No industry in America faces more trying public relations issues than the pharmaceutical industry. For more than a decade, pressure has been mounting on pharmaceutical pricing, coupled with questions about the ethics of pharmaceutical marketing.
The debate reached new levels of intensity last year, when Merck & Company pulled its blockbuster Vioxx off the market amid charges that the company had deliberately and knowingly marketed an unsafe product.
With the reputation of the pharmaceutical industry at an all-time low, The Holmes Report invited several experts from the healthcare public relations business to discuss the problem and offer solutions. Participants in the discussion included:
• Michael Kuczkowski, senior vice president in the healthcare practice at Edelman;
• JeanAnn Morgan, managing director and deputy chair of the U.S. healthcare practice at Burson-Marsteller;
• Paul Oestreicher, director of the U.S. health and pharma practice at Hill & Knowlton;
• Peter Pitts, senior vice president of global health public affairs at Manning Selvage & Lee;
• Laura Schoen, president of global healthcare at Weber Shandwick Worldwide;
• Kristen Spensieri, head of the brandtectonics division of Chandler Chicco Agency; and
• Paul Holmes, editor of The Holmes Report.
The discussion took place at the New York offices of Manning Selvage & Lee. The following transcript has been edited for length and clarity, and to make my questions sound more intelligent than they actually were.
Paul Holmes: By any objective measure, the pharmaceutical industry contributes more to society than almost any other industry I can think of. So an obvious first question is, why do people hate pharmaceutical companies so much?
Peter Pitts: I think you have kind of a perfect storm. If you ask when people started hating pharmaceutical companies, I think it’s a relatively recent phenomenon. In the recent 2003 election cycle I think some people were looking for issues that would inflame people’s emotions and one of those things was drug re-importation, and people want to know why drug prices are so high. You have an ageing population, you have an activist AARP, you have Medicare reform, and then you have consumer advertising that inflames people’s passions. The reason it came to the boil was the ineptitude of industry in recognizing the problem and then dealing with it. The industry can point to a whole series of pyrrhic victories, including Medicare modernization. It did some aggressive lobbying and it won, but it left people with an extraordinarily bad taste in their mouths. And then course there was Vioxx, and the whole issue of drug safety and the whole issue of the industry not being open and transparent.
Laura Schoen: I think there are certain things in western civilization that are embedded in principles and I think part of that heritage is the right of access to healthcare in developed economies. People think that part of what you get for being American is access to all the science and technology that can keep you alive. And when the price blocks a sizeable percentage of the population from having access, people equate that almost with murder and there is all this outrage. There is no sense that in a capitalist system you have to pay, that there are different levels of access. I think that works with cars and apartments but not with healthcare.
JeanAnn Morgan: People feel that healthcare is their right. And in large part the pharmaceutical industry is sometimes seen as profiting from people’s misfortune. People need these drugs and are outraged that they have to pay for them, as opposed to valuing the benefits these drugs are providing them.
Paul Oestreicher: There is some element of the industry being a victim of its own success. There have been so many developments in technology, cures and life-enhancing treatments. The problem associated with that is the good stories have been moved into the business pages. It’s difficult to find good positive stories elsewhere.
Kristen Spensieri: The challenge is value, and how to communicate value in a complex, ever-shifting landscape. We’re industry people and we can barely keep up with the issues that surface every day. How is a consumer, who has just been diagnosed with a potentially life-threatening disease going to interpret what is being covered in a medical journal about drug counterfeiting when they are focused on what’s happening that’s relevant to their disease?
PP: The speed of acceleration of discoveries raises expectations. In 1959 when the polio vaccine was discovered, if you asked people how much would they pay for that they would say, “Anything.” Today, these miracles are not miracles any more and people expect them. And when they say drugs are too expensive and you ask them how much should they be they say. “They should be free.” There’s no 20 percent less or 50 percent less, they should be free. People feel they have a basic human right to get these drugs. How do you serve that right in a market-based economy?
KS: I think communication needs to be personal. To the person who’s just been diagnosed, innovation is only as meaningful as it is personal to them. We have to take the stories from the business pages to them in a way that’s relevant and palatable. And I think the industry is trying to do that.
Michael Kuczkowski: I think the dramatic decline of the industry’s reputation began in 1997 when co-pays and people out-of-pocket spending on medicines began to soar. I think it started when people had to start paying for these medicines, and a lot of them were baby boomers who needed a lot more medicines.
