today we have a hearing in title direct to consumer advertising marketing education or deception each member will be recognized for a five minute opening statement i will begin nearly ten years ago the u s food and drug administration its rules relating to direct to consumer advertisements for prescription pharmaceutical products since then spending on d t c has increased from about one point one billion in one thousand nine hundred seventy to about four point two billion in two of time the pharmaceutical industry insist that direct to consumer ads are mainly an education endeavor designed to educate consumers about new products research shows that advertising results in patients doctors and discussing previously on diagnosed conditions we must acknowledge that direct to consumer ads are also designed to market and sell these products research has shown that advertising may result in advertise drugs being prescribed similar less expensive drugs may have been just as appropriate every one dollar spent on direct to consumer advertising results and up to a six dollar increase in sales and one study demonstrate that every one thousand dollars spent in direct to consumer adverse events resulted in twenty four new prescriptions the purpose of this hearing is to examine the misleading and deceptive tactics direct to consumer versus meant for prescription pharmaceutical products are hearing today will examine three specific television advertisement ads for lipitor or featuring mr robert jarvik food and family ads for vytorin and cancer fatigue or quality of life ads for interview that he did not begin taking lipitor until a few months after he began filming his commercials these ads are in violation of the american medical association guidelines concerning the involvement of health professionals and advertisement improve the quality of life for patients this was clearly an instance of off label marketing practice that is prohibited by the f d a not only did the company advertise the drug but the f d a did very little to stop  in three examples of drug companies acting improperly our goal today is to expose the misleading aspects of each of these television ad campaigns but also but also those of direct to consumer ads in general we also intend to explore better should not have to rely on the oversight function of congress to make sure drug companies tell the truth in their advertisements it is likely that direct to consumer ads will continue and pharmaceutical companies may continue using the same question practices that were used in these and cancer fatigue campaign will also hear from kaiser family foundation about the effects of direct to consumer the american medical association regarding their policy on the portrayal of health professionals and direct consumer ads and the government accountability office concerning f roles in regulating direct to consumer ads we also hear from dr ruth from duke university who will provide an overview of research on help people understand and remember information in drug ads and how to improve their ability to do so we will learn some of the techniques used in broadcast adverse events that affect consumers process the information and direct consumer ads this information may reveal that it's not simply a matter of what is said in a direct to consumer ad but more importantly what people take away from it the only one of two countries that allow direct to consumer ads pharmaceutical companies should consider it a privilege to be allowed to air direct to consumer ads in this country as with all privileges there are responsibility and we should make sure that pharmaceutical companies conduct themselves responsibly the food and drug administration shares the responsibility to make certain drugs or market responsibly to consumers i also believe that congress shares the responsibility and i intend to make certain that our committee ensures pharmaceutical market their products properly i believe that congress needs to the side whether the u s should continue to be one of only two countries in the world that allows direct to consumer ads and if we continue to allow such advertising whether any further limits on direct consumer ads should be required three ads that we will discuss that they are indicative of typical direct to consumer ad campaign it appears that we need to enforce significant restrictions on direct consumer ads to protect american consumers from manipulative commercials designed to mislead and this even for the profit the pharmaceutical companies look forward to the testimony of each witness today it's my sincere hope that that he's hearing will lead to a better understanding of the effects of direct to consumer advertisements and their proper role in our health care system next turn to my friend for an opening statement mr shimkus saying the chairman today this committee subcommittee will conduct oversight on direct to consumer advertising by drug companies this topic has long been a controversy and one i think part of the frustration on our side is that some of the premises are not correct because last fall when the subcommittee on health and then the full committee passed the f d a amendment act of two thousand and seven we created a new standard that statements and drug ads must be clear nutro we had to weigh concerns about first amendment commercial speech rights of companies against concerns of drug ads were misleading and confusing and before we get started i think we need to be clear about f d a is authority with respect to drug a must instead pursue an injunction from the courts the f d a amendments act specifically gave the f d a power to impose civil fines on companies section one o four the act amend section three o three of the food and drug and cosmetic act and provides that f d a may impose civil fines on companies one the direct to consumer ads are identified as being false and misleading granted the f d a has only had this  authority since the act was passed last fall and the act just went into effect one month ago they do have the power to impose these civil fines and that's part of the frustration we strengthen the law we ha gave the f d a power to act and we haven't really given time to really impose a civil fines on and this feeling at this leads me to my concern about the timing of this hearing this is a hearing of the subcommittee on oversight and investigation our job is to uncover facts and see where the facts take us while i believe oversight of the drug advertising is important and necessary wonder if this is the appropriate time to be debating these issues at least for some of the topics we will be discussing today as i mentioned earlier the f d a m m s act which was signed into law last fall created a new standard for statements broadcast drug ads the regulations to interpret the standard are still being drafted we have given f d a new power to impose fines on companies that make false and misleading statements in ads yet today we are reviewing three ad campaigns that were in place before the new law was enacted and there are now off the air pfizer pull its ads for poll that asked for by torn in january johnson johnson's procrit ads have been off the air for three years there have been a number of suggestions in the media and elsewhere about why these ads were pulled some have concluded that the fact that they were pulled  admission that the ads were misleading or deceptive before we make any conclusive conclusion about these ads i think we need to take careful look at the evidence so far the companies have produced thousands of pages of documents and perhaps even hundreds of thousands of pages about these ads these documents show how they were drafted the rough draft of the ads the companies communications with advertising campaigns and with the f d a as division of drug marketing advertising and communication we need to determine what the companies knew about the science supporting these advertising at the time they created the ads in the case of vytorin and procrit the committee is still investigating the issue of what the companies knew and in particular when they knew it this is a long way between finding that language in an ad may be confusing or not as clear as possible and concluding that there was an intent to deceive we need to be careful about drawing conclusions before we have had a chance to review all the evidence before us i also think it is important to take a step back and put these ads into perspective americans see these ads all the time maybe even every day research from the kaiser family foundation and a representative from the foundation is testifying today us two thirds of americans believe that these ads help educate them about diseases that they may not have been aware of and about available treatment with regard to what people did after seeing the ad the foundation's research showed that the vast majority of people almost seventy percent have not talked to their doctors about drug ads they've seen those that did the doctors responded in a variety of ways including recommending lifestyle changes recommending another prescription recommending the drug in the ad or recommending the over the counter drugs in this sense an argument could be made that ads for drugs prompt a conversation that needs to happen between doctors and patients about patients health and whether or how a patient should be treated in addition to balancing these benefits we need to remember that there is a first amendment concern at play here the case law consistently supports the right of companies to engage in commercial speech of course that speech cannot be misleading or fall and it is the f d a is job to ensure that this does not happen we need to take a look at f d a as review of these ads whether their system is designed to pinpoint the ads that contain false or misleading statements and whether the agency is taking action again this isn't an unusual time to be looking at this issue in congress just change the standard require a clear conspicuous and neutral statement about the side effects and this informant standard did not apply to the ads before us today i also look forward to the testimony of the american medical association and the thoughts about the role of these bonnets approval vioxx was indicated for small subset of the population to experience pain and all drivers but it couldn't tolerate other drugs box was never intended for the fast number of americans who suffer from arthritis and joint pain and yet the drug's advertisement pain vioxx wasn't readily available to the public without a prescription and that maybe a prescription is actually needed we know from the example of vioxx and i'll products are safe even after the approval of the f d a and post market studies are necessary to ensure the patient safety however many drugs are heavily marketed to see advertisements and consequently a large number of patients are exposed number of health risks in this hearing we will look at several different issues with  advertisements pfizer's dr jarvik advertisement and the misleading information that containment patients see an advertisement with the word world renowned inventor who they think is a doctor celebrity they begin to believe the product is safe and yet we soon appropriate was approved event the need for blood transfusion in a very specific group of patients the committee will also look at the bad torrent ads and the fact that they were still being broadcast when the study on its effectiveness was delayed for two years the f d a determin the ads violated policy by not putting a disclaimer on the effect or member there's no way we can determine the full risk range of risk based on a clinical trial own and in essence once the drugs in the marketplace it becomes the new clinical trial and does increase the number of individuals who go to their position but the same time it increases the likelihood that more people be exposed to any number of negative effects of these drugs before they are  deal of work with the f d a reauthorization last summer and the reagan util language in that legislation which was to allow for post market surveillance which was to allow the exact same type of surveillance to which mr green just diluted was unfortunately not funded in the u s d a appropriations bill last summer for reasons quite frankly i don't understand we managed to do several earmarks in that  appropriation bill but we didn't seem to be able to find the money to fund the very critical after market surveillance which would answer some of the questions that that we have here in front of us today i'll just say it my years as a practicing physician i wasn't a great fan of direct to consumer advertising but i recognize it does it does have a function in patient education certainly the vytorin commercial that you aired for us just a few moments ago has never been my favorite commercial i've sometimes wondered about the  actual content of that commercial but it does provide a bit of patient education in that there are two sources two sources for elevated cholesterol and it is important for patients to understand that if they're going to play an active role in the maintenance of their health and the the ability to lower their their cholesterol function overall dr jarvik appearance on the other commercial that you  aired i am trying to see where the inappropriateness of that occurred i've reviewed the criteria that were laid out for us by the president the a m a i will confess to you that i don't see the problem that was in that ad there is no question that the introduction of statens into the armamentarium of the average primary care physician has made a big impact on the duction of heart disease in this country and as a consequence i forget the figures of doctors or whom he gave us in earlier testimony but i think it's eight hundred thousand premature deaths from cardiac disease that have been prevented by the introduction of those types of medicine so there's been significant savings to the medicare program because of the introduction of these types of medications so it is to me it's a little bit of a mystery why why we are why we are including that in the body of evidence that we're that we're studying today and you know mr chairman there are a variety of things that go into the decision making process between a doctor and a patient when the decision time comes for prescribing a medication this is something that came home to me when we were undergoing the process of rewriting the f d a reauthorization bill last summer and the enormous responsibility that is laid upon each of us on this committee to do the correct things so that the practice of medicine is not compromised in this country i want  be very very careful as we proceed down this road because honestly i can see that we could make some decisions that would be not in the best interest in allowing the physician and the patient to have all of the information before them when they when they make decisions i mean after all we want there to be more transparency in the practice of medicine today we want our patients to become more active participants in not just the maintenance of their health but the treatment of their disease and this is yet one additional tool that is available to them and one other thing i would just say and i will be interested when we hear from the g a o testifying today the bar graphs that show the increase in the amount of direct consumer advertising that has occurred since two thousand  and it's just i'm curious as to whether or not we subtracted out the public service type announcements for the like the partnership prescription the p p a bus that montel williams takes around the country if that type of ad ty's ng is included in that block of data that that shows an increase and because curious about that because the amount of time and effort that was spent on marketing drugs to treat erectile dysfunction seem to me to be disproportionate and i've always considered that the companies would do themselves a great favor by increasing the public service part of their announcements and not just the the marketing of lifestyle drugs but it's an interesting topic mr chairman it's timely topic and i will balance my time i think the gentleman is a member of this committee and a position i hope you'll stay for at least through our first panel i think you'll find it very educational from a perspective of a physician and also a member of this subcommittee if the chairman will just be a housekeeping issue we do have the other hearings going on on stem cells right  we're going to be doubly educated on two different topics today but i appreciate the fact you're holding this hearing because the united states is one of only two countries in the world that permits direct to consumer advertising of prescription drugs after all these are not over the counter drugs a doctor has to give a prescription and yet the billions of dollars in advertising directed to consumers pays off because there is an increase in the purchase of drugs now if we look at an ideal world one would hope that the f d a would be approving the drug and we would know that it's going to be absolutely safe and effective that's what their objective is supposed to be but we don't live in a perfect or ideal world and when  drug first goes on the market we don't have every confidence about its safety sometimes we have to wait for a greater population group to use the drug before safety problems do occur now  if f d a has no other choice but to approve drugs based on this imperfect knowledge they have to wait and then because their samples are for pre approval is much smaller so we look to the what the institute of medicine has to say about this matter because they've studied it carefully and in two thousand and six they they had a groundbreaking study and they expressed some serious reservations about direct to consumer advertising in their report they cited the distortion of drug usage practices caused by d t c ads in which the use of more expensive