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Transcript of Direct-to-Consumer Promotion Public Hearing Panel 9

FDA Public Hearing

Direct-to-Consumer Promotion

Thursday, October 19, 1995

8:40 a.m.

Quality Hotel
3727 Colesville Road
Silver Spring, Maryland






Our next panel will be Cindy Pearson from the National Women's Health Network and Sidney Wolfe from Public Citizen's Health Research Group.

MS. PEARSON: Good morning. I am Cindy Pearson, representing the National Women's Health Network. The National Women's Health Network is a non-profit women's health advocacy group. We are supported by a national membership of 16,000 individuals and 300 local organizations. We accept no contributions from manufacturers of drugs or medical devices. Do you need more than that?

The Network was established nearly 20 years ago to provide people with information and services to enable them to take action on health issues affecting women and also to serve as a clearinghouse for women's health information. Some of the very earliest actions of the Network were taken on behalf of women's rights to have information about the drugs they take. Even before the Network was formally established, its founders were organizing, writing, testifying, and even demonstrating on behalf of women's rights to patient package inserts, a consumer's version of the prescription drug information available to physicians.

In the early 1980s when prescription drug companies began advertising directly to consumers, the Network had quite a debate about its position. The Network firmly believed that women and men can understand safety and efficacy information about drugs. Some within the Network argued that direct-to-consumer advertising would provide consumers with information not given to them by most physicians and be a benefit. Others argued that the FDA would not have the resources to police prescription drug advertising and suddenly misleading information would be communicated to consumers, thus ending up in a net harm rather than a benefit. In 1984, the Network testified against the resumption of direct-to-consumer advertising.

Since the voluntary moratorium on advertising ended in 1985, we have watched the evolution of prescription drug advertising and we believe that our fears have been borne out. Although safety and efficacy information is present, in reality, it is not communicated to consumers in a useful way. What is being communicated to consumers through direct-to-consumer advertising of prescription drugs is the exact same type of information that is communicated in any ad--a brand name, a reason to use the product, and, most importantly, an impression about that product.

For example, ads for Depo-Provera birth control shots convey the impression that busy women with hectic lives will find Depo-Provera convenient. Some women may well find Depo-Provera convenient. However, many others find it to be extremely inconvenient because of unpredictable vaginal bleeding. Even if women weighed through the long columns of tiny print and find irregular bleeding listed in the adverse reaction section of the physician labeling, the message communicated in the text is nowhere near as compelling as the message conveyed by the slick, sophisticated ad on the front of the page.

Breast-feeding advocates also believe that direct-to-consumer advertising of infant formula communicates a subtly misleading message, even here in the United States, where oversight is relatively strong.

Advertising works. It motivates people to act. That is why drug companies want to use it to sell their drugs. The printed word alone as a mechanism of communicating safety and efficacy information to consumers can't compete with modern advertising techniques.

Pharmaceutical companies employ the most sophisticated and expensive advertising campaigns. Besides inserting holograms, sandpaper to simulate a raspy joint, 3-D images with special glasses, and other expensive gizmos into advertisement, pharmaceutical companies are famous for lavish gifts. While we have no fear that companies will offer to send consumers on all-expense-paid trips to tropical locales, we are concerned about gift videos, patient reminder devices, and other materials that masquerade as educational tools when they are merely advertising tools.

Consumers are very sensitive to advertising and doctors are very sensitive to consumer pressure. Direct-to-consumer advertising throws a wrench into a far-from-clean process.

Many throwaway magazines sent to physicians are paid for by drug companies and their often ghostwritten articles are merely advertisements in academic garb. A significant proportion of the advertisements directed at physicians have misleading information in them. By the time a complaint is made and an ad changed, the misleading ad has gotten lots of exposure.

But at least, along with this propaganda, physicians also read peer review journals and have access to unbiased drug information in publications like The Medical Letter. Objective sources have a temporizing effect. Consumers, on the other hand, are bombarded by advertisement without the balancing flow of unbiased information communicated in a way that reaches them with the same force as the advertisement.

