some of the reps will argue 

with me. But overall, clinically, they work well. 

So my job as a clinician and a Medicaid advocate and a Medicare 

advocate is to make sure that I use the best drug at the lowest 

cost—where you get into this cost-effectiveness. But that is a difficult debate—when you have somebody in front of you with the ad 

that says this one is going to work better. The general concept in 

our population is that generics are somehow not as good. Where 

that came from I am not sure, but I do think DTC advertising perhaps contributed to that feeling that a branded drug is better than 

a non-branded drug at this point. 

So there are so many layers, and I agree—I think Dr. Lurie said 

exactly what I said about the overall cost. Whether the cost of the 

purple pill goes down by 20 cents if you don’t have as much advertising is not nearly as important as the fact that there are a lot 

of purple pill prescriptions written at roughly $100 to $110 a 

month when you could get by with Prilosec, over-the-counter 

omeprazole. 

Senator TALENT. Well, I am wondering—and maybe you would 

like to comment, Doctor—whether this does not cut both ways. On 

the one hand, a drug, unless it is the whole generic brand name 

distinction, a drug that is not likely to be covered because it is 

maybe a cosmetic or something like that, on the one hand, if the 

person is responsible for paying for it, if the patient is, that is sort 

of a countervailing influence that is introduced as against the advertising. On the other hand, those are also perhaps more likely to 

be the kinds of drugs for which there is less of a need under your 

criterion, Dr. Kravitz. 

So do you think that that cuts both ways? Should that be a factor 

in trying to figure out how to regulate this, Dr. Lurie, or just don’t 

worry about that? What do you think? 

Dr. LURIE. Well, to me the consumer foots the bill no matter 

what happens, whether it is in the form of insurance premiums, 

whether it is in the form of copayments, whether it is in the form 

of taxes, whether it is in the form of what Senator Wyden refers 

to as the double subsidy. Either way the patient pays. 

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To answer your initial question, my position would not be 

changed according to who the payer is, because ultimately the 

payer is the patient. 

Senator TALENT. Yes, and I am not arguing for it. I am exploring 

it. If a person going in and asking for something knows they are 

going to have to pick up more of the cost, that is an incentive for 

them not to ask for it, notwithstanding. Then we have more like 

a typical market where you are advertising anything else that a 

person has to pay for. 

Dr. LURIE. Certainly there are data to that effect. The problem 

always has been that those kinds of copayments are very blunt instruments in that they can dissuade patients from taking both 

unneeded drugs or marginally needed drugs and those truly needed 

ones. 

Senator TALENT. It would be very awkward to make a regulatory 

arrangement turn on that, because how do you—some things are 

covered by some policies and not by others and in different degrees. 

But it makes it look a little bit more like an over-the-counter drug 

where you are not proposing restrictions on that, in part because 

people are paying for that themselves, and so I think we have faith 

in the consumer to balance the claims against the price under 

those circumstances. 

Dr. LURIE. Well, the underlying assumption about the over-thecounter drug is that the gravity of the decision in deciding whether 

or not to take the drug is one that the patient can make for themselves, or that the drug is needed on an emergency basis and you 

don’t want to wait for the doctor. So I think that there is an appropriate distinction between OTC, and that is precisely why the concern about direct-to-consumer advertising has not focused on them. 

It has focused on the prescription drugs and the notion that the 

physician, who has always been the arbiter of that decision, hopefully in collaboration with the patient, is having an end run made 

around him. 

Senator TALENT. I suspect also the courts would view our interest in regulating advertisement of those more serious drugs more 

favorably than the other. 

Dr. Kravitz, let me ask you a couple things about your study to 

make sure I understand the conclusions. As I read it, in the cases 

where the person presented, the actor or actress, I guess, presented 

evidence of a major problem, where they made a brand-specific request, it seems to me like they were measurably less likely to get 

medicine prescribed than when they just made a general request. 

Is that true, and how do you explain that? 

