PANEL 4 PROCEEDINGS
Our next panel will be Panel 4: Mary Jane Sheffet and Donald Sullivan.
You may have noticed Mr. Schultz had to leave, and we are pleased to welcome his alternate for the afternoon, Ilisa Bernstein, from the Office of the Commissioners.
DR. SHEFFET: Thank you. I am Mary Jane Sheffet. I am on the faculty of the Marketing Department at Michigan State University. My department did pay my travel expenses here. As far as I have been able to ascertain, my department does not receive any money from any pharmaceutical manufacturer, advertising agency, or anyone else interested in this particular topic. I have asked if the university receives such money and could not get an answer. I assume that means maybe they do, maybe they don't. If they do, it does not come to my department, and I certainly have received no such money. I am representing only my own views and have done no consulting for either pharmaceutical companies nor advertising agencies involved in this particular topic.
MS. PEDERSEN: Thank you.
DR. SHEFFET: As a market professor, I do see advertising as providing information, and consumer advertising of prescription drugs provides consumers with additional information. We know consumers are seeking more information about health care, about drugs, about medical issues in general. Book sales, certainly, of the PDR and other paperback editions dealing with drugs are increasing. You can ask your doctor, ask your physician. One of the problems we know that happens is that people can't retain all of the information that they receive during a visit to the doctor. That is particularly true if what is being discussed is something important: I am prescribing this drug because you have a particular medical problem.
One of the benefits, I think, specifically of print advertising is that, as a consumer, I can keep that ad, and I can take the information in that ad with me and consult it later. I can keep that as a reference, and I think that is an important point. I want to see direct-to-consumer advertising for prescription drugs, but I want to see it not misleading, and I want to see it contain enough information that, as a consumer, I can learn enough from it and keep it as a reference.
Pharmacists have not been mentioned here this morning, and I find my own pharmacy to be an incredibly valuable source of additional information. In the case of drugs, they provide additional information. My pharmacy gives me a printout as well as answering any questions I may have. Package inserts also provide information, and certainly I would suggest those be provided in all drugs, and most specifically in any drug advertised to consumers. That is additional information I can take home, I can read, and I can get information from that.
The role of advertising, yes, it is to persuade. But its primary role is to give us information. It is to alert consumers about a condition they may not know about. We have heard about hypertension. There are other problems. Certainly in the case of Proscar and Hytrin, I understand it is quite possible, although I obviously have no firsthand information, that that particular kind of condition develops gradually, and the person may not be aware that there is a treatment available. They may not even be aware that that problem is coming and getting worse.
If you have a problem like that and you do not hear any advertising and you do not go to your doctor on a regular basis and that doctor doesn't happen to ask you the right questions, which can and does happen, you will remain ignorant. You won't know that there is some treatment out there available for you.
In the case of the drugs discussed this morning, I know we had Felbatol advertised also as an epilepsy treatment, and while I know the ads had to be removed because of other problems, what does that do? It tells patients that there is something new out there. Go see your doctor, or ask your pharmacist first and then go see your doctor. But if I don't know there is a new treatment for my migraine headache or my psoriasis, then I can't ask the right questions, and I can't be an informed consumer. If I don't know about it, I can't ask.
I know opponents to DTC advertising are concerned that these ads are misleading, that they fail to communicate risks. Marketing and psychology literature tell us it is extremely difficult to communicate risk information. It is much easier to communicate benefits because obviously we all want to know about the good parts and we don't want to know about the bad parts. That doesn't mean that we provide less information about risk. It means we provide more information. But we do have to provide that information in a format and a context that consumers can understand, not just Ph.D.s and not doctors. I am not a medical professional. So when I read most of the brief summaries--and I am obviously in the minority of people who actually read those--I don't understand 99 percent of it.
I would, however, like to be able to understand it without having to go to medical school, and I would like to have patient package inserts provided that I can also understand.
My daughter is on several drugs. She has attention deficit disorder, so we are regular consumers of Ritalin, for instance. I have read all I can find on that drug. I understand most of it, but not all of it.