drugs are are used are increased but there may be effective drugs that are less costly as a need specially if they're lower cost generics that are not being used because of the heavy advertising that steering consumers to the boy expensive drugs the i o m also described the mixed effects the d t c has as an educational tool they conceded that consumers might learn about conditions or diseases through a d t c ad that they might not otherwise been aware about on the other hand the report cited the fact that many ads overstate the benefits of a drug while understating the risks well that's in the commercial commercial advantage of the drug manufacturer and the i o m said that the d t c ads have a have an impact when people don't get the full information positions himself provide evidence of d t c ads do work surveys vary but roughly half of the physicians report that w patient asks them for a specific drug they prescribe what the i o m recommended that f d a be given some new authorities aimed at d t c advertising specifically out of a concern about that rapid uptake of new drugs with known risks caused by d t c ads the i o m thought congress should give f d a the authority to restrict advertising on a case by case basis during the first two years of a drug that whe drug is on the market when we consider f d a amendments last year we try to include that kind of provision the original bill would have given the f d a the authority to limit advertising to consumers of a newly approved drug while the agency is still reviewing the safety concerns about the drug for a period of up to three years f d a could have restricted d t c ads only if we determine on a case by case basis that additional data about serious risks needed to be compiled after approval and that the public health could not be adequately protected by less restrictive means like a disclosure statement this is a authority felt clearly within the bounds of the first amendment and i was disappointed that we didn't ultimately hold onto it the final legislation only included some extremely limited provisions and some very low civil monetary penalties for false and misleading ads they simply would not give the f d a the tools it needs to address what i think is a very concerning practice i want to mention briefly another concern that i have a advertising is a critical issue it actually represents a relatively small fraction of all drug promotion activities in fact i'm more concerned about the practice of advertising to physicians that form a promotion occurs much more frequently and outside of the public view so it receives less scrutiny by the american public we know though that it is inside the doctors offices where the most persuasive and effective advertising really goes on their promotional documents are accompanied by meals for the entire staff tickets to sporting events personalized gifts obviously this is a topic another day but i do hope we'll have an opportunity to address it so this job i look forward to hearing i thank you again for convening us and i hope this will be beneficial education for everyone involved opening statement and we'll have a couple of hours to get through this hearing so we'll be in recess for one hour will come to order when we left for our extended recess mr whitfield was waiting patiently for his opening statement gentlemen not recognized for his opening statement mr chairman thank you and certainly want to thank the witnesses today and we apologize for the delay which seems to be not uncommon here in the house this obviously is a quite an important hearing that we're having today and i do think it is important to reiterate what some other members have said that there is a basic legal principle in the united states of free commercial speech and i for one really do not have a problem with the advertisement of  medical products on television because i genuinely believe that one of the problems in our health care system today is a lot of information and i know that one of the numbers  mention the fact that for every one dollar of advertising that drug companies do on television there are six dollars of revenue for that product and i think dr  on the fact that we do not know however what health care dollars have been saved by patients using medicines that may have been advertised on television so i think to just have a sort of a blanket criticism of advertisement by drug companies is not really accurate or is not correct obviously we cannot stand for misleading advertising and deliberately misleading the american people and we do have a very we do have rules in effect relating to the f d a and ads that are put on television relating today because i think the bottom line is the more we have patients talking to their doctors and the more information that patients have i think that gives us the best opportunity to provide good health care that is i want to reiterate once again we certainly are not going to stand for put up with or allow misleading advertisement or advertisement that is blatantly incorrect so will have them give their opening statements at that time but that should conclude the opening statement of the members members are back and forth between the health subcommittee so we'll begin with our first panel the first panel  ruth who is director of medical technician laboratory at duke university dr de would you please come forward conduct your day at the policy of this subcommittee to take all testimony under oath please be advised that you have the right dr day we traditionally keep it at five minutes but then your courtesy of low extra time because of the expertise and what you want to explain to the committee so i let you begin your testimony doctor i'm going to need you to or should be a little button right there thank you good afternoon my name is a faculty member at duke university and director of the medical cognition laboratory there my expertise is in cognitive science how people understand remember and use information i recommend everyone consult the screens i'm going to be showing visual displays throughout my testimony i'm not here today as a naysayer i'm not here to say that direct to consumer advertising is bad and should be withdrawn from the market i'm also not here as a i'm not here to say that direct to consumer advertising  prescription drugs is good and should be retained instead i am here to report research on how people understand and remember information from these drug ads this research was not funded by any drug company ad agency advocacy group or government agency so the basic question is how do people understand information about drugs and the answer is with difficulty and there are many possible reasons for this there's a very heavy information load there can be complex and technical information and so forth however i'm going to focus on the problem of cognitive accessibility cognitive excessive bill that is the ease with which people can fine understand remember and use drug information and hopefully in a safe and effective manner cognitive in accessibility occurs whenever people have trouble doing any one or more of these things research in my lab looks at drug information from a variety of sources from television to the internet and hard copy and are just some of the types of information sources that we do study d t c or direct to consumer advertising does take place in all of these areas but today i'm focusing just on our research on the prescription drug ads on television our basic approach in research has three parts we begin with a cognitive analysis of the ads so wherever they've come from in this case television we obtain quantitative measures of cognitive excess ability and calculate various scores with them because together scuse me and then we compare the cognitive accessibility in the present haitian methods for benefits versus risks  particular and other things as well we even develop an enhanced version if we think there's a problem where we enhance the type of information that is a disadvantage and we retain exactly the same information but just presented in a way that people are more likely to get it then we perform cognitive experiments to test for the effects on attention conference in memory problem solving decision making behavior and when we can ultimately health outcomes many cognitive principles underlie this research that are well known and documented i have time to only address a few of them today as shown on the screen language chunking locations speed and attention which i'll be describing shortly so how do we get these t v ads that we analyze we've been collecting them since the year two thousand continuously through today and beyond and we essential use the broadcast capture method we record on a daily basis and capture the ads that are in bend imbedded in the various programs therefore we do not target specific health conditions or specific drugs we study all of them i'm going to start with some of our research from the early years two thousand thousand and one and  continue on these today but just to get us started what are regional findings were here's the way a typical experiment goes we show people a t v ad and then afterwards we test them on their knowledge about the benefits and the risks and other types of information we use a variety of cognitive tasks i'll only have time to really tell you about one type of task today so when we ask people what is this drug used for we then plot percent correct as a function of what drug and they saw in here some early results for three drugs paxil nasal next an ortho try cyclon and the results are good people know what the drug is used for range or about seventy to ninety plus percent correct that's good when we ask for the same ads and what are the possible side effects that were presented in the ad performance goes way down so here we have benefits here we have risks and so people are not getting this information well at all averaging over many experiments and many ads on average we're getting about eighty percent correct on the benefits and about twenty percent correct on the side effects with variations across specific ones of course so how are these benefits being presented that enable people to understand and remember them well here's an example where you were told something about a foot long frank in your grandpa frame and so on and so this ad does bring forward the idea of two sources of cholesterol food and family and the way the benefits are handled is very effective here's a case for wellbutrin x l and there's two message main messages in the ad that it treats the depression with a low risk of sexual side effects and we find that they repeat the low risk of sexual side effects so often that that's almost a stronger message than what the drug for here are other cases where there is great care taken in presenting the benefits for example in crest or the montra down with the bad up with the good type of cholesterol is very effective and the others are all effective as well in presenting two concepts many of which are difficult to understand and they're getting across and people understand them what about the risks well before i show you how the risks are presented and what the consequences are let's raise this question why should the public know about risk here is a quote drug information should be provided only in such medical terms as are unlikely to be understood by the ordinary individual and that came out in the u s code red regulations one thousand nine hundred eighty eight and that was a view that prevailed at that time today there are people who have viewpoints both pro and con as to what and how much consumers should know about the risks potential risks of of drugs those on the pro side site it's important for patients to have informed consent about what they're taking and understand what it is and then participate in decision making with their physicians for example they might try lifestyle changes before going to medication or just go forward on the medication and one i find particularly convincing is that then they would have a better idea of what appropriate actions to take should any of these side effects occur on the console some people say oh if you tell people too much about the risk of the scared they can understand them anyway maybe they won't comply and so on saw there are these differing views today but the balance has swung very considerably toward the pro side so now going back to the original finding that people know a lot about the benefits after an ad and not much about the side effects why is this so hard there are many possible reasons such as this fear idea their motivation education health literacy and so on so let's see how we look at what's going on here when we capture an ad one of the first things that we do is to get a transcript and by this i mean the soundtrack the spoken transcript by the voiceover or the characters on the screen and we look at all of it we get a written transcript but we focused for merrily on the benefits and the risks so let's look at the language level that is you there are many linguistic measures that we use in our research some of them govern complex from word selection and grammatical structure logical structure cohesion readability measures and so on but all of them speak to comprehensibility how easy would it be to understand here's one of our first studies from two thousand and one twenty nine drug ads and if you look average across all them what read level of comprehension would a person need in order to understand the benefits it's about a sixth grade grade level that's pretty good for a general population what grade level of complication comprehension would they need order understand the side effects on the ninth grade level so that's three grade levels higher in order to understand the side effects as opposed to the benefit so that's what part of the problem is and this is an average across many and some are even more extreme than shown here when we collected that you had to have eight grade levels higher to understand the side effects but of course not all of them a show this pattern and some are more equally balanced so now let's look at a speaker timeline for a drug the yellow boxes show when someone is speaking and just the straight black lines are when there is some silence and there is time going from left to right all right this is a particular ad for allegro and it started out the first yellow box it said it's allergy season or a leg or season and then there was a pause and then there was another message again a positive message and a pause and then there was a long block where it started by talking about what the side effects were and went immediately into other information so the point about this display is that for the first blocks of information there's what we call chunking you put together a set of information and then you separate it from surrounding information in this case with silence and that helps mental to justin's so to speak whereas a long block after you say the side effect if you keep talking there's less opportunity for that to happen so that's a case where the side effects are being disadvantaged in that criterion let's talk about location of information there's a well known phenomenon in the memory literature about what happens if you present a list of things for people to remember with their words or numbers or whatever when you them thought percent correct as a function of the location of the items in the list this typical finding comes out this is been repeated time and time again this is a well known phenomenon that people remember the information better at that information at the end of the listen beginning a list and have trouble with the information in the middle and it's in the middle a little bit past the middle so on the screen a little in the middle and towards the right so to speak so now let's use this to ask the question where is the location of side effects and say this group of ads that we capture we're going to look for each add where in time where the side effects presented so we're looking at location as a function of the lapse time and there are the results the pink bars are just for each drug and i put a box around to show this approximately sixty to eighty five percent of the time elapsed when the side effects come in when we combine all risks and risks include only side effects but contra indications who should not take a drug interactions with other drugs and so forth you'll see that exactly the worst locations being used for this negative information about the possible risks of the drugs so clearly the risks are being presented in an unfavorable location but you might say what effect does location have on  cognition or mental processes we need evidence so we produce our own little t v ad for a hypothetical drug called flu wade and its structure content is exactly like typical drug ads and our purpose is to very specific factors to observed effects on cognition and so people would see the ads and on a random basis half of them would see or excuse me here the side effects in the usual unfavorable location and or in a more favorable location exact same visual and auditory information they differ only in the location of where the side effects are presented we're now going to plot percent correct side effects for those two locations and people who receive the information the unfavorable location did not do well people who received it in a more favorable location did very well in fact there was one hundred percent increase in what they knew right after the ad there were still some people were unable to report any side effects at all but virtually all of them nearly all of them had seen had had the ad with the information the unfavorable location big difference there let's now talk about speed there are two interesting as in two thousand and five both for sleep medications a lunesta where there were some interesting variations in speed of speaking during the ad so we counted the speed of speaking in terms of cells