PO: I don’t think there are any wrong answers at all around the table so far. But I think we can probably trace it back even further, to the mid 80s and HIV/AIDS.
PH: Burroughs Wellcome and AZT was the first time I saw this incredible outrage and the response from the company was essentially, “We’re making a product that saves your life, why are you criticizing us?” And the answer was, because it costs $1,000 a pop…
PO: $10,000 a year was the first price for AZT. I think what AIDS activists did was pull us into a whole new era of direct-to-patient communication, which has been on the whole a good thing, but it started a chain of events that led to demand for access, and access means access to information, access to funding, access to input into the research protocols.
PP: It’s been difficult for pharma to think three dimensionally. Because the initial answer was if you can’t afford these drugs then we can’t afford to develop them. That may be true, but it’s the wrong answer. Ten years later, the answer is now, “If you can’t afford it, we’ll help you.” Where was that answer when it might have stemmed the tide of a lot of these problems.
PH: About the same time the AZT scandal came around, I was reading a book called We’re So Big and Powerful Nothing Bad Can Happen to Us, and one of the premises of the book was that crisis prone companies are companies that become insular and stop identifying with their external stakeholders. And the pharmaceutical industry was an example, a group of people who spend their lives doing good and so when they are criticized their automatic assumption is that their critics are trying to destroy something good, so why should we listen to them? Is there still that kind of insularity, or lack of empathy, or even arrogance within the industry?
LS: I don’t think the pharmaceutical industry ever had a good image. What changed in the 70s and the 80s with AIDS was that their business became scrutinized by the public. But prior to that they were like chemical companies. They didn’t talk to patients. They talked a little bit to doctors. But the mentality was like chemistry.
PP: And the heads of the companies were scientists.
LS: They never worried about communications or issues management or anything like that. So when things changed and there was an empowered patient it caught them completely unsurprised. They were huge companies that were set in their ways and had made no provision for dealing with those kinds of crises.
KS: And companies that had established themselves on the brand or product level, not on the therapeutic or corporate level. They were driven by brand marketing, not by a focus on disease categories or any of those broader issues.
JM: The roots of this industry are in science. The people in this industry are scientists, who get into the business because they want to do good, they want to make drugs that are going to help people. I don’t believe there’s arrogance; I think it was a sense of being caught. Look at how informed we have made our public. Now what do we do?
PP: When scientists ran drug companies they way they dealt with the outside world was very binary. When people said something, they said yes, no, wrong, right. But as business people took over the public’s anger at these binary answers was so great people started screaming. And when people start screaming at you, you either shut them out or you scream back. It’s very hard to embrace people and have a conversation with them when they are screaming at you.
PO: I think the reaction to events is generally good. But we are in this cycle of episode-reaction, episode-reaction, and the attitude of people is that those reactions are too little, too late. There’s a lack of leadership and initiative. We have not seen the industry pick up the leadership mantle in a timely fashion or in a way that matters to the public. So AARP issues a report on pricing and industry is left scrambling to explain. Or the publication of research trials in an Internet database—again, a good plan but a reaction to someone else’s criticism.
KS: Do you think the industry is really learning?
JM: I think so. I think what we’re seeing in this pharma-frenzied culture is a shift toward motivating dialogue, and I think companies—like every industry—look at themselves and ask what they have learned from their own history and how they can move forward. I think they are learning. It’s no longer just speaking at our audiences; it’s speaking with our audiences.
PH: Ten or 15 years ago PhRMA launched its first big image advertising campaign after the Clinton healthcare reform bill, and the message was almost entirely around innovation. Now Merck is launching a new ad campaign, and again the ads I have seen look at innovation. But it seems to me that message is an answer to a question nobody asked. I don’t hear anybody saying we hate the pharmaceutical industry because it’s not innovating enough. The criticisms are about price and access, not innovation.
PP: The problem is that the industry is speaking with two voices. On the one hand, the CEO says the right things. He says we’re selling too broadly. He says we’re advertising too heavily. He says the right things the people in Congress want to hear, the pundits want to hear. They’ve identified the core issues, the rot at the middle. But five floors below there’s a brand manager who has to sell a certain number of SKUs before the end of the quarter, and that brand manager is going to be as aggressive as he can to meet that goal, and the tactics that takes from a DTC advertising standpoint are completely contradictory to the direction the CEO wants to lead the company.
