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`ll.S. Food :md Drug AdministralioJJ
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`THALIDOMIDE:
`POTENTIAL BENEFITS AND RISKS
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`AN OPEN PUB LIC SCIENTIFIC WORKSHOP
`September 9-10, 1997
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`N atch~r C onfer~I"I-CQ C9ntsr - National lnstltutes of Health - Bethasda. M ~ryland
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`TRANSCRIPT
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`THALIDOMIDE: POTENTIAL BENEFITS AND RISKS
`
`OPEN PUBLIC SCIENTIFIC WORKSHOP
`
`Sponsored By
`
`NATIONAL INSTITUTES OF HEALTH
`
`FOOD AND DRUG ADMINISTRATION
`
`CENTERS FOR DISEASE CONTROL AND PREVENTION
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`Wednesday, September 10, 1997
`
`Auditorium
`N atcher Conference Center
`National Institutes of Health
`9000 Rockville Pike
`Bethesda, Maryland
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`CONTENTS
`(with hyperlink to speakers presentations)
`
`RISK MANAGEMENT
`
`Louis A Morris, Ph.D. , Moderator
`Chief, Division of Drug Marketing, Advertising,
`and Communications
`Center for Drug Evaluation and Research, FDA
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`CELGENE EXHIBIT 2024
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
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`Effective Risk Communication
`Louis A Morris, Ph.D. , Ph.D.
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`Role of Communication to Influence Behavior
`Martin Fishbein, Ph.D.,
`University ofPennsylvania
`
`Clinical Ethical Considerations in the Use of Thalidomide:
`A Practitioner's Perspective
`Gail J. Povar, M.D., M.P.H., F.AC.P.
`George Washington University School of Medicine
`
`Patients' Rights and Physicians' Responsibilities
`Mark Senak, J.D.
`AIDS Project Los Angeles
`
`Risk Management -- Educational, Advertising,
`and Marketing Efforts: Industry Perspectives
`Bruce A Williams
`Celgene Corporation
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`Questions
`
`PERSPECTIVES ON PRESENT AND FUTURE NEEDS
`
`Ann Ginsberg, M.D., Moderator
`National Institute of Allergy and Infectious Diseases, NIH
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`Research Perspective
`Gilla Kaplan, Ph.D.
`The Rockefeller University
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`Thalidomide: Bioethical and Legal Issues -(cid:173)
`Industry's Perspective on Present and Future Needs
`Peter Andrulis
`Andrulis Pharmaceuticals Corporation
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`Thalidomide Revisited: The Nightmare to Come
`Thomas H. Bleakley, J.D.
`Bleakley & McKeen, P.C.
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`Legal Perspective
`Frank C. Woodside, Ill, M.D., J.D.
`Dinsmore & Shohl
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`Questions
`
`OPEN PUBLIC SESSION
`
`Stephen C. Groft, Pharm.D. , Chair
`Director, Office of Rare Diseases, NIH
`
`Iris Long, M.D.
`ACT UP/New York
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`RESPONSES FROM WORKSHOPS ON RESEARCH
`ADVANCES AND OPPORTUNITIES
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`Stephen C. Groft, Pharm.D. , Chair
`Pharmacology, Pharmacokinetics, and Teratology
`of Thalidomide and Analogs
`
`J. David Erickson, D.D.S., Ph.D.
`Centers for Disease Control and Prevention
`
`Dermatology
`Mervyn L. Elgart, M.D.
`George Washington University School of Medicine
`
`Immunology /Rheumatology
`Philip Fox, D.D.S.
`National Institute of Dental Research, NIH
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`Hematology /Oncology
`James Pluda, M.D.
`National Cancer Institute, NIH
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`Infectious Diseases
`Lawrence Fox, M.D., Ph.D.
`National Institute of Allergy and
`Infectious Diseases, NIH
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`CLOSING REMARKS
`
`Theresa Toigo, R.Ph., M.B.A.
`Associate Commissioner for Special Health Issues, FDA
`
`Stephen Groft, Pharm.D.
`
`Janet Woodcock, M.D.
`Director, Center for Drug Evaluation
`and Research, FDA
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`P R 0 C E ED IN G S (8:14a.m.)
`
`DR GROFT: Good morning, everyone. I see you were able to make it through what for Washington this
`summer is an unusual event, a day of rain. So despite the travel and everything else, the problems that go with
`traffic, we do appreciate the rain and need it.
