Pain management presents a unique educational opportunity for pharmaceutical marketers and their health care advertising agencies. Risk management mandates, doctor and patient communication gaps, and aging brands can present challenges for pharmaceutical companies within the pain market, but an experienced advertising agency partner can help clients tackle daunting obstacles and restore confidence in brands. In the area of pain, Commonhealth has tackled doctor and patient communications; Dudnyk has worked with clients on launches and line extensions for clients on brands like Lidoderm, Percocet, Zydone, Vioxx, and Arcoxia; while Palio has tackled the daunting aspect of risk minimization programs.
Feb. 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. FDA has authority to require REMS programs under the FDA Amendments Act of 2007 when necessary to ensure that the benefits of a drug outweigh the risks.
Med Ad News: What are the challenges clients and agencies are encountering with advertising and marketing pain drugs?
Jeff Kozloff: There are three key areas of tension. There’s the tension between offering that relief and incurring liability, there’s tension between dependents and control, and I think the last one is the tension between functionality and freedom from pain. Patients and caregivers are sensitive to the patients' presentation while on opiods, typically, and they take pretty strong positions against medications that proceed to knock out a patient. So, it’s that balance of functionality and freedom from pain.
The biggest challenge is really that physicians have to set expectations, because pain is somewhat nebulous at times or more of a sensory experience from the patients perspective. The physician really has to set expectations for the patient’s pain.
Joe Gattuso: It is kind of different in some ways than a lot of the other categories that we work in. If it’s a Schedule III abusable drug there’s just certain realities that you need to know, such as a doctor can’t call in some of the narcotic pain medications, the patient has to pick it up in person at the pharmacy. Very strict risk management programs and surveillance directly tied to the approval of the drug.
Barry Schmader: The two biggest areas are abuse/addiction and diversion. Both of these particularly in the opioid area have caused marketers a lot of pain and angst. They can’t use the promotional language they would like to, marketing practices are heavily scrutinized, the risk management programs are so stringent — databases are required, patient and physician registration, a lot of educational materials. It’s just a lot of hoops to go through to get your product into patients’ hands.
Dan Bobear: The communication and the educational level of pain management is really low. I would say the knowledge level isn’t what it should be especially amongst the mainstream physicians and they don’t necessarily know how to recognize certain pain syndromes or how to write for them with the proper drugs. That educational curve is a pretty large barrier. The second part of that is the communication between physician and patient and a lot of the physicians kind of blow off the patients’ severe pain because they feel like they’re doing the best that they can do and they don’t take the time to really understand the symptoms and how best to treat.
Uwe Tigor: The DEA has been clinching down on and tracking scheduled pain medications for quite some time. What we’ve experienced with our marketing partners is an increasing crackdown on prescribing opioid medications for pain patients. Physicians can feel the pinch and its by now such a common scenario that even very popular television shows like Dr. House have stigmatized the subject of cracking down on the prescribing of effective pain medications. Chronic pain management is a huge unmet need area still in the country and most people’s chronic pain are not adequately managed. Physicians have a problem assessing pain — particularly specialty pain scenarios — appropriately and then treating them. This is partially because they are scared that if they prescribe appropriately and manage their patients aggressively for their pain that they pop up on the radar screen of federal enforcement agencies and that they get in trouble. It’s very hard to argue with crackdown efforts on the federal government if you’re in practice and if your license is potentially in danger, so that is something that we encounter quite a lot.
General practitioners will encounter patients with chronic and severe pain, in medical school referred to as drug-seeking behavior, which is true because a patient in pain is seeking a remedy. This reinforces the physicians’ suspicion that the patient really only is looking for a quick fix and not appropriate treatment and also hampers efforts in getting patients appropriate pain medication. That doubled with the FDA crackdown on safety through the amendment of the FDA ruling act in 2007, has made the control of chronic pain syndrome in the last 24 months less effective than it has been before.
Med Ad News: How is the agency combating these challenges?
Joe Gattuso: There are ways to educate the doctor in better ways of communicating to screen for drug-seeking behavior and that goes beyond just advertising. We actually call this conceptual literacy. Patients don’t really understand, conceptually, the difference between acute and chronic and so when the doctor gives them medication — some of which you’re asked to take everyday as maintenance therapy and others that you’re only asked to take when the pain is spiking — that’s actually harder than we think for patients to understand. A lot of times compliance isn’t abusing the drug, its just not using it correctly. There’s a lot of things that you need to teach the doctor and the patient just to get appropriate therapy. We think some of the communication education needs to be done on an interactive basis so online, have them practice questions get answers, understand why one is better than the other with doctors.
We are trying to use some of the newer communication channels to drive deeper into some of this education. Things that are more interactive are usually more effective than just straight print.
Dan Bobear: One of the things that we’ve done really well is we’ve worked on the physician patient communication piece. What we’ve done is we have some different methodologies, one of them is called the Brand Revolution group which is a type of research. The patient and physician are in the same room and the doctor goes back behind the glass and watches. You get to observe the disconnect between the patient and physician and how they view their pain and the condition. What we do from there is we build out different messaging and approaches to the pieces and how we talk about the symptoms, pain, and treatment options and really helps us to connect the physician and the patient and to have verbiage in our pieces in our programs that connect to the real needs.
Uwe Tigor: In terms of regulatory challenges, where agencies can be most helpful is by being proactive in being compliant with what the government is putting up as new regulations, and regulatory challenges. Most of our clients have been highly sensitized, yet have very little exposure to how do the new REMS mandate. We’ve aggressively followed up on the different industry meetings and kept our channels open to consultants and FDA to figure out what they mean. When our clients came to us for advise we were able to help them with the scoping of what they have before them, but also help them with implementations of these things. Every week and every month makes a huge difference if you could cut down on timelines and become a strategic partner to your clients, that is where agencies can be most effective.