LS: I agree with that.
JM: I’m not so sure. I see my clients really wanting to do the right thing. I see them really frustrated at negative headlines about the industry. I don’t think the line marketing manager is acting contrary to what is being said in the C-suite.
KS: Still the industry is wrapped around the issue of innovation. And when it comes to starting dialogue, innovation is only useful as our ability to communicate to people what that means to them. I think a lot of people assume the industry is innovative but they don’t know how that’s meaningful to them.
MK: A lot of people don’t think the industry is innovative. They think the government discovers all the medicines. But that speaks to a problem for the industry. It wants to argue on the facts on whatever the issue is—innovation or cost, the fact that pharmaceutical costs are only 10 percent of the healthcare dollar. That doesn’t help when people are angry, and when people who have insurance who are now paying five or ten times what they thought they would be paying at this point in their lives. These are the industry’s core customers. They are going to be taking more medicines as they get older. The industry has to figure out some way to respond to those customers.
JM: So the argument can’t be a rational one; it needs to be an emotional one?
MK: I think it’s both.
JM: Well we have the rational one…
MK: We have the rational one. There are armies of people out there who can make the rational case for the industry. The industry needs to make the emotional case.
PO: We can’t tell the audience what we want to tell them. We have to understand what the audience needs to hear. Those two things are not mutually exclusive, of course. But it concerns me we are focusing too much on one message. This is a complex industry and a complex environment and we have to think about several messages.
LS: So let’s go back. You have these pharmaceutical companies that were not quite chemical companies but they didn’t see why they had to communicate with anybody. Then they wake up in the 80s with all kinds of controversies and they have this rude awakening. And so they decide, “We’re going to learn from Nabisco and the car companies and do it just like them and promote how great everything is and make people feel that every drug they see is good for them and they should be taking it.” But people take drugs because something is wrong with them, because they have a health problem. So people need to understand that there is an inherent risk in everything they take, even an over-the-counter product. But you take them because you need them, because the consequences of not treating yourself are far worse than the potential side-effects. We have lost all the risk-benefit thinking in communication, nobody talks about it, because we went from silence to selling drugs like M&Ms.
PO: In this time when we need to be rebuilding credibility, we need to be communicating a little bit more serious tone. It doesn’t help our case when we try to communicate healthcare messages through animated characters and other popular vehicles.
LS: Going back to Paul’s question, nobody is questioning innovation—although that argument could be made, because a lot of innovation comes from buying drugs developed by small biotech companies. But forget about that, because they public is not interested. The public is questioning the right to access. The public is questioning ethics. Is it ethical to charge $100,000 for a cancer drug? And we are coming up with, “We’re innovative.”
PH: Let’s talk about Vioxx. I’m one of those people who thinks that Vioxx should not have been pulled off the market. Because I think for people who genuinely needed Vioxx it was an incredibly helpful drug and the risk-benefit equation made sense. The problem was that it was also being used by people who didn’t need it. They needed a pain killer and they thought Vioxx was just a better, stronger Advil. But at the very least, pharmaceutical companies have done nothing to discourage that kind of casual use, and in some cases the companies have encouraged it.
LS: I find there is a dichotomy, as Peter said. The people who are in charge of a company’s long-term best interest are not the people who are creating these PR and advertising campaigns. It is not in Pfizer’s best interest or Merck’s best interest to boost the sales of one drug for a single year and then have a debacle like this.
PH: But if you’re the CEO, you can’t claim you have all these maverick marketing directors working for you and you’re powerless to rein them in. You’re the CEO!
LS: But do you think the CEO sees every campaign and every ad?
PP: The CEO is responsible to the board of directors and when the CEO gets the call from Wall Street saying, “We’re putting a buy-plus next to your name because you’re sales look great,” how easy is it for the CEO to say, “You know, we’re selling too much of this stuff.” Vioxx is a very good example, because Vioxx was approved by the FDA and it was safe and effective, but the opportunity for Merck was to create a blockbuster, rather than having a good solid drug.
KS: But I don’t think companies are going to be able to talk about one-off blockbusters any more because I don’t think the science is moving in that direction. That’s why companies are going to need more integrated company, therapeutic and product messaging. The game is going to have to change.