`
`My name is Steve Groft, and myself and Terry Toigo have served as co-chairs of this workshop and had the
`opportunity to put together the program This morning we're ready to tum it over to risk communication, risk
`management. We've asked Lou Morris from the Food and Drug Administration to chair this session, be the
`moderator and put together the panel, which he has done an outstanding job of, so I'll just tum it over to Lou to
`get us started.
`
`I'll have some information later on about the breakout sessions, and then the CME credit for those who are
`filling out the forms. So between the first and second session, we'll put some information up on the overhead.
`
`Lou?
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`DR. MORRIS: Thank you, Steve.
`
`Good morning, everybody. Congratulations. You made it here. If you walked, you were fine. If you had to
`drive, you were lucky.
`
`This morning we're going to talk about risk management from a number of perspectives. First, we will be
`talking about it from a theoretical perspective in which we'll talk about both perception and behavioral
`influences. We'll then talk about some issues in informed consent and consumer perspectives, and then, lastly,
`we'll hear from Bruce Williams regarding Celgene's plans for a risk management program for their thalidomide
`product. The way I'd like to structure the session is, first, I'm going to introduce everybody in the panel, then
`we'll each take our tum at the podium, and then, finally, we'll have a question and answer period.
`
`So let me start by introducing myself. My name is Lou Morris. I work in the Division of Drug Marketing,
`Advertising, and Communications at FDA, where we work on regulatory issues and patient information issue,
`and I also am scholar in residence at the American University Center for Marketing Policy Research.
`
`On my right is Dr. Martin Fishbein, who for the last five years has been at the Centers for Disease Control,
`where he's worked on behavioral initiatives regarding HIV and AIDS policy. He's currently moving to the
`Annenberg Center, where he'll be an active member of a new public policy unit.
`
`On his right is Dr. Gail Povar. Dr. Povar is clinical professor of medicine at George Washington University,
`where she not only teaches new and innovative courses-- she mentioned she's teaching an Internet course this
`year-- but she actually sees patients. She's one of those few people who have multiple perspectives not only
`from a broad public policy and ethical sense, but also from a sense of patients' perspective.
`
`On her right is Mark Senak, who is with the AIDS Project in Los Angeles. He's the director of public policy
`there. Mark has a long career in AIDS activism He's been in the Gay Men's Health Crisis Center and the AIDS
`Action Council.
`
`Then on his right is Bruce Williams, who is the vice president for marketing and sales at Celgene. Mark
`actually moved Celgene from a research to a commercial corporation, and he's primarily responsible for
`developing there the thalidomide distribution and communications program We'll be very interested in hearing
`from him
`
`So with that, I'm going to start off, set my own timer. Can I have the first slide?
`
`Thalidomide has special meaning for lots of people, and for someone who has worked at FDA, this is one piece
`of the meaning for thalidomide that I think FDA staff has. In the library in the Center for Drugs, there's a
`picture of Dr. Frances Kelsey receiving an award from President Kennedy. That picture, I think every time we
`go into the library, communicates to people at FDA in a very special way.
`
`I know critics of FDA frequently think that we see thalidomide as the reason why we keep drugs off the market.
`At least for me, that's never been my interpretation of this. It does remind us that we have a very important job
`and that what we do has huge implications for individual patients and for the country as a whole. I think that's
`the way we have seen thalidomide historically, and I think that's the way we see thalidomide today. This is
`symbolic for us and it's symbolic because it means an awful lot about defining who we are and what we do. So
`the things we do and say about thalidomide I think have important implications at a national level and on a
`personal level for the people who work at FDA
`
`So with that aside, if we can tum that slide off, I'll move to the high tech stuff. We can try talking about risk
`communication and thalidomide. What I would like to do is present more of kind of a general theory and then
`some specific data that we've collected on thalidomide and risk communication.
`
`First, from a marketing perspective, I think it's clear that we can characterize products in three different ways,
`and we as consumers characterize products in these ways. First, we can characterize a product in terms of its
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`physical properties. We're taking a capsule of medicine, but it's more. It has more meaning to us than just that.
`
`It also has a functional property. Whatever this drug is, this thalidomide is, it has certain benefits that we
`anticipate, and it also has certain risks that we need to be aware of. For some products, products that have very
`high meaning, high involvement products, not only do we take in and think about what it is that people tell us,
`but we also elaborate on those meanings for these kinds of high involvement products and we integrate this
`information.