Undoubtedly, drug companies have funded articles in consumer magazines which showcase their drugs and advertised only in magazines which publish articles promoting their drugs. Cosmetic companies are famous for this. Consumers read an article and consider it objective information, which, when paired with an ad in the same publication, is a powerful combination. But wasting money on over-priced skin creams doesn't hurt hour health. Taking unnecessary or inappropriate drugs, on the other hand, could severely compromise a consumer's well-being.

Where can consumers get unbiased information about drugs? If direct-to-consumer advertising is permitted to continue, we believe that all pharmaceutical companies that participate should be made to fund an independent consumer-run organization, generously funded with enough resources to independently evaluate drugs advertised to consumer and drug claims made to those consumers.

The National Women's Health Network, which has never taken money from drug companies, volunteers for this effort. Think of it as the consumer version of trips to Hawaii.

The Physician's Desk Reference is funded by a coalition of drug companies. Consumers deserve access to their own version of the PDR and to unbiased information about drugs. Physicians have access to unbiased information which dilutes the propaganda. We cannot think of providing consumers with anything less. Thank you.

MS. PEDERSEN: Thank you, Ms. Pearson.


Dr. Wolfe?

DR. WOLFE : Although our organization strongly favors a ban on all cigarette advertising and promotion, we really do not favor a ban, a moratorium, as I will get to later, until things are clarified. It might be appropriate here. In fact, in the area of prescription--

MS. PEDERSEN: Excuse me.


MS. PEDERSEN: Could you start with the financial disclosures, please? Thank you.

DR. WOLFE: We have not, do not, nor possibly could ever be taking any money from drug companies, device companies, or the media that seems to be making a lot of money off this or any other organization that would be influenced by what is going on here.

MS. PEDERSEN: Thank you.

DR. WOLFE: Sorry. The one case that we have been involved in regarding the issue of prescription drug advertising, we were actually on the side of the advertisers. I would like to mention this because this has to do with accuracy. Back in the 1970s, a group of pharmacists in Virginia were taking out ads with prices of prescription drugs. No one doubted that the price they were advertising was the accurate price. They were harassed and attacked by their own State Pharmacy Association, who said, this is unprofessional, it's unethical, it violates codes of advertising, and so forth, and they were threatened with loss of license for just taking out ads saying, this drug costs this much.

We took this case and this case went to the Supreme Court in a case called Virginia Pharmacy. That accurate information, which was not misleading at all, said the Supreme Court, should go.

So I think that our test is, is this information accurate or misleading? Is it understandable to the intended audience, whether it's physicians in the case of physicians' drug advertising or patients? Is it fairly balanced, and so forth?

Before showing some overheads, I just want to go through at least my impressions of the history of this. In 1982 in what was the first massive direct-to-consumer promotion of prescription drugs could be seen the damage that is there when out-of-control, misleading advertising goes. As we always say, the drug approval process is important, because if we don't make good judgments on safety and efficacy, a drug can get approved which can damage people. But advertising can kill people and damage people, as well.

The drug was Oraflex. It was approved for marketing in April of 1982 and marketing began in May, accompanied by an unprecedented blitz of direct-to-consumer promotion. Six thousand press kits were directed at print and electronic media, making it appear that the drug was far more efficacious than it was and implying that it was no more dangerous than other drugs, or in some cases, less dangerous.

As a result of this campaign, within a month or two, half-a-million people took the drug. Many physicians described patients rushing to them and saying, I read in Time magazine or I saw on the ABC Evening News something about a new drug. Nothing else has worked. How can you withhold this from me? And whereas well-read, well-informed physicians resisted that, a large proportion of American physicians are not well-read, are not well-informed, and, in fact, are influenced by the same kind of advertising with the same degree of misleading information as patients.