Those kinds of drugs need to have information provided to consumers. I am not suggesting you advertise Ritalin to consumers, but I do want patient package inserts provided that give us information. And I do see the doctor as a gatekeeper. Consumers cannot go out and buy these products just because they see an ad. They have to get a prescription. I don't want to be able to buy these drugs from a kiosk in a shopping mall. I do want to have to go to the doctor to get the prescription, to get the additional information, and to be sure that it is the right drug for my condition, whether it be age, health factors, whatever. The doctor needs to be there as a gatekeeper. And I would suggest that if your doctor is upset or does not want to talk about this and finds this to be a topic that they are against and you are for it, then I suggest there is a mismatch between you and your physician.
I have asked all of the doctors with whom I deal, and they are very supportive. If they weren't, I guess I would be seeing another doctor. I want more information as a consumer. I also want the FDA to continue to regulate DTC.
I would recommend that the advertising be regulated, strongly regulated. While I know there are First Amendment issues involved, I want the FDA to continue to pre-clear the ads. What I would suggest, because these are potentially dangerous products, while I don't want total prior restraint, I do think that a model such as the Federal Trade Commission's advertising substantiation program could be implemented in the area of DTC advertising, require advertisers to submit carefully controlled, independently done studies that test whatever claims they are trying to make, and test the communication. What is it that is being communicated to consumers? That may be very different from the message that the advertiser intends. But we do need to know exactly what that ad is communicating.
I do think we need different regulation for broadcast versus print. We know consumers learn differently from the two different kinds of media. A broadcast ad simply is not able to communicate detailed risk and benefit information, not only because of the time restriction but also because of the type of media. Hearing something is not the same as being able to sit down and read it and refer back to it.
So the best we can hope for from broadcast media is attention, learning that something is available, possibly even remembering the brand name, although we have a lot of studies that suggest consumers don't even remember the brand names. They may remember the slogan, but they may not remember the brand name.
So I would suggest that the FDA demand increased copy testing and use a program like advertising substantiation. The manufacturers are clearly the ones that have the money and the interest in being sure that they are communicating clearly and accurately. I don't believe that they intentionally want to mislead, if only because they know the competitor is out there with a Lanham Act suit just waiting to fill in their names.
MS. PEDERSEN: Thank you, Dr. Sheffet.
MR. SULLIVAN: My name is Don Sullivan. I am a Ph.D. candidate in pharmaceutical administration at the Ohio State University College of Pharmacy. This is just a piece of my dissertation that I have been working on for the last year-and-a-half. I paid my own travel expenses out here. There was no financial support for this dissertation at all. It was all financed out of my own pocket. And the views I express are truly my own.
MS. PEDERSEN: I'm sorry. Could you speak to Paragraph 5 as well, your own financial interest?
MR. SULLIVAN: And I have no financial interest in this whatsoever.
As I said, this is a piece of my dissertation, looking at the effectiveness of direct-to-consumer advertising of prescription drugs. Mainly my interest was looking at: Does direct-to-consumer advertising have the effect of changing health behaviors?
What I am going to present today, because I have just finished collecting my data over the last couple of weeks, is a little piece of that which looked at how much risk information consumers actually retained from the ads that were sent to them.
Methodology: The target population were men over 60 with potential symptoms of BPH, benign prostatic hyperplasia. As you can probably guess, the ad I used was an actual ad that ran for a period of about six months. It was an ad for Hytrin. So an actual ad was used.
I used a systematic random sampling technique. I went through a professional company, limited my sample just to residents of Ohio, men over 60 that live within Ohio. They generated a sample of 1,092 study participants, of which that 364 were systematically assigned to one of two treatment groups or the control group. The risk retention part of the ad, there were ten items that measured risk retention. It was a true/false scale. They could either answer true, false, or did not know. Ten items, four from the face of the ad itself and six from the brief summary. I couldn't equilibrate five and five because there was such limited information on the front of the Hytrin ad containing risk information, so I had to go four and six.
Data was collected through a mail survey. My response rate was 30 percent, and there was no financial incentive provided to the respondents to respond.