per second and here for the ambient ad there was a speed up when the information came for the side effects whereas in lunesta there was no speed up and so we did an experiment with both of these ads we're focusing just on the speed now of the side effects with ambien being much faster twice as fast approximately than l a and you could still say so what just because it speeds up to speed affect knowledge that people take away and the answer is yes indeed so the faster they spoke the less people took away the final appealing and we were testing this in the in the laboratory and we found people were remembering the side effects at all in and the very very low and we we were wondering about this it only had five side effects and the limits of short term memory are approximately seven plus or minus two thoughts well within that but was particularly low and when we analyzed the ad we found that there were some interesting visual effects going on during the speaking of the side effects so instead of show you the video i have some stop action shots of what the bee does here so if you will fix your attention where the red arrows are on his wings i will now show show you some screen shots and watch what happens do you see how the wings moved and also flashed right that was going on during the side effects right afterwards there was a section on benefits and during this point this part of the bee was hovering and you could barely see is we wings at all he was just kind of hovering during the expression of the benefits at the end of the ad so we counted the number of wing flaps per second for the benefits section versus the side effects section that i've described and found that there were many more wing flaps going on during the side effects section and there were also some other flashing effect going on might have been graphic artifacts and those were all going on during the side effects and very little during the benefits so all of these wing flaps and wing flashes and sparkly things as centrally divided the attention of the viewers instead of concentrating on the auditory channel where the side of extreme presented they were pulled away to the visual channel and this led to decrease knowledge and there were many more comments from this particular ad that there weren't any side effects people actually denied they do say any and i first presented these results wings in another he was just hovering couldn't see any wing action much at all and another there was no b at all and so we did a head to head comparison in a laboratory experiment between the original wing flaps bad and the hover ad and looked at how much people knew about the side effects and as you can see everything else was the same the side effects and so on but they got much more of a takeaway message about the possible side effects from the hover ad so this is an example of visual distraction only one of many techniques that can be used so to go back to the original question why is it hard for people to get the information about risk specific and particularly side effects many of these cognitive principles only few of which i've been able to talk with you today are indeed responsible and we have attested them experimentally in the lab so here are some conclusions there's currently and has been for a long time an unfair balance between the presentation of the risks and the benefits in these ads now when i say unfair balance i mean in terms of the cognitive accessibility the presentation techniques that make it easier or harder for people to get the information i'm not talking about fair balance as the f d a does as to what's in the ad the business of what's in the ad is the companies and the f d a what i'm talking about is given what's in the ad how cognitively accessible is it to the viewer  so since the year two thousand as we reported many of the results there have been changes and many of them in have been addressed to our particular results in so ads but there seem to certainly need to be many more otherwise we're in the following situation that the ads are presenting writ risk information they're physically present but functionally absent what is the good of having information that physically present versus functionally absent it fulfills certain legal requirements but it does not communicated to the intended audience so some recommendations we need to have an evidence based approach in evaluating these ads to be used by industry and the regulators as well using the same criteria so say for example from a cation in speed in other things to have a checklist with the same quantitative measures and make sure that the treatment of benefits is as good as the treatment for the risks or roughly balance and then we can get into fair balance in the cognitive accessibility both types of information otherwise here's the final point risk school like this we send them out to the viewer and they go  up over the head and go on but i think we can get this information into the head and energy do it we need to increase cognitive accessibility this concludes the formal presentation of my testimony but mr chairman i would like to comment that the house and by the way in the briefing materials there is a longer article it goes into more the details about this research at the house requests i have examined ads for the hearing and if you would like that commentary if you would do so quickly ok very quickly we were able to conduct a full experiments onto the ads and i'll show you for the lipitor or add here is the same set of results for how well they did in getting the benefits versus the risks of same kind of pattern for the benefits one benefit came across much better the lowering the cholesterol rall than of the reducing the these mean the risk of heart attack and for the side effects neither came across well the that there could be must mean muscle pain or weakness and i do not think it is the fault of this ad i think it's the problem with the  this is a very serious side effect that can occur with the staten drugs but when you say muscle muscle pain and weakness these are things of that the public is experience many times and they don't understand how serious taken together they can  be and there was another thing in here that all the staten as tend to have something like you need to have you need simple blood test to check for liver problems when we ask people are there any medical tests you could have they did pretty well most say yes but when we ask what are they for they really didn't know most said they didn't know some said liver tests and then the others i didn't even list all the others are all over the place when so when we ask people when should these test take place nearly all the said before you take the test before you take the drug that qualifies you to take the death of the drug so there's no sense that certain drugs can affect liver function another function while taking them to the test might be a monitoring later on so it's a general thing where we need some public education about what it means when these statements are made the other one that we were able to do testing on was procrit and there's its  profile in terms of what people could a report about the benefits and risks a little bit more in balance here and both of the messages came across strongly that it does something for red blood cells and  also your energy level and so forth and there was something interesting about the side effects that one they got the one about diarrhea but not the other one because it was called a demon and i don't think the general public those it edema mean swelling so this is just a simple case had they used the term swelling they probably would have done much better that concludes my review of those ads thank you doctor before we go to questions mr dingell would you thank you we'll start with the questions and then i'll begin the question dr de techniques you described did you get them from any psychology textbook or from advertising manual all of them are from textbooks in cognitive psychology in cognitive science has for the research is being conducted i don't know if they are in the marketing i'm sure i do know many of them are in marketing textbooks  not all of them because there's the actual number of benefits and the actual number of side effects affect your research for example if a drug has two benefits but seven side effect there be more side effects to forget yes that's a good that's a good point we take care of that by the following if you recall the first slide that i show which were three drugs and i showed how poor the recall was for all the side effects they vary widely in terms of numbers three seven or nine and the results were all the same so in that experiment there was no difference in the two in the two studies that i just mentioned now for lipitor or and progress they were equally balanced each had two benefits each had two  side effects unless and as you can see the results were showed the same pattern i would just comment on the lip it tore at if i might it says that there are the two side effects you might consider liver problems as an implicit side effect but is not explicitly stated as such we do study memory load and find that's not driving our results well you just don't study the study all commercials not direct the consumer address oh no we know we are not an advertising outfit we study all drug information will study pharmacy leaflets will study medication guides will study the full prescribe ing informations at the physicians using as the approval documents are what they will let me ask you  if you do all these studies on pamphlets and ads and everything else i mean the ones that do a good job of presenting the risk and benefits in a way that people truly understand or remember them i would not do a categorical statement that some ads are good and some ads are bad overall but i can speak to some as are particularly good in certain features for example in connection with the speed up and when i first saw  real recent campaign on in a black suit for bladder problems i was absolutely stunned at how slowly the entire ad is spoken and there's absolutely no speed up for the side effects and we recently have tested that ad and people do very well with it well let me ask you this of an ad agency or drug company wanted to make sure that consumers actually receive the information they're supposed to receive from an ad is there a way to test for absolutely just as we've done here and it could be included in their market research that they do market research is usually designed to find out if there's brand awareness and the messages in the peel of the people speaking but some of ours are full experiments  taught about here today but some of the simple things that that we do can easily can be combined in their market research endeavors you or your group there at duke university ever been approached by a drug company or an ad agency  assist them in analyzing ads to make sure they're fair well i've never been approached by an ad agency period i have been approached by drug companies to help with their campaigns and i've not done so i have been approached by the f d a to give public testimony in various hearings on direct to consumer advertising and i have done that and in those meetings and in other professional meetings such as the drug information association there's a wide variety of stakeholders and i've spoken informally with everyone about my research and the techniques but i have not consulted on any specific ads or ad campaigns that anyone has w test to make sure that people actually understood the ad or the information in the ad would that take a lot of time and money to do well it does a full battery of what we do on an ad like this is  about thirty to forty minutes including the informed consent and so on we have a lot more than what we have i have talked with you about today but for just what i've talked with you today it could take about fifteen minutes as for the money the money would be very nice to be able to fund this we would be able to study a lot more as we are doing this ourselves on a shoestring but we study a wide variety of individuals of all educational levels and backgrounds and we study physicians as well as the consumers and we find that the physicians have the same kind of trouble with written information about the risks as opposed to benefits as the consumers  we don't have sufficient funding to do is much of a national look from our own laboratory across many consumer groups and i think the companies would have the funding to do that let me ask you another question there's a lot of interest of this hearing on the floor f members and when we're down voting there for over an hour number of members mention it one member asked me in particular to ask you this question john from the congressman from new york want to know the effect of these ads on children the cognitive accessibility code of operation and i believe at that time those types of ads were going to be aired after the ten o'clock hour when the family hours over but they are now during evening hours so something there has changed and i have anecdotal reports i've heard from colleagues but we have not done research about this mention that drugs or drugs you looked at reviewed that there was actually an eighth grade level difference between the risk and  the benefits of eighth grade that's a large swing in your study very large and it was floor flow event inhaler wasn't have i did not show that here today that was that was a long time ago and there were quite a few that had a sixty six grade difference as well it is i believe it is my responsibility to follow those ads over time and see if those things are corrected after they're reported and i've not done that yet i can't answer it was a slow event and it was eventually pulled from the market right mr whitfield for questions please thank you mr chairman dr de thank you for being with us today the medical cognition laboratory at duke how is that laboratory well this you said part of your laboratory my laboratory also looks at courtroom cognition how judges and jurors understand or remember information about laws and apply them to decision making so most of the laboratory now is devoted to medical cognition but we do have other projects as well and you're part of the duke university yes i am your laboratory and you're the director of that laboratory and the only funding is through duke university that's correct in my own pocket in my own time i have received no funding personally for this and i know in your opening statement you said that you're not saying that direct to consumer ads are bad and should be withdrawn  with you i mean i think the more information patients have the better one one part of your cognitive ability study that seems to be missing the mail which is a vital and very important part and which obviously i don't know if you've studied it or not but obviously before any patient can use any of these medicines that we're talking about they have to have a prescription and they have to have a consultation with their physician absolutely and i'm assuming pharmacists also have a responsibility with the patients as well i've studied physicians not for the direct to consumer ads because they tend not to like those anyway but i have studied them in the written information from company websites so i have taken exactly the side effects section from drugs and shown them to physicians either in the original form or an enhanced version that i've developed for showing side effects and they have studied them and then reported and in this particular case i'm thinking of now it was for a drug that they all regularly prescribe because this is at a medical convention or or meeting where i knew what their specialty was and they were they did a very poor job in reporting what those side effects were afterwards when the information was presented in the traditional way with sentences bullets however when i presented it in a way that is more graphic in design  emphasize the severity of the different side effects they improved dramatically there was no difference between the physicians and the lay persons in this you know and you know i think that's important part to the point that we need to make  i think many of us would really be concerned about i had patients looked at these ads and then they went to the drug store and said i want this but they can't get it without a prescription which second point  lives have you ever seen that in your research that is that you discussed in your testimony to a peer reviewed journal yes i have and well one was in the related work not the details of today in the psychology of learning a motivation the first one in this line and another with to the american association for artificial intelligence that was a jury  selection argumentation for consumer health and how many other laboratories similar to yours are there with universities around the country i'm not really sure i know of clusters of people who do research on all of this and sometimes they have a wider narrower focus on certain issues and the all get together parry article for no i think we should but we wind up together at different meetings and i am thinking of convening a conference to bring people together to talk about the drug companies are required to include information about risks as well as benefits how does a drug come they are the f d a draw the line communicating risk information is there a point when an ad can include too much information on risk and viewers began to tune out the information i have to answer that first of all  is not for me to say how many can or should should be in there based on the available information about the drugs and i commented that before that's the business of the f d a and the companies but i think your question is about how much information is too much you're talking about information load and we have found that it's not how much information is presented but how it is presented so to go back to this last