PP: When you ask people outside the industry what is a blockbuster, they say it’s a drug that does something really fabulous. [LAUGHTER.]
MK: Fabulous sales.
PO: What Vioxx did was completely reframe the risk-benefit equation. In response to that we have all the key stakeholders demanding more information. The pendulum has swung to the point where there is a danger of over-communicating. If you think there’s an information glut now, just wait. We’re going to have a very difficult time sorting through what’s important and what people need to pay attention to.
PP: That could be a healthy thing, though.
PO: I’m not saying it’s not healthy. But we need new mechanisms on how we are going to sort through all the information.
PH: The point is, you can’t just dump data on people without giving them the context they need to understand it. But it’s not beyond the savvy of the industry to provide that context, right?
MK: I think in large part we have to recognize that people have not wanted to pay attention to a lot of the information we have been putting out…
PP: Because they want to think it’s 100 percent safe.
MK: Right. And DTC advertising has not contradicted that. It hasn’t been saying, “Hey, big risk.” Risk communications people in an organization are the anti-sales department. So when you look at the disagreement among people who know more about the science than I do, it begins to get disorienting and people don’t like that. Doctors don’t even like it. So I think there’s going to be a big change in how we talk about risk, but I actually do think that over time… I like it better when people tell me the truth, even if it’s about a complex topic that I don’t fully understand.
LS: I think if you look at one of the recent discussions about safety and efficacy, it has not always been a service to the public. If you focus on anti-depressants, they have revolutionized the lives of people with mental illness. What was the life of someone with depression like before the 80s, before Prozac? Being institutionalized, being unable to function…
PO: Being sedated.
LS: Exactly. But then you have this miscommunication that anti-depressants are good for everyone from babies to grandmothers, that everyone should be on anti-depressants…
PH: You saw the same thing in the obesity arena with fen-phen. Valuable drugs for people who were genuinely obese, but they….
LS: But those drugs didn’t revolutionize care, and anti-depressants did.
PH: But it happens across a wide range of therapies. Have we rapidly redefined the term “erectile dysfunction” so that every man in America is suffering from it? Because every man in America is the target of those consumer ads. This is a drug that was designed to deal with what marketers told us was a serious medical condition, but now it seems it’s for everyone who wants to have good sex.
PP: One of the things that changed between making chemicals and selling pharmaceuticals was, you had these chemical companies that made products that were regulated and they were sold through various mechanisms. And then they were allowed to advertise, and it was like giving a teenager a Maserati. They wanted to drive it as fast as they could, but they didn’t know how to do that so they went out and hired people from the consumer goods industry and they taught they how to do it. But what happened is you took an industry that sold a certain way, because they were different. Healthcare is different.
JM: To add to that, I think it’s been about branding when it should be more about bonding, when you’re talking about something as personal as healthcare. It should be about trust. Branding is fine, if it’s done in a way that is creating bonds with the end user, who integrates that message into his or her lifestyle for a healthy outcome. We have to make that shift from a branding approach to a bonding approach.
MK: The Viagra story, which is easy to throw darts at, at the end of the day it got people to go in and talk to their doctors, which is something we want people to do. And many of those people have things like hypertension or high blood pressure and maybe they would not have been diagnosed and treated without those ads.
PO: I think Paul’s point is right, that all drugs are not for everyone and the message needs to be more personalized, and more targeted and in some cases more private. And I think we’re seeing things move in that direction and we’re seeing the web being used in different ways.
JM: On some level it feels like “back to the future” when I look at what Pfizer is doing with no DTC advertising until six months after a drug is launched, so the company has the opportunity to educate physicians. If you go back to the history of these companies, the sales rep was the scientist, who was hired to help the physician understand the science, so it was more of a peer-to-peer exchange.
LS: One of the questions I have is, while I don’t think there’s anything wrong with lifestyle drugs like Viagra, the question is should Medicare pay for it?
PP: ED is just one example. The question is whether ED is a condition that should result in a blockbuster drug?
LS: I don’t think pharmaceutical companies should be condemned for producing these drugs.
KS: But the question is, who is this therapy applicable for? Healthcare communication has to be targeted, it has to be local, it has to be about risk-benefit, and it has to be meaningful to the target audience at the time. You don’t think about ED until you hear about it or you have it.