The way the study was actually conducted, it was actually a true experimental design, as I said before. The first group, represented by X-1, received a product-specific advertisement, which was the actual ad for Hytrin, which was an actual drug ad. The second group received a disease-specific institutional advertisement. That was an that just talked about the problems, the symptoms, and the potential cures--or potential medicinal agents to take care of symptoms of BPH. It didn't mention any drug products whatsoever in the ad, so it followed just strictly a disease-specific institutional advertising. And Group 3 was a control group.
I used a mail-type intervention basically for cost reasons because I was funding this myself. What I did was I sent the ad, either the product-specific or the disease-specific ad, to the two treatment groups at one-week intervals. So every week for three weeks, the same patient got the same ad, and then a week after that, they got the survey, the mailed survey, to complete.
Looking at results by group, one of the first questions they were asked in the survey was had they ever heard of Hytrin for BPH. And I know that Hytrin is also used to treat hypertension and several other cardiovascular disorders, but the question specifically asked if they had ever heard of Hytrin for the treatment of BPH.
Of the product-specific ad group, 37 percent said they had heard of the drug Hytrin for BPH. For the disease-specific and the control group, which for this intervention were essentially the same because they didn't receive an actual product ad, it was 11 percent and 20 percent, respectively.
Doing a Chi-square analysis, that does come out to be a significant difference between the three groups. I also had another question towards the end of the questionnaire in the demographics section which actually asked them had they ever seen an ad for Hytrin for BPH. Again, I stressed BPH because I know Hytrin is also used for cardiovascular disorders. Again, 33 percent said they had seen an ad for Hytrin; 10 percent and 11 percent, respectively, in the other two groups said they had seen an ad. The reason the 10 percent and the 11 percent in the other two groups was probably due to the fact that there is still ongoing advertising campaigns for Hytrin. Again, using Chi-square analysis, there was a significant difference between the product-specific ad and the other two groups.
Risk retention. Actual risk retention of risk information, side effects, adverse effects, within the ad itself by experimental group between the three groups, there was no statistical difference between the three groups in their ability to answer the questions true, false, or did not know.
Now, you may think that this might be a problem, but remember only about a third of the actual group that got three sets of the ad actually said they actually had seen the ad or remembered seeing the ad. But I did go ahead and do an analysis, and I looked at, however--and this was true for all ten risk questions. None of them was statistically significant. However, for the product-specific ad group, the one that got the ad for Hytrin, I actually took an average of all respondents to all ten questions, and only 7.6 percent actually answered the risk question correctly, 4.5 percent answered incorrectly, and 87.9 percent said they didn't know the answer to the question.
Now, I further broke it down looking at risk retention information in respondents who indicated that they had seen a Hytrin ad. So the rest of the analysis of the slides I am going to provide actually are only looking at the respondents that said they had seen a Hytrin ad.
When looking at the differences between whether they answered a question correctly, incorrectly, or did not know between when analyzed against those who didn't see the ad, it was statistically significant with a p value of 0.001, that the ones who did actually received the ad answered more of the questions correctly than those who didn't. And the percentages are down here below. For this group, with the ones who actually indicated that they had seen the ad for Hytrin, 22.8 percent answered the question, any given question correctly; 10.3 percent answered incorrectly; and about 67 percent said they don't know. Now, that dropped significantly from the previous group.
I further broke down risk information, and I stated this before. There were four questions of risk information based on information in the ad itself and six questions off the brief summary in the back.
Now, this ad for Hytrin, the manufacturer had actually rewritten or restated the brief summary, so it wasn't just a reproduction or photocopy of the package insert that was approved for marketing. They actually reworked this into a question and answer type, more consumer-friendly type of brief summary.
When we looked at the ad itself and broke down percentage answered correctly versus the four questions versus the six and the brief summary, we found that the questions off the front of the ad, the face of the ad, 27.5 percent answered them correctly, the ones off the back 17.3 percent. The percentage who didn't know dropped from 70.5 to 61.5 when comparing the information off the front versus the back.