Dan Bobear: These REMS mandates cause major fear and loathing from clients. The key to this is ‘knowledge is power and knowledge is confidence’ and if you have the knowledge then its not the end of the world. You can use it to your advantage and you can help to guide a client through that. We actually designed with our clients one of the first risk maps for opioids years ago, that was before REMS and then we designed one I think it was the first REMS for an opioid for a client and also worked on polidimide for one of the most comprehensive risk maps years ago.
Med Ad News: What have you noticed about the dynamic of the patient/doctor relationship in the pain from your research?
Jeff Kozloff: Patients are looking to physicians for projections of the pain treatment’s potential efficacy and long-term prognosis, but inherently this is sort of shorter term management disease. This isn’t an area that offers patients a cure and it really is an area where physicians and patients have to negotiate what’s better and what they’re willing to pay for in terms of side effects, potential abuse liability, or other risks.
Joe Gattuso: Unlike something like hypertension or diabetes or cholesterol, there’s no way to monitor pain really. The basic job of the patient is to try to take a subjective feeling and communicate it to the doctor in a way that the doctor can think about, act upon. A lot of it is our subjective experience of pain or in some cases our pain tolerance so right off the bat in terms of communication there’s a difficulty in basically just communicating what it’s feeling like to the patient. We will say rather than try and describe that it feels hot, shooting, sharp, talk about what effect is it having on their life for example. Giving information about sleep and ability to do things, whether they are jobs or leisure, is actually more valuable to the doctor. Patients don’t talk about those things quite as much as they do about just simple answers to just diagnostic questions, so a lot of times they’re just not sharing what actually might be the most important information. How’s it affecting their life?
Another big area is just the dynamic that the patients have probably self medicated and I’m talking about appropriate self medication like OTCs etc, multiple times and multiple combinations of things over time. They’ve also probably seen many doctors, so very often they’ve been on all kinds of medications, OTC and Rx. They’ve probably been on all kinds of combinations of those drugs and so just getting a good medical history on a pain patient is a very complicated process.
Med Ad News: What does the future of pain marketing/advertising look like?
Joe Gattuso: Take it from the outcomes level first before you even thinking about brand level. Really understand that for both the physician and the patient there’s actually some really significant obstacles to just good care. Attack it from that basis and the brand will find its appropriate use. A lot of it is helping [patients and physicians] have common language and common process to assess what the pain is, what kind of pain it is, what kind of medications would help them manage the pain through their life. Think of it form the point of view of quality of life rather than changing a number like high blood pressure or diabetes. Certainly try and mediate the concern about addiction and dependence.
Communications agencies really have an important role to play in all of this. If we’re being effective at closing some of these gaps in language and communication and if we’re addressing in educational forums and others, some of these issues we really are impacting the outcomes. The outcome is people who are in chronic pain to live a better quality of life. It’s sort of fundamental to what a doctor and healthcare is about, it’s either curing disease or making pain better.
Barry Schmader: Less marketing of a particular product for across-the-board pain and more specific targeted to a particular physician audience for a particular indication. We’ve got some products, and the global product like an Arcoxia, that has a lot of different conditions for chronic and acute and goes to a lot of different physicians. Where we’re going is there is a master sales aid, but it’s more modular so that they can target physicians a little more easily. The challenge then becomes how do you keep the sales force straight and on message in particular countries.
Frank Powers: The other thing you are going to see is a straightforward, much more adherent to the PI type of marketing. You’re going to see people a little more conservative than not in this particular class because of the potential abuse factor and the potential to be burned as we’ve seen with some of the larger pharma having to pull back when you look at Bexxtra and you look at Vioxx and what’s gone on. There’s distrust of our industry around pain and because of those two withdrawals. Just in the U.S. alone you’re looking at the physician community being distrusting of facts coming from pharma companies in this class of drugs.
Barry Schmader: We’ve had experience launching a product for neuropathic pain in Lidoderm, and I think that’s kind of the last unexplored area where physicians don’t quite understand it fully and how to treat it. So things like fibromyalgia, post-herpetic neuralgia, and even some neuropathic pain especially with diabetes, that’s also kind of the forefront of where pain management is going. Whether they be different delivery systems or traditional products used in a different way. There’s lots of great products for chronic and acute pain, but I think that’s a place where physicians are beginning to understand and treat.
Med Ad News: What are some global differences within the pain market?
Frank Powers: The European market is much more willing to treat with acetaminophen to treat pain than they would be to go to straight pharmaceutical Rx traditional products that we would in the U.S. Their marketing over there and the professional audience over there has a different mind set.
Barry Schmader: What we’ve been doing is patient brochures, patient communications, explaining a particular condition, information about how their condition, where the pain is coming from. More patient education about what their condition is and how to take a particular medication the doctors’ prescribe rather than the risk management program.
Frank Powers: Our current client is Merck in the pain area and they have a division dedicated to [risk management], so we don’t really need to go there. We need to focus on the professional communication, which is our core competency, and communication to the patient via the professional.
Med Ad News: How early do marketers have to look at this aspect?
Dan Bobear: Technically, if you look at the greater realm it can happen at the point of approval, several clients that we have its become an element of lifecycle management. Much later in the lifecycle if there’s a safety concern that has popped up once the drug has been entered into general use. It’s not infrequent that drugs enter into some risk mitigation program once they’ve launched, even if they’ve launched with out a REMS program out front.