PO: Who pays is one fundamental question, and access is another. We have to figure out in our society, when the consumer is taking a greater role and greater responsibility for making healthcare decisions and paying for them, the appropriate ways to communicate and market in that new environment.
JM: When someone comes out of a hospital and they have just had cardiovascular surgery that cost hundreds of thousands of dollars, and they are outraged at what they are paying for drugs.
PO: How many times have you been to the pharmacy and the person in front of you is ranging at the pharmacist, and then what happens is the pharmacist agrees?
LS: Let me be a provocateur here. What about the fact that 60 percent of patients who are prescribed a drug do not take it any longer after three months? What about all this money we are spending on late-stage disease that could have been prevented if people took their pills as prescribed? A huge cost s late-stage disorders, and in our culture nobody wants to die and we have to keep them alive at any cost.
KS: But once again, are we providing the tools that people really need?
LS: There are two sides to the coin here. If you give patients the straight story, the straight story means they have some responsibility as well.
PH: Innovation is easy to talk about in an ad, because you find an adorable child whose alive today because of one of your medications, or someone’s grandmother who can still get around because of a miracle treatment, and those are wonderful images. But it seems to me that the answers we’re talking about all require a much more serious discussion, a national dialogue about what kind of healthcare system we want, what kind of trade-offs we’re prepared to make as a society. You can’t do that through advertising, but you can do it through public relations, and the pharmaceutical industry could be leading that dialogue.
PP: Miles White [chairman and CEO of Abbott Laboratories] had an op-ed in The Wall Street Journal a few months ago that said exactly that. He said we have some tough decisions to make about our future. To your point, for the pharmaceutical industry to enhance its image, to stop being demonized, part of the answer is to acknowledge that some of the criticism is appropriate, but that there are also tough answers to some of the questions like, “Are drugs too expensive?” The answer should be, “No, drugs are not too expensive. And Americans are not taking too many drugs; they’re not taking enough drugs.” They may be the wrong drugs, but that’s another issue. That may not be what people want to hear, but there are some tough truths out there that we have to discuss.
LS: I have said at pharmaceutical conferences that I do not understand why two or three of my clients have not joined forces to do a major public awareness campaign around the importance of compliance. That would be much more meaningful that the kind of ads you’re talking about, with children running around.
KS: Those kind of serious discussions are a place the industry is only just starting to go.
PP: Or just getting back to.
KS: But that hasn’t been the known.
PP: If you talk about quarterly goals and market share and sales quotas you are defining yourself as a marketing organization and not a healthcare organization and that is a shift that all pharmaceutical companies from top to bottom have made.
JM: I think the industry can help to facilitate this dialogue, but this is a societal issue. We talk about healthcare, but we really don’t practice healthcare, we practice sick care. Until we as a society acknowledge that we are not following a real healthcare model, that we continue to eat foods that are bad for us and smoke cigarettes and do all those nasty things that we all do, we can’t really address this issue.
PH: But society can’t lead a debate, and politicians have no interest in addressing difficult issues or forcing people to make difficult choices, so if industry doesn’t lead, who will?
JM: But it’s not just an industry thing. Industry can take the lead, but we as society have to take a look at ourselves and not just blame the industry. We’re all enabling this behavior.
PP: When you read The New York Times or listen to a politician giving a stump speech, the answer is always easy. It’s drugs from Canada. If we could just get drugs from Canada, everything would be perfect, because it’s all about price. That doesn’t help us have a serious dialogue and it doesn’t help pharma lead a dialogue, because the industry is defending its flank.
PO: I agree that it’s important for industry to re-examine the business it’s: drug research, drug development, healthcare, or whatever. But I also want to make sure the right expectations are being set. I don’t think the industry should have the entire burden of solving the healthcare crisis. We don’t expect the automobile industry to solve the transportation crisis, or the food industry to solve the obesity issue. We have to agree, as a society, that we are all in it together.
PP: The problem is that people who are in this with are more than happy to sit back and let the industry do the hard work. The price of co-pays has gone up four times the price of drugs, but when you tell people that they want to know why, and I always tell them, “Well, ask the insurance companies.” But the insurance companies have managed to get away with just a shrug, and the pharmaceutical industry bears the burden.
PH: But if the pharmaceutical industry is getting the blame, then the industry has to respond. It can’t just sit around and complain about how unfair it is. And I still think the industry has to get its own house in order before anyone is going to listen to those complaints.