Risk information within the ad itself, I listed three of the questions here. The fourth question, because I couldn't find any more risk information on the front of the ad, I actually indirectly made one up. The question actually said that you should not take this product if you have kidney, liver disorders. So it was indirectly based off information off the front, but these three questions came from information directly off the test of the ad.
The first one, Hytrin can cause a sudden drop in blood pressure at the beginning of treatment. The second one, Hytrin can cause a sudden rise in blood pressure at the beginning of treatment. And, three, if you miss doses and then start taking Hytrin again, you may feel dizzy, faint, or lightheaded. I think the manufacturer did a good job in stating what I felt were the most important aspects of the drug, safety information, risk information that consumers should know, and this is the way the responses fell out.
For Question 1, 36 percent of the respondents answered the question correctly, only 6 answered it incorrectly, 58 percent didn't know. For Question 2, 29 percent answered it correct; Question 3, 41 percent.
Now, in the far column, the percent correct with the star, that is the percentage that answered it correct that actually tried to answer it. So that actually excludes the don't-know group right here. So of those who tried to answer the question, 84 percent of Question 1 got it right; 72 and 83 of the other two questions.
Now, as I said, this was just a small piece of my dissertation. Actually, the whole instrument again looked at analyzing can direct consumer ads actually change health behaviors. And this part right here I am still in the process of analyzing, but I just wanted to show the type of research that I am doing right now. I will be analyzing it within the next three to four months and hopefully have final results by the first of the year.
I actually felt that there was actually three components to look at, and I used Azjem's theory of plan behavior as my model that I was going to test. Section 1 actually looked at attitudes toward direct consumer advertising and the attitude toward asking their physician for a prescription for the specific product. Section 2 was attitude toward the product Hytrin itself. Section 3 looked at the subjective norms of the individuals, and the subjective norms are made by multiplying the scores on the reference group times the normative beliefs, and I used four reference groups: the physician, the pharmacist, family, and good friends. How much influence these four groups have on the patient, asking their physician if they need a prostate exam, asking their physician, if they have a problem, should they take Hytrin.
Normative beliefs, those are the two normative beliefs I looked at, asking about having a prostate exam. The question would be worded: My physician thinks I should have a prostate exam, or my family thinks I should ask my physician about having a prostate exam.
Section 4 actually looked at the perceived behavioral control. The reason that was added was to look at how much control the consumer thinks they have in convincing a physician to actually write them a prescription for the product they want or how much control they have over their own health behavior, their health-seeking behavior.
Section 5 was going to look at behavioral intent. Section 6 was the risk retention, which I presented. And then the final phase, which will be conducted in a month, is actual behavioral follow-up, which will be telephone surveys to actually see which of the respondents actually went to their physician and talked to their physician about the drug Hytrin or actually asked their physician for a prostate exam.
Here's a picture of the model as it is going to be tested. Azjem's model uses only a single dimensional attitude component. I think there are actually three different attitude components to the patient's overall attitude in their health-seeking behavior. What I plan to do is look at all three, factor analyze it, and see if it does break out into three factors or only one, as a lot of the marketing research implies.
In conclusion, we have heard a lot of testimony and a lot of discussion about the physician is the gatekeeper in the prescription drug process. Coming from a pharmacist's perspective who is in touch with the patient, who actually sees them come in and ask for over-the-counter recommendations and over-the-counter suggestions. I think we had better not forget that consumers have other ways other than through physicians of obtaining prescription drugs, through other family, through other friends who are on prescription drugs. And I think it is important that if they see prescription drug information through an ad and know a family member or a good friend who is taking that product, economic-wise they might have some incentive to try a few tablets from that family member or good friend and save a physician visit, save actually paying for the prescription out of their own pocket based on that type of financial situation. So I think that always assuming that the physician is the true gatekeeper in patients taking prescription drugs, I think we need to be a little cautious about that.