So if you put together a patient who has been misinformed by an ad going to a doctor who is not adequately educated, you have a combination that says, go with it. Why not?

Shortly before the drug was taken off the market worldwide, several months after it was introduced, because of a large number of deaths in this country and other countries, the FDA did, in fact, write to the company protesting strongly about the false and misleading direct-to-consumer advertising campaign. This was at least in the minds of people, hardly the only reason, when the decision to impose a moratorium not many months later was made, a moratorium on direct-to-consumer advertising, which was technically not advertising, although it had many more benefits than advertising since it was free, largely, free space in at least those publications that went for it.

Well, as you know, the moratorium was imposed in 1983 early, and at the time it was imposed, this is an interview that Sam Gilston, then writing for Medical Advertising News, had with Dr. Hayes. "They," consumers, "ought to make decisions, but they have to be informed to make decisions. You cannot expect people to be able to read an advertisement about a drug or about a treatment of a disease and make informed judgments, judgments upon which they will act, if they don't know what the hell it's all about." Art liked to use the word "hell" in appropriate places. This was one.

He also said, "I do not think that it is appropriate for advertisements to attempt to sell a patient or a potential patient on the drug to use because that is a decision that has to be made by the physician or other health professional and the patient, maybe sometimes the family, as well."

He obviously went back and forth on this issue but expressed some views back then that were, I think, very telling and very accurate about concerns. In a speech that he gave a few months later, in 1983, he said, "We have done some preliminary thinking about these questions. From our perspective, any regulatory scheme should meet at least three fundamental criteria. It should effectively promote fair balance, regulatory scheme," and now we don't have one, which is, I think, part of the problem. "Second, it should not be unnecessarily restrictive. And third, it should be enforceable."

In 1984, the FDA did a study which Dr. Lou Morris was involved in, and amongst other findings--it was a survey of patients being shown hypothetical ads, and one of the findings, not very surprising, was that patients remembered more about the benefits than they did about the risks. That is certainly true of physician advertising, also.

In 1985, the moratorium was lifted, secondary to finding that the current regulations "were sufficient", the current regulations being the use of the regulations clearly intended for physician and other health professional advertising being interpreted in a way to apply to direct-to-consumer advertising.

In 1988, an interesting article in the New England Journal of Medicine by Dr. Eric Cohen from the Medical College of Wisconsin commented on this whole problem, citing a study that found that you had to spend more money and space on advertisements for products that were not as clearly useful as others. He said that drugs of lesser benefit require more advertising than those whose benefit is known confirms the premise that advertising seeks to increase sales, not knowledge.

In both 1989 and 1991, FDA said, amongst other things, we do not have the legal tools to stop misleading advertising now, direct-to-consumer, and then in 1991, we are now working on guidelines for direct-to-consumer advertising. We must consider new and revised regulations. As of now, we really don't have any regulations specific to this. I will get back to this at the end.


DR. WOLFE: This is not meant to be funny at all, but simply the reason why the drug industry generally and drug advertising is regulated is because of the nature of ads. The ads are seeking in any way possible to sell drugs and moving as far towards or beyond the boundary of false and misleading as opposed to as accurate as possible. A large enough proportion of drug ads to doctors are misleading. This is the background to which we are trying to look at the parallel issue of direct-to-consumer advertising. The only purpose is to sell drugs, not to educate the public.

We are talking about drug ads that talk about or imply a specific drug, not hypertension is undiagnosed. Go to your doctor or nurse or pharmacist and have your blood pressure taken. That is an educational message. We don't see a lot of those kinds of ads, unless they have one product and only product only in back of them.


DR. WOLFE: The next slide reviews the findings from the study by Wilkes, Shapiro, et al, published in the Annals of Internal Medicine three years ago. Among their findings were that 38 percent of the ads potentially violated five or more FDA regulations. Forty percent did not present a fair balance, the phrase that's important here and in the direct-to-consumer advertising, between effectiveness and side effects. Forty-seven percent did not highlight problems in special patient groups, such as the elderly.

