<DOC> [109 Senate Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:25879.wais] 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 U.S. GOVERNMENT PRINTING OFFICE 25-879 WASHINGTON : 2006 _____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512ÿ091800 Fax: (202) 512ÿ092250 Mail: Stop SSOP, Washington, DC 20402ÿ090001 SPECIAL COMMITTEE ON AGING GORDON SMITH, Oregon, Chairman RICHARD SHELBY, Alabama HERB KOHL, Wisconsin SUSAN COLLINS, Maine JAMES M. JEFFORDS, Vermont JAMES M. TALENT, Missouri RUSSELL D. FEINGOLD, Wisconsin ELIZABETH DOLE, North Carolina RON WYDEN, Oregon MEL MARTINEZ, Florida BLANCHE L. LINCOLN, Arkansas LARRY E. CRAIG, Idaho EVAN BAYH, Indiana RICK SANTORUM, Pennsylvania THOMAS R. CARPER, Delaware CONRAD BURNS, Montana BILL NELSON, Florida LAMAR ALEXANDER, Tennessee HILLARY RODHAM CLINTON, New York JIM DEMINT, South Carolina 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) 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. 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. 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 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. 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 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 educational 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 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. 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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 avenues 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 exercise 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. 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 cost-effective. 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 Holtz-Eakin. 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 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. 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. 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. 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 under-treatment 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 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:] [GRAPHIC] [TIFF OMITTED] T5879.043 [GRAPHIC] [TIFF OMITTED] T5879.044 [GRAPHIC] [TIFF OMITTED] T5879.045 [GRAPHIC] [TIFF OMITTED] T5879.046 [GRAPHIC] [TIFF OMITTED] T5879.047 [GRAPHIC] [TIFF OMITTED] T5879.048 [GRAPHIC] [TIFF OMITTED] T5879.049 [GRAPHIC] [TIFF OMITTED] T5879.050 [GRAPHIC] [TIFF OMITTED] T5879.051 [GRAPHIC] [TIFF OMITTED] T5879.052 [GRAPHIC] [TIFF OMITTED] T5879.053 [GRAPHIC] [TIFF OMITTED] T5879.054 [GRAPHIC] [TIFF OMITTED] T5879.055 [GRAPHIC] [TIFF OMITTED] T5879.056 [GRAPHIC] [TIFF OMITTED] T5879.057 [GRAPHIC] [TIFF OMITTED] T5879.058 [GRAPHIC] [TIFF OMITTED] T5879.059 [GRAPHIC] [TIFF OMITTED] T5879.060 [GRAPHIC] [TIFF OMITTED] T5879.061 [GRAPHIC] [TIFF OMITTED] T5879.062 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 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:] [GRAPHIC] [TIFF OMITTED] T5879.063 [GRAPHIC] [TIFF OMITTED] T5879.064 [GRAPHIC] [TIFF OMITTED] T5879.065 [GRAPHIC] [TIFF OMITTED] T5879.066 [GRAPHIC] [TIFF OMITTED] T5879.067 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 insufficient 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 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:] [GRAPHIC] [TIFF OMITTED] T5879.068 [GRAPHIC] [TIFF OMITTED] T5879.069 [GRAPHIC] [TIFF OMITTED] T5879.070 [GRAPHIC] [TIFF OMITTED] T5879.071 [GRAPHIC] [TIFF OMITTED] T5879.072 [GRAPHIC] [TIFF OMITTED] T5879.073 [GRAPHIC] [TIFF OMITTED] T5879.074 [GRAPHIC] [TIFF OMITTED] T5879.075 [GRAPHIC] [TIFF OMITTED] T5879.076 [GRAPHIC] [TIFF OMITTED] T5879.077 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. 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 brand-specific 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 immediate 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:] [GRAPHIC] [TIFF OMITTED] T5879.078 [GRAPHIC] [TIFF OMITTED] T5879.079 [GRAPHIC] [TIFF OMITTED] T5879.080 [GRAPHIC] [TIFF OMITTED] T5879.081 [GRAPHIC] [TIFF OMITTED] T5879.082 [GRAPHIC] [TIFF OMITTED] T5879.083 [GRAPHIC] [TIFF OMITTED] T5879.084 [GRAPHIC] [TIFF OMITTED] T5879.085 [GRAPHIC] [TIFF OMITTED] T5879.086 [GRAPHIC] [TIFF OMITTED] T5879.087 [GRAPHIC] [TIFF OMITTED] T5879.088 [GRAPHIC] [TIFF OMITTED] T5879.089 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. 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. 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 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- to-consumer 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. 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 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. 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. 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- the-counter 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 concern 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. 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.] <all>