I also think that the fair balance should be required, still should be required in direct-to-consumer ads for prescription drugs for the reasons I have shown, especially in the face of the ad, because consumers, even though it is a small percentage, consumers do use this information and do retain this information. I also think--and I don't have research on this, but I think manufacturers should also have to restate the brief summary requirement in more consumer-friendly or user-friendly terminology than just actually printing the brief summary or reproducing the package insert on the back of the ad.
Questions for the Panel
MS. PEDERSEN: Thank you, Mr. Sullivan.
Are there questions from the panel for either Dr. Sheffet or Mr. Sullivan? Ms. Baylor-Henry?
MS. BAYLOR-HENRY: I have a question for Dr. Sheffet. You have indicated that advertisements that provide disease-specific information are beneficial.
DR. SHEFFET: Yes.
MS. BAYLOR-HENRY: Having said that, would you opine on the merits or lack thereof of reminder advertisements?
DR. SHEFFET: The reminder ads that I have seen--and I guess my favorite is "Only Zantac is Zantac"--really, I haven't quite figured out what information that is communicating other than please don't let your pharmacist or your doctor give you a generic substitute for our brand-name drug. And given the restrictions that limit what you can say in a reminder ad, I don't find that kind of broadcast ad to be very useful. I realize the manufacturer is trying to reinforce their brand name, but I am not sure, given that you can't say Zantac is cheaper than Pepcid or try Tagamet, we are now over--you know, we now know they are over the counter, and I know Zantac is coming. So I am not sure given your current restrictions on reminder ads that they make much sense. Certainly not the broadcast ones.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: This is for Dr. Sheffet also. Early in your statement you expressed the wish that there were more good, quite thorough sources of information that consumers might have: patient package inserts and things in reasonable language that could give a thorough description.
I couldn't tell whether you hoped that direct-to-consumer advertising was part of fulfilling that hope or not. And I ask because I will mention a thought, which is that much of what seems overtly useful about direct-to-consumer advertising is to remind people that there is a treatment they might know about. You gave several examples of that. Well, you don't need a lot of detail for that, because you are not trying to help the patient judge whether that is the right treatment or not, because the physician in conversation with the patient is going to do that.
So some of the most important things to convey can be conveyed in very short ads with not too much information. So I was curious of your view about how content-rich advertising should be, and part of my thought is the more content you put in, the more opportunity to get into difficulties with balance.
DR. SHEFFET: Distinguish broadcast from print. In broadcast advertising, there is a very definite limit as to how much information you can provide, and maybe alerting people to a new treatment or we have a less expensive alternative if you are long-term--Cardizem came out with--those were print ads, primarily, but reminding people or telling them that there is something new available.
With respect to print advertising, I think you have an opportunity to provide a very good reference and more information, and, yes, I would hope that it would be in more understandable language. I applaud some of the changes that have been made certainly in some of the ads I have seen, and the Hytrin ads were one where the format was different and it was a much better vehicle in terms of communicating to the casual consumer or the average consumer that there is something out there available.
But I also want some form of fair balance and a brief summary. But I want it so that I can read it without getting an M.D. or a Doctor of Pharmacy degree. And I think DTC advertising can play that kind of role. But I do think that research has to be done by the manufacturer and monitored by the FDA to be sure that the information being communicated is providing the message that we want it to provide and also is giving a balance of risk and benefit information.
MS. PEDERSEN: Dr. Woodcock?
DR. WOODCOCK: Yes, I wanted to follow up on that. My question is: It seems to me you are advocating perhaps that more DTC ads might be okay if there was a quid pro quo. I don't understand the program you were referring to, but requiring research on the outcomes or effectiveness of the communication that is attempted in that effort, coupled with continued FDA regulation of the content in some manner.
DR. SHEFFET: Yes, the Federal Trade Commission's advertising substantiation program. Now, the FTC does not require pre-clearance, of course, of any ads. But if an advertiser makes a claim, they must be able to back that up or substantiate it with research data. What I would like to see the FDA do is adopt that program in that you require the advertiser, the manufacturer--and the FTC, by the way, holds both the manufacturer and the advertiser responsible--that they provide information. If they want to make a claim--Hytrin works more quickly than other drugs--they must have independently done tests to prove that their claim is true and submit those to the FDA prior to that ad being aired or printed.