The FDA itself--now, these are ads which, of course, hadn't been submitted for pre-approval because that's not the regulation works as to physicians, and the FDA, when they had reviewed many of those same ads, had come to very similar conclusions. Ultimately, long after the damage that Cindy Pearson alluded to was done, many of them were stopped.


DR. WOLFE: These are quotes. We were able to obtain the so-called raw data from the study. When the study was published, it did not mention brands or brand names. We got the actual drugs, what they were and what the reviewers had said, and I'll just read a couple of these.

With respect to an ad for Phenergen by Wyeth-Ayerst--one of the worst ads I've ever seen promotes the use of a dangerous medicine for trivial indications. The one for Noroxin by Mercke, Sharp and Dohme--advertisements like this one are reasons why something must be done to avoid such terribly misleading information about a drug to doctors.

Now, these are ads that are being viewed by the reviewing physicians and pharmacists in the context of their receipt, so to speak, by physicians who have training, not as much as we would like, in pharmacology and medicine and so forth.

Finally, on Unasyn by Roerig, these ads are fundamentally lacking in integrity.


DR. WOLFE: I'll take a couple minutes to just talk about this particular ad. This is an ad in a journal I never heard of until a few years ago called Medical Marketing and Media. It's a journal in which publications like USA Today or the New England Journal try to influence drug companies to take out ads. In this May 1995 issue of Medical Marketing and Media, USA Weekend is promising to deliver ultimately doctors and prescriptions via the medium of 38 million adults who read this. This is a boast, not an unwarranted one. This ad is probably fairly accurate, as opposed to the ads that are placed as a result of this ad.


DR. WOLFE: This is an ad that appeared in the Los Angeles Times in January of 1994 and it tells you the extent to which a company, ICN, in this case, will go to mislead and frighten patients. Respiratory synstitial virus is a relatively rare and life-threatening condition which this company is telling parents looks like a cold. Is it RSV? Symptoms, cold symptoms and so forth, it could be RSV.

The FDA got this ad stopped, an ad that was not submitted voluntarily because the voluntary guideline for submission isn't voluntarily complied with sometimes, and the FDA writing to the company said, Virazole's label carries a black box warning which provides important information for health care providers.


DR. WOLFE: A sudden deterioration of respiratory function has been associated, and so forth. The next thing stated by the FDA in their letter to ICN was, the entire advertisement lacks fair balance in that it provides no adverse effects, risks, or warning information. The statement, "Only severe respiratory tract infection should be treated with Virazole. The vast majority of infants and children with RSV have disease that is mild, self-limited," and so forth. The ad was stopped, but lots of people saw it. We do not know how much damage was done.


DR. WOLFE: Finally, the last slide. This is a survey commissioned by CVS in the early 1980s and it really answers the question, I think accurately, are patients eager to find out information, objective information, about drugs? And on efficacy and safety, something close to 80 percent said that it was a very important issue for them, to be informed about efficacy and safety, but something only 30 percent said that they were well-informed.

This sets the stage not for direct-to-consumer advertising but for mandatory patient package inserts, something that the FDA has considered and then dropped and then considered and is now in a sort of voluntary, possibly mandatory, phase.

So no one denies that patients want information, want accurate information, and are not getting it. The remedy, I would argue, is not direct-to-consumer advertising.

In summary, I believe that a moratorium by FDA should be reinstated on direct-to-consumer advertising, during which time the FDA finally does what it has been talking about for 12, 14 years, promulgate and finalize appropriate and specific regulations having to do with the promotion of prescription drugs direct to consumers. In the alternative, while such regulations are being developed and processed through the regulatory mill and the OMB, a much tighter enforcement should be done of these ads. Severe penalties should fall on those companies that violate, such as ICN. ICN, by merely stopping the campaign, was told, don't worry. No more regulatory action will be taken.