Dr. KRAVITZ. It is true. The percentage who received prescriptions with a general request was about three-quarters and with 

brand-specific a little over half. 

Senator TALENT. That is, obviously, statistically significant. 

Dr. KRAVITZ. That is statistically significant and clinically important. We did not measure the thought process of the clinician, and 

so we don’t—you know, all we have is theories. But one theory is 

that clinicians may rebel a little bit against requests that are 

branded, and they may be more likely to retain an open mind when 

the requests are not branded, when they are more general and 

when they focus on a condition. This has been a longstanding conVerDate 0ct 09 2002 12:51 Mar 16, 2006 Jkt 000000 PO 00000 Frm 00126 Fmt 6633 Sfmt 6633 H:\DOCS\25879.TXT SAGING1 PsN: JOYCE
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cern about the so-called poisoning of the physician-patient relationship with respect to DTC ads. 

Senator TALENT. Yes, I am wondering whether—but that did not 

present—I mean, that is not the same situation when they had presented minor symptoms. 

Dr. KRAVITZ. In fact, that is right. 

Senator TALENT. Isn’t that interesting. So you think that maybe 

the physician involved, if they mentioned a specific drug, perhaps 

suspected some of the underlying statements, thinking they are 

just trying to get this drug, and so they maybe were less likely to 

prescribe it? 

Dr. KRAVITZ. Possibly, or I think they may be—in a major depression condition, at least, we believe that they are hearing the 

general request as, ‘‘Do you think I might have this serious medical 

condition?’’ They are hearing a brand-specific request as, ‘‘I am the 

consumer, I watch a lot of TV, and I want this specific drug, and 

your judgment to the wind.’’ So there is a little bit of a backlash 

there, we think. 

Senator TALENT. One more question for you then. If we go to the 

next page in your handouts, patients receiving minimally acceptable initial care, does that show that people were more likely to get 

minimally acceptable care in general if they made a request of 

some kind for prescription drugs? 

Dr. KRAVITZ. Yes, that is right, and this is a key finding. We 

found that in the absence of a request, 56 percent of patients, actors, with major depression received minimally acceptable initial 

care, which sounds low, but it pretty much precisely corresponds to 

what some large national studies of quality of care for depression 

and lots of other chronic conditions have found. That percentage 

went up dramatically with any kind of request, even a little higher 

with——

Senator TALENT. Dr. Sweet and Dr. Lurie, does that give you 

some pause in your desire for regulation? I mean, if it is true that 

people are more likely to get—even though we do not understand 

why, more likely to get minimally acceptable initial care if they 

have made a request for some kind of prescription drug, would that 

change at all your attitude toward regulation of the DTC? 

Dr. SWEET. From my perspective, no, because one of our ‘‘asks’’ 

at the ACP is that there be more non-branded, disease-specific, 

public information, true consumer education, and I think Dr. 

Kravitz’s study supports that, especially in that 75 versus 50 percent. Those who asked, ‘‘in general do you think there is something 

that might help me,’’ probably got better care in the long run. 

Senator TALENT. OK. 

Dr. LURIE. No. In fact, that is what I referred to in my testimony. 

The point is that if you believe that a patient ought to get the 

antidepressant, the best way to do it is not through a DTC brand 

name advertisement. It is by a more generic request. So if that was 

the concern, this is actually not the most effective way. Of course, 

a more general public service announcement, for example, from the 

Public Health Service, would not have all the risks that we have 

otherwise talked about here. 

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On the other hand, the brand name advertisements have distinctly negative effects when it comes to adjustment disorders. So, 

no, I think it shows risk without benefit, as far as I am concerned. 

Senator TALENT. I have got to go. My staff tells me we are voting 

on confirming the next Chief Justice, and I probably ought to cast 

a vote in that. [Laughter.] 

So I am going to go ahead and go. Thank you all. This has been 

very interesting, I am sure, to all of us. I appreciate it, and I guess 

the hearing is now adjourned. 

[Whereupon, at 11:35 a.m., the committee was adjourned.]

Æ