`
`There's still a third level of meaning by which we can characterize products, and that is that products have
`symbolic meaning. They mean an awful lot to us. For me, as that previous slide showed, thalidomide has a
`special meaning. I think that ifyou ask people, at least of my age cohort, what it means, they're going to talk
`about what they see. They have a very, very vivid understanding and a recall of certain pictures that they saw.
`If you speak to anyone, they say yes, and they'll see these pictures.
`
`How people use products depends upon several things. It depends upon, first, how they perceive them That
`first part, that perception, depends upon their beliefs about the product itself and their personal use of the
`product. In my presentation, I'm going to focus on this.
`
`But it also depends on beliefs about other things. For example, beliefs about what other people think. It also
`depends on situational factors. Dr. Fishbein will give us a much broader perspective on the behavioral
`outcomes related to people's use of different products.
`
`Let's now turn to the people's perceptions of risk. One of the things we know from research is that knowledge is
`not simply something that's transferred. It's actually constructed. When people process information they only
`retain small bits and pieces. What they retain from a message, their takeaway is going to be fairly limited. One
`of the things we do know is that very vivid images are more likely to be transferred to people's memory.
`
`When they then have to act on those behaviors, that information is integrated with their current context. So
`meaning changes. Memory is very creative because we're only retrieving bits and pieces and then we're
`integrating it with our current situation. There's a lot of differences in terms of how people behave depending
`upon how familiar they are with the product. If it's a product that we're very, very familiar with, we're going to
`have a very standard way of seeing it. If we take an aspirin every day, we know what that aspirin means to us,
`we know what it does, we know when to take it, how to take it, and we know what to expect from it.
`
`However, if we take a new product, a product that we've never taken before -- a new drug, for example -- how
`we behave towards that product is going to be very variable because a lot will depend on the contextual
`situation. So, for example, if we get a headache after we take this unfamiliar product, we may say that new
`product did it. If we get a headache after taking an aspirin, we'll say, well, the aspirin wasn't strong enough, for
`example. We know what to expect in one case. In the other case, we don't know what to expect.
`
`People build mental models of products. They also have situational inputs. What is retrieved when knowledge
`is put to use is a very important issue. One of the things that we've been concerned about in the risk
`communication package for thalidomide is what's going to happen at the point in time when an individual is
`faced with a sexual encounter. How will that patient behave? Part of that's going to be dependent upon what
`they retrieve in memory at that point in time and if those memories are what we're trying to build in the risk
`communication package.
`
`The reason I put up these data, one of the things we want to know is what do people already know about a
`product. We're lucky enough that a couple of weeks ago we started collecting data from another study.
`
`The PowerPoint is not on. Help!
`
`(Laughter.)
`
`DR MORRIS: Let me go on to talk about what it is and I can describe it. We collected some data from a small
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`sample. This is an ongoing study and we literally just last week compiled the data that we had so far. In this
`study, we asked a very simple question. We gave people certain words. We just asked them to define them,
`what does this word mean. We collected these data from males and females and what I would show you with
`numbers, if we had them, is that there's an incredible age cohort effect if you look at these data, and I can tum
`this around and you can all see it.
`
`(Laughter.)
`
`DR MORRIS: That if you're over age 45, over 50 percent of the people, about two-thirds of the people, can
`correctly define at least partially what the word "thalidomide" means. If you're under 45, it's a total reversal.
`There it is. It's not real clear, but we separated out for genders. It's percent correct, partially correct, incorrect,
`or don't know.
`
`Ifyou look at the age groupings, ifyou look at the 45 split, about two-thirds of people either get it wrong or
`don't know if you're under 45. If you're over 45, two-thirds get it at least partially correct. It's a VANOVA, a
`visual analysis of variance here. You don't even need to do the statistics. It's an incredible cohort effect. We
`separated out for males and females, and we didn't find any difference in genders, but we do find this enormous
`cohort effect in terms of age.
`
`I think my explanation for it is, again, if you ask people over 45 about thalidomide, they just see these very
`vivid images. They retrieve it. Under 45, they just don't have those memories.