I have seven seconds to go. I thank you for inviting me. This is an issue that the National Women's Health Network and Public Citizens' Health Research Group have both been concerned with, both the accurate information in the form of package inserts and the more accurate, possibly, but not now, information in the form of direct-to-consumer advertising. We would be happy to answer any questions.

MS. PEDERSEN: Thank you, Dr. Wolfe.


Questions? Dr. Temple?


DR. TEMPLE: One of the points that many previous speakers, especially yesterday, have made--this is probably for Ms. Pearson, but you both may want to comment--was that the fact that the patient can't prescribe his or her own medicine is a substantial protection with respect to direct-to-consumer advertising and that the need for full balance and so on is not as great. I guess Sid's 84 percent figure goes to that point, but I'd like you to comment more specifically on that.

MS. PEARSON: Our reaction to that is that the incredible ability of advertising to create an impression leads women who have been exposed to these kinds of ads to go into their physician, initiate some amount of discussion about using this drug, but not have the discussion that they would have had without the ad, even though a discussion still takes place. Without the ad, it could have started from a neutral place with an opportunity for a balanced discussion with the provider of risks and benefits and other alternatives.

With that almost subconscious impression of the benefit that is going to come from the use of the drug, we believe that women don't have that same kind of full discussion. They come in very much aware of what they believe will be the benefits and kind of jump over the opportunity that they would have had with their provider to get a full and balanced description.

DR. TEMPLE: Consider the example you gave, Depo-Provera. Okay, the convenience is fairly obvious. You don't have to think about it.


DR. TEMPLE: Wouldn't, essentially, any OB-GYN person or family practitioner be able to mention that bleeding is a problem? You may or may not like this drug. It's not an obscure point or anything. Wouldn't that work?

MS. PEARSON: I think the way that information is communicated can have a huge effect on the way a woman perceives the likelihood and the impact on herself that this irregular bleeding might have. What our experience is is that some providers are very straightforward. They tell women exactly how bad it might be and how good it might be and what their likelihood is of experiencing that, but not every provider takes that much time or has that much time--people working in managed care are on pretty strict limits of how much time they have with patients--and if the patient comes in feeling herself to be relatively well informed and doesn't solicit that kind of information or doesn't want to spend much time with it, it's easy for a provider to slide over it quickly.

DR. TEMPLE: So you would say that if there is a major problem like that, it ought to be part of the ad, and I guess I also want both of you to comment on the brief summary. That and the brief summary came in for a lot of adverse discussion yesterday. We didn't encounter anybody who thought it was a good communication mode. I don't think any of us think so, either. But do you agree with that, also, and what alternative would you propose?

MS. PEARSON: We generally believe that the way it's working now isn't communicating safety and efficacy information in a usable way, and the brief summary comes in for our general belief that it's not working. It's hard to know what to propose that can counter the incredible ability of visual advertising, pictures, to create an impression.

Now, I was intrigued with what I heard this morning about the Internet, since now it's mostly a text medium, that the information is communicated by words. I know not completely, but it seems like that sort of arena has a bigger chance for the factual information to come across because it's not blocked by the photos and the music and the sounds.

DR. WOLFE: I'd like to go back and expand slightly on what I said before, which is that this is done in the context of all too often poorly-informed physicians whose information comes from their version of the advertising.

Joy Levin and her colleague, Scott Levin, have done a very good job in measuring the impact of direct-to-consumer advertising on prescription drugs, promoting it, holding seminars on it, and I think the ad that USA Today took out in Medical Marketing and Media is an ad based on information in a survey that they had done.

I don't think there's any question that in the face of more direct-to-consumer advertising, doctors are paying more attention to those patients who come to them saying, what about this brand name or that brand name, partly as a result of doctors' lack of training in pharmacology and other important issues having to do with the prescribing of drugs and partly because after the training, the training, so to speak, takes the form of the promotional materials more than anything else.