example  with the physicians looking it was for the it was for the drug avandia and as we took it on the company web site for the with for the patient information section there were twenty six side effects and no one can remember all twenty the information but when we gave it to them in the enhanced version they went up dramatically and depending on what cognitive task we use when we ask them another task number estimation task about how many were there people went up to perfect performance so it isn't how much information you give it's how you give it and i just ask one brief question does anyone purchase your test results from from the laboratory no one not for me i do not earn any money and so no one really has access to it i don't give it to mono no one has ever requested we have found that somebody came as a test subject and we found out later works for one of the companies ok thank you all know if i may just well follow up on mr whitfield questions and so the most important part of your testimony and if i could summarize it's not so much what's presented in the ad but what people takes away from the well i would say there's an intervening step it's not so much what's in it but how it's presented then affects what they will take away so that you can be in legal compliance with f d a regulations asked what needs to be in there but if you present it in a certain way you're really decreasing the chances of people going to walk away with it and conversely conversely presentation will determine what people think and i'm saying not presentation in terms of things going on and so forth but taking into account well known and well documented cognitive principles for the questions i'm going to for the question thank you thank you dr day for your testimony media research at the kaiser family foundation and dr marcia cross who is director of the health care division at the government accountability office association three witnesses it's a policy of this committed to take all testimony under oath please be advised witnesses have the right under the rules of the house to be represented by counsel do any of our three witnesses or three doctors here wish to be  let the record reflect that witnesses have replied in the affirmative each witness is now under old we will now he prepared a five minute opening statement from each witness you may submit a longer statement for inclusion in the hearing record  dr nielsen shall we start with you please from the american medical association thank you for being your kids or your testimony thank you chairman stupak and representative whitfield and to the rest of the committee thank you for holding this hearing my name is nancy nielson and i'm clinical professor of medicine and senior associate dean at the university of buffalo school of medicine i'm here today as president elect of the american medical association the a m a welcomes the opportunity to share our policy as well as the house of medicines perspective on d t c a's impact on the patient physician relationship on its adequacy as a source of information for patients and its role in driving health care costs d t c a has become ubiquitous over a very short period of time according to a recent consumer survey almost ninety one percent of americans have seen or heard the sheer volume that now appears on television in particular including ads for drugs to treat conditions like a reptile dysfunction raises questions about the timing and the appropriateness of these advertising advertisements for some consumers to children just before nine am this past easter sunday morning while home with the sick grandchild an ad appeared on t v advertising one of the drugs for reptile dysfunction i quickly made hot chocolate equally troubling there is mounting evidence that many of the television direct to consumer ads lack fair balance and include claims of benefits that overwhelm risk information and you just heard a very area testimony on that regard also intense advertising newly approved drugs can exacerbate significant safety problems the vioxx case is the last written of that issue the a m a has been and continues to be concerned about the positive possible negative impact of d on the patient physician relationship and on patient safety we are also increasingly concerned about the role that dca plays in fueling the increase in health care costs it is all the more urgent now as congress grapples with relating costs and the need to prioritize limited healthcare dollars d t ca has been a lightning rod of concern among our member physicians for over twenty years our policy on d evolved over this period and the current policy and we have submitted that to you was adopted in two thousand and six product specific advertisements are considered acceptable if they satisfy the a m a s guidelines and key points from these guidelines are seven first that d g c a should be indications specific and enhance consumer education about both a drug and a disease t should provide a clear accurate and responsible educational method message the information about benefits should reflect the true efficacy of a drug as determined by clinical trials leading to f d a approval three should not encourage self diagnosis or self treatment which of course is not the same as encouraging patients to report symptoms that we obviously favor for should exhibit a fair balance between benefit and risk and again you have just heard a better analysis of that than i can give you we certainly believe that the time and space devoted to the benefit and risk information and the ease with which people can find understand remember and use the information about benefits and risks should be comparable five should present risk information that will be understood by a majority of consumers without using strategies designed to minimize risks or distract from them as you have just seen six should not use an actor hooper trey's a physician or an actual physician to endorse the drug product unless there is a prominent disclaimer or disclosure and seven should be targeted for placement so as to avoid audiences like my grandson that are not age appropriate for the messages be determined by the f d a in negotiations with the manufacturer a m a encourages further research on the effects of d t c a and we support congress authorizing arc to perform periodic evidence based reviews to determine the impact on help outcomes and public health if d t c a is found to have a negative impact on either of these then congress should consider legislation to increase d regulation or pass possibly ban it in some or all media in conclusion recent events have heightened our concern and the a m a looks forward to working with you to ensure that consumers receive information that is accurate informative promotes communication between patients and physicians and does not drive inappropriate cost thank you very much for the opportunity to be here thank you doctor dr brody for your opening statement if you  push the button right there on that might be might have to pull that up a little bit thank you mr chairman and members of the oversight and investigation subcommittee thank you for the opportunity to testify today on the public's views of direct to consumer prescription drug advertising i am molly and brody vice president and director of public opinion and media research at the kaiser family foundation despite the fact that they account for just ten percent of health care spending overall prescription drugs and their costs have become a central health care affordability an access issue and the views of the american public mainly because they touch almost everyone more than half of americans regularly take prescription drugs and four in ten report some serious problem paying for their medications including having to skip doses because of the costs the public has mixed views of prescription drugs and the companies that make them on the positive side they appreciate the benefits of the drugs themselves and most people agree that medications have had a positive impact on their own lives and the lives of americans in general however on the negative side they're very concerned about high drug prices which nearly eight in ten sarah and reasonable and which in the public's views are largely driven by high company profits prescription drug advertisements have become ubiquitous and nine in ten adults report having seen or heard advertisements for medications americans have mixed views about the relative benefits and costs associated with these ads on the one hand most americans agree with the proponents of the drug ads who say that they raise awareness help educate the public and reduce stigma on the other hand most people agree with the critics of the ads who say they raise prescription drug prices and induce unnecessary demand further the public's views are mixed about how well the drug ads present specific information about the medicines they advertise while majority say they do a good job explaining the potential benefits and what can the condition the drug is designed to treat more than half say they do only a fair or poor job explaining the potential side effects the survey data strongly suggest that the drug advertisements are doing what they were designed to do prompting people to talk to their doctors and to get prescriptions about a third of americans report that they have talked to a doctor about a specific drug after seeing an ad and about eight in ten of that group says the doctor recommended a prescription as a result either for the drug they asked about or for another medication people report that these discussions lead to other actions as well for example more than half of those who talk to their doctor about a specific drug say the p recommended lifestyle or behavioral changes well about three in ten say the doctor recommended an over the counter drug now these findings are echoed in surveys we've done with physicians who are involved in direct patient care a large majority of whom report both getting inquiries from patients based on drug ads and at least sometimes recommending a prescription drug as a result eight in ten physicians say that patients ask them about specific diseases or treatments that they had heard about from ads at least sometimes including nearly three in ten you say they frequently get such inquiries when asked what actions they usually take when the patients ask them about medications the most common response is recommending a lifestyle or behavioral change with half of doctors say they do so frequently doctors are less likely to say they frequently give a prescription for the requested drugs however about three quarters say they at least sometimes recommend a different medication and more than half of it they at least sometimes give the patient a prescription for the drug they asked about with the survey data can't tell us is whether this advertising induced demand is good or bad from a health perspective is it mostly encouraging people who might not otherwise get treatment to seek needed medications or is it mostly leading to demand for unnecessary medications these are questions that go beyond the scope of what the public can tell us in a survey given that ultimately the doctor must decide whether or not to write the prescription it is helpful to recognize that the majority of the physicians do not seem to think these inquiries from patients are negatively impacting their doctor patient relationship although about one in five say that they do the data also shows that the public prioritizes affordability of prescription drugs and while government regulation in many areas is unpopular there is an appetite among many for increased government regulation when it comes to reining in prescription drug prices for the more typical arguments against such action do not substantially erode this public support to a lesser degree some about four in ten are supportive of more regulation in terms of making sure advertising claims are not misleading although many believe that there's already enough regulation in this area however since the public has both become more skeptical of drug ads over time and give these as lord low scores on their ability to affectively communicate about potential side effects the public would likely welcome efforts that may lead to improvements in prescription drug advertising practices thank you for the opportunity to testify today and for your attention to the public's views on this important matter a lot of questions  cross from the government accountability office thank you mr chairman and members of the subcommittee i'm pleased to be here as you examine the practice of direct to consumer advertising prescription drugs my remarks today are primarily based on our november two thousand and six report on trends in f d a as oversight of direct to consumer advertising as we've heard f d a regulates the promotion and advertising of prescription drugs including television magazine and internet materials to ensure they are not false or misleading drug companies do not have to obtain f d a is review of consumer advertising materials before their disseminated companies sometimes voluntarily choose to submit draft versions of the materials to f d a for advisory comments in advance of public distribution however except in limited cases companies are only required to submit final materials to f d a at the same time as they begin dissemination to the public we found that f d a reviews only a small portion of the materials it receives and the agency cannot ensure that it identifies for review the materials it considers to be highest priority this has occurred at a time when the number of materials for consumers has more than doubled in five years to over twenty one thousand items in two thousand and seven previously f d a officials told us that the agency prioritizes the review of materials with the greatest potential to negatively affect public health but there were no documented criteria for making this determination f d a tells us that it now has developed criteria to prioritize reviews as we recommended in two thousand and six however just as we previously reported f d a still does not systematically apply these criteria to identify the highest priority  so what happens if the reviewers find a problem with an ad if f d a identifies a violation the agency may issue a regulatory letter asking the drug company to pull the ad or take other action however since a two thousand and two policy change requiring internal legal review by f d a as office of chief counsel of all draft regulatory letters f d a process for drafting and issuing letters has taken longer and the agency has issued fewer letters per year prior to this policy change from one nine hundred ninety seven through two thousand and one it took f d a an average of two weeks to issue a letter by two thousand and seven the time had increased to over six months f d a fishbowls told us that the policy change was the primary factor contributing to the longer time not only do the policy change create delays but after the policy change f d a issued many fewer of these regulatory letters the agency issued fifteen to twenty five letters per year before the policy change but only issued two such letters in two thousand and seven f d a officials told us that the agency does not issue for all violative materials that it identifies instead it focuses on those that it considers the most serious and most likely to negatively affect consumers health at the time of our two thousand and six report we found that the effectiveness is regulatory letters at halting violative ads had been limited by the time these regulatory letters were issued drug companies had already discontinued more than half of these ads generally companies have complied with f requests and regulatory letters they have removed cited materials that were still being disseminated and those companies requested to issue corrective materials did so however f d a issuance of regulatory letters did not always prevent similar violations for the same drugs we found that almost one third of drugs cited had received multiple regulatory letters sometimes for similar types of violations and conclusion given substantial gro in direct to consumer advertising in recent years f d a is role and limiting the dissemination of false or misleading advertising to the american public has become increasingly important for filling this responsibility requires that the agency among other things review those advertising materials that are highest priority and take timely action to limit the dissemination of those that are false or misleading f d a is development of documented criteria to prioritize its reviews is a step in the right direction however as we recommended in two thousand and six we believe that f d a should take the next step of systematically applying those criteria to the materials it receives finally despite f d a agreeing with an earlier g recommendation in two thousand and two to issue regulatory letters more quickly the amount of time it takes to draft an issue letters has continued to lengthen we believe that delays in issuing regulatory letters limit f d a is effectiveness and overseeing direct to consumer advertising and in reducing consumers exposure to false and misleading ads mr chairman this completes my prepared remarks i'd be happy to respond to any questions you or other members of the subcommittee may have concerned about this for twenty years we have seen a change in the legal environment this apparently is protected under the first amendment and their fourth unlikely that the clock will be turned back to a ban however as was pointed out there are only two countries in the world that allow this kind of advertising the other being new zealand so it has been a concern and doctors frankly are not real fond of direct to consumer advertising because not because we don't want patients to come in and talk about their symptoms and we do value the educational aspects but it is frankly fairly clear that