`
`So from a risk perception standpoint, one of the things I think we need to think about is how do we build this
`risk profile. We can think of this in three successive levels of building. For a lot of products what we do is
`simply put out a simple warning label. That warning label has a signal word, it tells people what they should
`do, and what negative outcomes should occur. I think if you look at just about any consumer product --over(cid:173)
`the-counter drugs, ladders, lawn mowers, anything like that -- you're going to see this kind of warning message.
`That's the minimal thing we can do. It tells people, "Pay attention to me. Here's what's going to happen to you
`unless you take the following preventive action."
`
`At the next level, I think what we need to do is build very, very vivid memorable inputs. I was very pleased that
`the advisory committee said we need to make sure there is a picture or a video. There needs to be something
`that people retrieve. Another thing about these age cohorts, one of the things that my understanding is from my
`reading, is that if you look at the way people learn in Generation Y, it is very visual. I think that matches well.
`So I think that's an important issue.
`
`At the highest level, I think what we need is a very persuasive argument. We did some research a few years ago
`on pregnant women's use of alcohol. What we found, to our surprise, was that women who continued to drink
`during pregnancy were the ones who were more educated, not less educated. In our analysis what we found was
`that those women believed that they could control the risks by simply moderating the amount of alcohol they
`consumed. When we gave them risk messages, they counterargued them They said, well, that doesn't happen, I
`can control the risks.
`
`Our sense is that for people who are very involved in an issue, they may believe that they can control the risk
`themselves. What we have to do is persuade them, we have to counterargue their other examples and say, no, it
`really is important, for example, that you use two forms of birth control. One form is not enough. We may have
`to think about those kinds of messages.
`
`In terms of our concerns, there are many. One of the things is we're dealing with a very heterogeneous
`audience. It's heterogeneous in terms of literacy, it's heterogeneous in terms of existing knowledge, it's
`heterogenous in any number of factors. We're dealing with a single system How well can we segment, how
`well can we target, and how well can we communicate?
`
`The second concern that I have is that we're dealing with a long-term behavior and that things learned under
`one state of emotions, normal, rational emotions, those behaviors may not be engaged in when people are in a
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`different emotional state. Our learning doesn't generalize necessarily to those different states, and people may
`have conflicting motivations. I think Dr. Fishbein will talk more and more about how we have to understand all
`the relevant beliefs, not just the ones that we see, but the ones that consumers see as well.
`
`I think with that, I'll leave this, and I'll ask Dr. Fishbein to continue our trek through thalidomide. Thank you.
`
`(Applause.)
`
`DR. FISHBEIN: Good morning. I'd like to begin by thanking Steve Groft and the other organizers for inviting
`me to participate in this very important workshop, and, maybe more importantly, for recognizing the role of the
`behavioral and communication sciences in addressing what's clearly a very delicate and perplexing issue.
`
`I think what we just heard Lou talk about is kind of a traditional way oflooking at the product and information
`about the product and how this can impact on people's behavior, but I think the bottom line, unfortunately or
`fortunately, is that risk management in the context that we're dealing with it is really a question of behavioral
`change and it's a behavioral problem We're asking people to change their behavior.
`
`Yesterday, we heard quite a bit about what needs to be done or recommendations. Many panelists argued
`forcefully for the importance of education, but one of the things I'm going to try to show you today is that
`educating potential thalidomide users or the general public about the dangers of taking thalidomide during
`pregnancy, or simply telling them that what they must do in order to prevent pregnancy, is really unlikely to
`lead to behavioral change.
`
`I was asked to kind of provide an overview ofhow communications can effect behavior and behavioral change.
`It's really more of an overview of what do we know about factors that influence behavior. What I want to do is
`to briefly go over some lessons I think we've learned from behavioral science theory and research. Let me just
`go through a series of five lessons that I think are important.
`
`I think the first thing that we've learned is that we can change behaviors. We can change behaviors that many
`people felt were difficult, if not impossible, to change. As many of you may know, for the last five years I've
`been working in AIDS prevention and we've had to deal with some pretty difficult behaviors there, both sexual
`behavior and drug-taking behavior. There's now I think an abundant amount of evidence that well-designed,
`theoretically-based interventions or messages, or a combination of interventions and messages can, in fact,
`produce significant behavior change.
`
`There was a recent OMAR conference, a consensus development conference, on the effectiveness of behavioral
`interventions to produce behavior change in AIDS prevention that basically concluded that the evidence was
`now there that we can, in fact, produce behavior change. I think that's important to recognize, that even difficult
`behaviors can be changed if we know what we're doing.