PP: Industry is trying to say all the right things, but then it does something that undermines what it’s trying to say. I’m thinking specifically of certain kinds of advertising. I get up early and watch my wife watch the Today Show and she wants to know how much all these ads cost. And they cost a lot. And when people see that, it seems to be in conflict with what you’re saying you believe in as a company.
LS: But the ads are not bad. I think DTC communication is good. Because in markets where you cannot do that, patients get much worse care. They get the third-class drugs, because they don’t know what to ask for. But the goal should be to raise awareness and drive patients to their physicians. The goal should not be to force-feed the name of a drug to the point that people think that’s their salvation.
KS: People don’t get this information in isolation. They get it with popular culture messages and world event messages, and they have to take it in along with everything else they get.
LS: But just like doctors have the Hippocratic oath, a code of conduct, I think everyone who works in healthcare should have an equivalent code of conduct. What we do is different from selling cars. In our case we are dealing with matters of life and death and the public has a right to ask of all of us—including PR people—that if we see something that we know is not scientifically accurate or inappropriate communications, we say something.
PP: I think the broader question is, when someone reports something negative about one of our products we are very quick to make the call and demand the correction. How quick are we when they are overly effusive about something?
JM: Healthcare advertising is still in its infancy. Everyone around this table remembers the day when the first ad went out there. In fairness, it’s not a perfect industry, but it is an industry that is learning and trying to recalibrate as it goes and one example of that is the new 15 principles and PhRMA recently released, that speak to some of the issues we are talking about today.
KS: There is a need to collectively communicate about Share Cards and clinical trial registries and patient education, things that the industry has historically done but have been more of an afterthought in terms of our communications.
PO: The intent is good. I’ve worked inside the industry. I can vouch for that. And the guidelines are well intended, I think. But they read to me like a nice list of options that you can maybe agree with some not all. There’s a lot of “shoulds.” How many times does the word “should” appear in the guidelines, rather than “will” or “must.”
PP: It’s a trade association and it so there’s always that kind of language. I think it’s up to the individual company to say, “We will.” And Pfizer has said, “We will.”
JM: And Bristol-Myers Squibb has said, “We will.”
PP: But I think there are a lot of people who still think we are not in that big a mess, and that if we just hunker down it will go away. If we just close our eyes a little tighter, it will go away. It will be interesting to see 18 months from now who still adheres to those guidelines, particularly the one about reminder ads. Because in February, if someone says my competition has stopped doing reminder ads, so let’s swoop down and do a reminder ad and capture market share.
KS: But that’s where a company has to stand on its record. We will see things like that. But if the C-suite is saying it believes in certain principles and individual marketing directors are acting in ways that are at odds with that, then that’s a test for the company.
PH: But one of the interesting things about the pharmaceutical industry is that consumers are unlikely, it seems to me, to punish that kind of behavior. Because no patient is going to boycott a company’s drugs because it’s marketing practices are too aggressive. First of all, patients typically don’t know who makes what; and second of all, if a company makes the best drug for a particular illness, patients are not going to deprive themselves of that drug just to make a point.
KS: There are companies that are setting guidelines and taking leadership—the Pfizer guidelines or the Eli Lilly clinical trial registry—and these are things consumers and physicians need to see.
LS: If companies don’t do it, somebody is going to come and regulate all of them and create a price control mechanism that is detrimental to everyone. So the companies have to take that leadership and self-regulate.
KS: And physicians know companies.
LS: That’s a good point.
MK: Look at what’s happening at the state level, where attorneys general are taking companies to court over DTC advertising and marketing practices as a way of examining Medicaid fraud.
KS: But the industry also has to respond with platforms and initiatives that are beyond the product level. They have to come from the corporate level, not the brand level, because that’s the level that resonates with consumers.
PO: We have to have industry-wide initiatives and we have to have individual corporate initiatives if we want to change perceptions.
LS: I do think that corporate reputation matters. We may never see price controls on drugs here in the United States, but I already see and I’m sure most of you already see negative repercussions off the bad image of the pharmaceutical companies. It’s becoming harder and harder to get doctors to agree to participate in campaigns. It’s becoming harder and harder for the pharmaceutical companies to hire good people. The management of their business is going to become every day more challenging if they don’t get it right.