the majority of what's happening has a marketing effect rather than an educational effect and it is troubling when a patient comes in with a demand for a particular drug and that sometimes results in what you have heard described from the kaiser family foundation what would you believe because a doctor a the patient's general public are more apt to believe the credibility of that position it is our position that we strongly discourage physicians from appearing in ads they strongly discourage because we think that frankly they don't know the patients that they're talking to and it does lend the air of credibility we discourage it we say if it does happen then there should be a disclaimer indicating that the physician has been ad well there are lots of a lot of lots of heart experts we have physiologists at my medical school who teach cardiac physiology they certainly are heart experts that's very different than being a cardiologist so it could be a full fledged cardiologist many different kinds of expertise that could be referred to in that manner dr brody if i may can you tell us whether the public is interested in seeing more regulation or less regulation based upon your studies the it's not so much the ads themselves but as their perceived impact that the ads have on prices concern the public has about prescription drugs right now is the price of drugs so certainly we saw about two thirds of people interested in seeing more regulation when it came to prices but it's also leads me my takeaway message from the public is that because they have become more skeptical of drug ads over time because they're concerned about the relationship between ads and prices and because they also give them sort of low scores on their ability to communicate side effects i think that regulation in this area would be welcome i think any or any other effort would be welcome to trying to help improve prescription drug advertising i think some way from your study there it was like that we think they do a decent job of advertising but the thing they sort of fall off on or they don't tell us about are the side effects yet they gave good scores when it came to being able to communicate what the drug was for  appropriateness of the timing of ads but we did ask whether they felt like ads were too sexually explicit and about forty percent said that they felt that they were these direct consumer ads sexually explicit on the other hand this wasn't something that bothered people very much only about twenty percent said that that bothered them a lot so i think that it's only bother some people out there but i wouldn't say it to general impression but we didn't ask specifically about the timing of ads and i'm sure your group had to be at least eighteen or older to answer your questions i'm sorry in your tell you all in the folks in the audience here that i have a major concern on the timing of these ads and i would concur with you and i think my positions here over the many years of support of family our support the appropriateness of what's broadcast and i'm just putting that out for record because i've been in that same position although my grandchildren my children since i'm a late bloomer and dr day i apologize for not being here  distraction and consumer understanding of risk and benefit information in direct to consumer prescription drug broadcast advertisements published in the federal register on august twenty second two thousand and seven i have not read that sir we would you know the purpose of the study is in part to determine whether the use of come part of this debate so i would have courage you to to look at that and we add that into the tool box of u r and in fact our policy goes further than what has been passed by congress and i've heard just that pre approval as you know the do you concur with the statements of my college my friend from california that  made the assumption that we can't trust physicians because they are bought off by the pharmaceutical companies well i think what you heard from dr day is physicians are people like everybody else and the way things are presented to them is just as important as the way it is pre so you agree with i agree that physicians are people i do not agree that physicians are bought off by drug companies and in fact i mean that's the assertion made i heard that sir i was in the audience we have ethical position about that that we'd be happy to discuss with you no i'm i'm fine with your be happy i think i would i would address it with my colleague from california who made the assertion that i appreciate your profession i appreciate the hippocratic oath i think part of this problem is the prescribe or drug is done by who drugs are prescribed by physicians they can also be described prescribed in some states by other health professionals so let me so the health professionals that do the prescribe that's correct and it's part of the kaiser foundation research one of the benefits is it helps create information for people to go  to physicians and really in the kaiser study it said that on the most part that doctors directed patients who came for information to other drugs or lifestyle changes you would think that that would be beneficial when to indeed and in fact when a patient comes in discussing symptoms that can only be a good thing and i think that again that that's the debate  this but i think when it comes to kids and what's aired over there i'm willing to to really push that issue the ethical tenets of our profession are very clear that one should in prescribe drugs do what is best for that patient there's no question about that dr cross you're aware that the congress increase spending on staff assigned to review adds to six point two five million a year from the previous high of just over a million dollars yes i believe under the amendments act have you staffed up the f d a has increased the staff assigned to the division to review these  have new law we have new and we have increased staffing so we're moving in the right direction if we're concerned about direct to consumer marketing i put believe that there are a number of steps that are pas in this area you mentioned a change in policy with regard to review of regulatory letters so that the chief counsel's office reviews them for legal sufficiency why was this change made we don't really have a clear understanding of why this specific change was made we reported on it in two thousand and two and again in two thousand and six methink there was a concern that came down from just from the general counsel's office direction that this change be made to review the mister mr burton for questions and you want to an opening statement i'll just take five minutes and your to do but little of both absolutely since i've been delayed apologise for not being here for the had you know buyer beware drugs and food products mean so to the american people one of the drugs under review today i take lipitor or i've taken it for two years since i had a heart attack i go see my cardiologist every six months and according to him it's working fine and i'm working which may not be good news i'm we should consider changing the current laws we have for reviewing them at the f d a yes or as as i stated in my testimony it is a m a policy that the f d a be given authority and of course by that we we mean effective authority but to not only do the kind of sanctioning that has already been granted to them but also to give them the authority and the resources to carry out the mission to pre approve direct to consumer ads so you think this is a more important problem than plants in china that are putting poison  no sir that that's that's not at all what we mean the f d a has wide authority but as long as it is legal to do direct to consumer drug advertisements then it is very important that it be not be misleading to the public so as long as we have it there has to be regular new regulation these ads that we're reviewing today were were aired before the new the new law that we passed last year  in the new regulations have actually been implemented and understand it most of the ads that are in question today have been voluntarily pulled from television association will be happy to look at the issue in greater detail i don't consider this to be the most pressing issue this before this committee and as you know since i used to chair this committee i am a strong supporter of aggressive over investigation and will support to chairman dingell procedurally and almost anything you wish to investigate but i would hope that some of the other issues that were ongoing including our foreign food jobs and when it comes to foreign food and drugs from this country i think i've held thirteen hearings already in about sixteen months or so we've been in this position well it's true there are new rules some of us think they're very weak provisions but there are new provisions and i hope that these hearings not only highlight the fact there are some new rules will be implemented but maybe f d a will take it seriously number one number two apply pressure on the f d a to quickly enact these new rules and not take years to do it and take actions against violators so that some of the reasons why we're doing this on a lighter note knows that if you've been taking lipitor for two years  dr nielsen recognizing that the a m a position is pre clearance of these ads it's my understanding that you made some reference that direct to consumer ads actually may cause or contribute to over prescription drugs is that is that your position or is that correct that is our concern that we we respectfully request studies to look at that ok that there have been no studies on that there have been some as you've heard that have approached it in other ways but it is a concern as everyone is worried about healthcare costs particularly if the advertising is for drugs that are under patent which may be no more effective than a drug that is available that is considerably saying that puzzles me about all of this and i talked about it a little bit and i'll bring statement is the fact that the doctor prescribe the drugs the medicine and that's what they're trained to do to diagnose and prescribe the medicine so are you saying that doctors are actually influenced by their patients because of what patients see on television about ads i think there's no question that that's the case and it causes some problematic moments in the office i can tell you absolutely from my own twenty three years  practice that it happened periodically it happened several times a week not every day but several times a week patients came in a sensually convinced because particularly a t v ad convinced them that they needed a specific drug so the conversation then was not about the symptoms so much as it was about why that drug or some alternative was was was going to be right what is the responsibility of the doctor  that in their responsibilities very clear the doctor's ethical responsibility is to do what he or she thinks is the best thing for that patient when there are alternatives it is in fact quite possible that the physician may be persuaded by the patient's increased demand that as one of the alternatives that would be prescribed but it always has to be in the patient's best interest i know that it's difficult to speak categorically in every instance but generally speaking at least it's been my experience and i'm not a physician but when i go to a doctor when family members go to doctor when i served on the health subcommittee that generally speaking patients listen to their doctors and and generally speaking they're pretty comfortable with physicians decision they may go and get a second opinion or a third opinion which i think is good but  i would just be shocked by self to think that physicians would be so intimidated or are pressure by patients to prescribe a particular drug because of someone saying it on television and maybe i'm being naive but i just feel like that one of the problems our health care system today in my view is that patients generally most categorically do what the doctor  foundation and i will defer to my colleague to give us the statistics but you heard that that about half of the time the physician will prescribe something else or recommend an alternative or sometimes an over the counter approach on the other hand there are other studies which show that a patient may leave a physician if they do not get the drug that they that they are seeking and every doctor every doctor will tell you about that doesn't mean that they give them the drug so they don't leave but they've had patients leave them so i think it is not quite true that all patients do what their doctors recommend would that it were so frankly and would that we had better communication between patients and doctors about their symptoms you know this information age which we live today with the internet and people go online and draw all sorts of information is available i would say i don't have any drug specific information however what we're really talking about today is the primarily in on t v because that's been relatively new over past eleven years the print tend to be a little more balanced but the t v ads are the ones that are more concern and that's different than a patient searching for information about diabetes on the internet you're absolutely right you can get good involve direct to consumer advertising on treatment options for high cholesterol did your november two thousand and six report on direct to consumer recognize any beneficial relationship between those direct to consumer ads and treating high cholesterol yes we talked in that report about the research that's out there that talks about the role of these ads in informing and educating patients as well as some of the same concerns that we just heard from dr nielsen there's been research on both sides of this issue and there certainly is some evidence that it can play a positive role in informing patients about treatment options they may not have been aware of before new authorities have not yet been implemented by f d a and i think it's too soon to see how that will play out the civil monetary penalties would be a step in general beyond what they've been doing with untitled letters and warning letters the kind of regulatory they've been taking since in two thousand and seven they only issued such letters i think we're talking about potentially a very small number of actions that might be taken that whatever to the level of any authority regarding those advertisements and claims they can take action to ask the companies for support but they do not have the same authority in this area as they do in the area of prescription drugs and in fact the federal trade teenager about a lot of things whether it's victoria's secret's ads or feminine products or some of these supplements that claim incredible well anyway you know what i mean and none of those would really fall under this issue either and i think we have to be careful in this country to go down a slippery slope when the court has clearly said there's a right to commercial speech for a legal product as a supreme court ruled that on commercial speech in this area qualified to speak to that direct to consumer advertising of prescription drugs but that certainly is a concern that's been raised about about and i thought there was a court decision validated there's certainly been court decisions that have overturned prohibitions on some liquor advertising there has to be a demonstrated public i'm not a lawyer although i slept at all a day in one so i guess i can pretend to be one but it seems to me that there has to be an overriding public interest issue here and  i'm not sure that i hear a lot from my constituents both physicians who hate getting this rush of people coming in saying what about this drug i mean i understand that and i know given their time commitments patient that's got to be difficult to manage but i've always been a believer that more information is better than less and more freedom of closure of information is better than a government censor of information and then an open and free market  and that's why we have been very careful to say that that our educational can in fact be beneficial i mean you hear you will hear things on the radio on t v know your numbers that could refer to your blood  pressure cholesterol that's very helpful that's important patients do you need that kind of information that that is really not the concern it is some of what you heard earlier although we didn't have the sophistication of the glittery baby wings very interesting the risks and benefits one has to be very careful because frankly the educational mission we would support the marketing we would you and i think that the study that was referred to earlier that the f d a is proposing to do we'll look at just that ok you also mentioned so we know the side effects of a doctor that it was not quite that it was when a new product to the market if it is significantly different then hopefully the f d a would have the authority negotiate with the manufacturer something different that calls to mind is the issue of emerging science as the science emerges that the combination is no more effective than a committed to direct to consumer advertising and we value our colleagues who are in the pharmaceutical industry we ask them merely to be ethical and fair and new science the office and there's a change in policy was there a problem before that we had to change the policy that takes us along like six months to get a letter out to a drug company don't advertise it was your problem but the highlight that said here's a reason why it's going to chief counsel  process don't make sure you're right with your problems it's not clear that there was a problem the stated purpose for the policy change was to ensure legal supportability of the letters that were being issued the letters that had previously been issued had not been challenged however on the basis of their legality so