DR. WOODCOCK: I think we have sort of this structure for the claim. The problem we have is that I think that information about pharmaceuticals in general is somewhat more complicated.
There has been a lot of stress about risk information at this meeting so far and how risks, especially low probability risks, are hard to communicate. One of the things that is hard for people to hold in their mind, except maybe the pharmacists and physicians in this audience, is that actually the benefits of a lot of pharmaceuticals are also low probability and that they are proved generally because the overall probability of benefit to risk is still positive. And yet for an individual patient, the probability for certain major classes of things that we approve, the overall probability is not particularly high.
Would this research also look at the effectiveness of how information like that is communicated?
DR. SHEFFET: Oh, yes. I think you can do research that says--I mean, maybe one of the things you require in the ad is a statement that says while this drug may be very beneficial, only half the people who take it are going to experience this.
DR. WOODCOCK: Lucky, that's right.
DR. SHEFFET: I'd be very optimistic. Because I know that there are a tremendous number of drugs that have efficacy only for a certain number of people, and certainly doctors are very good at saying I can't guarantee this is going to work, but let's try this. And maybe part of the communication message is that maybe we are stressing the risk information too much. But we do need to let consumers know that--and I know we have in this country sort of a "if I take a pill, I'll feel better" mentality, so just give me the right pill. But maybe part of what we do need to communicate is this isn't going to work for everybody but there is a good chance, talk to your doctor, talk to your pharmacist.
MS. PEDERSEN: Dr. Morris?
DR. MORRIS: Yes, I had a question for Mr. Sullivan. In looking at the results of your study, it is clear that the communication of risk information was somewhat low. I'm wondering if you could provide us with any additional context to understand those numbers, any data on or information about the communication of benefits or general norms for recall in this kind of study. What would we expect on--you know, is risk different than benefit? Maybe that is the question.
DR. WOODCOCK: Could I add something to that, Lou? And also if somebody walked away from a physician's office after getting information about a drug, would you expect them to retain more information?
MR. SULLIVAN: We definitely know from advertising literature that advertising effectiveness has like an exponential decline over a series of several weeks. That is why I actually chose one week after the three ads to actually send them the survey.
Like I said, this was just a small piece that was tagged on to the survey at the end of the survey. Really the main interest was looking, like I said, at the behavior. I didn't test benefits at all because the survey was already upwards of eight pages long, including all the other information in the demographics. So I tried to limit this section as much as I could to the information that I included. In comparison to other products or other types of medical services, I am not really aware of how these percentages compare to risk information provided in other settings.
MS. PEDERSEN: I have just one question for Dr. Sheffet. You had recommended that FDA consider using more copy tests to substantiate the communication that might be included in the direct-to-consumer ad. Do you have a recommendation to the agency as to what the acceptable level would be in terms of what the copy tests demonstrate? Does it have to be 75 percent comprehension, or how would we assess what constituted adequate communication?
DR. SHEFFET: Given the nature of the product that we are dealing with here, which is a prescription drug and it is a fairly dangerous one, I would hope that you would set a fairly high level of 75 to 80 percent. That is going to be difficult to reach, and--well, I won't go into it, but there are a lot of different ways you can do copy testing, and certainly I know Lou Morris is certainly well aware of all of those.
One of the things that I think you do need to be careful about is that the message that consumers are taking away from the ad is really the message that is intended. And I guess my concern is that obviously "Only Zantac is Zantac" has a limited message, but telling people that there is a new treatment for the epilepsy drug--and I know there was concern expressed about that--you don't want to get people to stop taking a medication they are taking because they think there is a brand-new one out there that is better. You do want them to know that there is something else out that might be more effective and that they should go see and get more information about that.
So I hope you would set a fairly high level.
MS. PEDERSEN: Any final questions?
MS. PEDERSEN: Okay. We will now take a lunch break and resume at 1:15.
[Whereupon, at 12:20 p.m., the proceedings were recessed to be resumed at 1:15 p.m.]