`
`The second lesson that we've learned is that information in and of itself can, in fact, produce behavior change.
`We've been told many times that information in and of itself was insufficient. What the behavioral sciences has
`to offer in this arena is really an understanding of the kinds of information that's necessary to produce behavior
`change.
`
`As I mentioned earlier, knowledge about a disease and how it's spread, or knowledge about a drug and its
`potential dangers, in and of itself is insufficient to produce behavior change. Simply telling somebody that they
`must use condoms all the time if they're a male, or that they should use a minimum of at least two contraceptive
`techniques if they're a female, isn't enough to produce behavior change. Again, what the behavioral sciences
`and what the behavioral science theory has to offer is an understanding of the kinds of information that are
`necessary to provide to the public or to a person in order to get them to change their behavior.
`
`The third lesson that we've learned is that the most effective interventions will be those directed at specific
`behaviors, not at behavioral categories or goals. What I mean by that, let me use a simple example. Ifl try to
`convince people that they should lose weight, weight loss isn't a behavior, it's an outcome of performing a
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`behavior. There are many different factors that are going to influence whether or not a person loses weight.
`Two people who follow exactly the same regime may wind up one of them losing a lot of weight, and the other
`not, because of metabolic factors. So simply trying to get somebody to increase their intentions to lose weight is
`no guarantee that they'll lose it.
`
`In the same way, preventing pregnancy is not a behavior. It's the outcome of a number of behaviors. So trying
`to convince people that they should prevent pregnancy isn't necessarily going to lead to some positive outcome.
`
`Well, if we're not going to try to get people to lose weight, what should we get them to do? Most people say
`you could have them diet or exercise. But dieting and exercising aren't behaviors either. They're categories of
`behavior. What I mean by dieting isn't necessarily what you mean by dieting, and what I mean by exercise isn't
`necessarily what you mean by exercise, so when we tell people that they should diet or exercise, we're not
`really giving them a very clear message.
`
`So "practice contraception" doesn't give you a very clear message. We're going to need to say something more
`specific. The more we get down to particular behaviors -- always use a condom every time you have vaginal
`intercourse with your spouse or with some other person --then we may start having some impact on behavior.
`
`Intentions to perform specific behaviors will tend to influence the likelihood that those behaviors will be
`performed. Intentions to reach goals or to engage in behavioral categories may or may not have any impact on
`specific behaviors. So, again, one of the lessons that we've really learned is that when we're developing
`interventions or messages, we've got to identify a particular behavior or set of behaviors that we want changed,
`and then worry about what kinds of information do we have to provide in order to produce that behavioral
`change.
`
`The next lesson we've learned, and perhaps the most important one, is despite the fact that behavior is very
`complex, and all of us can think oflots and lots and lots of variables that may influence behavior, there's a
`general consensus that's starting to be reached, at least in the behavioral sciences, that there really are only a
`limited number of variables that need to be considered in attempts to influence or maintain behaviors. Let me
`just try to briefly and quickly go through what those variables are.
`
`As I mentioned before, one of the things that we've found out is probably the best predictor of what people are
`going to do in the future is what they've done in the past, but we can't change past behavior.
`
`The next best single predictor, and sometimes it's even better than past behavior, are people's intentions or
`commitment to engage in a behavior. If someone commits or really says it's very likely that I'm going to do
`this, the chances are pretty good that they will in fact do it. It's not a perfect predictor, but it's there.
`
`But in order to perform a behavior you have to have necessary skills. You have to have the ability to actually
`carry it out. One of the things in this new area that many of you will be getting into is that if in fact you're
`recommending to men that they should consistently and correctly use condoms all the time, there is an ability
`factor.
`
`People don't always use condoms correctly. In fact, some 75 percent of condom users have used condoms
`incorrectly at least once, and by incorrectly, it has to do with when they put it on, when they take it off, how
`they put it on, whether they remember to leave a reservoir at the tip. There is a whole set of abilities related to
`proper condom use, as opposed to consistent condom use. All too often we neglect the skills.
`
`Another factor that we need to take into account is, is there anything out there in the environment that's actually
`preventing this behavior from occurring? Are there environmental constraints? I draw on AIDS issues because
`that's where I've been working for the last five years, but clearly, if condoms aren't available, you can't use
`them. It doesn't matter how strong your intentions are and how well you know about how to put them on. If
`they're not out there, if you don't have access to certain services, facilities, and skills, you can't carry out
`intentions that involve the utilization of those skills.