it's not clear that there was a direct link to that having said that we don't object to wanting to ensure the supportability of the letters they issue it's the time that it has taken and they committed to issuing that much more quickly in two thousand and two they said they were putting in place a process to do reviews within fifteen days sure that letters were issued within forty five days but every single office of chief counsel it's going to necessarily expedite a review of an ad or enforcement action certainly we point to that as a as marking a change that has greatly reduced the number of regulatory actions taken in this area prescription itself no sir ok but is normally on what the pharmacist will hand to the patient correct just just asking the questions but there is a discussion  taking prescription i really trust my doctor and i believe ninety nine point nine percent of everyone who sees a physician we go back years in every organization that disappoint us but i give the physicians a lot more credit than i and i think you are doing today by them being able to stand up and say i don't care what you're in you're my patient this is not right for you go and i believe that they're strong enough border to backbone and i would trust a doctor over an ad any day of the week because we all know oh ads are there sell you things it's not i mean cocoa puffs you name it americans know that because we have free over the air t v you have to support that through advertising revenue and advertising is there to sell you things so that's i think that's part of our frustration we love our doctors they are true professionals and i just think they're i just think they're tougher  then what is being said here today and i trust them to be able to stand up against a large pharmaceutical company that may be advertising something that's not in their patients best interest let me ask another question we're going to talk about specific ads in the next panel of the three drugs that we're going to be addressing are all three of them not in compliance based upon conveyed what i'm just trying to stand up for my docs who i know i'm here to stand up for for the hundreds of thousands of educated ethical dedicated and hard working physicians but it is true that that patients have doctors are right at the top seventy two percent say they get a lot of information about prescription drugs from their doctor pharmacist ranks second information about the product in the prescription drug package ranks third forty three percent say they get a lot from that twenty two percent say they get a lot from government agencies like the f d a families and friends internet and then at the bottom of the list of ads for prescription drugs in terms of where people say they're getting the most information  cent thirty three percent said they trusted a lot and that was down to eighteen percent now i'm sorry that they trusted them most of the time that they could what the pharmaceutical drug companies had to say in guidelines you know i think most americans know when a celebrity appears in an ad they probably are compensated but we think with the physicians that they should be clear about that with it's been a good panel we could go on and on but i think we're in this mess you thank you all very much for your testimony today is the policy of this subcommittee to take all testimony under oath please be advised each of you have the opportunity to have honored to have a right on the rules of the house to be advised by counsel during your testimony any of you wish to be represented by counsel mr sage  statement will start from my left mr sage would you like to begin please good afternoon mr chairman ranking member shimkus and members of the subcommittee my name is jim sage and i am the senior director and anticipates and addresses the needs of patients and physicians pfizer developed safe and effective medicines to revenge and treat some of the world's most serious illnesses in two thousand and seven we invested seven point six billion dollars in research and development and we use d t c to increase awareness of our products to educate consumers about the conditions that they treat and to increase patient and physician discussion about those conditions unlike most other industries pharmaceutical companies cannot sell their products directly to the people who use them instead our products must be prescribed by physicians as a result the prescribing doctor role is indispensable when considering  encourage an active partnership between patients and their doctors millions of americans suffer from treatable medical conditions that remain under under rated or under treated this is certainly the case with high cholesterol is only half of those who have this condition have been diagnosed and of those who have been diagnosed only half have received treatment elevated l d l cholesterol is one of the most common risk factors for cardiovascular disease heart disease and studied for approximately fifteen years and over four hundred clinical trials in over eighty thousand patients with tours and research and development for nearly a decade before coming to market our commitment to research did not stop there but continu several landmark trials these trials helped form the basis for current understanding of cardiovascular risk and for updated cardiovascular disease prevention guidelines in fact six of these trials have been cited by independent guideline bodies as impacting current standards of care what we learn from this research is that when diet and exercise alone are not enough limits or as a safe and effective medicine to reduce l d l cholesterol by thirty nine to sixty percent in a significantly reduced the risk of heart attack and stroke in a broad range of patients with common risk factors including hypertension diabetes and preexisting heart disease now let's start from the science has proven lipitor safety and effectiveness to our company's television advertising campaign for lipitor featuring dr store advertisements because he is a recognized for his work related to the human heart honestly and sincerely embraced our heart health campaign in pfizer believe that the ads one effective way to deliver an important preventative health message to a large number of patients by encouraging them to reduce the risk of heart disease through diet and exercise as well as through consultation with their doctors about the importance of managing their cholesterol dr john rocker's he does m d degree from the university of utah college of medicine in one thousand nine hundred seventy six although not a practicing physician he has devoted his entire career to medical science related to the human heart he has invented medical devices to help patients with advanced heart disease and he's collaborated with other physicians and scientists on these activities as dr driver has said publicly he has the training experience and medical knowledge to understand the conclusions of the extensive clinical trials have been conducted to support the safety and effectiveness of w well pfizer and dr jarvik are confident that the statements included in these ads fairly represent the scientific data for limpets or so if asked why pfizer decided to stop using dr jarvik in our advertisements we chose dr dhar to participate in these ads because he's a nationally prominent expert with the knowledge and experience to speak intelligently and sincerely about the benefits of living to work well fortunately the way the dr jarvik was presented in these created misimpressions in distractions from our primary message which was to encourage patients and physicians to discuss the leading cause of death in the world cardiovascular disease going forward we are committed to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople in summary pfizer believes it is important to continue to educate consumers about the risks of elevated cholesterol and the value that lipitor provides is a potential treatment option we believe it affected way to accomplish this objective thank you i look forward  cholesterol level through diet and exercise alone as early as nine hundred sixty one scientists identified elevated levels of cholesterol as among the risk factors for coronary heart disease the leading killer of americans understanding of the role of high cholesterol and heart disease and in the development of effective treatments the toll of heart disease remains too high and the level of understanding and treatment remain approximately forty six million adults in the u s have been diagnosed with high cholesterol and might benefit from promise to tickle treatment however just fourteen point five million adults are currently being treated with a cholesterol lowering medication of those treated more than four million or nearly one third are not attaining the desired cholesterol goals established by the national cholesterol education program the result is unnecessary disease and suffering it is against this backdrop that merck sharing plow pharmaceuticals approach the decision to create and broadcast advertisements provide tauren which is a combination of two medicines which limits the absorption of cholesterol from food and since a stat in medicine that moderates the body's inherited natural production of cholesterol high cholesterol alone has no symptoms advertising can be especially helpful in informing people about the need to address this important condition as well as reminding them to fill their prescriptions and take their medicines as directed by their physician as we developed our advertising we learned that the vast majority of people understood the role of diet and exercise and cholesterol control but did not appreciate the genetic causes this leads to their disproportionately blaming themselves for condition that is often inherited the advertising that merck suring plough pharmaceuticals broadcast from september two thousand and four until january of this year used a unique memorable effective approach to educate about the importance of lowering cholesterol the two sources of cholesterol the importance of diet and the additional l d l lowering that can come from drug therapy when a healthy diet is not enough our food and family advertisements were entertaining this approach kept consumers engaged while we delivered a serious educational message and our consumer research has consistently shown that the information about the two sources of cholesterol is getting through we commissioned a harris survey that found that prior to our advertising just sixteen percent of people were aware that there were two sources of cholesterol in the year following our advertising we found a full fifty four percent of people now understood this we also learned that our advertising had helped relieve the guilt people often carry when they are unable to control their high cholesterol with diet and exercise and encouraged them to have discussions with their physicians about additional options for controlling their cholesterol in developing the advertising campaign we sought advice from the food and drug administration on the proposed content of our advertisements and revised our advertisements in response to those comments these advertisements only made claims that are supported by research that were evaluated by the f d a and that were consistent with our f d a approved labeling sharing plan pharmaceutical suspended our vytorin food and family broadcast advertising in january we took this action in anticipation of the confusion that could be created by our release of the results of the enhanced trial mr chairman has trial was a relatively small study of a unique patient we will continue to responsibly inform patients and prescribers about l d l cholesterol the importance of diet and exercise and vytorin as we move forward we will continue to consult with physicians patients and the f d a to ensure that the information we provide will continue to educate and motivate patients to improve their health i appreciate the opportunity to appear before you and welcome your questions thank you miss taylor your opening statement please and members of the subcommittee good afternoon i'm kim taylor the president of the biotech i'm pleased to be here today to speak with you about direct to consumer advertising and in particular the broadcast television advertisement of all things by takes medicine procrit which the company stopped airing three years ago because the subcommittee expressed interest in our history a procrit television advertisement which focused on the treatment of anemia associated with cancer chemotherapy i will focus my testimony on this indication when the f d a approved procrit for the treatment of chemotherapy and used to name me a premise the approval on the ability of the essays to treat anemia by increasing a patient's hemoglobin reducing the likelihood that a chemotherapy patient would require a transfusion of red blood cells and reducing the amount of blood that would be needed in the case of a transfusion e s a is a very effective at reducing a chemotherapy patients need for transfusions as the a stated in its march two thousand and eight briefing at the ankle logic drugs advisory committee review of the essays across several studies approximately fifty percent of anemia patients receiving chemotherapy required transfusions as compared to approximately twenty to twenty five percent of patients who received a size concurrently with chemotherapy the development of a product that could reduce chemotherapy related transfusions was important to patients before procreate another e s a is became available and the making the therapy patients face the choice of living with anemia and the significant impact on even the most basic activities of daily living all that could require interrupting chemotherapy treatment or accepting the discomfort and medical risks associated with multiple transfusions i would like to describe for the subcommittee my understanding of the process by which all the biotech undertook direct to consume during the middle nineteen nineties cancer doctors began to have a greater awareness of a practice that is generally called supportive care consistent with an increased focus on supportive care researches investigated the use of procrit to address chemotherapy patients the name mia and decrease the need to transfusions studies validated the use appropriate in this way at the same time many patients with chemotherapy induced anemia were under diagnosis for this condition some patien educational campaign that included programs of outreach to patients patients educational campaigns and direct to consumer advertising or the biotech believes that a direct to consumer directed consumer advertising as one talk with his or her doctor about the symptoms of a name in only three discussing these symptoms with the doctor could the doctor then make the medical determination of whether that patient would benefit from procrit as the committee reviews  i would like to stress four fundamental points first the statements in the advertisements regarding the benefits of procrit were true responsible and substantiated by clinical studies showing that the administration  significant improvements in the symptoms of anemia in chemotherapy patients second the advertisement for consistent with the f d a approved indication for appropriate in this case the treatment of chemotherapy induced a after procrit was approved for the treatment of chemotherapy induced anemia well beyond the current pharmaceutical industries and johnson and johnson's own internal guidelines on the waiting period for direct to consumer advertising and finally the advertisement was submitted to the f d a as required by regulations and also by take had extensive and ongoing discussions with appropriate f d a officials about the content of the advertisement as a state of the medical knowledge of all  significant benefits to patients with chemotherapy induced anemia and i'd be happy to answer any questions you have thank you thank you thank you to each of you for being here today we will probably go a couple around the question so let's start with mr sage  eight this is your your marketing research and it's basically a report on the research of having the dr jarvik in there there's a lot of things like he's an expert in college cardiology his resume his background speaks for itself cannot conceive a man that would selling a product of that type of background integrity i don't think he's doing it for money he's doing it because he's found something that helps the heart is not a paid actor not a fly by night doesn't really show that so your question is whether or not he was it was clear that he wasn't being paid well it's the perception of the people there according to your two marketing reports right just to clarify these reports are two out of thirty reports that we've done with consumers  positions on page one exhibit number ten and exhibit number eleven right all right page eleven pfizer mindy goldberg social lipitor generic defense consumer research page eight has all these individual statements under that's not a one pager from some doctor just just to clarify mr mr chairman there was a study that was done with an outside vendor  ok and then on the other one page ten basically says the same thing i like the dr joy we get the best of all because of my money's not being paid he's a real person he's out a sterile doctor he's an expert he invented this person might have had a different reviewer comments for you if you would have known dr jarvik was right it's possible yes ok and is the a m a are you aware of the emmy guidelines that if a health professional appears in ads it's recommended that it's be disclosed that they're being paid chairman why didn't you do that then as i understand the decision at the time we consulted what we thought were the appropriate guidelines which were the pharma code our own internal guidelines on d t c as well as the f d a through pre clearance the reason that we didn't look