PH: Let’s focus for a minute on safety issues and particularly around transparency on safety issues, because another aspect of the Vioxx case that disturbed a lot of people was the belief that Merck had conducted trials that suggested an increased risk of heart disease and had not shared those results with patients and physicians.
PP: Safety is a relative concept. Prior to Vioxx, people assumed that drugs were safe.
PH: They’d never heard of thalidomide?
PP: That was a long time ago, and thalidomide was never approved for use in this country; it was a problem in Great Britain. I think if anything good comes out of Vioxx it will be that people understand that drugs have risks and they should know more about those risks. Then the question is how we accomplish that. Can you sell a product just as well, or even better, by talking about what the risks are.
PO: The risk equation has been reformulated because of Vioxx but I think the changes go back ever further. When the first few HIV drugs were approved, people just wanted them expedited, you had patient organizations lobbying. They were dying, they need access, they need to save their own lives. But the next generation faced a different hurdle because there was not the sense of urgency any longer. My point it that risk is a moving target.
PP: I don’t think the industry has accepted the need to communicate risk differently.
PO: But my point is that people accept different levels of risk.
LS: I think we do need to talk about risk more clearly, but I don’t know who is doing it, because it’s a little bit of a thankless task. It’s never a black and white situation. Someone has to explain to the public that when a drug is approved by the FDA, a certain number of people got tested, and statistically speaking you think you understand the potential adverse effects, but you don’t know for sure until you expand by tens of thousands the number of people taking the product. Somebody needs to explain that to the public. With a new drug, there is always a little bit more of a risk.
KS: This is where corporate reputation matters.
LS: The media is not going it. The industry wants scandals.
PH: But the issue was not that Vioxx wasn’t safe. I mean we all know that drugs have side-effects. The problem was that Merck had not shared that information. The issue is transparency.
MK: Who knew what when?
LS: There have to be guidelines. It can’t be up to the individual company. There should be clear, enforceable guidelines so everyone is in the same situation.
PP: Think about something like the brief summary. You open up the magazine and there’s an ad for a product, and then on the flip page there’s the brief summary, which is neither brief nor summary. Companies love the brief summary because it provides tremendous legal security. Everything is there. But nobody reads it. If you want to really communicate risk information, you have to understand how people internalize risk information. And the answer is, people don’t want to. If you had more strident comments, on the ad rather than on the flip-side—say the five greatest risks of this drug—I think people would have greater trust in that drug because at least you’re being upfront.
LS: The most wasted opportunity is the product information, the PI. Does anyone ever read that stuff? No, because it’s not meant to be read.
PP: Let’s say you take a drug and your ear falls off, and the company points out that the PI lists “skin peels off” as one of the potential side-effects. Your first question is, “Who can I sue?”
JM: You can’t have this discussion without some acknowledgement of the issue of tort reform. We live in an incredibly litigious society, so how do we reconcile that.
PH: But the warnings are absurd right now. The print is too small. I think if a company wants to defend itself in that kind of case, it ought to be able to prove that it presented the health warnings in a way that 80 percent of its consumers read and understood them before they used the product. The company should be responsible for communicate the health risks clearly and not be able to hide behind a label that is designed in a way that nobody reads it. If you can’t find a way to communicate the warnings that clearly, you have no business marketing drugs.
PP: But the problem is that the way drug makers communicate risk is the way they are required to by law.
MK: The regulators have to be part of that discussion.
PP: A lot of companies have done research about how to communicate risk, but they can’t implement it because of the FDA. The FDA is great on science, but they are bad at social science. That’s a big problem.
KS: But isn’t the answer to all these issues the same from a communications perspective? If you don’t give people context, and you don’t provide it in a medium that’s relevant to them, you haven’t done your job. This is an incredibly complex industry to navigate in every day and we have to provide context to all this information.
LS: But the problem with that is the media is so biased that you can’t have an honest debate without paid advertising, controlled media.
JM: I agree that the media are after the headline and the scandal and the story du jour. But I think that if we as an industry could engage the media more regularly, not just when we have a new launch but in an ongoing dialogue, that’s an opportunity to build trust. The time to hope for a reporter to cover your side of a story is not when he has the story. You have to develop a relationship that makes them want to believe you because you’ve been transparent all along. That’s happening, but it needs to happen more frequently.