Doctors are not aware, often, of these problems and survey after survey shows that doctors do not adequately inform women about the risks of drugs, not all doctors, but 40 to 50 percent of doctors do not regularly inform men or women of the important risks, such as risk of bleeding or whatever. I mean, it hasn't been done on a drug-specific level, but I don't think that the surveys are much different.

So in the context of a poorly-informed physician and in the context of physicians, many in that same group, who are not prone to be giving out with information about the risks of a drug, all the more influence can be had by the man or woman who comes in charged up with having seen one of these ads.

So I think that because of that, the standard of is the information, benefit and risk, a fair balance of the two understandable is the test that has to be put to the brief summary or any other part of these ads. To the extent that patients are coming away with many drugs thinking that the benefits greatly outweigh the risks, which in some cases are true and in other cases are not true, they are playing into the similarly-distorted views of the same drugs by the same physicians.

So I think that if, theoretically, we had a group of extremely well-informed physicians who did not depend on drug advertising and promotion for their source of information and who had far more in terms of quality and quantity education in medical school, residency, and so forth prescribing the drugs, it would be a different situation. That is not the reality of it. It is not likely to be the reality of it, and the considerations as to how these regulations need to be written and enforced have to be cognizant.

When someone designs a product, it has to be designed in such a way as to account for the entire spectrum of intelligence, physical abilities, and so forth on the part of the user, and I think in the same sense, this has to be done with this campaign or project of direct-to-consumer advertising with prescription drugs.

MS. PEDERSEN: There are two questions from the floor that Dr. Ostrove is going to read together, because I think they're related.

DR. OSTROVE: There are two related questions. One is that given the focus of the panel on the negatives of DTC, specifically those potential risks, have you considered the positive impact of DTC in health care for the public at large, and especially if you make the assumption that DTC advertising is not the medium for informing patients, how do you propose that we do inform them, especially when, as you stated, many physicians themselves are not very well informed?

DR. WOLFE: As both Cindy and I said, a way of informing patients is mandatory patient package information that has been cleared, made accurate, and is uniform so that everyone getting a prescription filled for a drug in a certain class is going to get pretty much the same kind of information, as opposed to outlandish claims making it seem as though one drug is better than or different from the other.

So one has to separate out selling drugs and educating about drugs. Selling drugs, advertising, is fine. That's what advertising is for. We cannot ban it, and as long as one realizes that the primary purpose, one has to minimize the damage that can be done in the process of selling by making it most accurate. When we are talking about educating the public, that's not the way to do it anymore than educating doctors.

I mean, no one would really seriously believe that prescription drug advertising is an appropriate way of educating doctors about drugs. That's just a silly idea, and I think for the same reason, educating patients about drugs is no more likely to be done. So separate out selling and educating with objective information.

I know that there are examples, i.e., ones that are not product-specific, that may perform an educational function. That's not what this meeting is about. I don't think people are here to object to some company out of the goodness of its heart, truly, taking out an ad, raising public awareness about a disease that is under-diagnosed and under-treated and that they have one of 20 of the remedies for it. That's not what this is about. That is a limited educational function of these ads, but we're talking about product-specific ads, not education.

DR. OSTROVE: As a follow-up to that, certainly, there have been questions raised about patient package inserts in terms of educating consumers prior to the prescription being given to the consumer. The patient package inserts are designed, really, for when a prescription has already been given and is designed to inform the consumer about how best to take the drug and what they should be looking for at that time. It's not designed necessarily to really be focusing on the benefits. So I think that--I guess I would reiterate the question as to how do you get at it prior to that prescribing decision?

DR. WOLFE: Let me just finish. Back in the 1970s, we petitioned FDA for patient package inserts on progestogen-containing drugs. At that time, with DS having gone out of favor, doctors were prescribing progestogens to prevent miscarriages on the theory that progestogen deficiency was a cause of miscarriage in women.

Physicians, prior to the patient package insert, were, in many instances, not telling women that the drugs weren't effective for that reason, A, and B, that they could cause, at least as was then thought, birth defects.