at the a m a guidelines is because we didn't consider dr jarvik prescribe physician but just represented them as a physician right we represented him very clearly as the inventor of the artificial heart which was to disclose probably brings me to my next question and go to exhibit number six and tab six there  not the inventor of the artificial heart that was says that is what it says ok so if you're not portrayed him as a prescribe means physicians he's not the inventor of the artificial heart and how are that we actually took corrective measures based on this feedback we clarified the communication he pointed out that the inventor of the jarvik artificial heart so this was taken into account mr chairman all right let me ask you this one exhibit fourteen and fifteen tabs fourteen and fifteen based on these document it appears that pfizer was about to embark upon doctors for a look at your campaign right it was a it was an idea that was under consideration based on the success of the jarvik campaign right at ten eleven that we showed you earlier it was in part influenced by our prior experience mr chairman and a couple of doctors have asked   promotional review committee is there a doctor review committee on advertising so that you have someone from  consumers go through an internal review process includes a review from lawyers regulatory people as well as physicians and then all those materials are filed with mr khan i got a follow up question to this question for all of you by the system mr connor sure yes we have a very extensive review process that includes not only physicians people familiar with the regulatory process as well as well as legal folks and in addition these as  of whom are licensed some of whom are not all of whom spent a lot of time on all of its work clinical programs so they're very familiar with the data mr khan they are licensed they are familiar with the data and this tailor also for us the licensed physician i guess voluntarily i would imagine a stipend would have to be paid just encourage in the common spend a day or two to do that but i but i'm asked question because i really don't know  why don't we have someone from the f d a we didn't but the more i hear the testimony based upon submissions and consultations there's in all these cases you have done some that have you not mr sage correct  in question and future ads in the dark campaign were submitted to f d a for comments and did they return comments they did where they were they anything or shattering or cause you with those yes or no i mean more information so can you give examples of something you've changed short so one of the claims that the f d a had a question about or concern about was a efficacy claim that we made against other l d l lowering medicines about our ability to lower cholesterol and we narrow that claim to be more precise to the existing data a same line please yes we did pre summit our ads to the f d a we did receive comments from the f d a did incorporate those comments a specific example as they asked us to strengthen the importance of diet in our ads and we did receive those comments miss taylor yes we did submit our ads in accordance with the regulations to the f d a on occasion we did receive some comments which we addressed with the f d a and had an ongoing and so this was adjusted to refer to patients with many types of cancer what was an advisory opinion or was these responses after the ads were already run and these were sponsors  that the ad that merck sharing plow used relating to vytorin there was never any question about the truthfulness are relating to the l cholesterol being lowered was it was there it was that ever in dispute about the truthfulness of that aspect no that was confirmed in our f d a approved label and also confirmed in the enhanced study but the part of the ad that was in dispute related to cardiovascular outcomes is that correct or wrong there i'm sorry could you repeat that what part of did it relate to the cardiovascular outcomes of using the drug are you referring to the most recent letter that we received from the f d a ok so we initially our ads to the f d a we got comments from the f d a and our ads made those changes to based on the f d a as comments and we ran those ads most recently on january twenty third of this year we received a change of opinion from the f d a which so they've changed their opinion on some of the comments that they have and they would like us to consider putting a disclaimer about outcomes that vytor does not have outcomes above and beyond simple staton which is a component of vytorin so we've just received those comments and now we are working with the f d a to try to address those comments and there are some i don't remember the details of this but wasn't there some issue relating to the release date of information from the enhance study and did that affect the change of opinion line or so i'm not sure what prompted the f d a to change of opinion letter to the opinion letter came to us this year on january twenty third so we're going to work with them to accommodate those chain but did your company delayed the release of the enhanced that a no sir i can tell you that the enhanced study the main debate that occurred around the enhanced study it was around the quality of the data and there was a significant scientific debate about the quality of the data i witnessed some of that debate there were pros and cons to that debate ultimately merck sure unplowed did take steps to ensure that the quality of the data was there and to ensure that the data was meaning the truthfulness of the comments about the effectiveness of l d l relating to the l d l the lowering of it ryan that is correct mr carson so the only issue relating to your ad was about dr jarvik meaning in the ad is that correct is correct and the only issue there was that one he was paid into he was not a practicing physician is that correct correct and your company made the decision to just pull the ad is that correct we alternately made the decision to pull the ad mar intent was never to to mis portray dr jarvik we took steps not to do that but ultimately they were misimpressions so we decided to pull the ad that lipitor or is clinically proven to reduce the risk of heart attack that  thank you mr chairman i appreciate your courtesy and allow me to sit in here i've been a long time member of this subcommittee until recently it's nice to be back and thank you for your courtesy in bringing me back mr stage was the ford f one fifty truck the best selling truck in the ms taylor thanks for being here to discuss procrit and the advertisement for procrit i'm an open book i just want to be clear up front i'm biased when it comes to procreate i lost my mother about five years ago to bone marrow cancer she had cancer for about six years and when she was first diagnosed they gave her about a year to live live in six years she got to meet three of her grandchildren over the course that time it was a great miracle in our family but obviously through extensive chemo and other cancer treatments she was also someone who took procrit and some of the best days we had with my mom when she was benefiting from the benefits appropriate first of all thanks for producing a product that no drug is perfect but certainly in our family's case and i know many many other families  procrit changed over time over the time that you had them on the air they were changed amended over time and i'm not sure that some of the ads that we've heard about today give a full picture of the ads that aired over the course of time can you very briefly just talk about the reasoning that you had overtime for changing the ads as you did most of the changes that were made in the ads specifically i think i believe to clarify  in weakness very apparent to them and so the advertisement then tended to focus towards these key symptoms representing a mia that would allow a patient to recognize and in consequence and and gave us a degree of confidence even historically these ads did talk and represent a meaning definition that patients would understand and were well represented but so i know some of the criticism of your ads have been because of the discussion of symptoms and i'm not a doctor i'm not a medical expert but i know that particular in the case of anemia as we saw on my mother's case  it's diagnosed in part by the presence of the symptoms and a lot of folks particularly patients who i think back to my mom's situation she you know she was just tired she didn't want to complain about just being tired when she was a cancer patient so i would imagine that educating people like my mom or others about symptoms that might come with a more serious medical condition rather than the fact that maybe they were just up late talking to kids or grandkids the night before would have something to do with whether or not they were getting a proper medical treatment is that correct that's correct and i think we need to to be careful about talking about here because these were not giving them giving them correct in their name yes so that they could perform strenuous exercise these were in many cases every day acts of living that enabled them to carry on just a normal life well they're going through perhaps one of the most traumatic and invasive experiences in their life which is to undergo chemotherapy did you as far as you know did your ads raise the awareness in the in the patient community that that their symptoms might might be being caused by anemia yes we believe it did  in fact that's why we discontinued our ads in two thousand and five from our research we believe that there was a sufficient understanding of the symptoms and recognition of them as being related to anemia roughly seven  to seven out of ten patients with chemotherapy will suffer from debilitating unamiable through the course of treatment thanks to chairman i look forward to round t the enhanced study showed no difference between vytorin as zocor cholesterol build all is that correct it showed no difference in the success of the carotid artery as measured by imaging and we're talking about fractions of a millimeter difference here which in part was some of the reasons for some of the quality questions is to really go through a better understanding of this data and that was a significant scientific debate between april two thousand and six january two thousand and eight vytorin was advertised as a public television is that correct it was advertised between vytorin d t c advertising was done between september of two thousand and four and measured by imaging it did show that we lowered cholesterol more than send the stat and consistent with our label and it also showed that our drug was safe and well tolerated consistent with our label so now it is also true th strengthens the black box warning on the procrit a label is that correct that's correct are you familiar with the findings in the judge or rather the february twenty seventh two thousand and eight issue of the journal the american medical association concerning the risks of procrit i believe now isn't it true that study researchers reported findings which demonstrated that risk in cancer patients is by about ten percent is that true  i would have to check on that for you as they also follow the program and other e s a could actually enhance cancer growth at the same time doctors were using other drugs to control the disease is that not true i would have to check that as well so are you prepared to state under oath the judge johnson national advertising campaign patients who had undergoing chemotherapy and who experience to take in weakness to seek advice from the doctor about the sentence and allow the doctor to make a decision at that point or no these ads all will you agree to follow the american medical association's guidelines regarding the use of actors and health professionals so you're telling me that you're not going to follow make i don't know our guidelines are consistent with the the with the former guidelines and the pharma guidelines are consistent i believe with the i on the importance of lowering bad cholesterol focus on the importance of diet and focus on the fact that vytorin does lower bad cholesterol we believe that these are important not only from a from a public health perspective but lowering bad cholesterol this is the cornerstone of  heart disease prevention we're going to we believe it's important to continue to do that in a balanced and appropriate way and we will review what we're going to communicate that is a yes or no so we believe it's important to continue to communicate the importance of lowering bad cholesterol  i'm still trying to understand is that a yes or no so we're going to continue to communicate the importance yes we're going to do you communicate the importance of bad cholesterol lowering it as well as diet and b we would be unlikely to be doing d t c advertising without valid outcomes clinical outcomes study that's correct now this should be a fairly simple question barbara has issued guidelines on the subject d your right my left sir will you follow the farmer guidelines or yesterday pfizer does follow the pharma guidelines and has its own more stringent internal guidelines so yes sure we do feel it's important that physicians have experience with the drugs before we advertise that in the case of vytorin physicians did have experience with both as well as some of the  period which may depend on the product of the condition being treated but an adequate waiting period is most necessary yes confusion between the answer in the question carson as i said i'm not in a position to decide that policy for pfizer and certainly take that recommendation back or i will take that recommendation back for consideration so  again i'm not in a position to qualify that for the entire company but we most certainly would look at it so i have got a yeses i've got will take it or visors what i'm being told are yes yes yes maybe maybe you'd like to select one of your number to tell me what would be your to add that to your a that decision for the company it's not a question of whether or not we take adverse events seriously so it's something we want to evaluate for me what's most important is that we promote what's consistent with our label what it's accurate information and what motivates patients to take an action see their physician so i continue to do that in the appropriate balanced manner is it yes when i'm not in a position to be able to make that decision here but from a personal perspective what's important is that patients have access to report that and all our current do you have patient x patient reporting numbers to report any adverse effects in the meantime there is a mechanism with our advertising to follow that  weren't here if we're going to do that i would think the f d a would be another group to bring back this to see what they knew and when they knew it and how they knew it and like i want to say this with double but more importantly it was the doctor dr day show that people had a hard time remembering the side effects and the way you structured the ad so they did not know what it was in fact dr de showed that people wildly misrepresented the need for a blood test while taking lipitor or don't you think the serious side effects of these drugs should also have equal aaron with the benefits of the drugs that mr chairman i think it's obviously important to communicate the side effects as well as the benefits in these ads i also want to point out an equal manner in an equal manner so you don't how quick you say the words and how all of our doctor days or destroyed your ad where you placed your side effects chairman all our ads are reviewed internally many of those ads are reviewed by the f d a they're accurately balance did you ever have a cognitive assessment made on your ads no we did not i was not aware of the  know anything about it i don't know all right let me ask this question for you vytorin it appears that this is what we were talking to boulder is an emerging science right you're going to a rare population you're targeting where you're not people have cholesterol and people who have bodies naturally produce it because your family knows people have cholesterol that is produced that you inherit as well as right but what about your enhanced study wasn't that targeted at people who not only have cholesterol but whose family history would suggest they have cholesterol problems no sir why the hotdogging uncle frank then no sir the enhanced study was a very specific patient population called heterozygous f h sure it was predisposed to having very high levels of cholesterol because of family history while they determine very high levels of cholesterol but everybody gets cholesterol  i don't disagree with you and one part you make to claims number one you're going to flight fight cholesterol number two you're to go out to those folks whose family history produces cholesterol correct enhanced trial because of this right for those who have very high level of l d l cholesterol right no sir we got approved based on our ability to lower bad cholesterol that that is the way that the f d a approved drugs in this market it was just bad cholesterol so why are you haven't frank the hot dog ok you know frank virginia and virginia ham were trying to do a few things one were trying to say that lowering bad cholesterol is important too we're trying to right there are we also your study what you thought it would be and what it end up being was two different things we did plan for a variety of a range of options we knew what you thought what the study was going to show it did not show that in fact it took  data i'm not a scientist but i witnessed that debate and that there were pros and cons around that once you go to the exhibit book then all right let's go to the exhibit book if we have several emails emails from ur sure employers well from coordinators of the enhanced study that shows the results were delayed it's exit