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`These are three important variables. The other three are more psychosocial, I suppose, and they have to do with
`attitudes. These are attitudes towards performing a behavior. Lou is talking about the attitudes or perceptions
`toward the product itself, but these have to do with attitudes towards using the product.
`
`In terms of risk management, it's attitudes towards carrying out or conducting the behavior that you want
`people to engage in. So the feeling that it's good or bad to always use condoms every time I have vaginal sex
`with my main partner, or to always use two contraceptive methods when I'm engaging in vaginal sex.
`
`The norms have to do with perceptions about what others think one should or shouldn't do. One of the factors
`that is going to influence the likelihood that I engage in a behavior is my perception of what others expect me
`to do as well as my perception of what others are doing. I'll come back to this.
`
`Then the final variable that seems to be very important in influencing behavior and behavior change is the
`notion of self-agency or self-efficacy. People are unlikely to engage in behaviors that they don't believe they
`really can do. So it's a perception that I have the necessary skills and abilities. Unlike the skills and abilities at
`the top, which really have to do with whether you know what to do, this has to do with your perception. If you
`don't perceive that you're capable of carrying out a certain behavior, you're very unlikely to try to carry out that
`behavior. If you try to do something and it doesn't succeed, you're very likely to just give up. On the other hand,
`if you believe you can do something, even if you fail the first time, you may continue to persist.
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`Let me try to make some sense. I've also talked about the fact that attitudes, this feeling that performing this
`behavior is good or bad, are based on underlying behavior or beliefs. That is, my beliefs that if I perform this
`behavior, certain outcomes will occur. The more I believe good outcomes will occur, the less I believe bad
`outcomes will occur, the more I think performing this behavior is a good thing.
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`For norms, it's beliefs about what specific others think I should or shouldn't do, or what specific others are
`doing. Self-efficacy has to do with my perception of barriers to carrying out a behavior.
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`Let me try to just summarize this and talk about a general model of behavior and behavior change. What the
`model is suggesting is that there really are three variables that are critical in determining whether or not a
`person will perform some specific behavior: skills, the intention or commitment to do it, and environmental
`constraints. What this is really saying is given that a person has the intention to perform some behavior, they
`are likely to perform it as long as they have the skills available and there are no environmental constraints.
`
`Clearly, what this suggests is that the kinds of messages or interventions that are going to be necessary to
`produce behavior change-- to get women to always use contraceptives, to get men to always use condoms-(cid:173)
`are going to be very different if they haven't yet formed an intention to do this, if they haven't made a
`commitment to engage in this behavior, than if they've made the commitment but either don't have the skills or
`there's something out there preventing them from doing it. What this is really saying is we need very different
`interventions, and probably very different messages, depending upon where people are in terms of their
`commitment to engage in some course of action.
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`If they haven't made a commitment, then the likelihood of forming or making this commitment is going to
`depend on one of three factors: their attitudes, their perception of the norms, and their self-efficacy, which I
`described. One of the things that is important to recognize is that the relative importance of these three factors
`will vary as a function of both the behavior you're considering and the population you're considering. That is,
`for a given behavior, attitudes may be more important than norms, while for some other behavior self-efficacy
`may be what really influences intention.
`
`So we need to figure out which of these is the predominating factor. For the same behavior, it may be
`attitudinally influenced in one population, but normatively influenced in another. So again, we need to do our
`homework. You just don't put out a message and expect it to have an effect on behavior change. What we need
`to do is figure out whether the behavior we want, in fact, people intend to do it or not. If they don't intend to do
`it, then is their intention due to their attitudes, their norms, or their self-efficacy?
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`But saying I want to make somebody more favorable to performing a behavior isn't enough. We have to know
`where that attitude comes from, and that's talking about underlying beliefs and their valuative aspects, or
`normative beliefs and motivations to comply with the norms, and these efficacy beliefs about barriers. That is,
`is it more difficult to do it under some circumstances than others?
`
`I'm going through this very quickly because I'm trying to give you an overview, but what I hope I'm getting
`across is that behavior change is complex. Designing effective behavior change messages is no easier than
`developing vaccines. You don't just throw together a message, just as you don't throw together a vaccine or
`some other drug. You need to test it, you need to evaluate it, you need to quantify it, and you n