To be sure, once the patient package inserts started, the physicians, aware that patients were going to be going into the pharmacy and picking up this piece of paper 20 minutes later, depending on how long it took to get to the pharmacy, changed not only their prescribing of the drug--they didn't completely stop prescribing it but were much more likely to inform people. So I think that there is an important feedback. A physician knowing that a patient is going to learn something about a drug is more likely to talk about it. So I think that even at the level of prior to prescribing, there is an important impact of having a patient package information.

In fact, one of the groups trying to stop the patient package inserts, the mandatory program, were physicians who were arguing, correctly, that it would interfere with the doctor-patient relationship. Of course, they were referring to those doctor-patient relationships in which doctors weren't informing patients.

MS. PEARSON: I just wanted to say that I agree with Dr. Wolfe that mandatory patient package inserts with a standardized format are an important way of informing consumers. I don't think we can ever get completely at as much education as needed before the prescription is written, but we have had the exact same experience that Dr. Wolfe describes in seeing the trickle-down effect on the interaction between provider and patient after patient package inserts came into effect with menopausal estrogens and oral contraceptives.

We also know that on many drugs, particularly those used for chronic conditions, that there is another decision after the decision to write the prescription. There is the decision of the patient to begin taking the prescription or to continue taking the prescription, and a patient package insert can be very informative and useful there. It can possibly improve compliance where it's needed and it can weed out some people who are inappropriate prescribed.

So we realize that PPIs don't solve all the problems, but they are a practical way to get at the issue.

MS. PEDERSEN: Thank you. Two final questions, one, first, Dr. Morris, and then Dr. Temple.

DR. MORRIS: This question is for Ms. Pearson, but Dr. Wolfe, I hope that you will comment, as well. Ms. Pearson, you said an interesting notion, that it's really the overall impression of the advertisements that are misleading, and Dr. Wolfe has suggested a call for very appropriate and specific regulations. I'm wondering, when I think of appropriate and specific, I think of kind of word-smithing or correcting things, but you're saying the big problem is really the overall impression. What ideas do you have where those impressions may be either corrected or lessened?

MS. PEARSON: I don't know. I mean, it's so--the ability of modern advertising to communicate an impression is so far beyond what any of us who spend our time reading and writing can compete with that it seems almost insurmountable. The only thing we can think of as a remedy is to have available to the public a source of unbiased information that is communicated in a way that somehow comes near the communicative power of advertising.

DR. WOLFE: I think that we are really talking about the same thing. The impression that Cindy is talking about, to me, is the same as the understanding that derives from looking at the ad, reading it, and so forth. There was an on-campus outdoor survey done five years ago by some physician researchers in New Jersey looking at the reaction, impression, understanding of a group of students upon seeing some of the ads for the nicotine patches.

Not surprisingly, their impression, because that's the way the ads were, was that this pharmacologic fix was all you needed, that you really didn't need to also be involved in some kind of counseling and supportive psychotherapy, group therapy, and so forth to take care of the psychological as opposed to just the pharmacologic aspect of addiction.

To me, that is an example of a test of the impact or understanding or impressions that a group of people has when viewing and reading an ad. I think that that isn't as quantitative as we are used to when we are measuring someone's weight or blood pressure, but you, as an expert in this area, probably know that you can go a long way in terms of gauging not only the impression, reaction, understanding, but also asking whether or not, based on that, someone would go to their physician and ask for it. The data that hopefully you all have gotten some, if not all of, from Scott Levin shows the impact of these campaigns in terms of patients going to their physician and asking for it.

So I think that somewhere in this realm of impression, understanding, and so forth one can design regulations that wind up testing ads, not necessarily every ad, although I think pre-clearance will have to be part of this process, so that some measure of understanding and impressions, whether they are accurate or not, can be made.

MS. PEDERSEN: Dr. Temple?