number twenty two i believe has to have a number two point two shows that results were delayed several times even against the wishes of the principal investigator you know why the so i know that the delay there was significant steps taken to look at the quality of the data and i know that that process around the quality of the data and to ensure that the data could be analyzed meaningfully did take longer than anticipated cholesterol dot com and that website actually advertises for mail order dietary supplement to lower cholesterol so it seems to me that two sources of cluster zero is the cornerstone of my to ad and yet you reference a commercial dietary supplement a website to support the f d a application why not publish a scientific study or an internal research document mr chairman the reference to this web site was clearly an error but does treat the two sources of cholesterol alright so that was a mistake  you submit your ad to the f d a but yet it takes two years to release the study so why don't you just release the study when it was completed to the f d a like it did your ad what's more important the ad or the results of your study so this was a scientific issue and it is my so many of the f d a is not a scientific issue in fact you're required to submit your studies to the f d a that's a legal requirement that the data quality question this is a question of the quality of the data to ensure that the data can be analyzed i saw the debates between the scientists aroud the enhance study and making sure that that quality is there ultimately m s p did take steps to ensure the quality of the data and to make sure that it could be analyzed meaning prior to blighting the data and that did take longer than we anticipated well maybe we will have another hearing but i know we'll have one on vytorin just on vytorin maybe even direct a consumer advertising comet just to continue on this line of questioning i understand there an obviously been some questions about what enhance showed what it actually showed my understanding is that while enhanced showed no significant difference in the impact on the artery wall staton alone is that correct that is correct and enhance was not designed with enhanced design to study or to measure the effect that vytorin has on cardiovascular outcomes  released earlier this year so a little less than two years with any clinical trial we know that immediately following the last patient visit there's a process of quality control analyzation of the data the study sponsor is to ensure that the data are reliable you have to blend the results you have to analyze the results my understanding is that for a number of reasons with enhanced in particular with regard to the data including the methodology that was used for measuring reference several times this measuring this question of millimeters or something the artery wall thickness is that quality control process took a little longer than expected that's correct how much longer i can give the exact amount of time but the scientists did feel that getting this right getting the quality control questions right was very important and there was a robust debate among many scientist about the quality issues and ultimately m s p did take steps to ensure that quality do you think you would come under some heat if you release the study more quickly and you found out later that the methodology or the data were insufficient or wrong somehow you know i can't comment on that i'm not could probably answer that question i can say you're going to be damned if you did and damned if you didn't so let me let me move on but let's let me just be clear did you know the results of the enhanced study while your ad for vytorin was on air i was not made aware of the results of the enhanced trial until january the eighth of this year and at that point return ads were off the air you had already chosen to take them off the air we took them off the air on january the fourteenth i was made aware of the study results on january the eighth of this year so you made the decision about the ads before you even had the results of the enhanced study i made the decision about the as it was on january the fourteenth century the same day that we released the primary endpoint results of the enhanced trial and the press release the reason i made the decision to stop the ads was mainly because there's already been a lot of there was already a lot of scientific discussion about enhanced as well as speculation about the results since we were releasing the primary endpoint results i don't want the ad at the same time because i thought there was going to potentially be confusion out in the marketplace so i chose to stop the ads at that time so just to be clear in backing off for a second bad cholesterol l d l can come from two sources i think most people know that today probably a lot of people that haven't known that years and years ago but that's correct that's correct i have my physical this week i'm going through my debt with my doc ok more information than you need went through with my doc my my good cholesterol bad cholesterol numbers and essentially your bad cholesterol if your bad cholesterol numbers high it could be from what you eat could be genetic that's correct so it's possible that someone who has a great diet someone who eats all the right things still has bad a high level of bad cholesterol because of genetics is that is that possible that's absolutely correct and that's part of the reason you want to educate on two sources because you've got a high diet so even a person who thinks they're totally responsible said i only salad i don't eat anything that any cholesterol in it there's no reason i should have a high level of bad cholesterol could still be at risk for health consequences because they have a high level of bad cholesterol that's possible is not that is correct and that person would probably benefit from knowing the fact that bad cholesterol our colleagues my friends in the majority have issued a number of letters about all the studies requesting information from you all are you still in the process of providing documents  response to these requests and if we would start mr sage in the school like i did last time we've complied with the committee's request and continue to provide information as needed so i mean so we we are as a committee still receiving information from you if there's any new information to be had you're going to receive it yes mr condit yes we are and we continue to comply with the committee and we are in an ongoing process of sending them information so is there any outstanding information that we still have yet to get to the committee on your product that we're in the process of getting or are you waiting for more requests  in the last four months give me an idea of how many documents you may have sent here start mr sage and go do you have any idea of the number of documents two hundred ninety that it's in the same vicinity two hundred nine thousand mister i don't have the specific number i'm sorry mine in standing is it's a lot less ok maybe a hundred thousand i really really don't know i mean that is a lot less than two hundred ninety thousand i can find out for you as soon as possible do you know if all the interviews of people involved in the studies are still being conducted mr i quite understand your your question in our case we're not speaking about a study so if you can clarify that would be helpful let me just go to mr k same question to you during the repeat we believe there are still more interviews that are not going to need to be conducted the chairman saying is going to be a lot more so i get ready for two hundred ninety thousand more pages  understanding i think i think part of the part of the concern on this side is that i think there's still information to be had in this tough to do and i said this in my opening statement it's tough to do oversight investigation when not all the staff for and not all the documents we don't have the f d a here i'm new at this business but that that's part of  american people an explanation as to why procreate t v ads were allowed to run for seven years miss taylor are you aware that many of the experts inside and outside the f d a consider the seven year procrit ad campaign t v ad you gentlemen could give that to miss taylor go to exhibit thirty nine isn't it true that ortho biotech and johnson and johnson was repeatedly cited by d f d a for false and misleading advertising in connection with direc tumor advertising appropriate as a treatment for fatigue exhibit thirty nine nov sixth one thousand nine hundred eighty letter to the f d a from the f d a to johnson johnson it states appropriate is tended among other things to treat anemia associated with certain chemotherapies regiments not tiredness in general exhibit number forty four june thirtieth two thousand letter from the f d a to johnson and johnson reference promotional campaign for appropriate f d a wrote the claims made to the promotional materials are in violation of food drug cosmetic and implementing regulations due to expanding the use of a product as a treatment for fatigue exhibit number fifty dated twelve twenty one zero one letter from the requesting that johnson johnson revise the advertising materials accordingly claims or implications as the f d a pro create treats weakness and fatigue or that procreate increases strength are misleading pro create is indicative for the treatment of e your ads don't have anyone in there that lost their hair to chemotherapy that's a real simple thing you could comply with the have of their ad in fact i believe it's exhibit number fifty exhibit fifty look at it even the f d a said your models you're using in your in your ads are not accurate because you have people who have hair and we know in chemotherapy lose your hair it's number two the summer twenty one two thousand one hundred fifty the reason patients are misleading because the patient models the picked are not representative of the general population of chemotherapy patients who would appear weaker and have hair loss among other side effects  that doesn't sound like a discussion the me a sort of a directive on how you should be doing your ad and you never present an ad what a person with with all care we didn't i believe this is a comment i don't have the follow up discussion but i do believe that subsequent ads which were grade with f d a and which did not have patients who had hair loss were excepted by f d a in the subsequent period let me ask you this daemon anywhere in your advertising did you say that use appropriate for cancer patients who had tumors that procreate would likely to enlarge those tumors and endangered the lives of those patients i know that was not a specific warning in the what the f d a told you about that you didn't put that in there don't you think people should know that before they take your drug that in fact it could worsen your condition not make it better by swallowing making the to worse well more and shorten using your ad for tiredness for weakness because you have any letter from the f d a you know all those documents were by the us that said you could advertise for that in fact all the way through there's been discussions with the here we're also dealing with stem cells and the ambassador to mexico and medicare payments so there's always something going on on the on the issue of this is that you were just discussing i'm sorry ms taylor that you were just discussing with the chairman or the the studies regarding tumor growth when when did that come up when did that become a concern for your company in fact  was really specific to say this is for non human a logic type of tumors is that correct mr nunn my lord not by that because there was concern for for other if there were if it were by lloyd condition that it might in fact be stimulatory is that correct i'm not aware of the exact reason for it but it was a theoretical concern when we first had approval for the product is there any indication as to which types of tumors might be so affected with the theoretic concern of enhanced or  increased tumor growth i'm not aware of specific cuma types that were identified at that point what are there in fact studies ongoing now to to look into that and answer these questions yes where we're tempting to complete a very large study it's very difficult to recruit for because of the very nature of it and in trying to do a definitive study such as a placebo controlled study very difficult retrospective study is always fraught with some difficulty but has there been any attempt to to retrospectively go back and mine the data and look at that basis there is currently underway  collaboration is doing a very large review of all all the data on of all the essays believe that's roughly about fifteen thousand patients experience that's in analysis now and we should have that in the coming months very good on the one issue appropriate it pretty self was it ever approved for the indications of treatment of fatigue and improve quality of life program is approved for the treatment of chemotherapy and used the the reduction in red blood cells so the the indication existed for pretty low red cell mass as a result of chemotherapy and it really then today i referenced in my opening statement that perhaps there is some good in just delivering the information that cholesterol comes from two sources that the average person with a diagnosis of hypercholesterolemia may not be aware of the fact that yes there are some things that they do that affects their cholesterol level but there may be some things that are embedded in their deep within their cells or their d n a or their family history that that it results in high cholesterol so there may be just be a benefit from even just stating that and providing that documentary that educational information to patients that not correct that is correct we know that there are many patients that are diagnosed but on treated that when you educate them that your cholesterol comes from two sources it takes way one of the barriers and one of the barriers is until they know that they feel it's all their fault so no matter how much they die no matter how much they say they feel it's still their fault once you educate them this motivates them to at least have the conversation with their doctor about any additional treatments they should consider and the just wanted intuitive basis to me it always made sense the addition of those two of those two compounds to fight high cholesterol levels one of the difficulties with statens is some people don't tolerate them as well because of side effects is it ever the case that you can use a lower level of stat and by the combination with other medicines to achieve the desired result of lower that could cholesterol level that is correct by two and provide us additional significantly greater l d l lowering and we've got head to head studies to currently what is the what is the level of l d l which is the upper limit that that you want to be under with that varies depending on your risk factors but it could be anywhere less than one thirty less than one hundred less than seventy depending on your response that you have but the overall trend as far as a recommendation for the medical community has been to recommend a lower number as the upper limit of normal so even over the last ten or fifteen years time is it correct that is correct very well as chairman i'll yield back my time  since it came up let me just ask this come up by both sides here about the erectile dysfunction and what it should be advertised since two of the makers are here a bit mr sage advice is made by pfizer would you agree we should pull those ads during until later at night when it's not affecting young audiences policy on advertising to advertise it on shows that have at least ninety percent adult viewership agree to move your advertising where kids would not see it mr chairman i'm the general manager of the joint venture my responsibilities are solely on by torn and so i cannot comment on other products either parent organization all right how about as an individual do you think we should show those ads during certain hours they should be appropriate always and appropriate always the show g thirteen i think we really need to look at on some of these movie channels it is and and some good stewardship would help go a long way drugs but we also know there is a lot of trash on t v and their ads i mean it's even tough when you're sitting watching a ballgame with your kids on a weekend and you know you have to i have to sit there with the clicker as soon as any ad comes on because some ad for some trashy t v program that's on later in the week on that same station then comes on and you're flipping the channel and you're muting it and it's like a test to see how quickly you can do it so i agree that there is i absolutely agree that there are appropriate ads that should be on certain programs or maybe certain times of the day but it's really really tough and it's certainly not it's certainly not unique to this industry or any other industry as they run as ads run that sometimes may be inappropriate for kids and i absolutely agree that this is a problem but it's certainly a broader problem that we're talking about here and i would certainly be delighted to work with you mr chairman and ranking member and others if we're going to develop some sort of a proposal for the well thinks and at the request of the minority we will have another hearing on direct to consumer advertising so maybe maybe that could be a part of it and then when that concludes all the questions i want to thank all of our witness and in this panel on their way to go and thank you for your testimony today i ask unanimous consent that the hearing record remain open for thirty days for additional questions for the record that objection record will remain open i ask unanimous consent that the contents of our document binder be entered in record without objection t