DR. TEMPLE: Patient inserts, for the most part, don't tell you why you should use a drug. They only tell you how to use it once it's been prescribed for you. They are not advocacy documents, not surprisingly.

DR. WOLFE: They do have information on what it's supposed to be used for and some of the risks, as well.

DR. TEMPLE: In a sort of loose way, but they don't make you run to your pharmacy or run to your doctor and say, you've got to give me this. Maybe they could be written that way--

DR. WOLFE: No, you're right. Right.

DR. TEMPLE: --but that isn't for the most part how, but let me just pursue it. There are some things that the public health would suggest would--there are some situations in which the public health would be benefitted by treatment. You want hypertension to be treated. There's grossly insufficient use of beta blockers post-infarction, according to my reading of the data. Not everybody who should be getting aspirin should be [sic]. There's a whole bunch, especially cardiovascular, but probably one could identify other areas where there's a positive good that would come from better awareness. In fact, there are national campaigns to encourage some of those things.

Making people aware that there is a pharmacologic way that might help you become un-addicted to cigarettes is something that one might consider valuable. It is probably useful to know that there are antihistamines that don't make you sleepy and more likely to have an accident. You can identify certain things like that.

Do you actually see a positive value for at least some of those, if the information was balanced, or do you think that the risks of not getting it right are so high that the whole thing should be discouraged? I'm trying to figure out where you come on that.

DR. WOLFE: It is possible--I mean, it's interesting that the examples you cited, I do not think I've seen any beta-blocker direct-to-consumer ads. I may be wrong.

DR. TEMPLE: That's right. They're mostly generic. No one's too interested.

DR. WOLFE: Well, thank you. That's the point, then. The point is that if there isn't money to be made selling these things--

DR. TEMPLE: I was hoping someone would--

DR. WOLFE: --there isn't going to be a whole hell of a lot of advertising. Again, these are public health campaigns which need to be addressed in all of the ways public health addresses things. If we had a Surgeon General, I could see much more coming out of a Surgeon General not just on the area of AIDS and tobacco and so forth but in some of these other areas.

So yes, you happen to have focused on areas that have been, I think, devoid of any advertising because the products that would be used to treat the under-treated people with those problems are off-patent and are available. So yes, that's an example of education and it's also an example of something that is on a completely different track from at least the present concepts having to do with direct-to-consumer advertising of drugs.

MS. PEARSON: Where we see a possible benefit for advertising, direct-to-consumer advertising of products that some of them are on-patent now is in contraceptives and STD prevention. I wish, I really wish before my kid hits puberty that these fabulous modern advertising techniques that we have at our disposal now to sell Coca-Cola and Mutant Ninja Turtles and everything else finally will be turned to birth control and STD prevention. We would be very happy to loosen up on our kind of fear that single drug-specific ads always are worse than they are better for the individual consumer if we could see some move from these industries of promoting their products which we would get an enormous public health benefit from.

DR. WOLFE: One thing that comes to mind is that I do not watch a lot of television, but when I do, I not infrequently see very expensive, very slick, and mainly not misleading ads taken out by the Defense Department urging people to be all that they can be and things like that. These ads do work as one of the ways of recruiting people.

I would imagine that the amount of money that is spent by the Defense Department recruiting people for our "national defense", such as it is, outstrips by orders of magnitude the amount of money that is spent by the government on advertising concerning personal defense and the very issues that Bob is talking about, trying to encourage people to use beta-blockers post-MI and so forth as opposed to calcium channel blockers.

I think that if we begin setting our priorities right and diverting money through public means to give out that kind of information, we could accomplish just as much in terms of personal defense as the Defense Department accomplishes in terms of getting people into the Army, Navy, or Air Force or Marines. So I think you've hit on an important problem. Advertising from a non-commercial source is one answer.

MS. PEDERSEN: Thank you very much, Dr. Wolfe and Ms. Pearson. We will now take a break until 20 minutes until 11:00.